Precigen Reports Third Quarter 2023 Financial Results and Progress of Clinical Programs
– Based on FDA confirmation in
– 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
– Continued focus on cost containment resulted in a reduction in SG&A costs of 17% for the nine months ended
"
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."- 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.
- Complete Responses are durable and all complete responders remain surgery-free (follow-up range: 18-24 months) after PRGN-2012 treatment completion.
- 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 theNational 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 ofSeptember 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,
Third Quarter 2023 Financial Results Compared to Prior Year Period
Research and development expenses decreased
SG&A expenses decreased
Total revenues decreased
Total other income, net, increased
Loss from continuing operations was
First Nine months 2023 Financial Results Compared to Prior Year Period
Research and development expenses decreased
SG&A expenses decreased
Total revenues decreased
Total other income, net, increased
Loss from continuing operations was
UltraCAR-T®
UltraCAR-T is a multigenic autologous CAR-T platform that utilizes
UltraCAR-T® Clinical Program
UltraCAR-T® Library Approach
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
AdenoVerse™ Immunotherapy
AdenoVerse™ Immunotherapy Clinical Program
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
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
Investor Contact:
Vice President, Investor Relations
Tel: +1 (301) 556-9850
investors@precigen.com
Media Contacts:
press@precigen.com
glenn.silver@finnpartners.com
|
||
Consolidated Balance Sheets |
||
(Unaudited) |
||
(Amounts in thousands) |
|
|
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 |
|
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 |
|
|||||
Consolidated Statement of Operations |
|||||
(Unaudited) |
|||||
Three months ended |
Nine months ended |
||||
(Amounts in thousands, except share and per share data) |
|
|
|
|
|
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 |
|
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