Full Press Release Details
Precigen Reports Full Year 2023 Financial Results
and Business Updates
GERMANTOWN, MD, March 19, 2024 -
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 full year 2023 financial results and business updates.
is poised to be a transformative year for Precigen, as we are on track to present pivotal Phase 2 data in the second quarter and
submit a BLA for PRGN-2012 in the second half, a milestone bolstered by the Breakthrough Therapy Designation and accelerated approval
pathway granted by the FDA," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are preparing our manufacturing
facility and commercial operations in anticipation of the launch of PRGN-2012 in 2025. We are also looking forward to exciting updates
from our UltraCAR-T programs, which offer a novel approach compared to traditional CAR-T therapies and have garnered significant interest
from potential partners due to the safety, preliminary efficacy, and manufacturing advantages."
multiple value inflection points anticipated in
2024, we remain steadfastly committed to a strategy of sound financial management," said Harry Thomasian Jr., CFO
of Precigen. "We are evaluating various financing opportunities to strengthen
our balance sheet as we prepare our lead asset PRGN-2012 for potential commercial launch in 2025."
Key Program Highlights
AdenoVerse Immunotherapies
UltraCAR-T Cell Therapies
Financial Highlights
Full Year 2023 Financial Results Compared to
and development expenses increased $1.4 million, or 3.1%, compared to year ended December 31, 2022. Salaries, benefits, and other personnel
costs increased $2.8 million due to an increase in the hiring of employees to support the growth in the Company's development activities,
and to a lesser extent, increases in salaries of our continuing employees. These increases were offset by less expenses incurred related
to preclinical research programs for the comparable period.
expenses decreased $7.6 million, or 15.8%, compared to the year ended December 31, 2022. This decrease was primarily driven by a
reduction in professional fees of $6.5 million, due to decreased legal fees associated with certain litigation matters, and $0.7 million
decreased insurance-related premiums.
decreased $20.7 million, or 76.9%, compared to the year ended December 31, 2022. Collaboration and licensing revenues decreased $14.6
million, or 99.5%, compared to the year ended December 31, 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 $5.9
million, or 48.8%, compared to the year ended December 31, 2022. This decrease is 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.
income, net, increased $8.5 million, compared to the year ended December 31, 2022. This was primarily due to $6.3 million in reduced interest
expense associated with the Convertible Notes as they were fully retired in the second quarter of 2023, and $3.1 million increased interest
income due to higher interest rates on investments. This increase was partially offset
million decrease in gain recorded on the early retirement of a portion of our Convertible Notes compared to the year ended December 31,
recorded a $10.4 million impairment charge in the fourth quarter of 2023 related to its Exemplar subsidiary as a result of the Company's
annual goodwill impairment test.
continuing operations was $95.9 million, or $(0.39) per basic and diluted share, compared to loss from continuing operations of $79.8
million, or $(0.40) per basic and diluted share, in year ended December 31, 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
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
non-viral plasmids would be selected from the library to build a personalized UltraCAR-T treatment. After initial treatment, this approach
has the potential to allow for redosing of UltraCAR-T targeting the same or new tumor-associated antigen(s) based on the treatment response
and the changes in antigen expression of the patient's tumor. Precigen believes that the combination of the advanced UltraVector DNA
construction platform and the ease of overnight manufacturing gives this library approach a proprietary advantage over traditional T-cell
The UltraPorator system is an exclusive device
and proprietary software solution for the scale-up of rapid and cost-effective manufacturing of UltraCAR-T therapies and potentially represents
a major advancement over current electroporation devices by significantly reducing the processing time and contamination risk. The UltraPorator
device is a high-throughput, semi-closed electroporation system for modifying T cells using Precigen's proprietary non-viral gene transfer
technology. UltraPorator is being utilized for clinical manufacturing of Precigen's investigational UltraCAR-T therapies in compliance
with current good manufacturing practices.
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
T-cell immune responses as well as an ability to boost these responses via repeat administration. Superior performance characteristics
and high yield manufacturing of AdenoVerse vectors leveraging UltraVector technology allows Precigen to engineer cutting-edge
investigational gene therapies to treat complex diseases.
AdenoVerse Immunotherapy Clinical
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 an
anti-PDL1/TGF-Beta Trap in patients with HPV-associated cancers (NCT04432597), a
Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell
carcinoma (OPSCC) (NCT05996523), a Phase 2 study of PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in patients
with recurrent or metastatic cervical cancer (NCT06157151), and a Phase 1/2 study of PRGN-2012 AdenoVerse immunotherapy in patients
with recurrent respiratory papillomatosis (RRP) (NCT04724980). PRGN-2012 has been granted Orphan Drug Designation and
Breakthrough Therapy Designation in patients with RRP by the FDA and Orphan Drug Designation by the European Commission.
Precigen, UltraCAR-T, UltraPorator, AdenoVerse,
UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks