UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02. | Results of Operations and Financial Condition. |
Attached as Exhibit 99.1 is a copy of a press release of Precigen, Inc., dated August 10, 2020, reporting its financial results for the quarter ended June 30, 2020.
This information, including the Exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
| Item 7.01. | Regulation FD Disclosure. |
On August 10, 2020, Precigen, Inc. provided a slide presentation to accompany its press release. A copy of the presentation is furnished as Exhibit 99.2 hereto. Precigen is also furnishing a reconciliation of a non-GAAP measure as Exhibit 99.3 hereto.
This information, including the Exhibits attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press release dated August 10, 2020 | |
| 99.2 | Slide presentation of Precigen, Inc. dated August 10, 2020 | |
| 99.3 | Reconciliation of non-GAAP measure | |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Precigen, Inc. | ||
| By: | /s/ Rick L. Sterling | |
| Rick L. Sterling | ||
| Chief Financial Officer | ||
Dated: August 10, 2020
Exhibit 99.1
Precigen Reports Second Quarter and First Half 2020 Financial Results
– Announced proprietary electroporation device, UltraPorator™, designed to scale-up UltraCAR-T® manufacturing at multiple medical centers –
– Announced positive topline results from Phase 1b study of AG019 ActoBiotics™ for type 1 diabetes –
– Met primary endpoints of safety and feasibility in Phase I study of INXN-4001 for heart failure –
– Guidance maintained for clinical readouts in 2020 –
GERMANTOWN, MD, August 10, 2020 – 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 financial results for 2020.
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 the American 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 of Precigen, 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 at June 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. |
“Precigen has continued this quarter to streamline operations and focus efforts on delivering value to stakeholders through forward progress on our programs,” said Helen Sabzevari, PhD, President and CEO of Precigen. “In the clinic, we recently announced encouraging data from the AG019 Phase 1b monotherapy study in Type 1 diabetes and the INXN-4001 Phase I study of patients with chronic heart failure and expect additional results on these and other clinical programs in the coming months. Additionally, we are pleased to announce our proprietary UltraPorator manufacturing device, which we believe sets Precigen on the path to commercial viability for rapid decentralized manufacturing of UltraCAR-T at multiple medical centers.”
Second Quarter 2020 Financial Results Compared to Prior Year Period
Total revenues declined $2.4 million from the quarter ended June 30, 2019 primarily due to a decline in Precigen’s collaboration and licensing revenues as the Company continues to transition from a collaboration business model to a model where the Company develops and advances its most valuable healthcare products on its own. While Trans Ova’s revenues were comparable period over period, gross margins on their products and services increased $1.3 million over the comparable prior quarter as a result of the implementation of operational efficiencies gained through improved inventory management, reduction in workforce, and lower royalty rates on certain licensed technologies.
Research and development expenses decreased $14.0 million, or 50%, from the quarter ended June 30, 2019. Salaries, benefits, and other personnel costs decreased $4.8 million as Precigen suspended the operations of its MBP Titan subsidiary in the second quarter. Precigen’s research and development expenses for third-party vendors decreased $7.8 million primarily as a result of the suspension of its MBP Titan operations and also depriortized certain internal programs at its ActoBio subsidiary in the fourth quarter of 2019. Selling, general and administrative (SG&A) expenses decreased $0.5 million and include a decrease of $4.0 million in fees paid to third-party vendors as well as a reduction in salaries and benefits for corporate employees as Precigen reduced its corporate headcount by 25% from December 31, 2019 to June 30, 2020 as it scaled down the Company’s corporate functions to support a more streamlined organization. These decreases were partially offset by an increase in compensation costs which primarily resulted from stock compensation expenses related to equity grants made in the first quarter of 2020 and one-time severance costs for terminated employees. In conjunction with the suspension of MBP Titan’s operations in the second quarter of 2020, Precigen recorded $22.0 million in non-cash impairment charges related to the write-down of goodwill and long-lived assets.
First Half 2020 Financial Results Compared to Prior Year Period
Total revenues increased $4.8 million over the six months ended June 30, 2019 primarily due to an increase in Precigen’s collaboration and licensing revenues as the Company accelerated the recognition of previously deferred revenue upon the mutual termination of one of its collaboration agreements in February 2020. This increase was partially offset by a decrease in collaboration revenues related to other programs as Precigen continues to transition from a collaboration business model to a model where it develops and advances its most valuable healthcare programs on its own. Trans Ova’s revenues increased $1.3 million over the six months ended June 30, 2019 primarily due to an increase in services performed and the expansion of its commercial dairy business. Gross margins on their products and services increased $4.6 million over the comparable prior period as a result of the implementation of operational efficiencies gained through improved inventory management, reduction in workforce, and lower royalty rates on certain licensed technologies.
Research and development expenses decreased $22.1 million, or 40%, from the six months ended June 30, 2019. Salaries, benefits, and other personnel costs decreased $6.9 million as Precigen suspended the operations of its MBP Titan subsidiary in the second quarter. Precigen’s research and development expenses for third-party vendors decreased $12.8 million primarily as a result of the suspension of its MBP Titan operations and also depriortized certain internal programs at its ActoBio subsidiary in the fourth quarter of 2019. SG&A expenses decreased $8.5 million and include a decrease of $7.9 million in fees paid to third-party vendors as well as a reduction in salaries and benefits for corporate employees as Precigen reduced its corporate headcount by 25% from December 31, 2019 to June 30, 2020 as it scaled down its corporate functions to support a more streamlined organization. These decreases were partially offset by an increase in compensation costs which primarily resulted from stock compensation expenses related to equity grants made in the first quarter of 2020 and one-time severance costs for terminated employees. In conjunction with the suspension of MBP Titan’s operations in the second quarter of 2020, Precigen recorded $22.0 million of noncash impairment charges related to the write-down of goodwill and long-lived assets.
Conference Call and Webcast
Precigen will host a conference call today, Monday, August 10th at 4:30 PM ET to discuss the results and provide a general business update. The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061 (International) and providing the number 6003292 to join the Precigen Conference Call. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call. Participants may also access the live webcast through Precigen’s website in the Events section at https://investors.precigen.com/press-and-events.
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 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 unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.
Trademarks
Precigen, UltraPorator, UltraCAR-T, ActoBiotics, 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 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 and clinical trials and discovery programs, potential benefits of platforms and product candidates including in comparison to competitive platforms and products, and future plans for Precigen’s remaining non-healthcare assets. 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 businesses, operating results, cash flows and/or financial condition, (ii) ongoing transition efforts following Precigen’s recent divestment of several assets and businesses; (iii) Precigen’s strategy and overall approach to its business model, its recent efforts to realign its business, and its ability to exercise more control and ownership over the development process and commercialization path; (iv) the ability to successfully enter new markets or develop additional products, including the expected timing and results of investigational studies and preclinical and clinical trials, including any delays or potential delays as a result of the COVID-19 pandemic, whether with its collaborators or independently; (v) the ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that it may form in the future; (vi) the ability to hold or generate significant operating capital, including through partnering, asset sales and operating cost reductions; (vii) actual or anticipated variations in operating results; (viii) actual or anticipated fluctuations in competitors’ or collaborators’ operating results or changes in their respective growth rates; (ix) cash position; (x) market conditions in Precigen’s industry; (xi) the volatility of Precigen’s stock price; (xii) the ability, and the ability of collaborators, to protect Precigen’s intellectual property and other proprietary rights and technologies; (xiii) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies, including federal, state, and local government responses to the COVID-19 pandemic; (xiv) outcomes of pending and future litigation; (xv) the rate and degree of market acceptance of any products developed by Precigen, its subsidiaries, collaborations or joint ventures; (xvi) the ability to retain and recruit key personnel; (xvii) expectations related to the use of proceeds from public offerings and other financing efforts; (xviii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and (xix) the challenges inherent in leadership transitions. For further information on potential risks and uncertainties, and other important factors, any of which could cause Precigen’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Precigen’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.
For more information, contact:
| Investor Contact: Steven Harasym Vice President, Investor Relations Tel: +1 (301) 556-9850 investors@precigen.com |
Corporate Contact: Marie Rossi, PhD Vice President, Communications Tel: +1 (301) 556-9850 press@precigen.com |
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
| (Amounts in thousands) |
June 30, 2020 | December 31, 2019 | ||||||
| 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 | ||||||
| Goodwill |
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 | ||||
|
|
|
|
|
|||||
Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
| (Amounts in thousands, except share and per share data) |
Three months ended | Six months ended | ||||||||||||||
| June 30, | 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 | ) | ||||||||
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|
|
|
|
|
|
|
|||||||||
| Other Expense, Net |
||||||||||||||||
| Unrealized and realized appreciation in fair value of equity securities and preferred stock, net |
— | 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 income taxes |
(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 income taxes |
— | (6,626 | ) | (26,056 | ) | (15,862 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (43,354 | ) | $ | (38,931 | ) | $ | (99,352 | ) | $ | (101,067 | ) | ||||
| Net loss attributable to the noncontrolling interests |
— | 165 | — | 1,592 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss attributable to Precigen |
$ | (43,354 | ) | $ | (38,766 | ) | $ | (99,352 | ) | $ | (99,475 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Amounts Attributable to Precigen |
||||||||||||||||
| Net loss from continuing operations attributable to Precigen |
$ | (43,354 | ) | $ | (32,140 | ) | $ | (73,296 | ) | $ | (83,613 | ) | ||||
| Net loss from discontinued operations attributable to Precigen |
— | (6,626 | ) | (26,056 | ) | (15,862 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss attributable to Precigen |
$ | (43,354 | ) | $ | (38,766 | ) | $ | (99,352 | ) | $ | (99,475 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net Loss per Share |
||||||||||||||||
| Net loss from continuing operations attributable to Precigen per share, basic and diluted |
$ | (0.26 | ) | $ | (0.21 | ) | $ | (0.45 | ) | $ | (0.55 | ) | ||||
| Net loss from discontinued operations attributable to Precigen per share, basic and diluted |
— | (0.04 | ) | (0.16 | ) | (0.10 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss attributable to Precigen per share, basic and diluted |
$ | (0.26 | ) | $ | (0.25 | ) | $ | (0.61 | ) | $ | (0.65 | ) | ||||
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|
|
|
|
|
|
|
|
|||||||||
| Weighted average shares outstanding, basic and diluted |
164,065,087 | 153,749,929 | 162,201,915 | 153,351,208 | ||||||||||||
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Exhibit 99.2 Precigen, Inc. 2Q-2020 Business Update 10 August 2020 1Exhibit 99.2 Precigen, Inc. 2Q-2020 Business Update 10 August 2020 1
Forward-looking Statements Some of the statements made in this presentation are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 and can be identified by forward-looking words such as “may,” “will,” “potential,” “seek,” “expect,” “believe,” “anticipate,” “intend,” “continue,” “opportunity,” “groundwork,” “poised,” “future,” “update” and similar expressions. Examples of forward-looking statements in this presentation, include statements about the timing, pace and progress of preclinical and clinical trials and discovery programs, potential benefits of platforms and product candidates including in comparison to competitive platforms and products, and future plans for the company’s remaining non-healthcare assets. 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 in this presentation. These risks and uncertainties include, but are not limited to, (i) the impact of the COVID-19 pandemic on our businesses, operating results, cash flows and/or financial condition, (ii) ongoing transition efforts following the company’s recent divestment of several assets and businesses, (iii) Precigen’s strategy and overall approach to its business model, its recent efforts to realign its business, and its ability to exercise more control and ownership over the development process and commercialization path; (iv) the ability to successfully enter new markets or develop additional products, including the expected timing and results of investigational studies and preclinical and clinical trials, including any delays or potential delays as a result of the COVID-19 pandemic, whether with its collaborators or independently; (v) the ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that it may form in the future; (vi) the ability to hold or generate significant operating capital, including through partnering, asset sales and operating cost reductions; (vii) actual or anticipated variations in operating results; (viii) actual or anticipated fluctuations in competitors’ or collaborators’ operating results or changes in their respective growth rates; (ix) cash position; (x) market conditions in the company’s industry; (xi) the volatility of Precigen’s stock price; (xii) the ability, and the ability of collaborators, to protect Precigen’s intellectual property and other proprietary rights and technologies; (xiii) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies, including federal, state, and local government responses to the COVID-19 pandemic; (xiv) outcomes of pending and future litigation; (xv) the rate and degree of market acceptance of any products developed by Precigen, its subsidiaries, collaborations or joint ventures; (xvi) the ability to retain and recruit key personnel; (xvii) expectations related to the use of proceeds from public offerings and other financing efforts; (xviii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and (xix) the challenges inherent in leadership transitions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Precigen’s Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Precigen’s subsequent filings with the Securities and Exchange Commission. All informationin thispresentationisasof the date itscover page,and Precigen undertakes no duty to update this information unless required by law. This presentation includes reference to Segment Adjusted EBITDA, which is a non-GAAP financial measure. This measure is provided as additional information, not as an alternative to GAAP measures, and is intended to enhance an overall understanding of Precigen’s financial performance. A reconciliation of Segment AEBITDA to net loss from continuing operations before income taxes has been furnished on an exhibit to Precigen’s current report on Form 8-K shortly prior to this presentation. All of the pharmaceutical products described in this presentation are investigational new drugs, which are currently undergoing pre-clinical and/or human clinical trial testing. As a result, none of them have had their safety or efficacy established or are approved by the U.S. Food and Drug Administration or any other regulatory agency. © 2020 Precigen, Inc. All rights reserved. 2Forward-looking Statements Some of the statements made in this presentation are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 and can be identified by forward-looking words such as “may,” “will,” “potential,” “seek,” “expect,” “believe,” “anticipate,” “intend,” “continue,” “opportunity,” “groundwork,” “poised,” “future,” “update” and similar expressions. Examples of forward-looking statements in this presentation, include statements about the timing, pace and progress of preclinical and clinical trials and discovery programs, potential benefits of platforms and product candidates including in comparison to competitive platforms and products, and future plans for the company’s remaining non-healthcare assets. 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 in this presentation. These risks and uncertainties include, but are not limited to, (i) the impact of the COVID-19 pandemic on our businesses, operating results, cash flows and/or financial condition, (ii) ongoing transition efforts following the company’s recent divestment of several assets and businesses, (iii) Precigen’s strategy and overall approach to its business model, its recent efforts to realign its business, and its ability to exercise more control and ownership over the development process and commercialization path; (iv) the ability to successfully enter new markets or develop additional products, including the expected timing and results of investigational studies and preclinical and clinical trials, including any delays or potential delays as a result of the COVID-19 pandemic, whether with its collaborators or independently; (v) the ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that it may form in the future; (vi) the ability to hold or generate significant operating capital, including through partnering, asset sales and operating cost reductions; (vii) actual or anticipated variations in operating results; (viii) actual or anticipated fluctuations in competitors’ or collaborators’ operating results or changes in their respective growth rates; (ix) cash position; (x) market conditions in the company’s industry; (xi) the volatility of Precigen’s stock price; (xii) the ability, and the ability of collaborators, to protect Precigen’s intellectual property and other proprietary rights and technologies; (xiii) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies, including federal, state, and local government responses to the COVID-19 pandemic; (xiv) outcomes of pending and future litigation; (xv) the rate and degree of market acceptance of any products developed by Precigen, its subsidiaries, collaborations or joint ventures; (xvi) the ability to retain and recruit key personnel; (xvii) expectations related to the use of proceeds from public offerings and other financing efforts; (xviii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and (xix) the challenges inherent in leadership transitions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Precigen’s Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Precigen’s subsequent filings with the Securities and Exchange Commission. All informationin thispresentationisasof the date itscover page,and Precigen undertakes no duty to update this information unless required by law. This presentation includes reference to Segment Adjusted EBITDA, which is a non-GAAP financial measure. This measure is provided as additional information, not as an alternative to GAAP measures, and is intended to enhance an overall understanding of Precigen’s financial performance. A reconciliation of Segment AEBITDA to net loss from continuing operations before income taxes has been furnished on an exhibit to Precigen’s current report on Form 8-K shortly prior to this presentation. All of the pharmaceutical products described in this presentation are investigational new drugs, which are currently undergoing pre-clinical and/or human clinical trial testing. As a result, none of them have had their safety or efficacy established or are approved by the U.S. Food and Drug Administration or any other regulatory agency. © 2020 Precigen, Inc. All rights reserved. 2
Q2 2020 Financial Highlights Improvement in quarter over quarter Segment Adjusted EBITDA Reduction in capital requirements driven by suspension of MBP Titan operations and streamlining corporate functions Trans Ova Genetics and Precigen Exemplar cash flow positive in H1 2020 Current cash on hand sufficient to fund operations into late 2021 3Q2 2020 Financial Highlights Improvement in quarter over quarter Segment Adjusted EBITDA Reduction in capital requirements driven by suspension of MBP Titan operations and streamlining corporate functions Trans Ova Genetics and Precigen Exemplar cash flow positive in H1 2020 Current cash on hand sufficient to fund operations into late 2021 3
Precigen’s goal is to develop a commercially viable UltraCAR-T platform Scale-up q Minimal handling of cells during production q Rapid and efficient gene transfer q Process a large number of T cells Manufacturing q Consistent manufacturing across various sites þ Overnight manufacturing at medical centersq Ease of technology transfer þ No large, centralized facility required Design þ Viral vectors not required þ Optimized non-viral gene delivery þ High cell viability þ Multigene expression using single transposon þ No ex vivo expansion necessary þ Cell product homogeneity þ Enhanced in vivo expansion and persistence þ Kill switch on every UltraCAR-T cell 4 4Precigen’s goal is to develop a commercially viable UltraCAR-T platform Scale-up q Minimal handling of cells during production q Rapid and efficient gene transfer q Process a large number of T cells Manufacturing q Consistent manufacturing across various sites þ Overnight manufacturing at medical centersq Ease of technology transfer þ No large, centralized facility required Design þ Viral vectors not required þ Optimized non-viral gene delivery þ High cell viability þ Multigene expression using single transposon þ No ex vivo expansion necessary þ Cell product homogeneity þ Enhanced in vivo expansion and persistence þ Kill switch on every UltraCAR-T cell 4 4
Today’s electroporation devices have scale-up limitations § Relatively low throughput § Processing of one cuvette at a time § Labor and time intensive process § Multiple batches needed for manufacturing a dose § Manual handling may increase contamination risk 5Today’s electroporation devices have scale-up limitations § Relatively low throughput § Processing of one cuvette at a time § Labor and time intensive process § Multiple batches needed for manufacturing a dose § Manual handling may increase contamination risk 5
™ UltraPorator is designed to commercially scale-up UltraCAR-T manufacturing § Precigen’s proprietary system § Electroporation optimized for UltraCAR-T § Semi-closed system minimizes manual handling § Rapid, high efficiency gene transfer protocol § High throughput system handles a large number of T cells per batch 6™ UltraPorator is designed to commercially scale-up UltraCAR-T manufacturing § Precigen’s proprietary system § Electroporation optimized for UltraCAR-T § Semi-closed system minimizes manual handling § Rapid, high efficiency gene transfer protocol § High throughput system handles a large number of T cells per batch 6
® PRGN-3005 UltraCAR-T , a first-in-class therapy in ovarian cancer § Phase 1 trial is ongoing § Arm A: Intraperitoneal (IP) infusion; Arm B: Intravenous (IV) infusion § Enrollment in Dose Level 3 of IP arm is ongoing § 100% manufacturing success to date § Encouraging preliminary findings of UltraCAR-T safety & kinetics § Initial data readout from IP arm expected in 2H20 MUC16 CAR Kill Switch mbIL15 PRGN-3005 UltraCAR-T Direct infusion of PRGN-3005 UltraCAR-T into intraperitoneal cavity allows for direct access to tumor antigen expressed on cancer cells 7® PRGN-3005 UltraCAR-T , a first-in-class therapy in ovarian cancer § Phase 1 trial is ongoing § Arm A: Intraperitoneal (IP) infusion; Arm B: Intravenous (IV) infusion § Enrollment in Dose Level 3 of IP arm is ongoing § 100% manufacturing success to date § Encouraging preliminary findings of UltraCAR-T safety & kinetics § Initial data readout from IP arm expected in 2H20 MUC16 CAR Kill Switch mbIL15 PRGN-3005 UltraCAR-T Direct infusion of PRGN-3005 UltraCAR-T into intraperitoneal cavity allows for direct access to tumor antigen expressed on cancer cells 7
® PRGN-3006 UltraCAR-T , a first-in-class therapy in AML § Phase 1/1b trial is ongoing § Arm 1: No Lymphodepletion; Arm 2: With Lymphodepletion § Enrolling patients in Arm 1 and Arm 2 concurrently § 100% manufacturing success to date § Encouraging preliminary findings of UltraCAR-T safety & kinetics § Initial data readout expected in 2H20 CD33 CAR Kill Switch mbIL15 PRGN-3006 UltraCAR-T™ 8® PRGN-3006 UltraCAR-T , a first-in-class therapy in AML § Phase 1/1b trial is ongoing § Arm 1: No Lymphodepletion; Arm 2: With Lymphodepletion § Enrolling patients in Arm 1 and Arm 2 concurrently § 100% manufacturing success to date § Encouraging preliminary findings of UltraCAR-T safety & kinetics § Initial data readout expected in 2H20 CD33 CAR Kill Switch mbIL15 PRGN-3006 UltraCAR-T™ 8
™ PRGN-2009, a first-in-class off-the-shelf AdenoVerse immunotherapy for HPV-associated cancers § IND to initiate Phase 1/2 trial cleared by the FDA § Phase 1 to evaluate safety and response in patients with HPV-associated cancers § Gorilla adenoviral vector, with ability for repeat injections, designed to activate immune system to recognize and target + HPV solid tumors • Optimized HPV antigen design for improved immune response designed to differentiates from competition § Development through a CRADA with NCI PRGN-2009 AdenoVerse Immunotherapy 9™ PRGN-2009, a first-in-class off-the-shelf AdenoVerse immunotherapy for HPV-associated cancers § IND to initiate Phase 1/2 trial cleared by the FDA § Phase 1 to evaluate safety and response in patients with HPV-associated cancers § Gorilla adenoviral vector, with ability for repeat injections, designed to activate immune system to recognize and target + HPV solid tumors • Optimized HPV antigen design for improved immune response designed to differentiates from competition § Development through a CRADA with NCI PRGN-2009 AdenoVerse Immunotherapy 9
PRGN-2009 incorporates innovative multi-epitope antigen design optimized to induce a robust immune response against HPV16/18 PRGN-2009 multi-epitope antigen design targets HPV16/18 PRGN-2009 design advantage Innovative multi-epitope antigen design Robust antigen specific immune response Broad HPV16/18 antigen coverage Off-the-shelf Ability to repeat administer PRGN-2009 generates a robust anti-tumor response in a + syngeneic mouse model of HPV cancer Limitations of competing approaches 2500 Vaccines * § Limited antigen coverage * 2000 § DNA vaccines may have a relatively poor immunogenicity 1500 TCR-T Cells § Applicable in only a small subset of patients due to HLA 1000 polymorphism § Target only a single antigen epitope of HPV 500 § Long and expensive manufacturing process 0 *P<0.05 § Potential for mispairing of endogenous and exogenous TCR chains 10 PBS PRGN-2009 B intrafusp alfa PRGN-2009+ 3 Tumor Volume (mm )PRGN-2009 incorporates innovative multi-epitope antigen design optimized to induce a robust immune response against HPV16/18 PRGN-2009 multi-epitope antigen design targets HPV16/18 PRGN-2009 design advantage Innovative multi-epitope antigen design Robust antigen specific immune response Broad HPV16/18 antigen coverage Off-the-shelf Ability to repeat administer PRGN-2009 generates a robust anti-tumor response in a + syngeneic mouse model of HPV cancer Limitations of competing approaches 2500 Vaccines * § Limited antigen coverage * 2000 § DNA vaccines may have a relatively poor immunogenicity 1500 TCR-T Cells § Applicable in only a small subset of patients due to HLA 1000 polymorphism § Target only a single antigen epitope of HPV 500 § Long and expensive manufacturing process 0 *P<0.05 § Potential for mispairing of endogenous and exogenous TCR chains 10 PBS PRGN-2009 B intrafusp alfa PRGN-2009+ 3 Tumor Volume (mm )
™ AG019 ActoBiotics , a first-in-class therapy in Type 1 Diabetes § Phase 1b/2a trial ongoing § Phase 1b: AG019 monotherapy; Phase 2a: AG019 in combination with teplizumab (anti-CD3 mAb) § Recent-onset T1D patients (adults and adolescent) § AG019 is a capsule formulation to express human Proinsulin (hPINS) and human Interleukin-10 (hIL-10) § First-in-class disease modifying antigen-specific immunotherapy to prevent, delay or reverse T1D AG019 ActoBiotics § Positive topline data from Phase 1b arm § AG019 monotherapy was well tolerated § Preliminary data show encouraging trend in insulin C-peptide levels and increase in islet-specific Tregs Delivery of AG019 to GALT via oral delivery induces hPINS- specific regulatory T cells which migrate to inflamed tissue 11™ AG019 ActoBiotics , a first-in-class therapy in Type 1 Diabetes § Phase 1b/2a trial ongoing § Phase 1b: AG019 monotherapy; Phase 2a: AG019 in combination with teplizumab (anti-CD3 mAb) § Recent-onset T1D patients (adults and adolescent) § AG019 is a capsule formulation to express human Proinsulin (hPINS) and human Interleukin-10 (hIL-10) § First-in-class disease modifying antigen-specific immunotherapy to prevent, delay or reverse T1D AG019 ActoBiotics § Positive topline data from Phase 1b arm § AG019 monotherapy was well tolerated § Preliminary data show encouraging trend in insulin C-peptide levels and increase in islet-specific Tregs Delivery of AG019 to GALT via oral delivery induces hPINS- specific regulatory T cells which migrate to inflamed tissue 11
INXN-4001, a innovative gene therapy product for heart failure (HF) § Phase 1 Clinical trial Ongoing § Phase 1 enrollment complete § Triple-effector non-viral INXN-4001 is delivered via Retrograde Coronary Sinus Infusion (RCSI) § Cardiac-specific delivery to the ventricle § Interim Phase 1 data showed improvement in cardiac function and no product related adverse events 1 1. S100A1 for progenitor cell recruitment 2. SDF-1α for angiogenesis 2 balloon 3. VEGF165 for calcium handling 3 catheter INXN-4001 12 Multigenic plasmid with three effector genes INTERNAL & CONFIDENTIALINXN-4001, a innovative gene therapy product for heart failure (HF) § Phase 1 Clinical trial Ongoing § Phase 1 enrollment complete § Triple-effector non-viral INXN-4001 is delivered via Retrograde Coronary Sinus Infusion (RCSI) § Cardiac-specific delivery to the ventricle § Interim Phase 1 data showed improvement in cardiac function and no product related adverse events 1 1. S100A1 for progenitor cell recruitment 2. SDF-1α for angiogenesis 2 balloon 3. VEGF165 for calcium handling 3 catheter INXN-4001 12 Multigenic plasmid with three effector genes INTERNAL & CONFIDENTIAL
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Non-GAAP Financial Information This presentation includes Segment Adjusted EBITDA, which is a non-GAAP financial measure within the meaning of applicable rules and regulations of the Securities and Exchange Commission (SEC). Management believes this financial metric is a key indicator of operating results since it excludes noncash revenues and expenses that are not reflective of the underlying business performance of an individual enterprise. The Company defines Segment Adjusted EBITDA as net loss before (i) interest expense, (ii) income tax expense or benefit, (iii) depreciation and amortization, (iv) stock-based compensation expense, (v) adjustments for bonuses paid in equity awards, (vi) loss on impairment of goodwill and other long-lived assets, (vii) equity in net loss of affiliates, and (viii) recognition of previously deferred revenue associated with upfront and milestone payments as well as cash outflows from capital expenditures and investments in affiliates. For the six months ended June 30, 2020, the Company modified the current period definition of Segment Adjusted EBITDA to exclude adjustments recorded to reverse bonuses accrued as of December 31, 2019, as the Company determined in March 2020 that those bonuses would be paid through the grant of equity awards instead of cash. Segment Adjusted EBITDA for the six months ended June 30, 2019 was not impacted by this change. Segment Adjusted EBITDA is provided as additional information, not as an alternative to Precigen’s consolidated financial statements presented in accordance with GAAP, and is intended to enhance an overall understanding of the Precigen’s current financial performance. Exhibit 99.3
Reconciliation of Segment Adjusted EBITDA for Reportable Segments to Consolidated Net Loss from Continuing Operations Before Income Taxes The table below reconciles Segment Adjusted EBITDA for reportable segments to consolidated net loss from continuing operations before income taxes: Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Segment Adjusted EBITDA for reportable segments $ (5,999) $ (16,201) $ (26,209) $ (36,483) All Other Segment Adjusted EBITDA 637 (2,479) 1,129 (3,717) Remove cash paid for capital expenditures and investments in affiliates 1,879 4,155 4,620 7,667 Add recognition of previously deferred revenue associated with upfront and milestone payments 5,573 6,247 18,046 10,859 Other expenses: Interest expense (4,592) (4,353) (9,184) (8,658) Depreciation and amortization (4,783) (4,863) (9,593) (10,207) Impairment losses (22,041) — (22,041) — Stock-based compensation expense (4,897) 484 (10,615) (7,764) Adjustment related to bonuses paid in equity awards — — 2,833 — Equity in net loss of affiliates (251) (716) (602) (1,464) Other 3 — 12 — Unallocated corporate costs (7,344) (11,426) (17,526) (29,448) Eliminations (1,659) (3,162) (4,246) (6,012) Consolidated net loss from continuing operations before income taxes $ (43,474) $ (32,314) $ (73,376) $ (85,227)