GERMANTOWN, Md., Aug. 14, 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 second quarter and first half 2024 financial results and business updates.
"We are all in on PRGN-2012 given the immense unmet need for RRP patients and our groundbreaking pivotal data supporting the potential of what we hope to be the first-ever FDA approved therapy to treat RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "By strategically focusing our portfolio, streamlining resources and recent public offering, we have optimized the company to rapidly prepare for submission of a rolling biologics license application under an accelerated approval pathway. We are excited to have initiated enrollment in the confirmatory clinical trial and will continue to accelerate our commercial readiness campaign for a potential launch in 2025 under the leadership of our newly hired Chief Commercial Officer. Additionally, we plan to maximize portfolio value by focusing on strategic partnerships to further advance our highly promising UltraCAR-T programs."
"Our recent reprioritization and public offering is expected to fund our operations into early 2025 allowing us to focus on advancement of PRGN-2012 while continuing to explore potential non-dilutive financing opportunities for future liquidity," said Harry Thomasian Jr., CFO of Precigen.
Key Program Highlights
Financial Highlights
Second Quarter 2024 Financial Results Compared to Prior Year Period
Research and development expenses increased $3.8 million, or 32%, compared to the three months ended June 30, 2023. Salaries, benefits, and other personnel costs increased $2.1 million primarily due to severance charges related to the shutdown of the Company's ActoBio subsidiary. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the same period in 2023.
SG&A expenses increased by $1.0 million, or 11%, compared to the three months ended June 30, 2023. This increase was primarily driven by severance costs incurred related to the suspension of ActoBio operations of $0.4 million, increased costs associated with PRGN-2012 commercial readiness as well as increased professional fees incurred related to general corporate matters compared to the same period in 2023.
In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.
Total revenues decreased $1.1 million, or 59%, compared to the three months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.
Net loss was $58.8 million, or $(0.23) per basic and diluted share, compared to net loss of $20.3 million, or $(0.08) per basic and diluted share, in period ended June 30, 2023.
First Half 2024 Financial Results Compared to Prior Year Period
Research and development expenses increased $5.9 million, or 25%, compared to the six months ended June 30, 2023. Salaries, benefits, and other personnel costs increased by $3.3 million primarily due to $2.1 million of severance charges related to the shutdown of the Company's ActoBio subsidiary and an increase in the hiring of employees related to the advancement of PRGN-2012 in 2023 at Precigen. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the prior year period. These increases were offset by lower costs incurred at contract research organizations for other programs compared to the same period in 2023.
SG&A expenses decreased by $0.5 million, or 2%, compared to the six months ended June 30, 2023. This decrease was primarily due to lower stock compensation and insurance expenses in 2024 compared to the same period in 2023. These decreases were offset by severance costs incurred in the second quarter of 2024 related to the suspension of ActoBio's operations, and increased costs related to PRGN-2012 commercial readiness compared to the same period in 2023.
In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.
Total revenues decreased $1.9 million, or 51%, compared to the six months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.
Net loss was $82.5 million, or $(0.33) per basic and diluted share, compared to net loss of $43.1 million, or $(0.18) per basic and diluted share, in period ended June 30, 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, visit www.precigen.com or follow us on X @Precigen, 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
Vice President, Investor Relations
Tel: +1 (301) 556-9850
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Media Contacts:
Donelle M. Gregory
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Glenn Silver
Lazar-FINN Partners
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Precigen, Inc. and Subsidiaries Consolidated Balance Sheets (Unaudited) | ||
(Amounts in thousands) | June 30, 2024 | December 31, 2023 |
Assets | ||
Current assets | ||
Cash and cash equivalents | $ 9,345 | $ 7,578 |
Short-term investments | 10,191 | 55,277 |
Receivables | ||
Trade, net | 511 | 902 |
Other | 505 | 673 |
Prepaid expenses and other | 3,163 | 4,325 |
Total current assets | 23,715 | 68,755 |
Property, plant and equipment, net | 13,451 | 7,111 |
Intangible assets, net | 5,091 | 40,701 |
Goodwill | 24,918 | 26,612 |
Right-of-use assets | 5,550 | 7,097 |
Other assets | 435 | 767 |
Total assets | $ 73,160 | $ 151,043 |
Liabilities and Shareholders' Equity | ||
Current liabilities | ||
Accounts payable | $ 4,846 | $ 1,726 |
Accrued compensation and benefits | 6,675 | 8,250 |
Other accrued liabilities | 6,642 | 6,223 |
Settlement and Indemnification Accrual | 3,213 | 5,075 |
Deferred revenue | 378 | 509 |
Current portion of lease liabilities | 1,269 | 1,202 |
Total current liabilities | 23,023 | 22,985 |
Deferred revenue, net of current portion | 1,818 | 1,818 |
Lease liabilities, net of current portion | 5,072 | 5,895 |
Deferred tax liabilities | 77 | 1,847 |
Total liabilities | 29,990 | 32,545 |
Shareholders' equity | ||
Common stock | - | - |
Additional paid-in capital | 2,093,080 | 2,084,916 |
Accumulated deficit | (2,047,001) | (1,964,471) |
Accumulated other comprehensive loss | (2,909) | (1,947) |
Total shareholders' equity | 43,170 | 118,498 |
Total liabilities and shareholders' equity | $ 73,160 | $ 151,043 |
Precigen, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited) | ||||
Three Months Ended | Six Months Ended | |||
(Amounts in thousands, except share and per share data) | June 30, 2024 | June 30, 2023 | June 30, 2024 | June 30, 2023 |
Revenues | ||||
Product revenues | $ 31 | $ 324 | $ 169 | $ 648 |
Service revenues | 673 | 1,438 | 1,592 | 2,965 |
Other revenues | 13 | 5 | 21 | 5 |
Total revenues | 717 | 1,767 | 1,782 | 3,618 |
Operating Expenses | ||||
Cost of products and services | 1,014 | 1,697 | 2,089 | 3,224 |
Research and development | 15,693 | 11,874 | 29,942 | 24,037 |
Selling, general and administrative | 10,306 | 9,316 | 20,457 | 20,954 |
Impairment of goodwill | 1,630 | - | 1,630 | - |
Impairment of other noncurrent assets | 32,915 | - | 32,915 | - |
Total operating expenses | 61,558 | 22,887 | 87,033 | 48,215 |
Operating loss | (60,841) | (21,120) | (85,251) | (44,597) |
Other Income (Expense), Net | ||||
Interest expense | (2) | (136) | (4) | (460) |
Interest income | 319 | 828 | 927 | 1,460 |
Other income, net | 43 | 44 | 80 | 424 |
Total other income, net | 360 | 736 | 1,003 | 1,424 |
Loss before income taxes | (60,481) | (20,384) | (84,248) | (43,173) |
Income tax benefit | 1,689 | 65 | 1,718 | 120 |
Net loss | $ (58,792) | $ (20,319) | $ (82,530) | $ (43,053) |
Net Loss per share | ||||
Net loss per share, basic and diluted | $ (0.23) | $ (0.08) | $ (0.33) | $ (0.18) |
Weighted average shares outstanding, basic and diluted | 252,366,533 | 248,003,322 | 250,803,790 | 240,307,403 |
| Last Trade: | US$0.91 |
| Daily Change: | 0.0021 0.23 |
| Daily Volume: | 753,231 |
| Market Cap: | US$264.840M |
August 06, 2024 | |
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