Full Press Release Details
Precigen Reports Third Quarter 2024 Financial
Results and Business Updates
pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission
for PRGN-2012 in RRP under accelerated approval pathway -
and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch -
clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from FDA to initiate prior to submission of
the BLA; continuing enrollment -
for end of Phase 1b meeting with FDA in early 2025 for PRGN-3006 in AML -
preclinical data at SITC 2024 for PRGN-3008, a next generation UltraCAR-T targeting CD19 showcasing potential to be best-in-class CD19-targeting
CAR-T treatment in oncology and autoimmunity-
GERMANTOWN, MD, November 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 third quarter 2024 financial results and business updates.
"The strategic reprioritization of our portfolio
announced last quarter has enabled us to focus our team and allocate resources to advance PRGN-2012 as rapidly as possible. We are excited
about our imminent submission of a BLA for PRGN-2012 in RRP as we have finalized our pre-BLA meetings and are aligned with the FDA on
the content for all modules and plan for submission in the fourth quarter. Our commercial and manufacturing readiness campaigns for PRGN-2012
are well underway to support a potential 2025 launch," said Helen Sabzevari, PhD, President and CEO of Precigen. "Although
our primary focus is on PRGN-2012, we continue to demonstrate the many advantages of the UltraCAR-T platform over conventional CAR-Ts.
Our recent data presentation at SITC for our next generation UltraCAR-T targeting CD19 reinforces the potential to be the best-in-class
CD19-targeting medicine in oncology and autoimmune diseases, such as lupus nephritis. We are excited about the potential of this platform
and the strategic partnership discussions that currently are underway."
"Following our reprioritization and public
equity offering announced in August, we remain focused on fiscal management while appropriately investing in activities necessary for
the potential launch of PRGN-2012. We are making good progress on a number of potential financing options, including strategic partnerships
and other transactions. We will update our investors on this progress in the coming months," said Harry Thomasian Jr., CFO of Precigen.
Key Program Highlights
PRGN-2012 AdenoVerse Gene Therapy in RRP
PRGN-2009 AdenoVerse Gene Therapy in HPV-associated
PRGN-3006 UltraCAR-T in AML
PRGN-3008 UltraCAR-T Targeting CD19 in Oncology and
Financial Highlights
Quarter 2024 Financial Results Compared to Prior Year Period
SG&A expenses increased by $0.6 million, or
7%, compared to the three months ended September 30, 2023. As a result of the Company's increased focus on PRGN-2012, commercial
readiness costs increased in the current quarter versus the prior year period. In addition, the third quarter of 2024 included severance
costs incurred related to the Precigen workforce reduction. These increases were partially offset by a reduction in insurance expenses
due to decreasing rates and professional fees incurred related to general corporate matters compared to the same period in 2023.
Research and development expenses decreased by
$0.2 million, or 2%, compared to the three months ended September 30, 2023. The decrease was primarily the result of the Company's
portfolio reprioritization, which included a $2.0 million decrease in costs associated with ActoBio resulting from the shutdown of operations
during the second quarter of 2024 as well as lower costs of $0.7 million incurred at contract research organizations for other programs
compared to the same period in 2023. These decreases were offset by increased costs of approximately $2.5 million associated with PRGN-2012
in advance of the Company's planned BLA submission and the Company's ongoing confirmatory trial, as well as severance costs
incurred related to the Precigen workforce reduction in the third quarter of 2024.
Other income (expense), net, decreased by $3.8
million compared to the three months ended September 30, 2023. This decrease was primarily due to the reclassification of cumulative translation
losses of $2.9 million as a result of the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction
in interest income compared to the same period in 2023.
Total revenues decreased $0.4 million, or 31%,
compared to the three months ended September 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.
Net loss was $24.0 million, or $(0.09) per basic
and diluted share, compared to net loss of $19.8 million, or $(0.08) per basic and diluted share, in the three months ended September
Nine months 2024 Financial Results Compared to Prior Year Period
expenses increased by $0.1 million, or 1%, compared to the nine months ended September 30, 2023. As a result of the Company's increased
focus on PRGN-2012, commercial readiness costs increased versus the prior year period. In addition, the second and third quarter of 2024
included higher severance costs associated with the suspension of ActoBio's operations and the 2024 Precigen workforce reduction. These
increases were partially offset by a decrease in stock compensation and insurance expenses due to decreasing rates in 2024 compared to
the same period in 2023.
and development expenses increased $5.7 million, or 16%, compared to the nine months ended September 30, 2023, primarily as a result of
the Company's increased focus on PRGN-2012. There were $4.4 million of increased costs associated with PRGN-2012 in advance of the
Company's planned BLA submission, including the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012
pivotal clinical trial activities and professional fees incurred related to the Company's manufacturing facility. Additionally,
personnel costs increased by $3.0 million due to an increase in the hiring of employees related to the advancement of PRGN-2012 in the
third and fourth quarters of 2023 and severance charges incurred related to the Precigen workforce reduction in the third quarter of 2024.
These increases were offset by lower costs incurred at contract research organizations for other programs compared to the prior year period
as well as a reduction in total ActoBio operating expenses compared to the nine months ended September 30, 2023.
(expense), net, decreased $4.3 million, or 166%, compared to the nine months ended September 30, 2023. This decrease was primarily due
to the reclassification of cumulative translation losses of $2.9 million resulting from the final closing of the ActoBio facilities in
the third quarter of 2024, as well as a reduction in net interest income compared to the same period in 2023.
with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived
assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.
decreased $2.3 million, or 45%, compared to the nine months ended September 30, 2023. This decrease was related to reductions in product
and service revenues at Exemplar.
was $106.5 million, or $(0.41) per basic and diluted share, compared to net loss of $62.8 million, or $(0.26) per basic and diluted share,
in the nine months ended September 30, 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, UltraCAR-T, UltraPorator, AdenoVerse,
UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks
of their respective owners.
Cautionary Statement Regarding Forward-Looking
Some of the statements made in this press release
are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about
future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the
timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio
of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected
in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and
actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company
has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements
are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties,
and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking
statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent
reports filed with the Securities and Exchange Commission.
Vice President, Investor Relations
Tel: +1 (301) 556-9850