Full Press Release Details
GERMANTOWN, Md.,March 19, 2025/PRNewswire/ --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 full year 2024 financial results and business updates.
"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," saidHelen Sabzevari, PhD, President and CEO of Precigen. "Already this year, our BLA for PRGN-2012 received priority review from the FDA with anAugust 2025PDUFA 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," saidHarry Thomasian Jr., CFO of Precigen.
Key Program Highlights
PRGN-2012 (nonproprietary name: zopapogene imadenovec†) AdenoVerse®Gene Therapy in RRPPRGN-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 Designation,Orphan Drug Designation, andan accelerated approval pathwayfrom the FDA, andOrphan Drug Designationfrom the European Commission.
PRGN-2009 AdenoVerse®Gene Therapy in HPV-associated cancersPRGN-2009 is an investigational off-the-shelf AdenoVerse gene therapy designed to activate the immune system to recognize and target HPV-associated cancers.
PRGN-3006 UltraCAR-T®in AML and MDSPRGN-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 grantedOrphan Drug Designationin patients with acute myeloid leukemia (AML) andFast Track Designationin patients with relapsed/refractory (r/r) AML by the FDA.
Financial Highlights
Full Year 2024 Financial Results Compared to Prior Year PeriodTotal revenues decreased$2.3 million, or 37%, and cost of products and services decreased$1.8 millionor 30% compared to the year endedDecember 31, 2023. These decreases were primarily related to reductions in product and service volumes at Exemplar.
Research and development expenses increased$4.5 million, or 9%, compared to the year ended December 31, 2023. This increase was primarily the result of$3.1 millionof increased costs associated with the initiation of the PRGN-2012 confirmatory clinical trial, increased drug manufacturing material costs related to PRGN-2012 for potential commercial use, and professional fees incurred in conjunction with the Company's completed BLA submission and commercial readiness planning as well as the design and implementation of our manufacturing facility. Additionally, employee-related expenses rose by$3.0 millionprimarily due to severance charges incurred as a result of the Precigen workforce reduction in 2024 and the suspension of ActoBio's operations. These increases were partially offset by a$1.9 millionreduction in depreciation and amortization expense as a result of the impairment of noncurrent assets related to the suspension of ActoBio's operations during the second quarter of 2024 as well as a reduction in clinical study expenses associated with programs that were deprioritized during the third quarter of 2024.
SG&A expenses increased$0.9 million, or 2%, compared to the year ended December 31, 2023. As a result of the Company's increased focus on PRGN-2012, commercial readiness costs increased in 2024 compared to the prior year. In addition, the second and third quarters of 2024 included higher severance costs associated with the suspension of ActoBio's operations and the Precigen workforce reduction. These increases were partially offset by a decrease in stock compensation and insurance rates in 2024 compared to the same period in 2023.
The Company recorded a$5.8 million impairment charge in the fourth quarter of 2024 related to its Exemplar subsidiary as a result of the Company's annual goodwill impairment test. Also, in conjunction with the suspension of ActoBio's operations, the Company recorded$34.5 millionof impairment charges related to goodwill ($1.6 million) and other noncurrent assets ($32.9 million) in the second quarter of 2024.
Total other income, net, increased$3.6 million, or 106% compared to the year ended December 31, 2023. This increase was primarily derived from an$8.5 milliongain on the sale of intellectual property rights and royalty rights related to a non-core asset inDecember 2024as well as a$0.5 millionreduction in interest expense due to the final retirement of the Company Convertible Notes in the second quarter of 2023. This increase was partially offset by a reclassification of cumulative translation losses of$2.9 million, which resulted from the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction of$1.8 millionin interest income compared to the same period in 2023.
Net loss was$126.2 million, or$(0.47)per basic and diluted share, compared to net loss of$95.9 million, or$(0.39)per basic and diluted share, in year endedDecember 31, 2023.
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, visitwww.precigen.comor follow us onLinkedInorYouTube.
TrademarksPrecigen, 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 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 Securities and Exchange Commission.
Investor Contact:Steven M. HarasymTel: +1 (301) 556-9850[email protected]
Media Contacts:Donelle M. Gregory[email protected]
†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.
SOURCE Precigen, Inc.
| Precigen, Inc. and SubsidiariesConsolidated 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 SubsidiariesConsolidated 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 |