Precigen Reports Third Quarter 2024 Financial Results and Business Updates
PGEN 11.14.2024
Drug:PRGN-2012 PRGN-2012
Diseases:recurrent respiratory papillomatosis
Date of Upcoming Event:2024-11-14
Name of Upcoming Event:SITC 2024
About Gravity Analytica
Recent News
- 01.16.2025 - 43rd Annual J.P. Morgan Healthcare Conference
- 01.13.2025 - Precigen to Present Plans for Realizing Commercial Vision for PRGN-2012 at the 43rd Annual J.P. Morgan Healthcare Conference
- 01.09.2025 - Precigen to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Recent Filings
–Completed pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission for PRGN-2012†in RRP under accelerated approval pathway –
–Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch –
–Confirmatory clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from FDA to initiate prior to submission of the BLA; continuing enrollment –
–Preparing for end of Phase 1b meeting with FDA in early 2025 for PRGN-3006 in AML–
–Presented preclinical data at SITC 2024 for PRGN-3008, a next generation UltraCAR-T targeting CD19 showcasing potential to be best-in-class CD19-targeting CAR-T treatment in oncology and autoimmunity–
"The strategic reprioritization of our portfolio announced last quarter has enabled us to focus our team and allocate resources to advance PRGN-2012 as rapidly as possible. We are excited about our imminent submission of a BLA for PRGN-2012 in RRP as we have finalized our pre-BLA meetings and are aligned with the FDA on the content for all modules and plan for submission in the fourth quarter. Our commercial and manufacturing readiness campaigns for PRGN-2012 are well underway to support a potential 2025 launch," said
"Following our reprioritization and public equity offering announced in August, we remain focused on fiscal management while appropriately investing in activities necessary for the potential launch of PRGN-2012. We are making good progress on a number of potential financing options, including strategic partnerships and other transactions. We will update our investors on this progress in the coming months," said
Key Program Highlights
PRGN-2012 AdenoVerse®Gene Therapy in RRP
- PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy 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). PRGN-2012 receivedBreakthrough Therapy Designationfrom the
US Food and Drug Administration (FDA). PRGN-2012 also receivedOrphan Drug Designationfrom the FDA andOrphan Drug Designationfrom theEuropean Commission . - Results from the pivotal clinical study of PRGN-2012 for the treatment of RRPwere presented at the 2024
American Society of Clinical Oncology (ASCO) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients."- Pivotal study met primary safety and efficacy endpoints.
- 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; Complete Responses have been durable beyond 12 months with median duration of follow up of 20 months as of the
May 20, 2024 data cutoff. - 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment.
- PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
- PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.
- PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders.
- The Company has completed the pre-biologics license application (BLA) meeting with the FDA and is in full alignment on the content of the BLA, including the clinical and chemistry, manufacturing and controls (CMC) module, and the path for a fourth quarter 2024 rolling BLA submission under an accelerated approval pathway.
- The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential 2025 launch.
- Patient enrollment continues to advance in the confirmatory clinical trial of PRGN-2012 in accordance with the guidance from the FDA to initiate the study prior to submission of the BLA.
PRGN-2009 AdenoVerse®Gene Therapy in HPV-associated cancers
- PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the
National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. As part of thestrategic reprioritization announced earlier, the Company has paused enrollment in the cervical cancer Phase 2 clinical trial at non-NCI sites.
PRGN-3006 UltraCAR-T®in AML and MDS
- The Company has completed enrollment of thePhase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps.
PRGN-3008 UltraCAR-T® Targeting CD19 in Oncology and Autoimmune Diseases
- PRGN-3008 is an autologous CD19-directed UltraCAR-T, based on
Precigen's next generation UltraCAR-T platform, which is engineered to express a CD19 chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) for enhanced persistence and maintenance of stem cell memory/naïve (Tscm) phenotype, an intrinsic PD-1 blockade without complex and expensive gene editing techniques to avoid exhaustion, and a safety/kill switch, all from a single non-viral transposon to ensure a homogenous cell product. - Next generation UltraCAR-T aims to improve on conventional CAR-T through overnight manufacturing, incorporation of a safety/kill switch, built-in PD1 downregulation that avoids the need for checkpoint inhibitor combination, and the ability for repeat dosing. These advantages give
Precigen's CD19 UltraCAR-T the potential to be the best-in-class treatment for B-cell malignancies and autoimmune indications for the proven CD19 target. - Preclinical data for PRGN-3008 were presented at the
Society for Immunotherapy of Cancer (SITC) 39thAnnual Meeting in a poster presentation titled, "Non-viral engineered next generation CD19 UltraCAR-T with membrane bound IL-15 (mbIL15) and PD-1 blockade preserves stem cell memory/naïve phenotype and enhances anti-tumor efficacy."- Preclinical data showed that inin vivotumor models, a single administration of PRGN-3008 enhanced expansion and persistence, produced robust antitumor efficacy with complete tumor clearance, and demonstrated significantly longer survival compared to conventional CD19 CAR-T cells.
- In a simulation of tumor relapse in thein vivomodel, PRGN-3008 demonstrated persistence and long-term antitumor immunity extending overall survival without additional PRGN-3008 treatment.
- In a humanized mouse model of lupus nephritis, additional preclinical data for PRGN-3008 in an autoimmune setting presented at the 2024 Cell and Gene Meeting on the Mesa showed complete elimination of B-cells as well as a decrease in antibodies to double-stranded DNA (dsDNA), a specific marker of lupus.
Financial Highlights
- The Company closed a public offering of its common stock in
August 2024 , resulting in net proceeds of approximately$30.9 million (after deducting underwriting discounts, fees and other underwriting expenses). - In
August 2024 , the Company began a strategic prioritization of its clinical portfolio and streamlining of its resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of PRGN-2012.
Third Quarter 2024 Financial Results Compared to Prior Year Period
SG&A expenses increased by
Research and development expenses decreased by
Other income (expense), net, decreased by
Total revenues decreased
Net loss was
First Nine months 2024 Financial Results Compared to Prior Year Period
SG&A expenses increased by
Research and development expenses increased
Other income (expense), net, decreased
In conjunction with the suspension of ActoBio's operations, the Company recorded
Total revenues decreased
Net loss was
Trademarks
Cautionary Statement Regarding Forward-Looking StatementsSome 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
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†zopapogene imadenovec is the international nonproprietary name (INN) for the investigational therapeutic known as PRGN-2012. Zopapogene imadenovec has not been approved by any health authority in any country for any indication. |
(Amounts in thousands) | ||
Assets | ||
Current assets | ||
Cash and cash equivalents | $ 24,725 | $ 7,578 |
Short-term investments | 3,906 | 55,277 |
Receivables | ||
Trade, net | 479 | 902 |
Other | 250 | 673 |
Prepaid expenses and other | 5,153 | 4,325 |
Total current assets | 34,513 | 68,755 |
Property, plant and equipment, net | 13,538 | 7,111 |
Intangible assets, net | 4,773 | 40,701 |
24,918 | 26,612 | |
Right-of-use assets | 5,307 | 7,097 |
Other assets | 425 | 767 |
Total assets | $ 83,474 | $ 151,043 |
Liabilities and Shareholders' Equity | ||
Current liabilities | ||
Accounts payable | $ 4,320 | $ 1,726 |
Accrued compensation and benefits | 6,612 | 8,250 |
Other accrued liabilities | 5,676 | 6,223 |
Settlement and Indemnification Accrual | 3,213 | 5,075 |
Deferred revenue | 407 | 509 |
Current portion of lease liabilities | 988 | 1,202 |
Total current liabilities | 21,216 | 22,985 |
Deferred revenue, net of current portion | 2,032 | 1,818 |
Lease liabilities, net of current portion | 4,761 | 5,895 |
Deferred tax liabilities | 89 | 1,847 |
Total liabilities | 28,098 | 32,545 |
Shareholders' equity | ||
Common stock | - | - |
Additional paid-in capital | 2,126,342 | 2,084,916 |
Accumulated deficit | (2,070,979) | (1,964,471) |
Accumulated other comprehensive income (loss) | 13 | (1,947) |
Total shareholders' equity | 55,376 | 118,498 |
Total liabilities and shareholders' equity | $ 83,474 | $ 151,043 |
Three Months Ended | Nine Months Ended | |||
(Amounts in thousands, except share and pershare data) | ||||
Revenues | ||||
Product revenues | $ 66 | $ 82 | $ 235 | $ 730 |
Service revenues | 886 | 1,296 | 2,478 | 4,261 |
Other revenues | 1 | 1 | 22 | 6 |
Total revenues | 953 | 1,379 | 2,735 | 4,997 |
Operating Expenses | ||||
Cost of products and services | 1,009 | 1,537 | 3,098 | 4,761 |
Research and development | 11,370 | 11,583 | 41,312 | 35,620 |
Selling, general and administrative | 9,836 | 9,196 | 30,293 | 30,150 |
Impairment of goodwill | - | - | 1,630 | - |
Impairment of other noncurrent assets | - | - | 32,915 | - |
Total operating expenses | 22,215 | 22,316 | 109,248 | 70,531 |
Operating loss | (21,262) | (20,937) | (106,513) | (65,534) |
Other Expense, Net | ||||
Interest expense | (2) | (1) | (6) | (461) |
Interest income | 283 | 856 | 1,210 | 2,316 |
Other income (expense), net | (2,985) | 281 | (2,905) | 705 |
Total other income (expense), net | (2,704) | 1,136 | (1,701) | 2,560 |
Loss before income taxes | (23,966) | (19,801) | (108,214) | (62,974) |
Income tax benefit (expense) | (12) | 6 | 1,706 | 126 |
Net loss | $ (23,978) | $ (19,795) | $ (106,508) | $ (62,848) |
Net Loss per share | ||||
Net loss per share, basic and diluted | $ (0.09) | $ (0.08) | $ (0.41) | $ (0.26) |
Weighted average shares outstanding, basic anddiluted | 275,881,170 | 248,520,724 | 259,254,775 | 243,075,262 |
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