Full Press Release Details
Precigen Reports First Quarter 2024 Financial
Results and Business Updates
Phase 2 study data of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis to be presented at the 2024 ASCO
Annual Meeting as a late-breaking oral presentation on June 3rd -
to host a conference call on June 3rd following the PRGN-2012 ASCO presentation to discuss in detail the pivotal study results
and provide business updates -
rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; commercial readiness activities
underway for a potential launch in 2025 -
trial-in-progress presentations for PRGN-2009 in combination with pembrolizumab for the treatment of recurrent/metastatic cervical cancer
and oropharyngeal cancer to be presented at ASCO -
and the Recurrent Respiratory Papillomatosis Foundation to co-sponsor the inaugural RRP Awareness Day on June 11th to raise
awareness and bring together individuals living with RRP, caregivers, clinicians, and government officials -
- Cash, cash equivalents,
and short-term investments totaled $44.8 million as of March 31, 2024 -
GERMANTOWN, MD, May 14, 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 first quarter 2024 financial results and business updates.
are excited to share the pivotal Phase 2 data for our PRGN-2012 study in patients with RRP at ASCO and look forward to providing
additional details regarding the results at our planned conference call following the presentation. We remain on track for a PRGN-2012
rolling BLA submission in the second half of 2024 and we are actively moving ahead with our commercial readiness efforts in anticipation
of a potential launch of PRGN-2012 in 2025," said Helen Sabzevari, PhD, President and CEO of Precigen. "Based on the competitive
advantages of PRGN-2012, including a favorable route of administration, safety profile and the efficacy demonstrated in the clinical trial
results so far, we believe, PRGN-2012 has the potential to be the first-in-class and best-in-class treatment for RRP patients. We anticipate
PRGN-2012 to overwhelmingly be the treatment of choice for RRP patients, if approved, as indicated by our commissioned research of healthcare
providers and key opinion leaders which found PRGN-2012's competitive advantages highly compelling."
multiple milestones anticipated in
2024 and 2025, 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
Financial Highlights
Quarter 2024 Financial Results Compared to Prior Year Period
and development expenses increased $2.1 million, or 17%, compared to the three months ended March 31, 2023. Salaries, benefits, and other
personnel costs increased $1.5 million due to an increase in the hiring of employees throughout 2023 to support the growth in the Company's
clinical development activities as well as increased fees paid to consultants and contract research organizations in the first quarter
of 2024 compared to the same period in 2023.
expenses decreased $1.5 million, or 13%, compared to the three months ended March 31, 2023, primarily driven by a reduction in stock compensation
and insurance expenses in the first quarter of 2024 compared to same period in 2023. In addition, the costs associated with PRGN-2012
commercial readiness increased compared to the same period in 2023.
decreased $0.8 million, or 43%, compared to the three months ended March 31, 2023. This decrease was due to the reduction in products
and services performed at Exemplar. Gross margin on product and services also declined in the current period primarily as a result of
the decreased revenues at Exemplar.
was $23.7 million, or $(0.10) per basic and diluted share, compared to net loss of $22.7 million, or $(0.10) per basic and diluted share,
in period ended March 31, 2023.
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
Precigen's AdenoVerse 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 gene therapies 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 Clinical Programs
Precigen's AdenoVerse platform is currently
under clinical investigation in a Phase 1/2 study of PRGN-2009 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
in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer (NCT06157151), and a Phase 1/2 study of PRGN-2012
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.
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 Programs
Precigen's UltraCAR-T platform is currently
under clinical investigation for hematological and solid tumors, including a Phase 1/1b study of PRGN-3005 in patients with advanced,
recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (NCT03907527), a Phase 1/1b study of PRGN-3006 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 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 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.
Precigen, UltraCAR-T, UltraPorator, AdenoVerse,