Full Press Release Details
Precigen Reports Fourth Quarter and Full Year
2022 Financial Results and Business Updates
GERMANTOWN, MD, March 6, 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 fourth quarter and full year 2022 financial results.
"2022 was a successful year with respect
to clinical advancements for Precigen's UltraCAR-T and AdenoVerse programs. We showcased highly encouraging safety and efficacy
results from Phase 1 dose escalation of PRGN-3006 UltraCAR-T in AML at ASH and Phase 1 dose escalation and expansion cohort data of our
PRGN-2012 AdenoVerse immunotherapy in RRP at our Company's R&D Day," said Helen Sabzevari, PhD, President and CEO of Precigen.
"These data set us up for a strong 2023 as we continue our focus on rapidly advancing clinical programs and pursuing the most promising
regulatory paths to licensure."
"Through the actions that we have taken over
the past year, we have significantly strengthened our financial position. These actions included the divesture of Trans Ova Genetics,
from which the non-dilutive proceeds were used to early retire over 85% of our outstanding $200 million of convertible notes due in July,
and our public offering of common stock in January 2023. We also continue to focus on cost containment," said Harry Thomasian Jr.,
CFO of Precigen. "Based on present expectations, these actions provide a healthy cash runway to advance our clinical priorities
Key Program Highlights
Financial Highlights
Fourth Quarter 2022 Financial Results Compared
to Prior Year Period
decreased $1.9 million, or 52%, from the three months ended December 31, 2021. Product and service revenues generated by Exemplar decreased
$1.8 million from the three months ended December 31, 2021. Gross margin on product and services decreased comparable to the prior year
due to the reduction in revenues and increased costs for supplies, drugs, and personnel at Exemplar.
and development expenses decreased $1.4 million, or 11%, from the three months ended December 31, 2021. This decrease was primarily driven
by a reduction in contract research organization costs of $0.9 million, primarily due to timing differences, the completion of the 1b/2a
clinical trial of AG019 in the fourth quarter of the prior year, as well as a continued prioritization of clinical product candidates,
with less expense incurred related preclinical research programs for the comparable period.
expenses decreased $0.3 million, or 2%, from the three months ended December 31, 2021. Salaries, benefits, and other personnel costs decreased
$1.4 million primarily due to reduced headcount as the Company scaled down corporate functions to support the more streamlined organization,
offset by other costs which were primarily due to timing and not individually significant.
continuing operations was $22.2 million, or $(0.11) per basic and diluted share, compared to loss from continuing operations of $26.7
million, or $(0.13) per basic and diluted share, in 2021.
Full Year 2022 Financial Results Compared to
Total revenues increased $12.6 million, or 89%,
from the twelve months ended December 31, 2021. Collaboration and licensing revenues increased $14.2 million from the twelve months ended
December 31, 2021, primarily due to the recognition of revenue related to agreements for which revenue was previously deferred, as it
became probable that additional performance under the agreements would not be required. Product and service revenues generated by Exemplar
decreased $1.3 million from the twelve months ended December 30, 2021. Gross margin on product and services decreased comparable to the
prior year due to the reduction in revenues and increased costs for supplies, drugs, and personnel costs.
Research and development expenses decreased $0.8
million, or 2%, over the twelve months ended December 31, 2021. Salaries, benefits, and other personnel costs increased $1.8 million due
to an increase in the hiring of employees to support the growth in the Company's development activities as well as general salary increases.
This increase was partially offset by a decrease in contract research organization costs and lab supplies of $2.4 million, primarily due
to timing differences, the completion of the 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, as well as a continued
prioritization of clinical product candidates, with less expense incurred related preclinical research programs for the comparable period.
SG&A expenses decreased $4.0 million, or 8%,
from the twelve months ended December 31, 2021. Salaries, benefits, and other personnel costs decreased $4.9 million primarily due to
(i) a reduced headcount as the Company scaled down corporate functions to support the more streamlined organization and (ii) reduced stock
compensation costs. This increase was partially offset by an increase of $0.9 million in legal and professional fees, primarily related
to ongoing litigation.
Loss from continuing operations was $79.8 million,
or $(0.40) per basic and diluted share, compared to loss from continuing operations of $110.8 million, or $(0.56) per basic and diluted
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
Twitter @Precigen, LinkedIn or YouTube.
About 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
neutralizing antibodies and effector T cell immune responses as well as an ability to boost these antibody and T cell responses via repeat
administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors combined with UltraVector
technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases.
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.
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 and its cash runway. 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, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic,
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
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets