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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):
January 8, 2024
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 7.01 |
Regulation FD Disclosure. |
On January 8, 2024, Precigen, Inc. (the “Company”) issued
a press release providing an overview of certain research and development and corporate updates that the Company will present at the 42nd
Annual J.P. Morgan Healthcare Conference on January 10, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
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
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: January 8, 2024
Exhibit 99.1
Precigen Highlights Pipeline Updates to be Presented
at the
42nd Annual J.P. Morgan Healthcare Conference
| – | PRGN-2012
Phase 2 pivotal study data in RRP is anticipated in the second quarter of 2024; the Company
plans to submit a BLA under an accelerated approval pathway in the second half of 2024; commercial
readiness preparations are underway for a potential launch in 2025 –
|
| – | Company
presentation scheduled for January 10 at 5:15 PM PST – |
GERMANTOWN, MD,
January 8, 2024 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing
in the development of innovative gene and cell therapies to improve the lives of patients, today released highlights of pipeline updates
to be presented at the 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024 at 5:15 PM PST in San Francisco, California.
AdenoVerse™ Immunotherapies
“In the second
quarter of this year, we anticipate presenting Phase 2 pivotal study data for our lead asset, PRGN-2012, in recurrent respiratory papillomatosis,
RRP, and submitting the Company’s first BLA under an accelerated approval pathway in the second half of this year. In anticipation
of a potential launch in 2025, we are actively preparing for commercial readiness. This is an exciting time for Precigen as we prepare
to transition from a clinical to commercial stage biotechnology company. I am incredibly proud of the Precigen team for achieving the
first breakthrough therapy designation and accelerated approval pathway so rapidly for an RRP treatment and for the life-changing potential
that PRGN-2012 has for RRP patients,” said Helen Sabzevari, PhD, President and CEO of Precigen.
| · | PRGN-2012
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 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. |
| · | PRGN-2012
is currently under investigation in a Phase 1/2 pivotal single-arm study in adult patients with RRP (clinical trial identifier: NCT04724980). |
| · | PRGN-2012
demonstrated strong efficacy and favorable safety profile in the Phase 1 portion of the study with 50%
of patients (N=12) in durable and ongoing Complete Response more than two years after PRGN-2012 treatment. |
| · | A
Phase 2 data presentation is anticipated in the second quarter
of 2024. |
| · | A
planned Biologics License Application (BLA) submission under an accelerated approval pathway
is anticipated in the second half of 2024. |
| · | Commercial
readiness preparations are underway for a potential launch in 2025. |
| · | PRGN-2009
in OPSCC and Cervical Cancer: PRGN-2009 is an investigational
off-the-shelf AdenoVerse immunotherapy designed to activate the immune system to recognize
and target HPV-associated cancers. |
| · | The
Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients
with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) is currently enrolling
patients (clinical trial identifier: NCT05996523). |
| · | The
Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients
with recurrent/metastatic cervical cancer is anticipated to initiate in the first quarter
of 2024 (clinical trial identifier: NCT06157151). |
UltraCAR-T®
Cell Therapies
“We continue
to advance our UltraCAR-T clinical programs and remain enthusiastic about the data we are seeing in our Phase 1b expansion studies. Precigen's
UltraCAR-T cell therapies are engineered to specifically address the limitations of conventional CAR-T therapies by improving in vivo
CAR-T expansion and persistence, adding a safety/kill switch to reduce the risk of toxicity and malignancy, utilizing a non-viral
design to reduce the risk of malignant transformation associated with lentivirus and retrovirus vectors, eliminating long turnaround
times for manufacturing and reducing the high cost of treatment,” adds Sabzevari. “We look forward to sharing new results
for these assets during the planned presentations for our PRGN-3006 and PRGN-3007 UltraCAR-T programs in 2024. In addition to ongoing
clinical trials, we are excited by the preclinical data for a new and differentiated CD19 targeted UltraCAR-T, which has best-in-class
potential for this validated target capitalizing on the unique advantages of the UltraCAR-T platform over conventional CAR-T.”
| · | PRGN-3006
in AML/MDS: PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor
T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting
CD33, membrane bound IL-15 (mbIL15), and a safety/kill switch. PRGN-3006 has been granted Orphan
Drug Designation in patients
with acute myeloid leukemia (AML) and Fast
Track Designation in patients
with relapsed/refractory (r/r) AML by the FDA. |
| · | PRGN-3006
is currently under evaluation in a Phase 1b clinical trial (clinical trial identifier: NCT03927261)
for the treatment of patients with r/r AML or higher-risk myelodysplastic syndromes
(MDS). |
| · | The
first-in-human, Phase 1 dose escalation portion of the study with lymphodepletion was completed
in r/r AML and higher-risk MDS patients. |
| · | Phase
1 dose escalation data showed that PRGN-3006 was well-tolerated with no dose-limiting toxicities
(DLTs) and a 27% objective response rate (ORR) in heavily pre-treated r/r AML patients infused
following lymphodepletion. |
| · | An
interim Phase 1b dose expansion data presentation is anticipated in the second half of 2024.
|
| · | PRGN-3005
in Ovarian Cancer: PRGN-3005 is an investigational multigenic, autologous CAR-T cell
therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15,
and a safety/kill switch. |
| · | The
Phase 1b dose expansion portion of the Phase 1/1b study is ongoing (clinical trial identifier:
NCT03907527).
|
| · | PRGN-3007
in Advanced ROR1+ Hematological and Solid Tumors: PRGN-3007 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 safety/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 (clinical trial identifier:
NCT05694364). |
| · | A
preliminary Phase 1 dose escalation data presentation is anticipated by the end of 2024.
|
| · | UltraCAR-T
Targeting CD19: Preclinical data for the Company’s UltraCAR-T targeting CD19 (a
validated target) have demonstrated significant potential and the Company is preparing to
initiate a Phase 1 study to support a potential best-in-class CD19 CAR-T leveraging the unique
advantages of the UltraCAR-T platform. |
Precigen's
42nd Annual J.P. Morgan Healthcare Conference presentation will be available on the Company website in the Events
& Presentations section following the presentation.
###
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.
Trademarks
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 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, product candidate approval and
commercialization 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
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