Full Press Release Details
Precigen Reports Second Quarter and First Half
2023 Financial Results and Provides Update on Portfolio Prioritization and Capital Allocation Strategies to Extend Projected Cash Runway
GERMANTOWN, MD, August 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 second quarter and first half 2023 financial results
and business updates.
"Today we announced that the FDA confirmed
the ongoing Phase 1/2 study of PRGN-2012 will serve as the pivotal study to support accelerated approval, an important milestone that
brings Precigen a step closer in our transition to a commercial stage company and in realizing our vision of bringing life-changing therapies
to patients with unmet medical need. We look forward to working with the FDA to submit a BLA and potentially bringing the first drug therapy
for RRP patients. As a result of this exciting milestone, we are prioritizing our portfolio activities to maximize the potential success
of PRGN-2012 while continuing to strategically advance other key programs," said Helen Sabzevari, PhD, President and CEO of Precigen.
"We have built a strong portfolio based on the AdenoVerse and UltraCAR-T platforms and continue to advance important programs with
a focus on agility, efficiency and commercial viability."
a result of our capital raise in January, our portfolio prioritization and other cost-saving measures, including completely retiring our
convertible notes, the Company's balance sheet is well positioned for the future,"
said Harry Thomasian Jr., CFO of Precigen. "These measures have enabled us to extend our projected cash runway into 2025, exclusive
of non-dilutive strategies, including strategic partnerships, which could extend our cash runway further."
PRGN-2012 AdenoVerse
Immunotherapy in RRP
positive Phase 1 clinical data that
showed that 50% of adult RRP patients (who had 3 surgeries to treat the disease in the year prior treatment) were "surgery-free"
(Complete Response) after PRGN-2012 treatment during the 12 month follow-up. All complete responders continue to be surgery-free with
a minimum follow-up of 18 months post-treatment.
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
Financial Highlights
Second Quarter 2023 Financial Results Compared
to Prior Year Period
and development expenses decreased $0.1 million, or 0.7%, compared to the three months ended June 30, 2022. This decrease was primarily
driven by reduced spending on preclinical research programs.
expenses decreased $3.4 million, or 27%, compared to the three months ended June 30, 2022. This decrease was primarily driven by a reduction
in professional fees of $2.2 million, due to decreased legal fees associated with certain litigation matters, as well as a $1.1 million
reduction in salaries, benefits, and other personnel costs due to reduced head count.
decreased $1.1 million, or 39%, compared to the three months ended June 30, 2022. This decrease was related to reductions in services
performed at Exemplar.
income, net, increased $2.7 million compared to the three months ended June 30, 2023. This was primarily due to reduced interest expense
associated with the Company's convertible notes as they were retired in the second quarter of 2023, and increased interest income
due to higher interest rates on investments.
continuing operations was $20.3 million, or $(0.08) per basic and diluted share, compared to loss from continuing operations of $26.1
million, or $(0.13) per basic and diluted share, in Q2 2022.
First Half 2023 Financial Results Compared to
and development expenses increased $0.3 million, or 1.2%, compared to the six months ended June 30, 2022. This increase was primarily
driven by a continued prioritization of clinical product candidates, offset by reduced spending on preclinical research programs.
expenses decreased $5.4 million, or 21%, compared to the six months ended June 30, 2022. This decrease was primarily driven by a reduction
in professional fees of $4.2 million, due to decreased legal fees associated with certain litigation matters, as well as a $1.1 million
reduction in salaries, benefits, and other personnel costs due to reduced head count.
decreased $4.8 million, or 57.1%, compared to the six months ended June 30, 2022. This decrease was 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 $5.2 million compared to the six months ended June 30, 2022. This was primarily due to reduced interest expense
associated with the Company's convertible notes as they were retired in the second quarter of 2023, and increased interest income
due to higher interest rates on investments.
continuing operations was $43.1 million, or $(0.18) per basic and diluted share, compared to loss from continuing operations of $50.0
million, or $(0.25) per basic and diluted share, in the six months ended June 30, 2022. The 2023 second quarter loss was lower than the
2023 first quarter loss primarily due to continued reductions in SG&A expenses.
Medicine with Precision
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 commercialization. For more information about Precigen, visit www.precigen.com
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.
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).
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 cancer 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 therapies.
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