Precigen Reports Second Quarter and First Half 2020 Financial Results
Business Highlights:
- UltraPorator™:
Precigen advanced the development of its proprietary electroporation device, UltraPorator™, including the initiation of both the manufacturing of a cGMP-compliant system and the process of technology transfer to its clinical sites. UltraPorator is a semi-closed, high-throughput system with a proprietary hardware and software solution designed to significantly reduce processing time and contamination risk, limitations of other electroporation devices and hurdles to the viable scale-up and commercialization of certain therapeutic programs. The Company expects to implement the system at multiple medical centers for the expansion phases of PRGN-3005, PRGN-3006 and the future UltraCAR-T clinical trials;
- PRGN-3005 UltraCAR-T®:
Precigen initiated the dosing of patients in the third dose level of the intraperitoneal (IP) arm of the Phase 1 clinical trial of PRGN-3005 UltraCAR-T for treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (clinical trial identifier: NCT03907527). Preclinical data for PRGN-3005 UltraCAR-T presented at theAmerican Association for Cancer Research (AACR) Virtual Annual Meeting II demonstrated significantly superior expansion, persistence and preferred memory phenotype of UltraCAR-T in vivo and significantly superior efficacy in an ovarian cancer model compared to traditional CAR-T;
- AG019 ActoBiotics™:
Precigen ActoBio, Inc. , a wholly-owned subsidiary ofPrecigen , announced the Phase 1b monotherapy portion of the ongoing Phase 1b/2a clinical trial for investigational therapy AG019 ActoBiotics met the primary endpoint assessing safety and tolerability in patients with early-onset type 1 diabetes (T1D) (clinical trial identifier: NCT03751007, EudraCT 2017-002871-24). The Phase 1b portion of the study evaluates safety and tolerability of 2 different doses of AG019 monotherapy, a capsule formulation composed of ActoBiotics delivering the autoantigen human proinsulin (hPINS) and the tolerance-enhancing cytokine human interleukin-10 (hIL-10). Preliminary results demonstrate an encouraging trend in C-peptide levels, a biomarker for T1D disease progression, as well as, an increase in the frequency of islet-specific Tregs, a potential mechanistic indicator of therapeutic activity; and
- INXN-4001: Precigen Triple-Gene, a majority-owned subsidiary of
Precigen , announced six-month follow-up data from the Phase I trial of INXN-4001 (clinical trial identifier: NCT03409627), a multigenic, non-viral, plasmid-based investigational therapeutic candidate under evaluation for the treatment of heart failure. The study met the primary endpoints to evaluate safety and feasibility for INXN-4001. INXN-4001, delivered via retrograde coronary sinus infusion (RCSI), was well-tolerated. Preliminary data suggest an overall improvement in patient reported outcomes in 50% of patients six months after treatment;
Second Quarter 2020 Financial Highlights:
- Total revenues of
$30.4 million ; - Net loss of
$43.4 million , or$(0.26) per basic share, of which$31.7 million was for non-cash charges; and - Cash, cash equivalents, and short-term investments totaled
$133.0 million atJune 30, 2020 .
First Half 2020 Financial Highlights:
- Total revenues of
$60.3 million ; - Net loss from continuing operations of
$73.3 million , or$(0.45) per basic share, of which$40.4 million was for non-cash charges.
"
Second Quarter 2020 Financial Results Compared to Prior Year Period
Total revenues declined
Research and development expenses decreased
First Half 2020 Financial Results Compared to Prior Year Period
Total revenues increased
Research and development expenses decreased
Conference Call and Webcast
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
For more information, contact:
Investor Contact: Vice President, Investor Relations Tel: +1 (301) 556-9850 |
Corporate Contact: Vice President, Communications Tel: +1 (301) 556-9850 |
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Consolidated Balance Sheets |
|||||||
(Unaudited) |
|||||||
(Amounts in thousands) |
|
|
|||||
Assets |
|||||||
Current assets |
|||||||
Cash and cash equivalents |
$ |
46,713 |
$ |
65,793 |
|||
Short-term investments |
86,292 |
9,260 |
|||||
Receivables |
|||||||
Trade, net |
23,337 |
20,650 |
|||||
Related parties, net |
294 |
600 |
|||||
Other |
364 |
4,978 |
|||||
Inventory |
12,729 |
16,097 |
|||||
Prepaid expenses and other |
3,266 |
6,444 |
|||||
Current assets held for sale |
— |
110,821 |
|||||
Total current assets |
172,995 |
234,643 |
|||||
Property, plant and equipment, net |
46,956 |
60,969 |
|||||
Intangible assets, net |
64,759 |
68,346 |
|||||
|
54,122 |
63,754 |
|||||
Investments in affiliates |
859 |
1,461 |
|||||
Right-of-use assets |
20,683 |
25,228 |
|||||
Other assets |
1,341 |
1,362 |
|||||
Total assets |
$ |
361,715 |
$ |
455,763 |
|||
Current liabilities |
|||||||
Accounts payable |
$ |
3,650 |
$ |
5,917 |
|||
Accrued compensation and benefits |
7,719 |
14,091 |
|||||
Other accrued liabilities |
9,342 |
12,049 |
|||||
Deferred revenue |
6,592 |
5,697 |
|||||
Lines of credit |
— |
1,922 |
|||||
Current portion of long-term debt |
32,108 |
31,670 |
|||||
Current portion of lease liabilities |
4,514 |
4,182 |
|||||
Related party payables |
175 |
51 |
|||||
Current liabilities held for sale |
— |
47,333 |
|||||
Total current liabilities |
64,100 |
122,912 |
|||||
Long-term debt, net of current portion |
191,205 |
186,321 |
|||||
Deferred revenue, net of current portion |
32,858 |
48,136 |
|||||
Lease liabilities, net of current portion |
21,212 |
23,849 |
|||||
Deferred tax liabilities |
2,698 |
2,834 |
|||||
Other long-term liabilities |
100 |
— |
|||||
Total liabilities |
312,173 |
384,052 |
|||||
Commitments and contingencies |
|||||||
Shareholders' equity |
|||||||
Common stock |
— |
— |
|||||
Additional paid-in capital |
1,802,413 |
1,752,048 |
|||||
Accumulated deficit |
(1,752,221) |
(1,652,869) |
|||||
Accumulated other comprehensive loss |
(650) |
(27,468) |
|||||
Total shareholders' equity |
49,542 |
71,711 |
|||||
Total liabilities and shareholders' equity |
$ |
361,715 |
$ |
455,763 |
|
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Consolidated Statements of Operations |
|||||||||||||
(Unaudited) |
|||||||||||||
(Amounts in thousands, except share |
Three months ended |
Six months ended |
|||||||||||
June 30, |
|
||||||||||||
2020 |
2019 |
2020 |
2019 |
||||||||||
Revenues |
|||||||||||||
Collaboration and licensing revenues |
$ |
4,315 |
$ |
6,450 |
$ |
15,036 |
$ |
12,421 |
|||||
Product revenues |
8,540 |
7,800 |
13,501 |
12,637 |
|||||||||
Service revenues |
17,381 |
18,400 |
31,327 |
29,783 |
|||||||||
Other revenues |
188 |
186 |
398 |
580 |
|||||||||
Total revenues |
30,424 |
32,836 |
60,262 |
55,421 |
|||||||||
Operating Expenses |
|||||||||||||
Cost of products |
8,141 |
8,502 |
14,230 |
16,224 |
|||||||||
Cost of services |
6,770 |
8,218 |
14,306 |
15,310 |
|||||||||
Research and development |
14,208 |
28,239 |
33,099 |
55,177 |
|||||||||
Selling, general and administrative |
18,739 |
19,250 |
41,757 |
50,299 |
|||||||||
Impairment of goodwill |
9,635 |
— |
9,635 |
— |
|||||||||
Impairment of assets |
12,406 |
— |
12,406 |
— |
|||||||||
Total operating expenses |
69,899 |
64,209 |
125,433 |
137,010 |
|||||||||
Operating loss |
(39,475) |
(31,373) |
(65,171) |
(81,589) |
|||||||||
Other Expense, Net |
|||||||||||||
Unrealized and realized appreciation in fair |
— |
5,760 |
— |
6,209 |
|||||||||
Interest expense |
(4,592) |
(4,353) |
(9,184) |
(8,658) |
|||||||||
Interest and dividend income |
773 |
1,024 |
1,446 |
2,385 |
|||||||||
Other income (expense), net |
71 |
(2,656) |
135 |
(2,110) |
|||||||||
Total other expense, net |
(3,748) |
(225) |
(7,603) |
(2,174) |
|||||||||
Equity in net loss of affiliates |
(251) |
(716) |
(602) |
(1,464) |
|||||||||
Loss from continuing operations before |
(43,474) |
(32,314) |
(73,376) |
(85,227) |
|||||||||
Income tax benefit |
120 |
9 |
80 |
22 |
|||||||||
Loss from continuing operations |
$ |
(43,354) |
$ |
(32,305) |
$ |
(73,296) |
$ |
(85,205) |
|||||
Loss from discontinued operations, net of |
— |
(6,626) |
(26,056) |
(15,862) |
|||||||||
Net loss |
$ |
(43,354) |
$ |
(38,931) |
$ |
(99,352) |
$ |
(101,067) |
|||||
Net loss attributable to the noncontrolling |
— |
165 |
— |
1,592 |
|||||||||
Net loss attributable to |
$ |
(43,354) |
$ |
(38,766) |
$ |
(99,352) |
$ |
(99,475) |
|||||
Amounts Attributable to |
|||||||||||||
Net loss from continuing operations |
$ |
(43,354) |
$ |
(32,140) |
$ |
(73,296) |
$ |
(83,613) |
|||||
Net loss from discontinued operations |
— |
(6,626) |
(26,056) |
(15,862) |
|||||||||
Net loss attributable to |
$ |
(43,354) |
$ |
(38,766) |
$ |
(99,352) |
$ |
(99,475) |
|||||
Net Loss per Share |
|||||||||||||
Net loss from continuing operations |
$ |
(0.26) |
$ |
(0.21) |
$ |
(0.45) |
$ |
(0.55) |
|||||
Net loss from discontinued operations |
— |
(0.04) |
(0.16) |
(0.10) |
|||||||||
Net loss attributable to |
$ |
(0.26) |
$ |
(0.25) |
$ |
(0.61) |
$ |
(0.65) |
|||||
Weighted average shares outstanding, basic |
164,065,087 |
153,749,929 |
162,201,915 |
153,351,208 |
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