Full Press Release Details
GERMANTOWN, Md.,May 14, 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 first quarter 2025 financial results and business updates.
"We are extremely pleased with the progress of our PRGN-2012 program and its immense potential for RRP patients. We remain laser-focused on advancing the program toward the rapidly approaching PDUFA target action date in August. If approved, PRGN-2012 has the potential to be the first and only FDA-approved therapeutic for the treatment of RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "We encourage anyone interested in learning more about RRP and hearing directly from RRP patients, caregivers, and the healthcare community supporting them to join Precigen and the Recurrent Respiratory Papillomatosis Foundation for the 2025 International RRP Awareness Day onJune 11. Panelists will discuss the patient and caregiver experience with RRP, the significant burden of living with a rare and chronic disease such as RRP, and the challenges of repeated surgeries."
"We completed the first quarter with continued financial discipline while appropriately investing in activities related to the potential launch of PRGN-2012. We ended the quarter with cash, cash equivalents, and investments of$81 million, and we reiterate that our cash runway is expected to take us into 2026, without consideration of product-related revenue from the potential commercial launch of PRGN-2012 later this year," said Harry Thomasian Jr., CFO of Precigen.
Key Program and Company Highlights
2025 International RRP Awareness DayThe Company and the Recurrent Respiratory Papillomatosis Foundation (RRPF) will host the 2025 International RRP Awareness Day onJune 11. RRP Awareness Day brings together patients with recurrent respiratory papillomatosis (RRP), their caregivers, and the healthcare community supporting them to encourage dialogue and build community among those affected by this rare, debilitating chronic disease. To stay up-to-date with RRP Awareness Day activities and to register for theJune 11webcast, please visitwww.RRPAwareness.org.
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 adults with RRP. PRGN-2012 receivedBreakthrough Therapy Designation,Orphan Drug Designation, andan accelerated approval pathwayfrom theUS Food and Drug Administration (FDA), and Orphan 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) and Fast Track Designationin patients with relapsed/refractory (r/r) AML by the FDA.
Financial Highlights
First Quarter 2025 Financial Results Compared to Prior Year PeriodTotal revenues increased$0.3 million, or 26%, compared to the three months endedMarch 31, 2024. This increase was primarily related to increased volume of products sold and services rendered at Exemplar.
Research and development expenses decreased by$3.8 million, or 27%, compared to the three months endedMarch 31, 2024. The decrease was primarily due to a$1.8 milliondecrease in costs associated with ActoBio, including depreciation, amortization, personnel, and other operating costs after the Company closed ActoBio's operations in late 2024. Additionally, there was a decrease of$1.2 millionincurred at contract research organizations and an$0.8 milliondecrease due to a reduction in the number of Research and Development employees as a result of the Company's asset prioritization announced in the third quarter of 2024.
SG&A expenses increased by$2.2 million, or 22%, compared to the three months endedMarch 31, 2024. This increase was primarily associated with PRGN-2012 commercial readiness. This increase was partially offset by a reduction in insurance rates and license and patent fees compared to the three months endedMarch 31, 2024.
Total other income (expense), net, changed from income of$0.6 millionin the three months endedMarch 31, 2024, to expense of$31.6 millionin the three months endedMarch 31, 2025. This change was primarily driven by the recording of a$32.5 millionincrease in the fair value of warrant liabilities, which was influenced by an increase in the stock price of Precigen and to a lesser extent, an increase in the liability to account for the additional warrants that will be issued as part of the paid-in-kind dividends related to the Company's Series A Preferred Stock. This decrease was partially offset by a$0.3 millionincrease in interest income resulting from increased investment balances.
Net loss was$54.2 million, or$(0.18)per basic and diluted share, compared to net loss of$23.7 million, or$(0.10)per basic and diluted share, in the three months endedMarch 31, 2024. The non-cash change in the fair value of warrant liabilities of$32.5 millionrecorded in the three months endedMarch 31, 2025reduced basic and diluted earnings per share in that period by$0.11.
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. |
| Precigen, Inc. and Subsidiaries | ||
| Consolidated Balance Sheets | ||
| (Unaudited) | ||
| (Amounts in thousands) | March 31, 2025 | December 31, 2024 |
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | $ 6,058 | $ 29,517 |
| Short-term investments | 74,184 | 68,393 |
| Receivables | ||
| Trade, net | 751 | 926 |
| Other | 313 | 237 |
| Prepaid expenses | 3,295 | 3,341 |
| Total current assets | 84,601 | 102,414 |
| Long-term investments | 750 | - |
| Property, plant and equipment, net | 14,668 | 13,831 |
| Intangible assets, net | 4,136 | 4,455 |
| Goodwill | 19,139 | 19,139 |
| Right-of-use assets | 5,066 | 5,056 |
| Other assets | 427 | 371 |
| Total assets | $ 128,787 | $ 145,266 |
| Liabilities, Mezzanine Equity and Shareholders' (Deficit) Equity | ||
| Current liabilities | ||
| Accounts payable | $ 3,107 | $ 3,531 |
| Accrued compensation and benefits | 9,621 | 8,417 |
| Other accrued liabilities | 6,568 | 4,812 |
| Indemnification Accruals | 3,213 | 3,213 |
| Deferred revenue | 549 | 589 |
| Current portion of lease liabilities | 928 | 956 |
| Total current liabilities | 23,986 | 21,518 |
| Deferred revenue, net of current portion | 1,836 | 1,934 |
| Lease liabilities, net of current portion | 4,489 | 4,546 |
| Warrant liabilities | 83,018 | 50,537 |
| Total liabilities | 113,329 | 78,535 |
| Mezzanine Equity | ||
| Series A Preferred Stock | 29,518 | 28,218 |
| Shareholders' equity (deficit) | ||
| Common stock | - | - |
| Additional paid-in capital | 2,130,787 | 2,129,207 |
| Accumulated deficit | (2,144,859) | (2,090,706) |
| Accumulated other comprehensive income | 12 | 12 |
| Total shareholders' (deficit) equity | (14,060) | 38,513 |
| Total liabilities, mezzanine equity and shareholders' (deficit) equity | $ 128,787 | $ 145,266 |
| Precigen, Inc. and Subsidiaries | ||
| Consolidated Statements of Operations | ||
| (Unaudited) | ||
| Three Months Ended March 31, | ||
| (Amounts in thousands, except share and per share data) | 2025 | 2024 |
| Revenues | ||
| Product revenues | $ 203 | $ 138 |
| Service revenues | 1,115 | 919 |
| Other revenues | 23 | 8 |
| Total revenues | 1,341 | 1,065 |
| Operating Expenses | ||
| Cost of products and services | 1,100 | 1,075 |
| Research and development | 10,478 | 14,249 |
| Selling, general and administrative | 12,359 | 10,151 |
| Total operating expenses | 23,937 | 25,475 |
| Operating loss | (22,596) | (24,410) |
| Other Income (Expense), Net | ||
| Change in fair value of warrant liabilities | (32,481) | - |
| Interest expense | (1) | (2) |
| Interest income | 918 | 608 |
| Other income, net | 7 | 37 |
| Total other (expense) income, net | (31,557) | 643 |
| Loss before income taxes | (54,153) | (23,767) |
| Income tax benefit | - | 29 |
| Net loss | $ (54,153) | $ (23,738) |
| Net Loss per share | ||
| Net loss per share, basic and diluted | $ (0.18) | $ (0.10) |
| Weighted average shares outstanding, basic and diluted | 293,879,653 | 249,220,335 |