– Fast Track designation received for
PRGN-3006 UltraCAR-T®, an important
milestone for patients with relapsed or refractory acute myeloid
leukemia, a rapidly progressing disease with limited treatment
options –
– Phase 1b expansion arm initiated for PRGN-3006
UltraCAR-T® at Dose Level 3
with lymphodepletion –
– Dosing initiated in patients at
Dose Level 3 via intravenous infusion with lymphodepletion in the
PRGN-3005 UltraCAR-T® Phase 1
study –
– Phase 2 study initiated for
PRGN-2012 AdenoVerse™ Immunotherapy as an
adjuvant treatment in patients with recurrent respiratory
papillomatosis –
– Cash, cash equivalents, short-term
and long-term investments totaled $142.1
million as of March 31,
2022 –
– Company to host a pipeline update
call in the coming months –
GERMANTOWN, Md., May 9, 2022
/PRNewswire/ -- 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 2022 financial results and business updates.
"Precigen's portfolio has been prioritized based on the positive
preliminary data we have seen for key programs and we are exploring
potential rapid paths to licensure with the FDA for programs with
compelling data in diseases that have a high unmet medical need.
The FDA Fast Track designation recently received for PRGN-3006
UltraCAR-T will help facilitate development and expedite the review
process and is an important milestone for patients with relapsed or
refractory acute myeloid leukemia," said Helen Sabzevari, PhD, President and CEO of
Precigen. "As a result of these advancements, we look forward to
hosting a call to provide pipeline updates in the coming
months."
"We remain focused on enhancing our financial position,
expanding our financial flexibility, and extending our cash runway
to help Precigen achieve our near-term objectives," said
Harry Thomasian Jr., CFO of
Precigen. "As the year progresses, we intend to expound on these
initiatives."
Key Business Highlights
- PRGN-3006 UltraCAR-T® in Acute Myeloid Leukemia
(AML)
-
- In April 2022, Precigen announced
that the US Food and Drug Administration (FDA) granted Fast Track
designation for PRGN-3006 UltraCAR-T in patients with relapsed
or refractory (r/r) AML. Fast Track designation facilitates
development and expedites the review process for drugs that address
serious conditions and high unmet medical needs, such as r/r
AML.
- Enrollment and dosing were completed in the dose escalation
phase of the Phase 1 PRGN-3006 UltraCAR-T clinical trial for both
the lymphodepletion and non-lymphodepletion cohorts.
- The Phase 1b expansion arm was
initiated and the first patient was dosed at Dose Level 3 with
lymphodepletion. The Company plans to incorporate repeat dosing in
2022.
- PRGN-3005 UltraCAR-T® in Ovarian Cancer
-
- Enrollment and dosing was completed in the dose escalation
phase of both the intraperitoneal (IP) and intravenous (IV) arms of
the Phase 1 clinical trial.
- Dosing was initiated in patients at Dose Level 3 with
lymphodepletion prior to IV administration of PRGN-3005
UltraCAR-T.
- The Company plans to initiate a Phase 1b expansion arm and incorporate repeat dosing in
2022.
- Next Generation UltraCAR-T® Platform
-
- An abstract titled, Incorporation of intrinsic checkpoint
blockade enhances functionality of multigenic autologous
UltraCAR-T® cells manufactured using non-viral gene delivery and
rapid manufacturing process, was presented as a poster
presentation at the American Association for Cancer Research (AACR)
Annual Meeting 2022. The poster highlighted preclinical data
showcasing the advancement of the UltraCAR-T platform to
simultaneously express CAR, membrane bound IL-15 (mbIL15), a kill
switch, and address the inhibitory tumor microenvironment by
incorporating a novel mechanism for intrinsic downregulation of one
or more checkpoint inhibitor genes.
- PRGN-2012
AdenoVerse™ Immunotherapy in
Recurrent Respiratory Papillomatosis (RRP)
-
- Enrollment was completed in the dose escalation and expansion
cohorts of the Phase 1 study.
- The first patient was dosed in the Phase 2 study of PRGN-2012
in adult patients with RRP (clinical trial identifier:
NCT04724980).
- The Company plans to seek FDA guidance on a rapid regulatory
strategy for licensure given the high unmet medical need for this
patient population.
- PRGN 2009
AdenoVerse™ Immunotherapy in Human
Papillomavirus (HPV)-associated Cancers
-
- Enrollment in the Phase 1 monotherapy arm was completed in
patients with recurrent or metastatic HPV-associated cancers
(clinical trial identifier: NCT04432597).
- Enrollment is ongoing in the Phase 1 combination arm in
patients with recurrent or metastatic HPV-associated cancers. The
Company expects to complete enrollment in the Phase 1 combination
arm in the second quarter of 2022.
- Enrollment is ongoing in the Phase 2 monotherapy arm in newly
diagnosed oropharyngeal squamous cell carcinoma (OPSCC)
patients.
First Quarter 2022 Financial Highlights
- Net cash used in operating activities of $18.7 million in 2022 compared to $16.4 million in 2021. This increase was
primarily due to the acceleration of the Company's pipeline
programs;
- Cash, cash equivalents, short-term and long-term investments
totaled $142.1 million as of
March 31, 2022; and
- Total revenues of $32.0 million
in 2022 compared to $24.5 million in
2021.
First Quarter 2022 Financial Results Compared to Prior Year
Period
Total revenues increased $7.5
million, or 31%, from the quarter ended March 31, 2021. Product and service revenues
generated by Trans Ova and Exemplar increased $7.6 million primarily due to higher customer
demand for animals and services as a result of stronger beef and
dairy industries in the current year as well as an increase in
services performed at Exemplar, offset by a $0.1 million reduction in collaboration and
license revenue from the quarter ended March
31, 2021.
Gross margin on products and services improved as a result of
the increased revenues, a change in pricing structure for certain
customers, and operational efficiencies that have been gained
through improved inventory management offset by increased costs for
supplies, drugs, and personnel costs.
Research and development expenses increased $2.2 million, or 21%, from the quarter ended
March 31, 2021. Contract research
organization costs and lab supplies increased $1.6 million with the advancement of the
Company's clinical and preclinical programs.
Selling, general and administrative (SG&A) expenses
increased $0.9 million, or 5%, over
the three months ended March 31,
2021. Professional fees increased $1.6 million, primarily due to increased legal
fees associated with certain litigation matters. This increase was
partially offset with a decrease in salaries, benefits, and other
personnel costs of $1.3 million
primarily due to reduced stock compensation in 2022 and reduced
head count.
Loss from continuing operations was $19.3
million, or $(0.10) per basic
share, compared to loss from continuing operations of $21.8 million, or $(0.11) per basic share, in 2021.
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
commercialization. For more information about Precigen, visit
www.precigen.com or follow us on Twitter @Precigen,
LinkedIn or YouTube.
Trademarks
Precigen, UltraCAR-T, AdenoVerse 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
Statements
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 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
(Unaudited)
|
|
(Amounts in thousands)
|
|
March 31, 2022
|
|
|
December 31, 2021
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
40,321
|
|
|
$
|
42,920
|
Short-term investments
|
|
|
71,821
|
|
|
|
72,240
|
Receivables
|
|
|
|
|
|
|
|
Trade, net
|
|
|
24,308
|
|
|
|
20,832
|
Related parties, net
|
|
|
15
|
|
|
|
73
|
Other
|
|
|
543
|
|
|
|
566
|
Inventory
|
|
|
12,730
|
|
|
|
13,261
|
Prepaid expenses and other
|
|
|
5,199
|
|
|
|
6,736
|
Total current assets
|
|
|
154,937
|
|
|
|
156,628
|
Long-term
investments
|
|
|
29,914
|
|
|
|
48,562
|
Property, plant and
equipment, net
|
|
|
33,583
|
|
|
|
34,315
|
Intangible assets,
net
|
|
|
51,427
|
|
|
|
54,115
|
Goodwill
|
|
|
53,613
|
|
|
|
54,148
|
Right-of-use
assets
|
|
|
10,963
|
|
|
|
10,900
|
Other assets
|
|
|
1,131
|
|
|
|
1,188
|
Total assets
|
|
$
|
335,568
|
|
|
$
|
359,856
|
|
|
|
|
Liabilities and Shareholders'
Equity
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,415
|
|
|
$
|
5,405
|
Accrued compensation and benefits
|
|
|
6,052
|
|
|
|
11,223
|
Other accrued liabilities
|
|
|
10,494
|
|
|
|
11,595
|
Deferred revenue
|
|
|
2,669
|
|
|
|
4,442
|
Current portion of long-term debt
|
|
|
355
|
|
|
|
402
|
Current portion of lease liabilities
|
|
|
1,590
|
|
|
|
1,551
|
Related party payables
|
|
|
26
|
|
|
|
27
|
Total current
liabilities
|
|
|
25,601
|
|
|
|
34,645
|
Long-term debt, net of
current portion
|
|
|
201,112
|
|
|
|
182,749
|
Deferred revenue, net
of current portion
|
|
|
23,023
|
|
|
|
23,023
|
Lease liabilities, net
of current portion
|
|
|
9,508
|
|
|
|
9,502
|
Deferred tax
liabilities
|
|
|
2,438
|
|
|
|
2,539
|
Other long-term
liabilities
|
|
|
50
|
|
|
|
50
|
Total liabilities
|
|
|
261,732
|
|
|
|
252,508
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
|
|
|
Common stock
|
|
|
—
|
|
|
|
—
|
Additional paid-in capital
|
|
|
1,991,670
|
|
|
|
2,022,701
|
Accumulated deficit
|
|
|
(1,916,135)
|
|
|
|
(1,915,556)
|
Accumulated other comprehensive (loss) income
|
|
|
(1,699)
|
|
|
|
203
|
Total shareholders'
equity
|
|
|
73,836
|
|
|
|
107,348
|
Total liabilities and
shareholders' equity
|
|
$
|
335,568
|
|
|
$
|
359,856
|
Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
|
|
(Amounts in thousands, except share
and per share data)
|
|
|
Three months
ended
|
|
|
March
31,
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
Collaboration and
licensing revenues
|
|
$
|
—
|
|
$
|
66
|
|
|
Product
revenues
|
|
|
8,724
|
|
|
6,381
|
|
|
Service
revenues
|
|
|
23,209
|
|
|
17,931
|
|
|
Other
revenues
|
|
|
88
|
|
|
133
|
|
|
Total revenues
|
|
|
32,021
|
|
|
24,511
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses
|
|
|
|
|
|
|
|
|
Cost of
products
|
|
|
7,510
|
|
|
5,574
|
|
|
Cost of
services
|
|
|
9,589
|
|
|
7,402
|
|
|
Research and
development
|
|
|
12,760
|
|
|
10,521
|
|
|
Selling, general and
administrative
|
|
|
19,576
|
|
|
18,702
|
|
|
Impairment of
goodwill
|
|
|
482
|
|
|
—
|
|
|
Total operating expenses
|
|
|
49,917
|
|
|
42,199
|
|
|
Operating loss
|
|
|
(17,896)
|
|
|
(17,688)
|
|
|
|
|
|
|
|
|
|
|
|
Other Expense, Net
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(2,069)
|
|
|
(4,539)
|
|
|
Interest
income
|
|
|
434
|
|
|
392
|
|
|
Other income (expense),
net
|
|
|
223
|
|
|
(58)
|
|
|
Total other expense, net
|
|
|
(1,412)
|
|
|
(4,205)
|
|
|
Equity in net loss of
affiliates
|
|
|
(1)
|
|
|
(3)
|
|
|
Loss from continuing operations
before income taxes
|
|
|
(19,309)
|
|
|
(21,896)
|
|
|
Income tax
benefit
|
|
|
58
|
|
|
52
|
|
|
Loss from continuing operations
|
|
$
|
(19,251)
|
|
$
|
(21,844)
|
|
|
Income (loss) from
discontinued
operations, net of income taxes
|
|
|
—
|
|
|
4,526
|
|
|
Net loss
|
|
$
|
(19,251)
|
|
$
|
(17,318)
|
|
|
Net Loss per Share
|
|
|
|
|
|
|
|
|
Net loss from
continuing
operations per share, basic and
diluted
|
|
$
|
(0.10)
|
|
$
|
(0.11)
|
|
|
Net income (loss) from
discontinued
operations per share, basic and
diluted
|
|
|
—
|
|
|
0.02
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.10)
|
|
$
|
(0.09)
|
|
|
Weighted average shares
outstanding,
basic and diluted
|
|
|
199,629,218
|
|
|
193,499,546
|
|
|
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SOURCE Precigen, Inc.