false
0001356090
0001356090
2023-11-09
2023-11-09
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 9, 2023
Precigen,
Inc.
(Exact name of registrant as specified in its
charter)
Virginia |
|
001-36042 |
|
26-0084895 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
20374 Seneca Meadows Parkway, Germantown, Maryland 20876
(Address of principal executive offices) (Zip
Code)
(301) 556-9900
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
Common Stock, No Par Value |
|
PGEN |
|
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 2.02. |
Results of Operations and Financial Condition. |
Attached as Exhibit 99.1 is a copy of a press release of Precigen,
Inc., dated November 9, 2023, reporting its financial results for the quarter ended September 30, 2023.
This information, including the Exhibit attached hereto, shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press release dated November 9, 2023 |
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Precigen, Inc. |
|
|
|
|
By: |
/s/ Donald P. Lehr |
|
|
Donald P. Lehr |
|
|
Chief Legal Officer |
Dated: November 9, 2023
Exhibit 99.1
Precigen Reports Third Quarter 2023 Financial
Results and Progress of Clinical Programs
| – | Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in
RRP will serve as the pivotal study to support BLA submission under an accelerated approval request, the Company has expedited efforts
to attain commercial readiness – |
| – | Full results of the Phase 1 portion of the ongoing Phase 1/2 study of PRGN-2012 were published in the
peer-reviewed journal, Science Translational Medicine, and presented in an oral presentation at the ESGCT 30th Annual Congress – |
| – | Enrollment and dosing was completed in the Phase 2 study of PRGN-2012 in RRP; Phase 2 study completion
expected in the second quarter of 2024 – |
| – | Cash, cash equivalents, short-term and long-term investments totaled $79.0
million as of September 30, 2023; cash runway projected into 2025 – |
| – | Continued focus on cost containment resulted in a reduction in SG&A costs of 17% for the nine months
ended September 30, 2023, compared to the prior year over the same period – |
GERMANTOWN, MD, November 9, 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 third quarter 2023 financial results and progress
of clinical programs.
“Precigen has made tremendous progress in
reducing our operating costs and we are actively reprioritizing our programs to enable commercial readiness for our lead asset, PRGN-2012.
We anticipate completing the PRGN-2012 Phase 2 study in the second quarter of 2024 and, given the FDA’s guidance in August 2023
that the ongoing Phase 1/2 study of PRGN-2012 will serve as the pivotal study to support an accelerated approval request, we are working
to expedite the submission of a BLA as quickly as possible,” said Helen Sabzevari, PhD, President and CEO of Precigen. “We
have recently published exciting new data for both of the Company's core platforms, AdenoVerse and UltraCAR-T, including presentations
at the ESGCT 30th Annual Congress for PRGN-3007 UltraCAR-T and PRGN-2012 AdenoVerse immunotherapy, and publication of a manuscript in
Science Translational Medicine that includes full Phase 1 data from the PRGN-2012 clinical study. Each publication builds the body
of clinical evidence for the potential of our innovative therapeutic platforms in meeting unmet medical needs for patients.”
Program Highlights
PRGN-2012 AdenoVerse™ Immunotherapy in
RRP
| · | PRGN-2012
is an investigational off-the-shelf AdenoVerse immunotherapy designed to elicit immune responses
directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment
of recurrent respiratory papillomatosis (RRP). The US Food and Drug Administration (FDA)
has granted Breakthrough Therapy Designation and
Orphan Drug Designation for PRGN-2012 for the treatment
of RRP. |
| · | The
Company announced that the FDA has agreed that the ongoing Phase
1/2 (NCT04724980) single-arm study will serve as pivotal for the purpose of filing an accelerated
approval request for licensure. Based on this FDA guidance, the Company plans
to initiate a confirmatory study prior to submission of the biologics license application (BLA). |
| · | The Company presented positive Phase 1 data showing
clinical benefit and enhanced T-cell responses with repeated administration from the ongoing Phase 1/2 single-arm study at the European
Society of Gene & Cell Therapy (ESGCT) 30th Annual Congress in an oral presentation (Abstract# OR04) titled, “Significant
clinical benefit and enhanced T-cell responses with repeated administration of PRGN-2012, a novel gorilla adenoviral vector based immunotherapy,
in adult patients with severe recurrent respiratory papillomatosis.” |
| o | The presentation included full results of the Phase 1 study and add to the previously presented data for
PRGN-2012 which showed significant response in RRP patients with 50% of patients in Complete Response, requiring no post-treatment surgeries,
following PRGN-2012 treatment at |
Dose Level 2 with a favorable safety profile,
no dose-limiting toxicities and no treatment-related adverse events (TRAEs) greater than Grade 2.
| o | Complete Responses are durable and all complete responders remain surgery-free (follow-up range: 18-24 months) after PRGN-2012 treatment
completion. |
| o | PRGN-2012 treatment induced robust HPV-specific T cell responses which were
correlated with clinical responses in the study. |
| · | Full
results of the Phase 1 portion of the ongoing Phase 1/2 study of PRGN-2012 were published
in the peer-reviewed journal, Science Translational Medicine,
a leading publication from the American Association for the Advancement of Science (AAAS),
in a manuscript titled, “The
tumor microenvironment state associates with response to HPV therapeutic vaccination in patients
with respiratory papillomatosis.”
|
| · | Enrollment and dosing in the Phase 2 portion of
the study (N=23) is complete bringing the total number of enrolled patients to 35 at Dose Level 2. Patient follow up is currently ongoing
and the Phase 2 study is expected to be complete by the second quarter of 2024. |
PRGN 2009 AdenoVerse™ Immunotherapy in
HPV-associated Cancers
| · | PRGN-2009 is an investigational off-the-shelf
AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-positive solid tumors. |
| · | The
Company completed the Phase 1 (NCT04432597) study and presented
positive Phase 1 clinical data from the monotherapy and combination therapy arms
in patients with recurrent or metastatic HPV-associated cancers at the 2023 American Society
of Clinical Oncology (ASCO) Annual Meeting. |
| · | Enrollment was completed in the Phase 2 monotherapy
arm with 20 evaluable patients in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients. The Phase 2 (NCT05996523) combination
arm (PRGN-2009 in combination with pembrolizumab) in OPSCC is enrolling patients. |
| · | The Company plans to initiate a Phase 2 randomized,
open-label, two-arm study of PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer. |
PRGN-3006 UltraCAR-T® in AML
| · | PRGN-3006
is an investigational multigenic, autologous chimeric antigen receptor T (CAR-T)
cell therapy engineered to express a CAR specifically targeting CD33, membrane bound IL-15
(mbIL15), and a kill switch. The FDA granted Orphan Drug
Designation and Fast Track Designation for
PRGN-3006 UltraCAR-T for patients with relapsed or refractory acute myeloid leukemia (AML). |
| · | The
Company completed the Phase 1 (NCT03927261) dose escalation study and presented
positive data at the 64th American Society of Hematology (ASH) Annual Meeting
and Exposition. |
| · | The Phase 1b dose expansion study of PRGN-3006
is ongoing and an interim clinical data presentation is expected in 2024. |
PRGN-3005 UltraCAR-T® in Ovarian
Cancer
| · | PRGN-3005 UltraCAR-T is an investigational multigenic,
autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a kill switch. |
| · | The
Company completed the Phase 1 (NCT03907527) dose escalation cohorts of the intraperitoneal
(IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion
cohort in the IV arm and presented positive Phase 1 clinical
data in patients with advanced platinum resistant ovarian cancer at the 2023 ASCO
Annual Meeting. |
| · | As previously communicated, based on portfolio
reprioritization efforts, the Company will not add an extensive number of new sites this year. Instead, a new site will be activated under
the Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to continue the advancement of the
PRGN-3005 Phase 1b dose expansion study without incurring major clinical/contract research organization (CRO) costs. |
PRGN-3007 UltraCAR-T® in Advanced
ROR1+ Hematological and Solid Tumors
| · | PRGN-3007, based on the next generation of the UltraCAR-T platform, is
an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan
|
receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism
for the intrinsic blockade of PD-1 gene expression.
| · | The Phase 1 dose escalation portion of the Phase 1/1b study is ongoing. The
target patient population for the Phase 1/1b study includes ROR1+ advanced hematological and solid tumors. |
| · | The Company presented additional preclinical data (Abstract#
P469) for PRGN-3007 at the ESGCT 30th Annual Congress in a poster presentation titled, “Overnight-manufactured
UltraCAR-T® cells with first-in-class miRNA-based PD1 blockade demonstrates enhanced polyfunctionality and sustained cytotoxicity
against hematological and solid tumors.” |
Financial Highlights
| · | Cash, cash equivalents, short-term and long-term investments
totaled $79.0 million as of September 30, 2023. |
| · | Selling, general, and administrative (SG&A)
costs decreased versus the prior year, by 9% and 17% for the three and nine months ended September 30, 2023, respectively. |
“Following
our portfolio reprioritization and other cost-saving measures announced last quarter, Precigen continues to manage the balance sheet to
enable rapid progression of our lead assets,” said Harry Thomasian Jr., CFO of Precigen. “As we scale-up areas of our business
to prepare for commercialization, we are focused on fiscal management and exploring new non-dilutive capital opportunities, including
potential strategic partnerships, to maximize and extend our runway.”
Third Quarter 2023 Financial Results Compared
to Prior Year Period
Research
and development expenses decreased $1.0 million, or 8%, compared to the three months ended September 30, 2022. This decrease was primarily
due to continued reprioritization of clinical product candidates.
SG&A
expenses decreased $0.9 million, or 9%, compared to the three months ended September 30, 2022. This decrease was primarily driven by a
reduction in professional fees of $0.6 million, due to decreased legal fees associated with certain litigation matters, and $0.3 million
in decreased insurance related expenses.
Total revenues
decreased $15.3 million, or 92%, compared to the three months ended September 30, 2022. Collaboration and licensing revenues decreased
$14.6 million, or 100%, compared to the three months ended September 30, 2022, primarily due to the prior year period non-cash recognition
of revenue related to historical collaboration agreements for which revenue was previously deferred. Product and service revenues decreased
$0.7 million, or 34%, compared to the three months ended September 30, 2022. This decrease is related to reductions in services performed
at Exemplar.
Total other
income, net, increased $2.1 million compared to the three months ended September 30, 2022. This is primarily due to $2.0 million in reduced
interest expense associated with the Company’s Convertible Notes as they were fully retired in the second quarter of 2023, and $0.8
million increased interest income due to higher interest rates on investments. This increase was offset by a $0.9 million gain recorded
on the early retirement of a portion of the Convertible Notes in the third quarter of 2022 that did not occur in the third quarter of
2023.
Loss from
continuing operations was $19.8 million, or $(0.08) per basic and diluted share, compared to loss from continuing operations of $7.6 million,
or $(0.04) per basic and diluted share, in the three months ended September 30, 2022.
First Nine months 2023 Financial Results Compared
to Prior Year Period
Research
and development expenses decreased $0.8 million, or 2%, compared to the nine months ended September 30, 2022. This decrease was primarily
due to continued reprioritization of clinical product candidates.
SG&A
expenses decreased $6.3 million, or 17%, compared to the nine months ended September 30, 2022. This decrease was primarily driven by a
reduction in professional fees of $4.8 million, due to decreased legal fees
associated
with certain litigation matters, as well as a $1.2 million reduction in salaries, benefits, and other personnel costs due to reduced head
count, and $0.3 million in decreased insurance related expenses.
Total revenues
decreased $20.1 million, or 80%, from the nine months ended September 30, 2022. Collaboration and licensing revenues decreased $14.6 million
or 100% from the nine months ended September 2022, primarily due to the prior year period non-cash recognition of revenue related to historical
collaboration agreements for which revenue was previously deferred. Product and services revenues decreased $5.4 million, or 52%, from
the nine months ended September 30, 2022. This decrease primarily related to reductions in services performed at Exemplar as well as the
recognition of revenue in the first quarter of 2022 related to agreements for which revenue was previously deferred that did not occur
in 2023 of $1.0 million at Exemplar.
Total other
income, net, increased $7.3 million compared to the nine months ended September 30, 2022. This is primarily due to $5.7 million reduced
interest expense associated with the Convertible Notes as they were retired in the second quarter of 2023, and $2.1 million increased
interest income due to higher interest rates on the Company’s investments. This increase was offset by $0.8 million reduction in
the gain recorded on the early retirement of a portion of the Convertible Notes in 2023 compared to 2022.
Loss from
continuing operations was $62.8 million, or $(0.26) per basic and diluted share, compared to loss from continuing operations of $57.6
million, or $(0.29) per basic and diluted share, in the nine months ended September 30, 2022.
###
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
X @Precigen, LinkedIn or YouTube.
UltraCAR-T®
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 patient’s 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.
UltraCAR-T® Clinical Program
Precigen’s UltraCAR-T platform is currently
under clinical investigation for hematological and solid tumors, including a Phase 1/1b study of PRGN-3005 UltraCAR-T in patients with
advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (NCT03907527),
a Phase 1/1b study of PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic
syndrome (MDS) (NCT03927261) and a Phase 1/1b study of PRGN-3007 UltraCAR-T incorporating PD-1
checkpoint inhibition in patients with ROR1-positive (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL),
acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and triple negative breast cancer (TNBC) (NCT05694364).
PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation and Fast
Track Designation in patients with AML by the US Food and Drug Administration (FDA).
UltraCAR-T® Library Approach
Precigen's UltraCAR-T library approach is designed
to transform the personalized cell therapy landscape for cancer patients. Precigen's goal is to develop and validate a library of non-viral
plasmids to target tumor-associated antigens. Enabled by design and manufacturing advantages of UltraCAR-T, coupled with the capabilities
of the UltraPorator® system, Precigen is working to empower medical centers to deliver personalized, autologous UltraCAR-T
treatment with overnight manufacturing to any cancer patient. Based on the patient's cancer indication and biomarker profile, one or more
non-viral plasmids would be selected from the library to build a personalized UltraCAR-T treatment. After initial treatment, this approach
has the potential to allow for redosing of UltraCAR-T targeting the same or new tumor-associated antigen(s) based on the treatment response
and the changes in antigen expression of the patient's tumor. Precigen believes that the combination of the advanced UltraVector® DNA
construction platform and the ease of overnight manufacturing gives this library approach a proprietary advantage over traditional T-cell
therapies.
UltraPorator®
The UltraPorator system is an exclusive device
and proprietary software solution for the scale-up of rapid and cost-effective manufacturing of UltraCAR-T therapies and potentially represents
a major advancement over current electroporation devices by significantly reducing the processing time and contamination risk. The UltraPorator
device is a high-throughput, semi-closed electroporation system for modifying T cells using Precigen's proprietary non-viral gene transfer
technology. UltraPorator is being utilized for clinical manufacturing of Precigen's investigational UltraCAR-T therapies in compliance
with current good manufacturing practices.
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
T-cell immune responses as well as an ability to boost these responses via repeat administration. Superior performance characteristics
and high yield manufacturing of AdenoVerse vectors leveraging UltraVector® technology allows Precigen to engineer cutting-edge
investigational gene therapies to treat complex diseases.
AdenoVerse™ Immunotherapy Clinical
Program
Precigen’s AdenoVerse immunotherapy platform
is currently under clinical investigation in a Phase 1/2 study of PRGN-2009 AdenoVerse immunotherapy alone or in combination with an
anti-PDL1/TGF-Beta Trap (bintrafusp alfa) in patients with HPV-associated cancers (NCT04432597),
including the Phase 2 combination arm (PRGN-2009 in combination with pembrolizumab) in newly diagnosed patients with HPV-associated oropharyngeal
squamous cell carcinoma (OPSCC) (NCT05996523), and
a Phase 1/2 study of PRGN-2012 AdenoVerse immunotherapy in patients with recurrent respiratory papillomatosis (RRP) (NCT04724980).
PRGN-2012 has been granted Orphan Drug Designation and Breakthrough
Therapy Designation in patients with RRP by the FDA. Additionally, the FDA has cleared the IND to initiate a Phase 2
study of PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.
For patients interested in enrolling in NCI-led
clinical studies, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov,
and/or visit the website: https://trials.cancer.gov.
Trademarks
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
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 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 |
(Unaudited) |
(Amounts in thousands) | |
September 30, 2023 | |
December 31, 2022 |
Assets | |
| |
|
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 10,076 | | |
$ | 4,858 | |
Restricted cash | |
| - | | |
| 43,339 | |
Short-term investments | |
| 63,679 | | |
| 51,092 | |
Receivables | |
| | | |
| | |
Trade, net | |
| 988 | | |
| 978 | |
Other | |
| 13,117 | | |
| 12,826 | |
Prepaid expenses and other | |
| 5,128 | | |
| 5,066 | |
Total current assets | |
| 92,988 | | |
| 118,159 | |
Long-term in investments | |
| 5,271 | | |
| - | |
Property, plant and equipment, net | |
| 7,115 | | |
| 7,329 | |
Intangible assets, net | |
| 40,426 | | |
| 44,455 | |
Goodwill | |
| 36,894 | | |
| 36,923 | |
Right-of-use assets | |
| 7,197 | | |
| 8,086 | |
Other assets | |
| 797 | | |
| 1,025 | |
Total assets | |
$ | 190,688 | | |
$ | 215,977 | |
Liabilities and Shareholders' Equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 2,351 | | |
$ | 4,068 | |
Accrued compensation and benefits | |
| 6,621 | | |
| 6,377 | |
Other accrued liabilities | |
| 4,119 | | |
| 4,997 | |
Settlement and indemnification accruals | |
| 18,075 | | |
| 18,750 | |
Deferred revenue | |
| 509 | | |
| 25 | |
Current portion of long-term debt | |
| - | | |
| 43,219 | |
Current portion of lease liabilities | |
| 1,200 | | |
| 1,209 | |
Total current liabilities | |
| 32,875 | | |
| 78,645 | |
Deferred revenue, net of current portion | |
| 1,818 | | |
| 1,818 | |
Lease liabilities, net of current portion | |
| 6,192 | | |
| 6,992 | |
Deferred tax liabilities | |
| 2,125 | | |
| 2,263 | |
Total liabilities | |
| 43,010 | | |
| 89,718 | |
Shareholders' equity | |
| | | |
| | |
Common stock | |
| - | | |
| - | |
Additional paid-in capital | |
| 2,082,654 | | |
| 1,998,314 | |
Accumulated deficit | |
| (1,931,415 | ) | |
| (1,868,567 | ) |
Accumulated other comprehensive loss | |
| (3,561 | ) | |
| (3,488 | ) |
Total shareholders' equity | |
| 147,678 | | |
| 126,259 | |
Total liabilities and shareholders' equity | |
$ | 190,688 | | |
$ | 215,977 | |
Precigen, Inc. and Subsidiaries |
Consolidated Statement of Operations |
(Unaudited) |
| |
Three months ended | |
Nine months ended |
(Amounts in thousands, except share and per share data) | |
September 30, 2023 | |
September 30, 2022 | |
September 30, 2023 | |
September 30, 2022 |
Revenues | |
| |
| |
| |
|
Collaboration and licensing revenues | |
$ | - | | |
$ | 14,561 | | |
$ | - | | |
$ | 14,561 | |
Product revenues | |
| 82 | | |
| 342 | | |
| 730 | | |
| 1,455 | |
Service revenues | |
| 1,296 | | |
| 1,750 | | |
| 4,261 | | |
| 8,896 | |
Other revenues | |
| 1 | | |
| 69 | | |
| 6 | | |
| 234 | |
Total revenues | |
| 1,379 | | |
| 16,722 | | |
| 4,997 | | |
| 25,146 | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Cost of products and services | |
| 1,537 | | |
| 1,577 | | |
| 4,761 | | |
| 5,082 | |
Research and development | |
| 11,583 | | |
| 12,622 | | |
| 35,620 | | |
| 36,377 | |
Selling, general and administrative | |
| 9,196 | | |
| 10,137 | | |
| 30,150 | | |
| 36,496 | |
Impairment of goodwill | |
| - | | |
| - | | |
| - | | |
| 482 | |
Impairment of other noncurrent assets | |
| - | | |
| - | | |
| - | | |
| 638 | |
Total operating expenses | |
| 22,316 | | |
| 24,336 | | |
| 70,531 | | |
| 79,075 | |
Operating loss | |
| (20,937 | ) | |
| (7,614 | ) | |
| (65,534 | ) | |
| (53,929 | ) |
Other income (Expense), Net | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (1 | ) | |
| (2,036 | ) | |
| (461 | ) | |
| (6,137 | ) |
Interest income | |
| 856 | | |
| 56 | | |
| 2,316 | | |
| 131 | |
Other income, net | |
| 281 | | |
| 1,038 | | |
| 705 | | |
| 1,276 | |
Total other income (expense), net | |
| 1,136 | | |
| (942 | ) | |
| 2,560 | | |
| (4,730 | ) |
Equity in net income (loss) of affiliates | |
| - | | |
| 862 | | |
| - | | |
| 861 | |
Loss from continuing operations before income taxes | |
| (19,801 | ) | |
| (7,694 | ) | |
| (62,974 | ) | |
| (57,798 | ) |
Income tax benefit | |
| 6 | | |
| 50 | | |
| 126 | | |
| 197 | |
Loss from continuing operations | |
$ | (19,795 | ) | |
$ | (7,644 | ) | |
$ | (62,848 | ) | |
$ | (57,601 | ) |
Income from discontinued operations, net of income taxes | |
| - | | |
| 95,023 | | |
| - | | |
| 108,094 | |
Net (loss) income | |
$ | (19,795 | ) | |
$ | 87,379 | | |
$ | (62,848 | ) | |
$ | 50,493 | |
Net (loss) income per share | |
| | | |
| | | |
| | | |
| | |
Net loss from continuing operations per share, basic and diluted | |
$ | (0.08 | ) | |
$ | (0.04 | ) | |
$ | (0.26 | ) | |
$ | (0.29 | ) |
Net income from discontinued operations per share, basic and diluted | |
| - | | |
| 0.48 | | |
| - | | |
| 0.54 | |
Net (loss) income per share, basic and diluted | |
$ | (0.08 | ) | |
$ | 0.44 | | |
$ | (0.26 | ) | |
$ | 0.25 | |
Weighted average shares outstanding, basic and diluted | |
| 248,520,724 | | |
| 200,670,590 | | |
| 243,075,262 | | |
| 200,256,046 | |
v3.23.3
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Precigen (NASDAQ:PGEN)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Precigen (NASDAQ:PGEN)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024