Precigen Reports Fourth Quarter and Full Year 2021 Financial Results
"In 2021,
Key Business Highlights
- Public Offering: In January,
Precigen closed a public offering of 17,250,000 shares of common stock, which resulted in gross proceeds toPrecigen of approximately$129.4 million before deducting the underwriting discount and other offering expenses payable byPrecigen ; - PRGN-3006 UltraCAR-T in Acute Myeloid Leukemia (AML): In 2021, enrollment in the dose escalation phase of the Phase 1/1b PRGN-3006 UltraCAR-T clinical trial for the treatment of patients with relapsed or refractory AML or higher-risk myelodysplastic syndromes (MDS) was completed for both the lymphodepletion and non-lymphodepletion cohorts. Interim data for patients treated in Dose Levels 1-3 of the non-lymphodepletion cohort and Dose Levels 1-2 of the lymphodepletion cohort were presented at the 63rd
American Society of Hematology (ASH) Annual Meeting and Exposition inDecember 2021 ; - PRGN-3005 UltraCAR-T in Ovarian Cancer: In 2021, enrollment in the dose escalation phase of the Phase 1/1b clinical trial for the treatment of patients with advanced, recurrent platinum-resistant ovarian cancer was completed for both the intraperitoneal (IP) and intravenous (IV) arms. Interim data for patients treated in Dose Levels 1-3 of the IP arm were presented at the Company's 2021 research and development (R&D) Virtual Event in
November 2021 ; - PRGN-3007 Next Generation UltraCAR-T with Intrinsic PD-1 Inhibition: In 2021,
Precigen received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) to initiate a Phase 1 study of PRGN-3007 UltraCAR-T in advanced receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) hematological tumors, including chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including triple negative breast cancer (TNBC). An abstract highlighting PRGN-3007 preclinical data was presented as a poster presentation at the 63rd ASH Annual Meeting and Exposition inDecember 2021 ; - PRGN-2012 AdenoVerse Immunotherapy in Recurrent Respiratory Papillomatosis (RRP): In 2021,
Precigen received IND clearance from the FDA to initiate a Phase 1 study of PRGN-2012, an off-the-shelf (OTS) AdenoVerse immunotherapy, in patients with RRP and began dosing patients in the study.Precigen completed enrollment in the Phase 1 dose escalation and expansion cohorts. Interim data for the Phase 1 study were presented at the Company's 2021 R&D Virtual Event inNovember 2021 ; - PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers: In 2021,
Precigen completed enrollment in the PRGN-2009 Phase 1 monotherapy arm and enrollment is ongoing in the Phase 1 combination arm of the study. The Phase 2 monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients is also ongoing. InNovember 2021 , interim data for patients in the Phase 1 monotherapy and combination arms were presented at the Company's 2021R&D Virtual Event and Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting; and - AG019 ActoBiotics in Type 1 Diabetes (T1D): In 2021,
Precigen completed the Phase 1b/2a AG019 ActoBiotics clinical trial in T1D. Positive results from the trial were presented at the Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting inJune 2021 andEuropean Association for the Study of Diabetes (EASD) 57th Annual Meeting inOctober 2021 .
Fourth Quarter and Full Year 2021 Financial Highlights
- Net cash used in operating activities of
$55.8 million in 2021 compared to$77.0 million in 2020; - Net proceeds received from the issuance of common stock in
January 2021 were$121.0 million ; - Cash, cash equivalents, and short-term and long-term investments totaled
$163.7 million as ofDecember 31, 2021 ; - The Company anticipates that its cash, cash equivalents and short-term and long-term investments as of December 31, 2021 should enable the Company to fund operations well into 2023, assuming the Company's programs advance as currently contemplated; and
- The Company's non-core businesses continued to generate increased revenues and profitability.
Fourth Quarter 2021 Financial Results Compared to Prior Year Period
For the quarter ended
Total revenues increased
Full Year 2021 Financial Results Compared to Prior Year Period
For the year ended
Total revenues were comparable year-over-year, with increased revenues generated by
Trademarks
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, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, 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
Investor Contact:
Vice President, Investor Relations
Tel: +1 (301) 556-9850
investors@precigen.com
Media Contacts:
press@precigen.com
glenn.silver@finnpartners.com
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Consolidated Balance Sheets |
|||||||
(Unaudited) |
|||||||
(Amounts in thousands) |
|
|
|||||
Assets |
|||||||
Current assets |
|||||||
Cash and cash equivalents |
$ |
42,920 |
$ |
51,792 |
|||
Short-term investments |
72,240 |
48,325 |
|||||
Receivables |
|||||||
Trade, net |
20,832 |
16,487 |
|||||
Related parties, net |
73 |
19 |
|||||
Notes |
— |
3,689 |
|||||
Other |
566 |
232 |
|||||
Inventory |
13,261 |
11,359 |
|||||
Prepaid expenses and other |
6,736 |
7,192 |
|||||
Current assets held for sale or abandonment |
— |
9,853 |
|||||
Total current assets |
156,628 |
148,948 |
|||||
Long-term investments |
48,562 |
— |
|||||
Property, plant and equipment, net |
34,315 |
34,924 |
|||||
Intangible assets, net |
54,115 |
65,396 |
|||||
|
54,148 |
54,363 |
|||||
Right-of-use assets |
10,900 |
9,353 |
|||||
Other assets |
1,188 |
1,603 |
|||||
Total assets |
$ |
359,856 |
$ |
314,587 |
|||
Liabilities and Shareholders' Equity |
|||||||
Current liabilities |
|||||||
Accounts payable |
$ |
5,405 |
$ |
4,598 |
|||
Accrued compensation and benefits |
11,223 |
8,097 |
|||||
Other accrued liabilities |
11,595 |
9,549 |
|||||
Deferred revenue |
4,442 |
2,800 |
|||||
Current portion of long-term debt |
402 |
360 |
|||||
Current portion of lease liabilities |
1,551 |
2,657 |
|||||
Related party payables |
27 |
19 |
|||||
Current liabilities held for sale or abandonment |
— |
14,047 |
|||||
Total current liabilities |
34,645 |
42,127 |
|||||
Long-term debt, net of current portion |
182,749 |
171,522 |
|||||
Deferred revenue, net of current portion |
23,023 |
23,023 |
|||||
Lease liabilities, net of current portion |
9,502 |
7,744 |
|||||
Deferred tax liabilities |
2,539 |
2,897 |
|||||
Other long-term liabilities |
50 |
100 |
|||||
Total liabilities |
252,508 |
247,413 |
|||||
Commitments and contingencies |
|||||||
Shareholders' equity |
|||||||
Common stock |
— |
— |
|||||
Additional paid-in capital |
2,022,701 |
1,886,567 |
|||||
Accumulated deficit |
(1,915,556) |
(1,823,390) |
|||||
Accumulated other comprehensive income |
203 |
3,997 |
|||||
Total shareholders' equity |
107,348 |
67,174 |
|||||
Total liabilities and shareholders' equity |
$ |
359,856 |
$ |
314,587 |
|
|||||||||||||
Consolidated Statements of Operations |
|||||||||||||
(Unaudited) |
|||||||||||||
(Amounts in thousands, except share and per |
Three months ended |
Year ended |
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|
|
||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||
Revenues |
|||||||||||||
Collaboration and licensing revenues |
$ |
117 |
$ |
949 |
$ |
506 |
$ |
21,208 |
|||||
Product revenues |
5,282 |
3,952 |
27,295 |
24,349 |
|||||||||
Service revenues |
18,719 |
14,284 |
75,570 |
56,899 |
|||||||||
Other revenues |
103 |
148 |
502 |
722 |
|||||||||
Total revenues |
24,221 |
19,333 |
103,873 |
103,178 |
|||||||||
Operating Expenses |
|||||||||||||
Cost of products |
5,663 |
7,024 |
24,864 |
28,550 |
|||||||||
Cost of services |
9,263 |
6,766 |
33,521 |
26,963 |
|||||||||
Research and development |
13,019 |
10,671 |
50,141 |
41,644 |
|||||||||
Selling, general and administrative |
16,763 |
30,039 |
74,122 |
91,704 |
|||||||||
Impairment of other noncurrent assets |
— |
— |
543 |
920 |
|||||||||
Total operating expenses |
44,708 |
54,500 |
183,191 |
189,781 |
|||||||||
Operating loss |
(20,487) |
(35,167) |
(79,318) |
(86,603) |
|||||||||
Other Expense, Net |
|||||||||||||
Interest expense |
(4,886) |
(4,570) |
(18,891) |
(18,400) |
|||||||||
Interest and dividend income |
312 |
426 |
1,617 |
2,451 |
|||||||||
Other income (expense), net |
40 |
(310) |
(330) |
(165) |
|||||||||
Total other expense, net |
(4,534) |
(4,454) |
(17,604) |
(16,114) |
|||||||||
Equity in net loss of affiliates |
— |
(13) |
(3) |
(1,138) |
|||||||||
Loss from continuing operations before income taxes |
(25,021) |
(39,634) |
(96,925) |
(103,855) |
|||||||||
Income tax benefit (expense) |
(13) |
(48) |
160 |
82 |
|||||||||
Loss from continuing operations |
$ |
(25,034) |
$ |
(39,682) |
$ |
(96,765) |
$ |
(103,773) |
|||||
Income (loss) from discontinued operations, net of income tax benefit |
— |
(1,979) |
4,599 |
(66,748) |
|||||||||
Net loss |
$ |
(25,034) |
$ |
(41,661) |
$ |
(92,166) |
$ |
(170,521) |
|||||
Net Loss per Share |
|||||||||||||
Net loss from continuing operations attributable to |
$ |
(0.13) |
$ |
(0.22) |
$ |
(0.49) |
$ |
(0.62) |
|||||
Net income (loss) from discontinued operations attributable to |
— |
(0.01) |
0.02 |
(0.40) |
|||||||||
Net loss attributable to |
$ |
(0.13) |
$ |
(0.23) |
$ |
(0.47) |
$ |
(1.02) |
|||||
Weighted average shares outstanding, basic and diluted |
199,259,802 |
178,225,571 |
197,759,900 |
167,065,539 |
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