Full Press Release Details
Precigen Reports Third Quarter 2023 Financial
Results and Progress of Clinical Programs
GERMANTOWN, MD, November 9, 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 third quarter 2023 financial results and progress
of clinical programs.
"Precigen has made tremendous progress in
reducing our operating costs and we are actively reprioritizing our programs to enable commercial readiness for our lead asset, PRGN-2012.
We anticipate completing the PRGN-2012 Phase 2 study in the second quarter of 2024 and, given the FDA's guidance in August 2023
that the ongoing Phase 1/2 study of PRGN-2012 will serve as the pivotal study to support an accelerated approval request, we are working
to expedite the submission of a BLA as quickly as possible," said Helen Sabzevari, PhD, President and CEO of Precigen. "We
have recently published exciting new data for both of the Company's core platforms, AdenoVerse and UltraCAR-T, including presentations
at the ESGCT 30th Annual Congress for PRGN-3007 UltraCAR-T and PRGN-2012 AdenoVerse immunotherapy, and publication of a manuscript in
Science Translational Medicine that includes full Phase 1 data from the PRGN-2012 clinical study. Each publication builds the body
of clinical evidence for the potential of our innovative therapeutic platforms in meeting unmet medical needs for patients."
PRGN-2012 AdenoVerse Immunotherapy in
Dose Level 2 with a favorable safety profile,
no dose-limiting toxicities and no treatment-related adverse events (TRAEs) greater than Grade 2.
PRGN 2009 AdenoVerse Immunotherapy in
HPV-associated Cancers
PRGN-3006 UltraCAR-T in AML
PRGN-3005 UltraCAR-T in Ovarian
PRGN-3007 UltraCAR-T in Advanced
ROR1+ Hematological and Solid Tumors
receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism
for the intrinsic blockade of PD-1 gene expression.
Financial Highlights
our portfolio reprioritization and other cost-saving measures announced last quarter, Precigen continues to manage the balance sheet to
enable rapid progression of our lead assets," said Harry Thomasian Jr., CFO of Precigen. "As we scale-up areas of our business
to prepare for commercialization, we are focused on fiscal management and exploring new non-dilutive capital opportunities, including
potential strategic partnerships, to maximize and extend our runway."
Third Quarter 2023 Financial Results Compared
to Prior Year Period
and development expenses decreased $1.0 million, or 8%, compared to the three months ended September 30, 2022. This decrease was primarily
due to continued reprioritization of clinical product candidates.
expenses decreased $0.9 million, or 9%, compared to the three months ended September 30, 2022. This decrease was primarily driven by a
reduction in professional fees of $0.6 million, due to decreased legal fees associated with certain litigation matters, and $0.3 million
in decreased insurance related expenses.
decreased $15.3 million, or 92%, compared to the three months ended September 30, 2022. Collaboration and licensing revenues decreased
$14.6 million, or 100%, compared to the three months ended September 30, 2022, primarily due to the prior year period non-cash recognition
of revenue related to historical collaboration agreements for which revenue was previously deferred. Product and service revenues decreased
$0.7 million, or 34%, compared to the three months ended September 30, 2022. This decrease is related to reductions in services performed
income, net, increased $2.1 million compared to the three months ended September 30, 2022. This is primarily due to $2.0 million in reduced
interest expense associated with the Company's Convertible Notes as they were fully retired in the second quarter of 2023, and $0.8
million increased interest income due to higher interest rates on investments. This increase was offset by a $0.9 million gain recorded
on the early retirement of a portion of the Convertible Notes in the third quarter of 2022 that did not occur in the third quarter of
continuing operations was $19.8 million, or $(0.08) per basic and diluted share, compared to loss from continuing operations of $7.6 million,
or $(0.04) per basic and diluted share, in the three months ended September 30, 2022.
First Nine months 2023 Financial Results Compared
to Prior Year Period
and development expenses decreased $0.8 million, or 2%, compared to the nine months ended September 30, 2022. This decrease was primarily
due to continued reprioritization of clinical product candidates.
expenses decreased $6.3 million, or 17%, compared to the nine months ended September 30, 2022. This decrease was primarily driven by a
reduction in professional fees of $4.8 million, due to decreased legal fees
with certain litigation matters, as well as a $1.2 million reduction in salaries, benefits, and other personnel costs due to reduced head
count, and $0.3 million in decreased insurance related expenses.
decreased $20.1 million, or 80%, from the nine months ended September 30, 2022. Collaboration and licensing revenues decreased $14.6 million
or 100% from the nine months ended September 2022, primarily due to the prior year period non-cash recognition of revenue related to historical
collaboration agreements for which revenue was previously deferred. Product and services revenues decreased $5.4 million, or 52%, from
the nine months ended September 30, 2022. This decrease primarily related to reductions in services performed at Exemplar as well as the
recognition of revenue in the first quarter of 2022 related to agreements for which revenue was previously deferred that did not occur
in 2023 of $1.0 million at Exemplar.
income, net, increased $7.3 million compared to the nine months ended September 30, 2022. This is primarily due to $5.7 million reduced
interest expense associated with the Convertible Notes as they were retired in the second quarter of 2023, and $2.1 million increased
interest income due to higher interest rates on the Company's investments. This increase was offset by $0.8 million reduction in
the gain recorded on the early retirement of a portion of the Convertible Notes in 2023 compared to 2022.
continuing operations was $62.8 million, or $(0.26) per basic and diluted share, compared to loss from continuing operations of $57.6
million, or $(0.29) per basic and diluted share, in the nine months ended September 30, 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
X @Precigen, LinkedIn or YouTube.
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 patient's 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
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+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL),
acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and triple negative breast cancer (TNBC) (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
Precigen's UltraCAR-T library approach is designed
to transform the personalized cell therapy landscape for cancer patients. Precigen's goal is to develop and validate a library of non-viral
plasmids to target tumor-associated antigens. Enabled by design and manufacturing advantages of UltraCAR-T, coupled with the capabilities
of the UltraPorator system, Precigen is working to empower medical centers to deliver personalized, autologous UltraCAR-T
treatment with overnight manufacturing to any cancer patient. Based on the patient's cancer indication and biomarker profile, one or more