Precigen Reports Full Year 2024 Financial Results and Business Updates
Rhea-AI Summary
Precigen (PGEN) announced its full year 2024 financial results and significant progress with its lead therapy PRGN-2012. The FDA granted priority review for PRGN-2012's BLA with a PDUFA date of August 27, 2025, potentially making it the first FDA-approved treatment for recurrent respiratory papillomatosis (RRP).
Key clinical highlights include:
- 51% of patients achieved Complete Response with no required surgeries after treatment
- 86% of patients showed decreased surgical interventions
- Median duration of response was 2 years, with some patients surgery-free beyond 3 years
Financial position:
- Ended 2024 with $97.9 million in cash and investments
- Raised $87.5 million through preferred stock offering and asset sale
- Extended cash runway into 2026
- Net loss of $126.2 million ($0.47 per share) compared to $95.9 million in 2023
Positive
- FDA granted priority review for PRGN-2012 with PDUFA date of August 27, 2025
- Strong clinical efficacy with 51% complete response rate in RRP patients
- Raised $87.5 million through financing activities
- Extended cash runway into 2026, beyond potential commercial launch
- Large market opportunity with 27,000 US adult patients and 125,000+ outside US
Negative
- Net loss increased to $126.2 million from $95.9 million in 2023
- Total revenues decreased by 37% compared to 2023
- Research and development expenses increased by 9%
- Recorded $40.3 million in total impairment charges
- SG&A expenses increased by 2%
News Market Reaction
On the day this news was published, PGEN gained 0.56%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- FDA granted priority review to Company's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis and set PDUFA target action date for August 27, 2025
- Results from pivotal clinical study of PRGN-2012 were published in The Lancet Respiratory Medicine
- PRGN-2012 treatment demonstrated durable complete responses with median duration of response of two years, with some complete responders surgery-free beyond three years as of August 28, 2024 data cutoff
- Company continues to rapidly advance commercial and manufacturing readiness campaign in anticipation of 2025 commercial launch
- Company ended 2024 with
$97.9 million
"Last year, we achieved several milestones on our path to potentially bring our innovative PRGN-2012 therapy to RRP patients, including presentation of groundbreaking pivotal data and BLA submission to the FDA. Through prioritizing our portfolio and financing activities, we strengthened our financial position, enabling ongoing commercial and manufacturing readiness efforts for PRGN-2012 in anticipation of a potential 2025 launch. Our commercial organization has been working to scale up quickly, right-sizing the organization to rapidly capitalize on the immense demand from patients and treating physicians for a new treatment paradigm that may finally address the underlying cause of the disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "Already this year, our BLA for PRGN-2012 received priority review from the FDA with an August 2025 PDUFA action date, bringing us a step closer to launching the first and only FDA-approved treatment to the approximately 27,000 adult RRP patients in the US. FDA approval for PRGN-2012 would fundamentally change Precigen, enabling the transition from clinical to commercial stage with the real and imminent potential to begin realizing product sales this year and providing financial tailwinds to enable potential expansion of PRGN-2012 to new indications and geographical markets."
"As a result of the preferred stock offering and sale of intellectual property and related royalty rights for a non-core asset, we extended our cash runway into 2026, beyond the potential commercial launch of PRGN-2012 this year. We are preparing for the transition to a commercial stage company and the potential to add product-related revenue," said Harry Thomasian Jr., CFO of Precigen.
Key Program Highlights
PRGN-2012 (nonproprietary name: zopapogene imadenovec†) 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 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the FDA, and Orphan Drug Designation from the European Commission.
- In February 2025, the US Food and Drug Administration (FDA) accepted the company's biologics license application (BLA) for PRGN-2012, and granted priority review to the BLA with a Prescription Drug User Fee Act (PDUFA) target action date set for August 27, 2025. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss the BLA.
- Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were 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" and published in The Lancet Respiratory Medicine.
- Pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints.
- PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
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 24 months, with some complete responders surgery-free beyond three years as of the August 28, 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 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 anatomical Derkay scores and VHI-10 scores in complete responders.
- 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.
- The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential launch in 2025.
- Based on recently updated internal analysis derived from review of claims data, the market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US.
PRGN-2009 AdenoVerse® Gene Therapy in HPV-associated cancers
PRGN-2009 is an investigational off-the-shelf AdenoVerse gene therapy designed to activate the immune system to recognize and target 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.
PRGN-3006 UltraCAR-T® in AML and 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.
- The Company has completed enrollment of the Phase 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.
Financial Highlights
- In December 2024, the Company raised
$87.5 million $79.0 million $8.5 million - By year's end 2024, cash, cash equivalents, and investments totaled
$97.9 million
Full Year 2024 Financial Results Compared to Prior Year Period
Total revenues decreased
Research and development expenses increased
SG&A expenses increased
The Company recorded a
Total other income, net, increased
Net loss was
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 LinkedIn or YouTube.
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
Tel: +1 (301) 556-9850
investors@precigen.com
Media Contacts:
Donelle M. Gregory
press@precigen.com
†zopapogene imadenovec is the nonproprietary name for the investigational therapeutic known as PRGN-2012. Zopapogene imadenovec has not been approved by any health authority in any country for any indication.
Precigen, Inc. and Subsidiaries Consolidated Balance Sheets (Unaudited) | ||
(Amounts in thousands) | December 31, 2024 | December 31, 2023 |
Assets | ||
Current assets | ||
Cash and cash equivalents | $ 29,517 | $ 7,578 |
Short-term investments | 68,393 | 55,277 |
Receivables | ||
Trade, net | 926 | 902 |
Other | 237 | 673 |
Prepaid expenses and other | 3,341 | 4,325 |
Total current assets | 102,414 | 68,755 |
Property, plant and equipment, net | 13,831 | 7,111 |
Intangible assets, net | 4,455 | 40,701 |
Goodwill | 19,139 | 26,612 |
Right-of-use assets | 5,056 | 7,097 |
Other assets | 371 | 767 |
Total assets | $ 145,266 | $ 151,043 |
Liabilities, Mezzanine Equity and Shareholders' Equity | ||
Current liabilities | ||
Accounts payable | $ 3,531 | $ 1,726 |
Accrued compensation and benefits | 8,417 | 8,250 |
Other accrued liabilities | 4,812 | 6,223 |
Indemnification Accrual | 3,213 | 5,075 |
Deferred revenue | 589 | 509 |
Current portion of lease liabilities | 956 | 1,202 |
Total current liabilities | 21,518 | 22,985 |
Deferred revenue, net of current portion | 1,934 | 1,818 |
Lease liabilities, net of current portion | 4,546 | 5,895 |
Deferred tax liabilities | - | 1,847 |
Warrant liabilities | 50,537 | - |
Total liabilities | 78,535 | 32,545 |
Mezzanine Equity | ||
Series A Preferred Stock | 28,218 | - |
Shareholders' equity | ||
Common stock | - | - |
Additional paid-in capital | 2,129,207 | 2,084,916 |
Accumulated deficit | (2,090,706) | (1,964,471) |
Accumulated other comprehensive income (loss) | 12 | (1,947) |
Total shareholders' equity | 38,513 | 118,498 |
Total liabilities, mezzanine equity and shareholders' equity | $ 145,266 | $ 151,043 |
Precigen, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited) | ||
Year ended | ||
(Amounts in thousands, except share and per share data) | December 31, 2024 | December 31, 2023 |
Revenues | ||
Collaboration and licensing revenues | $ - | $ 75 |
Product revenues | 422 | 840 |
Service revenues | 3,470 | 5,301 |
Other revenues | 33 | 9 |
Total revenues | 3,925 | 6,225 |
Operating Expenses | ||
Cost of products and services | 4,267 | 6,119 |
Research and development | 53,070 | 48,614 |
Selling, general and administrative | 41,293 | 40,415 |
Impairment of goodwill | 7,409 | 10,390 |
Impairment of other noncurrent assets | 32,915 | 445 |
Total operating expenses | 138,954 | 105,983 |
Operating loss | (135,029) | (99,758) |
Other Income (Expense), Net | ||
Interest expense | (6) | (468) |
Interest income | 1,418 | 3,237 |
Other income, net | 5,589 | 627 |
Total other income, net | 7,001 | 3,396 |
Loss before income taxes | (128,028) | (96,362) |
Income tax benefit | 1,793 | 458 |
Net loss | $ (126,235) | $ (95,904) |
Net Loss per share | ||
Net loss per share, basic and diluted | $ (0.47) | $ (0.39) |
Weighted average shares outstanding, basic and diluted | 267,727,426 | 244,536,221 |
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SOURCE Precigen, Inc.
FAQ
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