Full Press Release Details
Precigen Reports Second Quarter and First Half
2024 Financial Results and Business Updates
June 2024, the Company announced groundbreaking pivotal study data for PRGN-2012 gene therapy at the 2024 ASCO annual meeting in which
more than half of RRP patients achieved Complete Response -
July 2024, the Company appointed Phil Tennant as Chief Commercial Officer to spearhead potential PRGN-2012 commercial launch -
August 2024, the Company announced a strategic reprioritization of its pipeline to focus on advancement of its lead program, PRGN-2012
rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; the Company has initiated enrollment
in the confirmatory clinical trial of PRGN-2012 -
In August 2024, the Company strengthened its cash position by raising approximately $31.4 million via a public offering of common
GERMANTOWN, MD, August 14, 2024 -
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
Quarter 2024 Financial Results Compared to Prior Year Period
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.
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.
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.
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.
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.
Half 2024 Financial Results Compared to Prior Year Period
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.
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.
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.
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.
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
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
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.
Vice President, Investor Relations
Tel: +1 (301) 556-9850
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
| (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
| Three Months Ended | Six Months Ended | |||||||||||||||
| (Amounts in thousands, except share and per share data) | June 30, 2024 | June 30, 2023 | June 30, 2024 | Jun 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 |