GERMANTOWN, Md., March 19, 2024 /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 2023 financial results and business updates.
"2024 is poised to be a transformative year for Precigen, as we are on track to present pivotal Phase 2 data in the second quarter and submit a BLA for PRGN-2012 in the second half, a milestone bolstered by the Breakthrough Therapy Designation and accelerated approval pathway granted by the FDA," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are preparing our manufacturing facility and commercial operations in anticipation of the launch of PRGN-2012 in 2025. We are also looking forward to exciting updates from our UltraCAR-T programs, which offer a novel approach compared to traditional CAR-T therapies and have garnered significant interest from potential partners due to the safety, preliminary efficacy, and manufacturing advantages."
"With multiple value inflection points anticipated in 2024, we remain steadfastly committed to a strategy of sound financial management," said Harry Thomasian Jr., CFO of Precigen. "We are evaluating various financing opportunities to strengthen our balance sheet as we prepare our lead asset PRGN-2012 for potential commercial launch in 2025."
Key Program Highlights
AdenoVerse™ Immunotherapies
UltraCAR-T® Cell Therapies
Financial Highlights
Full Year 2023 Financial Results Compared to Prior Year Period
Research and development expenses increased $1.4 million, or 3.1%, compared to year ended December 31, 2022. Salaries, benefits, and other personnel costs increased $2.8 million due to an increase in the hiring of employees to support the growth in the Company's development activities, and to a lesser extent, increases in salaries of our continuing employees. These increases were offset by less expenses incurred related to preclinical research programs for the comparable period.
SG&A expenses decreased $7.6 million, or 15.8%, compared to the year ended December 31, 2022. This decrease was primarily driven by a reduction in professional fees of $6.5 million, due to decreased legal fees associated with certain litigation matters, and $0.7 million decreased insurance-related premiums.
Total revenues decreased $20.7 million, or 76.9%, compared to the year ended December 31, 2022. Collaboration and licensing revenues decreased $14.6 million, or 99.5%, compared to the year ended December 31, 2022, primarily due to the prior year period non-cash recognition of revenue related to historical collaboration agreements for which revenue was previously deferred. Product and services revenues decreased $5.9 million, or 48.8%, compared to the year ended December 31, 2022. This decrease is related to reductions in services performed at Exemplar as well as the recognition of revenue in the first quarter of 2022 related to agreements for which revenue was previously deferred that did not occur in 2023.
Total other income, net, increased $8.5 million, compared to the year ended December 31, 2022. This was primarily due to $6.3 million in reduced interest expense associated with the Convertible Notes as they were fully retired in the second quarter of 2023, and $3.1 million increased interest income due to higher interest rates on investments. This increase was partially offset by a $0.9 million decrease in gain recorded on the early retirement of a portion of our Convertible Notes compared to the year ended December 31, 2022.
The Company recorded a $10.4 million impairment charge in the fourth quarter of 2023 related to its Exemplar subsidiary as a result of the Company's annual goodwill impairment test.
Loss from continuing operations was $95.9 million, or $(0.39) per basic and diluted share, compared to loss from continuing operations of $79.8 million, or $(0.40) per basic and diluted share, in year ended December 31, 2022.
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 X @Precigen, LinkedIn or YouTube.
UltraCAR-T®
UltraCAR-T is a multigenic autologous CAR-T platform that utilizes Precigen's advanced non-viral Sleeping Beauty system to simultaneously express an antigen-specific CAR to specifically target tumor cells, mbIL15 for enhanced in vivo expansion and persistence, and a kill switch to conditionally eliminate CAR-T cells for a potentially improved safety profile. Precigen has advanced the UltraCAR-T platform to address the inhibitory tumor microenvironment by incorporating a novel mechanism for intrinsic checkpoint blockade without the need for complex and expensive gene editing techniques. UltraCAR-T investigational therapies are manufactured via Precigen's overnight manufacturing process using the proprietary UltraPorator® electroporation system at the patient's medical center and administered to patients only one day following gene transfer. The overnight UltraCAR-T manufacturing process does not use viral vectors and does not require ex vivo activation and expansion of T cells, potentially addressing major limitations of current T cell therapies.
UltraCAR-T® Clinical Program
Precigen's UltraCAR-T platform is currently under clinical investigation for hematological and solid tumors, including a Phase 1/1b study of PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (NCT03907527), a Phase 1/1b study of PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS) (NCT03927261) and a Phase 1/1b study of PRGN-3007 UltraCAR-T incorporating PD-1 checkpoint inhibition in patients with ROR1-positive (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and triple negative breast cancer (TNBC) (NCT05694364). PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation and Fast Track Designation in patients with AML by the US Food and Drug Administration (FDA).
UltraCAR-T® Library Approach
Precigen's UltraCAR-T library approach is designed to transform the personalized cell therapy landscape for cancer patients. Precigen's goal is to develop and validate a library of non-viral plasmids to target tumor-associated antigens. Enabled by design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator® system, Precigen is working to empower medical centers to deliver personalized, autologous UltraCAR-T treatment with overnight manufacturing to any cancer patient. Based on the patient's cancer indication and biomarker profile, one or more non-viral plasmids would be selected from the library to build a personalized UltraCAR-T treatment. After initial treatment, this approach has the potential to allow for redosing of UltraCAR-T targeting the same or new tumor-associated antigen(s) based on the treatment response and the changes in antigen expression of the patient's tumor. Precigen believes that the combination of the advanced UltraVector® DNA construction platform and the ease of overnight manufacturing gives this library approach a proprietary advantage over traditional T-cell therapies.
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 Precigen's proprietary non-viral gene transfer technology. UltraPorator is being utilized for clinical manufacturing of Precigen's investigational UltraCAR-T therapies in compliance with current good manufacturing practices.
AdenoVerse™ Immunotherapy
Precigen's AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen's gorilla adenovectors, part of the AdenoVerse library, have potentially superior performance characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors leveraging UltraVector® technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases.
AdenoVerse™ Immunotherapy Clinical Program
Precigen's AdenoVerse immunotherapy platform is currently under clinical investigation in a Phase 1/2 study of PRGN-2009 AdenoVerse immunotherapy alone or in combination with an anti-PDL1/TGF-Beta Trap in patients with HPV-associated cancers (NCT04432597), a Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) (NCT05996523), a Phase 2 study of PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer (NCT06157151), and a Phase 1/2 study of PRGN-2012 AdenoVerse immunotherapy in patients with recurrent respiratory papillomatosis (RRP) (NCT04724980). PRGN-2012 has been granted Orphan Drug Designation and Breakthrough Therapy Designation in patients with RRP by the FDA and Orphan Drug Designation by the European Commission.
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
Vice President, Investor Relations
Tel: +1 (301) 556-9850
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Media Contacts:
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Precigen, Inc. and Subsidiaries Consolidated Balance Sheets (Unaudited) | ||
(Amounts in thousands) | December 31, 2023 | December 31, 2022 |
Assets | ||
Current assets | ||
Cash and cash equivalents | $ 7,578 | $ 4,858 |
Restricted cash | - | 43,339 |
Short-term investments | 55,277 | 51,092 |
Receivables | ||
Trade, net | 902 | 978 |
Other | 673 | 12,826 |
Prepaid expenses and other | 4,325 | 5,066 |
Total current assets | 68,755 | 118,159 |
Property, plant and equipment, net | 7,111 | 7,329 |
Intangible assets, net | 40,701 | 44,455 |
Goodwill | 26,612 | 36,923 |
Right-of-use assets | 7,097 | 8,086 |
Other assets | 767 | 1,025 |
Total assets | $ 151,043 | $ 215,977 |
Liabilities and Shareholders' Equity | ||
Current liabilities | ||
Accounts payable | $ 1,726 | $ 4,068 |
Accrued compensation and benefits | 8,250 | 6,377 |
Other accrued liabilities | 6,223 | 4,997 |
Settlement and Indemnification Accrual | 5,075 | 18,750 |
Deferred revenue | 509 | 25 |
Current portion of long-term debt | - | 43,219 |
Current portion of lease liabilities | 1,202 | 1,209 |
Total current liabilities | 22,985 | 78,645 |
Deferred revenue, net of current portion | 1,818 | 1,818 |
Lease liabilities, net of current portion | 5,895 | 6,992 |
Deferred tax liabilities | 1,847 | 2,263 |
Total liabilities | 32,545 | 89,718 |
Shareholders' equity | ||
Common stock | - | - |
Additional paid-in capital | 2,084,916 | 1,998,314 |
Accumulated deficit | (1,964,471) | (1,868,567) |
Accumulated other comprehensive loss | (1,947) | (3,488) |
Total shareholders' equity | 118,498 | 126,259 |
Total liabilities and shareholders' equity | $ 151,043 | $ 215,977 |
Precigen, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited) | ||
Year ended | ||
(Amounts in thousands, except share and per share data) | December 31, | December 31, |
Revenues | ||
Collaboration and licensing revenues | $ 75 | $ 14,661 |
Product revenues | 840 | 1,903 |
Service revenues | 5,301 | 10,094 |
Other revenues | 9 | 251 |
Total revenues | 6,225 | 26,909 |
Operating Expenses | ||
Cost of products and services | 6,119 | 6,339 |
Research and development | 48,614 | 47,170 |
Selling, general and administrative | 40,415 | 48,006 |
Impairment of goodwill | 10,390 | 482 |
Impairment of other noncurrent assets | 445 | 638 |
Total operating expenses | 105,983 | 102,635 |
Operating loss | (99,758) | (75,726) |
Other Expense, Net | ||
Interest expense | (468) | (6,774) |
Interest income | 3,237 | 133 |
Other income, net | 627 | 1,539 |
Total other income (expense), net | 3,396 | (5,102) |
Equity in net loss of affiliates | - | 862 |
Loss from continuing operations before income taxes | (96,362) | (79,966) |
Income tax benefit | 458 | 189 |
Loss from continuing operations | $ (95,904) | $ (79,777) |
Income from discontinued operations, net of income taxes | - | 108,094 |
Net loss | $ (95,904) | $ 28,317 |
Net Loss per share | ||
Net loss from continuing operations per share, basic and diluted | $ (0.39) | $ (0.40) |
Net income from discontinued operations per share, basic and diluted | - | 0.54 |
Net loss per share, basic and diluted | $ (0.39) | $ 0.14 |
Weighted average shares outstanding, basic and diluted | 244,536,221 | 200,360,821 |
| Last Trade: | US$0.90 |
| Daily Change: | 0.0001 0.01 |
| Daily Volume: | 849,280 |
| Market Cap: | US$264.250M |
August 14, 2024 August 06, 2024 | |
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