GERMANTOWN, Md., Aug. 9, 2021 /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 second quarter and first half
2021 financial results.
"We have made significant progress in the first half of 2021 and
are well on our way to meet or exceed the goals we set at the
beginning of the year. We are excited about the advancement of our
portfolio and look forward to providing further clinical updates
and data readouts at a planned R&D call on November 4th as well as at medical
congresses in the fourth quarter of the year," said Helen Sabzevari, PhD, President and CEO of
Precigen. "We see 2021 as a pivotal year for the UltraCAR-T,
ActoBiotics and AdenoVerse platforms with significant new clinical
data on our most advanced therapeutic candidates from these core
therapeutic platforms."
Business Highlights:
R&D Update Call
- Precigen will host an R&D call on November 4th that will be dedicated to
reviewing progress made in advancing the Company's clinical
pipeline, including the latest data for several of our key
programs.
PRGN-3005 UltraCAR-T®
- PRGN-3005 UltraCAR-T is a first-in-class investigational
therapy under evaluation in a Phase 1/1b clinical trial for the treatment of patients
with advanced, recurrent platinum resistant ovarian cancer. Study
subjects receive the PRGN-3005 infusion either via intraperitoneal
(IP) (Arm A) or intravenous (IV) (Arm B) infusion.
- Preliminary Phase 1 data previously reported from the two
lowest dose levels of the IP arm showed a favorable safety profile
with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine
release syndromes (CRS); encouraging expansion and persistence
without lymphodepletion; and clinical activity as evidenced by
regression in total target tumor burden.
- The dose escalation phase of both the IP and IV arms of the
trial is ongoing concurrently. Enrollment in dose level 4 of the IP
arm and dose level 3 of the IV arm is ongoing.
- The Company anticipates the presentation of interim data from
the Phase 1 trial in the fourth quarter of 2021.
PRGN-3006 UltraCAR-T®
- PRGN-3006 UltraCAR-T is a first-in-class investigational
therapy under evaluation in a Phase 1/1b clinical trial for the treatment of patients
with relapsed or refractory (r/r) acute myeloid leukemia (AML) or
higher-risk myelodysplastic syndromes (MDS). Study subjects receive
the PRGN-3006 infusion either without prior lymphodepletion (Cohort
1) or following lymphodepleting chemotherapy (Cohort 2). PRGN-3006
UltraCAR-T has been granted Orphan Drug Designation in patients
with AML by the US FDA.
- Preliminary Phase 1 data previously reported for the two lowest
dose levels in Cohort 1 and the lowest dose level in Cohort 2
showed a favorable safety profile with no DLTs or neurotoxicity;
encouraging expansion and persistence of PRGN-3006 UltraCAR-T in
both cohorts; and clinical activity as evidenced by reduction in
AML tumor blast levels. One of the patients treated with PRGN-3006
at the lowest dose level with lymphodepletion (Cohort 1), with
approximately nine million UltraCAR-T cells, achieved complete
remission with incomplete hematologic recovery (CRi) per European
Leukemia Net (ELN) criteria and subsequently received allogeneic
hematopoietic stem cell transplant (HSCT).
- The dose escalation phase of both the lymphodepletion and
non-lymphodepletion cohorts of the Phase 1 trial is ongoing
concurrently. Enrollment in dose level 4 of the non-lymphodepletion
cohort and dose level 3 of the lymphodepletion cohort is
ongoing.
- The Company anticipates the presentation of interim data from
the Phase 1 trial in the fourth quarter of 2021.
PRGN-2009 AdenoVerse™ Immunotherapy
- PRGN-2009 is a first-in-class, off-the-shelf (OTS)
investigational immunotherapy utilizing the AdenoVerse platform
that has been designed to activate the immune system to recognize
and target HPV-positive solid tumors. PRGN-2009 is currently under
evaluation in a Phase 1/2 clinical trial as a monotherapy or in
combination with bintrafusp alfa (M7824) in patients with
HPV-associated cancers. The trial is being conducted under a
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute (NCI).
- Preliminary Phase 1 data previously reported for the
monotherapy arm of the Phase 1 trial showed that the treatment was
well-tolerated with no DLTs. Furthermore, preliminary correlative
analysis from the patients treated at the lowest dose in the
monotherapy arm showed an increase in HPV-specific T-cell response
in 100% (3 of 3) of patients and an increase in the magnitude of
immune response with repeated PRGN-2009 administrations.
- As previously announced, enrollment in the Phase 1 monotherapy
dose escalation arm is complete, with all patients (n=6) receiving
multiple doses of PRGN-2009, as many as thirteen doses to date.
Subsequently, the monotherapy arm of the Phase 2 trial, which
evaluates PRGN-2009 as neoadjuvant therapy for newly diagnosed
oropharyngeal or sinonasal squamous cell cancer patients as a first
line treatment was initiated. Enrollment in the Phase 2 monotherapy
arm is ongoing with four patients enrolled to date. Enrollment in
the Phase 1 combination arm is also ongoing with six patients
enrolled to date.
- A trial-in-progress update on the PRGN-2009 study was provided
at the American Society of Clinical Oncology (ASCO) 2021 annual
meeting as a poster presentation by Charalampos S. Floudas, MD, DMSc, MS, Assistant
Research Physician, Genitourinary Malignancies Branch at the Center
for Cancer Research at the NCI.
- The Company anticipates the presentation of interim Phase
1 data in the fourth quarter of 2021.
PRGN-2012 AdenoVerse™ Immunotherapy
- PRGN-2012 is a first-in-class, investigational OTS AdenoVerse
immunotherapy designed to elicit immune responses directed against
cells infected with HPV 6 or HPV 11 for treatment of recurrent
respiratory papillomatosis (RRP). A Phase 1 clinical trial of
PRGN-2012 in adult patients with RRP is ongoing. The Phase 1 trial
is designed to follow 3+3 dose escalation of PRGN-2012 as an
adjuvant immunotherapy following standard-of-care surgical removal
of visible papillomas. Patients receive up to four injections of
PRGN-2012. The study is designed to enroll 3 to 6 subjects at each
dose level followed by an expansion cohort with 12 patients treated
at the maximum tolerated dose. The trial is being conducted under a
CRADA with the NCI. PRGN-2012 has been granted Orphan Drug
Designation in patients with RRP by the US FDA.
- In January 2021,the Company
announced US FDA clearance of the IND to initiate the PRGN-2012
Phase 1 trial.
- In March 2021, the first patient
was dosed and, subsequently, enrollment was completed in the 3+3
dose escalation portion of the Phase 1 trial. Enrollment then was
initiated and the first patient dosed in the expansion cohort of
the Phase 1 study at the maximum study dose, exceeding the
Company's goal this year.
AG019 ActoBiotics™
- AG019 ActoBiotics is a first-in-class, orally administered,
investigational therapy designed to address the underlying cause of
Type 1 diabetes (T1D) and is currently under evaluation in a Phase
1b/2a clinical trial for the
treatment of early-onset T1D. The study is assessing safety and
tolerability of AG019 administered as monotherapy or in combination
with teplizumab.
- Enrollment and dosing is complete in the Phase 1b and Phase 2a portions of the study.
- Positive topline data from the AG019 Phase 1b/2a clinical trial were reported at the
Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual
Annual Meeting by Kevan Herold, MD,
CNH Long Professor of Immunobiology and of Medicine (Endocrinology)
at the Yale School of Medicine, meeting
the Company's goal to present AG019 Phase 1b/2a data this year. The primary endpoints of
safety and tolerability for the Phase 1b AG019 monotherapy and the Phase 2a AG019
combination therapy were met. No serious adverse events (SAEs) were
reported. AG019, as a monotherapy and in combination with
teplizumab, showed stabilization or increase of C-peptide levels, a
biomarker for T1D disease progression, and induced antigen-specific
tolerance in conjunction with the reduction of disease-specific T
cell responses. Results indicated the potential of the oral AG019
monotherapy to preserve insulin production in recent-onset T1D
through its capacity to reduce autoreactive T cells and increase
the frequency of memory Tregs to induce antigen-specific immune
modulation.
- Additional data from the AG019 Phase 1b/2a clinical trial will be presented on
October 1, 2021 at 12:00 PM CET as an oral presentation at the
European Association for the Study of Diabetes (EASD) 57th Annual
Meeting. The abstract entitled, "AG019 ActoBiotics as monotherapy
or in association with teplizumab in recent-onset type 1 diabetes
was safe and demonstrated encouraging metabolic and immunological
effects" will be presented by Chantal
Mathieu, MD, PhD, Professor of Medicine at the Katholieke
Universiteit Leuven, Belgium.
- A clinical trial assessing the efficacy of prolonged treatment
of oral AG019 is planned.
Second Quarter and First Half 2021 Financial
Highlights
- Net cash used in operating activities of $24.2 million during the six months ended
June 30, 2021 compared to
$41.5 million during the six months
ended June 30, 2020;
- Cash, cash equivalents, short-term and long-term investments
totaled $200.4 million as of
June 30, 2021; and
- Total revenues of $33.6 million
and $58.1 million during the three
and six months ended June 30, 2021,
respectively, compared to $30.4
million and $60.3 million
during the three and six months ended June
30, 2020, respectively.
Second Quarter 2021 Financial Results Compared to Prior Year
Period
Research and development expenses increased
$4.2 million, or 44%, over the
quarter ended June 30,
2020. Contract research organization costs and lab supplies
increased $3.8 million with the
advancement of the Company's clinical and preclinical programs.
Selling, general and administrative ("SG&A") expenses increased
$2.1 million, or 12%. The majority of
the SG&A increase was due to an increase in professional fees.
Net loss from continuing operations was $20.1 million, or $(0.10) per basic share, of which $8.2 million was for non-cash charges in 2021
compared to net loss from continuing operations of $15.7 million, or $(0.10) per basic share, of which $8.7 million was for non-cash charges in
2020.
Total revenues increased $3.2
million, or 10%, over the quarter ended June 30, 2020. Collaboration and licensing
revenues decreased $4.0 million
primarily due to a decrease in the recognition of previously
deferred revenue in the current period resulting from fewer
services being performed pursuant to the Company's collaboration
agreements. Product and service revenues generated by Trans Ova and
Exemplar increased $7.2 million
primarily due to higher customer demand for Trans Ova's products
and services as a result of stronger beef and dairy industries in
the current year and a change in pricing structure with certain
customers, as well as increased services provided by Exemplar to
new and existing customers. Gross margin on products and services
improved as a result of the increased revenues, the change in
pricing structure for certain customers, and operational
efficiencies that have been gained through reductions in workforce
and improved inventory management.
First Half 2021 Financial Results Compared to Prior Year
Period
Research and development expenses increased
$3.4 million, or 16%, over the six
months ended June 30, 2020. Contract
research organization costs and lab supplies increased $3.8 million with the advancement of the
Company's clinical and preclinical programs. SG&A expenses were
comparable period over period due to offsetting changes. Salaries,
benefits, and other personnel costs decreased $1.6 million in 2021 primarily due to a reduced
headcount as the Company scaled down its corporate functions to
support a more streamlined organization and reduced stock
compensation costs for previously granted awards that became fully
vested in early 2021. These decreases were partially offset by an
increase in professional fees. Net loss from continuing operations
was $41.9 million, or $(0.21) per basic share, of which $17.9 million was for non-cash charges in 2021
compared to net loss from continuing operations of $36.6 million, or $(0.23) per basic share, of which $16.4 million was for non-cash charges in
2020.
Total revenues decreased $2.2
million, or 4%, from the six months ended June 30, 2020. Collaboration and licensing
revenues decreased $14.7 million as
the Company accelerated the recognition of previously deferred
revenue in the prior period upon the mutual termination of one of
its collaboration agreements in February
2020. Product and service revenues generated by Trans Ova
and Exemplar increased $12.6 million
primarily due to higher customer demand for Trans Ova's products
and services as a result of stronger beef and dairy industries in
the current year and a change in pricing structure with certain
customers, as well as increased services provided by Exemplar to
new and existing customers. Gross margin on products and services
improved as a result of the increased revenues, the change in
pricing structure for certain customers, and operational
efficiencies that have been gained through reductions in workforce
and improved inventory management.
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 unique therapies toward clinical
proof-of-concept and commercialization. For more information about
Precigen, visit www.precigen.com or follow us on Twitter @Precigen
and LinkedIn.
Trademarks
Precigen, UltraCAR-T, ActoBiotics,
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 Precigen's current expectations and
projections about future events and generally relate to plans,
objectives, and expectations for the development
of Precigen's business, including the timing, pace and
progress of preclinical studies, clinical trials, discovery
programs and related milestones, and the promise of the Company's
portfolio of therapies, and in particular its CAR-T therapies.
Although management believes that the plans, objectives and results
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.
These risks and uncertainties include, but are not limited to, (i)
the impact of the COVID-19 pandemic on our clinical trials,
businesses, operating results, cash flows and/or financial
condition, (ii) Precigen's strategy and overall approach to
its health-focused business model; (iii) the ability to
successfully enter new markets or develop additional products,
including the expected timing and results of investigational
studies and preclinical and clinical trials, including any delays
or potential delays as a result of the COVID-19 pandemic, whether
with its collaborators or independently; (iv) the ability to
successfully enter into optimal strategic relationships with its
subsidiaries and operating companies that it may form in the
future; (v) the ability to hold or generate significant operating
capital, including through partnering, asset sales and operating
cost reductions; (vi) actual or anticipated variations in operating
results; (vii) actual or anticipated fluctuations in competitors'
or collaborators' operating results or changes in their respective
growth rates; (viii) cash position; (ix) market conditions
in Precigen's industry; (x) the volatility
of Precigen's stock price; (xi) the ability, and the
ability of collaborators, to
protect Precigen's intellectual property and other
proprietary rights and technologies; (xii) the ability, and the
ability of collaborators, to adapt to changes in laws or
regulations and policies, including federal, state, and local
government responses to the COVID-19 pandemic; (xiii) outcomes of
pending and future litigation; (xiv) the rate and degree of market
acceptance of any products developed by Precigen, its
subsidiaries, collaborations or joint ventures; (xv) the ability to
retain and recruit key personnel; (xvi) expectations related to the
use of proceeds from public offerings and other financing efforts;
and (xvii) estimates regarding expenses, future revenue, capital
requirements and needs for additional financing. For further
information on potential risks and uncertainties, and other
important factors, any of which could
cause Precigen's actual results to differ from those
contained in the forward-looking statements, see the section
entitled "Risk Factors" in Precigen'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)
|
June 30,
2021
|
|
December 31,
2020
|
Assets
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
36,412
|
|
$
|
51,792
|
Short-term
investments
|
|
78,694
|
|
|
48,325
|
Receivables
|
|
|
|
|
|
Trade, net
|
|
26,016
|
|
|
16,487
|
Related parties,
net
|
|
22
|
|
|
19
|
Notes
|
|
—
|
|
|
3,689
|
Other
|
|
633
|
|
|
232
|
Inventory
|
|
11,413
|
|
|
11,359
|
Prepaid expenses and
other
|
|
3,484
|
|
|
7,192
|
Current assets held
for sale or abandonment
|
|
11
|
|
|
9,853
|
Total current
assets
|
|
156,685
|
|
|
148,948
|
Long-term
investments
|
|
85,269
|
|
|
—
|
Property, plant and
equipment, net
|
|
32,745
|
|
|
34,924
|
Intangible assets,
net
|
|
59,942
|
|
|
65,396
|
Goodwill
|
|
54,273
|
|
|
54,363
|
Right-of-use
assets
|
|
12,327
|
|
|
9,353
|
Other
assets
|
|
1,332
|
|
|
1,603
|
Total
assets
|
$
|
402,573
|
|
$
|
314,587
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts
payable
|
$
|
4,937
|
|
$
|
4,598
|
Accrued compensation
and benefits
|
|
7,766
|
|
|
8,097
|
Other accrued
liabilities
|
|
10,473
|
|
|
9,549
|
Deferred
revenue
|
|
3,276
|
|
|
2,800
|
Current portion of
long-term debt
|
|
356
|
|
|
360
|
Current portion of
lease liabilities
|
|
1,937
|
|
|
2,657
|
Related party
payables
|
|
22
|
|
|
19
|
Current liabilities
held for sale or abandonment
|
|
102
|
|
|
14,047
|
Total current
liabilities
|
|
28,869
|
|
|
42,127
|
Long-term debt, net
of current portion
|
|
176,922
|
|
|
171,522
|
Deferred revenue, net
of current portion
|
|
23,023
|
|
|
23,023
|
Lease liabilities,
net of current portion
|
|
11,821
|
|
|
7,744
|
Deferred tax
liabilities
|
|
2,692
|
|
|
2,897
|
Other long-term
liabilities
|
|
50
|
|
|
100
|
Total
liabilities
|
|
243,377
|
|
|
247,413
|
Commitments and
contingencies
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
|
Common
stock
|
|
—
|
|
|
—
|
Additional paid-in
capital
|
|
2,017,413
|
|
|
1,886,567
|
Accumulated
deficit
|
|
(1,860,758)
|
|
|
(1,823,390)
|
Accumulated other
comprehensive income
|
|
2,541
|
|
|
3,997
|
Total shareholders'
equity
|
|
159,196
|
|
|
67,174
|
Total liabilities and
shareholders' equity
|
$
|
402,573
|
|
$
|
314,587
|
Precigen, Inc. and
Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited)
|
(Amounts in
thousands, except share
and per share data)
|
|
Three months
ended
June
30,
|
Six months
ended
June
30,
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
Collaboration and
licensing revenues
|
$
|
301
|
$
|
4,315
|
$
|
367
|
$
|
15,036
|
Product
revenues
|
|
8,335
|
|
8,540
|
|
14,716
|
|
13,501
|
Service
revenues
|
|
24,803
|
|
17,381
|
|
42,734
|
|
31,327
|
Other
revenues
|
|
141
|
|
188
|
|
274
|
|
398
|
Total
revenues
|
|
33,580
|
|
30,424
|
|
58,091
|
|
60,262
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of
products
|
|
6,135
|
|
8,141
|
|
11,709
|
|
14,230
|
Cost of
services
|
|
8,898
|
|
6,770
|
|
16,300
|
|
14,306
|
Research and
development
|
|
13,681
|
|
9,474
|
|
24,202
|
|
20,801
|
Selling, general and
administrative
|
|
19,997
|
|
17,869
|
|
38,699
|
|
39,355
|
Impairment of other
noncurrent assets
|
|
543
|
|
—
|
|
543
|
|
—
|
Total operating
expenses
|
|
49,254
|
|
42,254
|
|
91,453
|
|
88,692
|
Operating
loss
|
|
(15,674)
|
|
(11,830)
|
|
(33,362)
|
|
(28,430)
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(4,667)
|
|
(4,592)
|
|
(9,206)
|
|
(9,184)
|
Interest
income
|
|
410
|
|
773
|
|
802
|
|
1,446
|
Other income
(expense), net
|
|
(192)
|
|
71
|
|
(250)
|
|
135
|
Total other expense,
net
|
|
(4,449)
|
|
(3,748)
|
|
(8,654)
|
|
(7,603)
|
Equity in net loss of
affiliates
|
|
—
|
|
(251)
|
|
(3)
|
|
(602)
|
Loss from continuing
operations
before income taxes
|
|
(20,123)
|
|
(15,829)
|
|
(42,019)
|
|
(36,635)
|
Income tax
benefit
|
|
60
|
|
120
|
|
112
|
|
80
|
Loss from continuing
operations
|
$
|
(20,063)
|
$
|
(15,709)
|
$
|
(41,907)
|
$
|
(36,555)
|
Income (loss) from
discontinued
operations, net of income taxes
|
|
13
|
|
(27,645)
|
|
4,539
|
|
(62,797)
|
Net loss
|
$
|
(20,050)
|
$
|
(43,354)
|
$
|
(37,368)
|
$
|
(99,352)
|
Net Loss per
Share
|
|
|
|
|
|
|
|
|
Net loss from
continuing operations per
share, basic and diluted
|
$
|
(0.10)
|
$
|
(0.10)
|
$
|
(0.21)
|
$
|
(0.23)
|
Net income (loss)
from discontinued
operations per share, basic and
diluted
|
|
—
|
|
(0.16)
|
|
0.02
|
|
(0.38)
|
Net loss per share,
basic and diluted
|
$
|
(0.10)
|
$
|
(0.26)
|
$
|
(0.19)
|
$
|
(0.61)
|
Weighted average
shares outstanding,
basic and diluted
|
|
199,021,587
|
|
164,065,087
|
|
196,275,820
|
|
162,201,915
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-and-first-half-2021-financial-results-301351238.html
SOURCE Precigen, Inc.