Precigen Reports Fourth Quarter and Full Year 2020 Financial Results
"2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key programs," said
Business Highlights:
Healthcare Transition
In
Public Offering
In
PRGN-3005 UltraCAR-T®
PRGN-3005 UltraCAR-T is a first-in-class investigational therapy under evaluation in an ongoing Phase 1/1b clinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer. Study subjects receive the PRGN-3005 infusion either via intraperitoneal (IP) (Arm A) or intravenous (IV) (Arm B) infusion (clinical trial identifier: NCT03907527). The study is being conducted in collaboration with the
- Preliminary Clinical Data: In
December 2020 ,Precigen reported preliminary Phase 1 data for patients at dose level 1 (n=3) and dose level 2 (n=3) in the IP arm. Data showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes (CRS) reported. PRGN-3005 UltraCAR-T cells showed encouraging expansion and persistence after low dose IP infusion without lymphodepletion. 50% (3 of 6) of patients experienced regression in total target tumor burden. - Enrollment Status: The Phase 1 trial is enrolling patients in the dose escalation phase of both the IP and IV arms. The dose expansion phase for the IP arm is anticipated to start in the second half of 2021.
PRGN-3006 UltraCAR-T®
PRGN-3006 UltraCAR-T is a first-in-class investigational therapy currently under clinical evaluation in an ongoing Phase 1/1b trial for the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS). Study subjects receive the PRGN-3006 infusion either without prior lymphodepletion (Cohort 1) or following lymphodepleting chemotherapy (Cohort 2) (clinical trial identifier: NCT03927261). The study is being conducted in collaboration with
- Orphan Drug Designation: In
January 2020 ,Precigen receivedUS Food and Drug Administration (US FDA ) Orphan Drug Designation for PRGN-3006 UltraCAR-T in patients with AML. - Preliminary Clinical Data: In
December 2020 ,Precigen reported preliminary Phase 1 data for patients at dose level 1 (n=3) and dose level 2 (n=3) without prior lymphodepletion and dose level 1 (n=3) with lymphodepletion. Data showed a favorable safety profile with no DLTs or neurotoxicity. Encouraging expansion and persistence of PRGN-3006 UltraCAR-T was observed in both lymphodepletion and non-lymphodepletion cohorts and across all dose levels. PRGN-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels. - The potential strength of the UltraCAR-T platform was highlighted at the
American Society of Hematology (ASH) 2020 annual meeting with a case study of a patient with multiple prior treatment failures. Data showed that UltraCAR-T cells persisted for more than seven months after a very low dose, only 24 million total UltraCAR-T cells in the infusion, without prior lymphodepletion. This patient had stable disease and data showed a decline in blast levels in blood and bone marrow concomitant with UltraCAR-T expansion and persistence. - One of the patients treated with PRGN-3006 at dose level 1 in the lymphodepletion cohort, with approximately nine million UltraCAR-T cells, had an objective response and achieved complete remission with incomplete hematologic recovery (CRi) per European Leukemia Net (ELN) criteria.
- Enrollment Status: The Phase 1 trial is enrolling patients in the dose escalation phase of both the lymphodepletion and non-lymphodepletion cohorts. A dose expansion phase is anticipated to start in the second half of 2021.
UltraPorator™
In 2020,
- FDA Clearance: In
October 2020 ,Precigen announced that the US FDA cleared UltraPorator as a manufacturing device for its UltraCAR-T clinical trials. - First Patients Dosed with UltraCAR-T Cells Manufactured with UltraPorator: In
November 2020 ,Precigen announced dosing of the first patients with UltraCAR-T cells manufactured using the UltraPorator system in the ongoing PRGN-3005 and PRGN-3006 Phase 1 clinical trials.
AG019 ActoBiotics™
AG019 ActoBiotics is a novel investigational therapy designed to address the underlying cause of Type 1 diabetes (T1D) and is currently under clinical evaluation in an ongoing Phase 1b/2a clinical study for the treatment of early-onset T1D (clinical trial identifier: NCT03751007; EudraCT 2017-002871-24).
- Phase 1b AG019 Monotherapy Clinical Data: In
August 2020 , Precigen ActoBio announced that the primary endpoint assessing safety and tolerability in the Phase 1b monotherapy portion of the study was met, and that preliminary results at six months after AG019 monotherapy treatment initiation showed an encouraging trend in the insulin C-peptide levels, a biomarker for T1D disease progression. Additional data announced inDecember 2020 showed that following a single 8-week treatment cycle of oral AG019, 58% (7 of 12) of the patients 17 years and older showed stabilization of C-peptide levels during the first 6 months and slower decline in C-peptide levels at 12 months compared to placebo. Results indicated the potential to preserve insulin production in early onset T1D through its capacity to induce antigen-specific immune modulation. The AG019 monotherapy treatment showed a favorable safety profile with no treatment discontinuations due to treatment emergent adverse events (TEAEs). - Interim Phase 2a Clinical Data: In
December 2020 , Precigen ActoBio announced interim data from the Phase 2a portion of the study showing the combination of AG019 and teplizumab had a favorable safety profile. Data showed that following the treatment with the combination of AG019 and teplizumab, 70% of the adult patients (7 of 10) showed stabilization of C-peptide levels at six months post treatment initiation with a trend towards higher C-peptide levels as compared to baseline levels. - Enrollment Status: Enrollment and dosing is complete in Phase 1b and Phase 2a portions of the study.
PRGN-2009 AdenoVerse™ Immunotherapy
PRGN-2009 is a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform currently under clinical evaluation in an ongoing Phase 1/2 clinical study designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597). The study is being conducted under a
- IND Clearance: In
April 2020 ,Precigen announcedUS FDA clearance of the IND to initiate the Phase 1/2 study. - First Patient Dosed: In
August 2020 ,Precigen announced that the first patient was dosed in the Phase 1/2 study. - Preliminary Clinical Data: In
January 2021 , for the first time,Precigen provided preliminary Phase 1 data that showed that all patients (n=6) enrolled in the Phase 1 monotherapy arm have received multiple PRGN-2009 administrations and repeated administration of PRGN-2009 treatment has been well-tolerated with no DLTs. Preliminary correlative analysis from patients treated at dose level 1 (n=3) demonstrated an increase in HPV 16 and/or HPV 18-specific T-cell response post PRGN-2009 administration in 100% (3 of 3) of patients and an increase in the magnitude and breadth of immune response has been shown with respect to repeat administration of PRGN-2009. - Enrollment Status: The Phase 1 monotherapy arm has completed enrollment and the Phase 1 combination arm, which combines PRGN-2009 with M7824, is enrolling patients. Phase 2 enrollment is anticipated to initiate in the second half of 2021.
PRGN-2012 AdenoVerse™ Immunotherapy
PRGN-2012 is a first-in-class, investigational OTS AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for treatment of recurrent respiratory papillomatosis (RRP).
- IND Clearance: In
January 2021 ,Precigen announced theUS FDA cleared the IND for the Phase 1 study (clinical trial identifier: NCT04724980) in adult patients with RRP. The study is being conducted under a CRADA with theCenter for Cancer Research (CCR) at the NCI. - Preliminary Preclinical Data: In
January 2021 ,Precigen presented data from preclinical studies in which PRGN-2012 was shown to induce robust HPV 6 and HPV 11-specific T-cell response in RRP patient samples in vitro.
INXN-4001
INXN-4001 is a multigenic investigational therapy for heart failure that uses a non-viral plasmid designed to constitutively express human SDF-1α, VEGF165, and S100A1 gene products to target the underlying molecular mechanisms of pathological myocardial remodelling. INXN-4001 is delivered to the ventricle via retrograde coronary sinus infusion (RCSI).
- Interim Data at Six-Month Follow-up: In
August 2020 , Precigen Triple-Gene announced encouraging six-month follow-up data from twelve chronic heart failure patients treated in the Phase 1 study (clinical trial identifier: NCT03409627). Data showed that the study met the primary endpoints to evaluate safety and feasibility for INXN-4001 and the infusions of INXN-4001 were overall well tolerated. Preliminary data suggest an overall improvement in patient reported outcomes in 50% of patients six months after treatment. - Interim Data at 12-Month Follow-up: In
January 2021 ,Precigen announced that the 12-month follow-up for Phase 1 clinical study is complete.
Fourth Quarter 2020 Financial Highlights:
- Revenues: Total revenues of
$19.3 million in 2020 compared to$17.0 million in 2019; - Net Loss: Net loss from continuing operations of
$39.7 million , or$(0.22) per basic share, of which$19.7 million was for non-cash charges in 2020 compared to net loss from continuing operations of$64.2 million , or$(0.41) per basic share, of which$32.9 million was for non-cash charges in 2019; and - Cash, Cash Equivalents, and Short-term Investments: Cash, cash equivalents, and short-term investments totaled
$100.1 million as ofDecember 31, 2020 .
Full Year 2020 Financial Highlights:
- Revenues: Total revenues of
$103.2 million in 2020 compared to$90.7 million in 2019; and - Net Loss: Net loss from continuing operations of
$103.8 million , or$(0.62) per basic share, of which$45.9 million was for non-cash charges in 2020 compared to net loss from continuing operations attributable toPrecigen of$168.7 million , or$(1.09) per basic share, of which$65.4 million was for non-cash charges in 2019.
Fourth Quarter 2020 Financial Results Compared to Prior Year Period
Total revenues increased
Research and development expenses decreased
Full Year 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 Precigen's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of Precigen's business, including the timing, pace and progress of preclinical studies, clinical trials, discovery programs and related milestones, and the promise of the Company's portfolio of therapies, and in particular its CAR-T therapies. Although management believes that the plans, objectives and results 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. These risks and uncertainties include, but are not limited to, (i) the impact of the COVID-19 pandemic on our clinical trials, businesses, operating results, cash flows and/or financial condition, (ii)
Investor Contact: |
Media Contact: |
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Vice President, Investor Relations |
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Tel: +1 (301) 556-9850 |
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Consolidated Balance Sheets |
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(Unaudited) |
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(Amounts in thousands) |
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Assets |
|||||||
Current assets |
|||||||
Cash and cash equivalents |
$ |
51,792 |
$ |
65,793 |
|||
Short-term investments |
48,325 |
9,260 |
|||||
Receivables |
|||||||
Trade, net |
16,487 |
20,650 |
|||||
Related parties, net |
19 |
600 |
|||||
Notes |
3,689 |
2,942 |
|||||
Other |
232 |
2,030 |
|||||
Inventory |
11,359 |
16,097 |
|||||
Prepaid expenses and other |
7,192 |
5,827 |
|||||
Current assets held for sale or abandonment |
9,853 |
111,444 |
|||||
Total current assets |
148,948 |
234,643 |
|||||
Property, plant and equipment, net |
34,924 |
43,952 |
|||||
Intangible assets, net |
65,396 |
68,346 |
|||||
|
54,363 |
54,119 |
|||||
Investments in affiliates |
— |
1,461 |
|||||
Right-of-use assets |
9,353 |
11,803 |
|||||
Other assets |
1,603 |
1,349 |
|||||
Noncurrent assets held for sale or abandonment |
— |
40,090 |
|||||
Total assets |
$ |
314,587 |
$ |
455,763 |
|||
Liabilities and Shareholders' Equity |
|||||||
Current liabilities |
|||||||
Accounts payable |
$ |
4,598 |
$ |
5,528 |
|||
Accrued compensation and benefits |
8,097 |
13,198 |
|||||
Other accrued liabilities |
9,549 |
11,674 |
|||||
Deferred revenue |
2,800 |
5,697 |
|||||
Lines of credit |
— |
1,922 |
|||||
Current portion of long-term debt |
360 |
31,670 |
|||||
Current portion of lease liabilities |
2,657 |
2,634 |
|||||
Related party payables |
19 |
51 |
|||||
Current liabilities held for sale or abandonment |
14,047 |
50,538 |
|||||
Total current liabilities |
42,127 |
122,912 |
|||||
Long-term debt, net of current portion |
171,522 |
186,321 |
|||||
Deferred revenue, net of current portion |
23,023 |
48,136 |
|||||
Lease liabilities, net of current portion |
7,744 |
10,119 |
|||||
Deferred tax liabilities |
2,897 |
2,834 |
|||||
Other long-term liabilities |
100 |
— |
|||||
Long-term liabilities held for sale or abandonment |
— |
13,730 |
|||||
Total liabilities |
247,413 |
384,052 |
|||||
Commitments and contingencies |
|||||||
Shareholders' equity |
|||||||
Common stock |
— |
— |
|||||
Additional paid-in capital |
1,886,567 |
1,752,048 |
|||||
Accumulated deficit |
(1,823,390) |
(1,652,869) |
|||||
Accumulated other comprehensive income (loss) |
3,997 |
(27,468) |
|||||
Total shareholders' equity |
67,174 |
71,711 |
|||||
Total liabilities and shareholders' equity |
$ |
314,587 |
$ |
455,763 |
|
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Consolidated Statements of Operations |
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(Unaudited) |
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(Amounts in thousands, except share and per share data) |
Three months ended |
Year ended |
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2020 |
2019 |
2020 |
2019 |
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Revenues |
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Collaboration and licensing revenues |
$ |
949 |
$ |
(658) |
$ |
21,208 |
$ |
14,059 |
|||||
Product revenues |
3,952 |
5,297 |
24,349 |
23,780 |
|||||||||
Service revenues |
14,284 |
12,096 |
56,899 |
51,803 |
|||||||||
Other revenues |
148 |
267 |
722 |
1,080 |
|||||||||
Total revenues |
19,333 |
17,002 |
103,178 |
90,722 |
|||||||||
Operating Expenses |
|||||||||||||
Cost of products |
7,024 |
7,800 |
28,550 |
31,930 |
|||||||||
Cost of services |
6,766 |
7,611 |
26,963 |
29,471 |
|||||||||
Research and development |
10,671 |
13,485 |
41,644 |
66,666 |
|||||||||
Selling, general and administrative |
30,039 |
26,646 |
91,704 |
98,634 |
|||||||||
Impairment of goodwill |
— |
29,642 |
— |
29,820 |
|||||||||
Impairment of other noncurrent assets |
— |
542 |
920 |
990 |
|||||||||
Total operating expenses |
54,500 |
85,726 |
189,781 |
257,511 |
|||||||||
Operating loss |
(35,167) |
(68,724) |
(86,603) |
(166,789) |
|||||||||
Other Income (Expense), Net |
|||||||||||||
Unrealized and realized appreciation in fair value of equity securities and preferred stock, net |
— |
5,221 |
— |
8,291 |
|||||||||
Interest expense |
(4,570) |
(4,542) |
(18,400) |
(17,666) |
|||||||||
Interest and dividend income |
426 |
603 |
2,451 |
3,871 |
|||||||||
Other income (expense), net |
(310) |
2,774 |
(165) |
3,445 |
|||||||||
Total other income (expense), net |
(4,454) |
4,056 |
(16,114) |
(2,059) |
|||||||||
Equity in net loss of affiliates |
(13) |
(473) |
(1,138) |
(2,416) |
|||||||||
Loss from continuing operations before income taxes |
(39,634) |
(65,141) |
(103,855) |
(171,264) |
|||||||||
Income tax benefit |
(48) |
905 |
82 |
930 |
|||||||||
Loss from continuing operations |
$ |
(39,682) |
$ |
(64,236) |
$ |
(103,773) |
$ |
(170,334) |
|||||
Loss from discontinued operations, net of income tax benefit |
(1,979) |
(104,979) |
(66,748) |
(153,582) |
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Net loss |
$ |
(41,661) |
$ |
(169,215) |
$ |
(170,521) |
$ |
(323,916) |
|||||
Net loss attributable to the noncontrolling interests |
— |
— |
— |
1,592 |
|||||||||
Net loss attributable to |
$ |
(41,661) |
$ |
(169,215) |
$ |
(170,521) |
$ |
(322,324) |
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Amounts Attributable to |
|||||||||||||
Net loss from continuing operations attributable to |
$ |
(39,682) |
$ |
(64,236) |
$ |
(103,773) |
$ |
(168,742) |
|||||
Net loss from discontinued operations attributable to |
(1,979) |
(104,979) |
(66,748) |
(153,582) |
|||||||||
Net loss attributable to |
$ |
(41,661) |
$ |
(169,215) |
$ |
(170,521) |
$ |
(322,324) |
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Net Loss per Share |
|||||||||||||
Net loss from continuing operations attributable to |
$ |
(0.22) |
$ |
(0.41) |
$ |
(0.62) |
$ |
(1.09) |
|||||
Net loss from discontinued operations attributable to |
(0.01) |
(0.68) |
(0.40) |
(1.00) |
|||||||||
Net loss attributable to |
$ |
(0.23) |
$ |
(1.09) |
$ |
(1.02) |
$ |
(2.09) |
|||||
Weighted average shares outstanding, basic and diluted |
178,225,571 |
155,230,741 |
167,065,539 |
154,138,774 |
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