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Precigen Reports Third Quarter 2022 Financial Results and Progress of Clinical Programs - Company will host virtual R&D event in early January 2023, timed to coincide with the 41 st Annual JP Morgan Healthcare Conference

Key Takeaway: Precigen Reports Third Quarter 2022 Financial Results and Progress of Clinical Programs Company will host virtual R&D event in early January 2023, timed to coincide with the 41st Annual JP Morgan Healthcare Conference, to showcase complete clinical trial data from Phase 1 dose

Full Press Release Details

Precigen Reports Third Quarter 2022 Financial
Results and Progress of Clinical Programs
Company will host virtual R&D event in early January 2023, timed to coincide with the 41st Annual JP
Morgan Healthcare Conference, to showcase complete clinical trial data from Phase 1 dose escalation and expansion
cohorts of PRGN-2012 AdenoVerse Immunotherapy in recurrent respiratory papillomatosis
to present two abstracts at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in December: PRGN-3006 UltraCAR-T
Phase 1 safety and efficacy data in acute myeloid leukemia (AML) and PRGN-3007 UltraCAR-T Phase 1/1b trial-in-progress in ROR1-positive
hematological and solid tumors -
$144.0 million of outstanding convertible notes due in July 2023 resulting in $5.4 million in savings via the discount realized and interest
cash equivalents, short-term investments and restricted cash totaled $153.8 million as of September 30, 2022 -
GERMANTOWN, MD, November 9, 2022 -
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 2022 financial results and progress
of clinical programs.
"Focusing and prioritizing our portfolio
has led to rapid progression of our clinical programs. We are exceptionally pleased with the pace and results we are seeing from our portfolio,
especially for the PRGN-2012 AdenoVerse Immunotherapy study in RRP, and are excited to showcase data at an investigator-led virtual R&D
event in January. We expect the data will make a compelling case for the potential of PRGN-2012 to address the underserved RRP patient
population and provide validation for the highly differentiated, first-in-class AdenoVerse therapeutic platform," said Helen Sabzevari,
PhD, President and CEO of Precigen. "We also have multiple data presentations at ASH in December, which will highlight continued
safety and efficacy of the UltraCAR-T platform."
continues to exercise financial prudence and we believe our cash runway is sufficient to advance our clinical priorities into Q4 2023,"
said Harry Thomasian Jr., CFO of Precigen. "Utilizing proceeds from the sale of Trans Ova, through today, we have been able to retire
$144.0 million of the outstanding convertible notes due in July 2023. Retiring this debt, combined with our efforts to streamline and
improve our operational efficiencies, further strengthens our financial position and significantly reduces our interest burden through
the term of the notes."
Key Program Highlights
The US Food and Drug Administration (FDA) has granted orphan
drug designation for PRGN-2012 for patients with RRP.
Enrollment was completed in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous
(IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm (clinical trial identifier: NCT03907527).
Patient follow up is ongoing and the Company expects Phase 1 data to be presented in the first half
Third Quarter and First Nine Months 2022 Financial
Third Quarter 2022 Financial Results Compared
to Prior Year Period
Total revenues increased $13.4 million, or greater
than 200%, from the quarter ended September 30, 2021. Collaboration and licensing revenues increased $14.5 million compared to the three
months ended September 30, 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 $1.1 million from the quarter ended September 30, 2021. Gross margin on products and services declined as a result
of the decreased revenues, and increased costs for supplies, drugs, and personnel costs.
Research and development expenses increased $0.2
million, or 2%, from the three months ended September 30, 2021. Contract research organization costs and lab supplies decreased $0.8 million
due to timing differences, the completion of our 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 to preclinical research programs for the comparable period.
This decrease was partially offset with an increase in salaries, benefits, and other personnel costs of $1.0 million primarily due to
an increase in the hiring of employees to support the growth of our operations.
SG&A expenses decreased $0.8 million, or 8%,
from the three months ended September 30, 2021. Salaries, benefits, and other personnel costs decreased $0.1 million primarily due to
reduced head count. Professional fees decreased $0.6 million, primarily due to decreased legal and consulting fees associated with certain
Loss from continuing operations was $7.6 million,
or $(0.04) per basic and diluted share, compared to loss from continuing operations of $26.3 million, or $(0.13) per basic and diluted
First Nine months 2022 Financial Results Compared
to Prior Year Period
Total revenues increased $14.6 million, or 138%,
from nine months ended September 30, 2021. Collaboration and licensing revenues increased $14.2 million from the nine months ended September
30, 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 increased $0.6
million from the nine months ended September 30, 2021, with that increase occurring earlier in 2022. Gross margin on product and services
remained comparable to the prior year as increased revenues were offset by increased costs for supplies, drugs, and personnel costs.
Research and development expenses increased $0.6
million, or 2%, from the nine months ended September 30, 2021. Salaries, benefits, and other personnel costs increased $2.2 million due
to an increase in the hiring of employees to support the growth in the Company's development activities. This increase was partially offset
with a decrease in contract research organization costs and lab supplies of $1.6 million, primarily due to timing differences, the completion
of our 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 $3.7 million, or 9%,
from the nine months ended September 30, 2021. Salaries, benefits, and other personnel costs decreased $3.6 million primarily due to $2.6
million reduced stock compensation in 2022 and reduced head count.
Loss from continuing operations was $57.6 million,
or $(0.29) per basic and diluted share, compared to loss from continuing operations of $84.1 million, or $(0.43) 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.
Precigen, UltraCAR-T, UltraPorator, AdenoVerse
and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their
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, 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.
Investor Contact: Steven M. Harasym Vice President, Investor Relations Tel: +1 (301) 556-9850 investors@precigen.com
Media Contacts: Donelle M. Gregory press@precigen.com Glenn Silver Lazar-FINN Partners glenn.silver@finnpartners.com
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
(Amounts in thousands) September 30, 2022 December 31, 2021
Assets
Current assets
Cash and cash equivalents $ 9,067 $ 36,423
Restricted Cash 82,443 -
Short-term investments 62,260 72,240
Receivables
Trade, net 1,175 1,341
Related parties, net 19 73
Other 1,260 566
Inventory 219 326
Prepaid expenses and other 6,363 5,471
Current assets held for sale - 40,188
Total current assets 162,806 156,628
Long-term investments - 48,562
Property, plant and equipment, net 7,611 8,599
Intangible assets, net 42,416 52,291
Goodwill 36,713 37,554
Right-of-use assets 8,828 9,990
Other assets 871 936
Noncurrent assets held for sale - 45,296
Total assets $ 259,245 $ 359,856
Liabilities and Shareholders' Equity
Current liabilities
Accounts payable $ 4,201 $ 3,112
Accrued compensation and benefits 5,792 7,856
Other accrued liabilities 11,685 7,817
Deferred revenue 76 1,490
Current portion of long-term debt 82,069 52
Current portion of lease liabilities 1,041 1,393
Related party payables - 74
Current liabilities held for sale - 12,851
Total current liabilities 104,864 34,645
Long-term debt, net of current portion - 179,882
Deferred revenue, net of current portion 1,818 23,023
Lease liabilities, net of current portion 7,939 8,747
Deferred tax liabilities 2,092 2,539
Long-term liabilities held for sale - 3,672
Total liabilities 116,713 252,508
Commitments and contingencies (Note 16)
Shareholders' equity
Common stock - -
Additional paid-in capital 1,996,104 2,022,701
Accumulated deficit (1,846,391) (1,915,556)
Accumulated other comprehensive (loss) income (7,181) 203
Total shareholders' equity 142,532 107,348
Total liabilities and shareholders' equity $ 259,245 $ 359,856
Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations (Unaudited)
Last updated: Nov 9, 2022