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 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 March 2, 2020, reporting its financial results for the quarter and year ended December 31, 2019.
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 March 2, 2020, Precigen, Inc. provided a slide presentation to accompany its press release. A copy of the presentation is furnished as Exhibit 99.2 hereto.
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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |||
| 99.1 |
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| 99.2 |
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| 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: March 2, 2020
Exhibit 99.1
Precigen Reports Fourth Quarter and Year End 2019 Financial Results
– Company completed series of transactions to support tighter focus on healthcare –
– Quarterly GAAP revenues from continuing operations of $17.0 million and net loss attributable to Precigen of
$169.2 million, of which $95.7 million was from discontinued operations and an additional $33.8 million was for
non-cash charges related to continuing operations –
GERMANTOWN, MD, March 2, 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 its fourth quarter financial results for 2019.
Recent Business Highlights:
| • | The Company announced the appointment of Helen Sabzevari, PhD as President and CEO of Precigen and Randal J. Kirk as Executive Chairman effective as of January 1, 2020. The Company also changed its name to Precigen, Inc. from Intrexon Corporation and its Nasdaq stock symbol to PGEN from XON effective February 1, 2020; |
| • | The Company closed sales of a number of its assets for an aggregate of $65.2 million and sold $35 million of its common stock in January 2020, thereby alleviating the going concern qualification associated with its 2019 consolidated financial statements as well as further streamlining corporate focus; |
| • | The Company sold its ownership stake in AquaBounty Technologies, Inc. (Nasdaq: AQB) in October 2019 for proceeds of $21.6 million; |
| • | Precigen announced that the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS) (clinical trial identifier: NCT03927261); |
| • | Precigen ActoBio, Inc., a wholly-owned subsidiary of Precigen, collaboration partner Oragenics, Inc. (NYSE American: OGEN) completed enrollment in the Phase 2 trial of AG013, an easy to use oral rinsing system designed to prevent and treat oral mucositis; and |
| • | Triple-Gene LLC, a majority-owned subsidiary of Precigen, completed the Phase 1 trial enrollment and reported preliminary data of its investigational multigenic gene therapy INXN-4001 for the treatment of heart failure. |
Fourth Quarter 2019 Financial Highlights:
| • | Total revenues from continuing operations of $17.0 million; |
| • | Net loss of $169.2 million attributable to Precigen, or $(1.09) per basic share, of which $95.7 million was from discontinued operations and an additional $33.8 million was for non-cash charges related to continuing operations; and |
| • | Cash, cash equivalents, and short-term investments for continuing operations totaled $75.1 million at December 31, 2019. |
Full Year 2019 Financial Highlights:
| • | Total revenues from continuing operations of $90.7 million; |
| • | Net loss of $322.3 million attributable to Precigen, or $(2.09) per basic share, of which $116.2 million was from discontinued operations and an additional $70.4 million was for non-cash charges related to continuing operations. |
“I am confident that we will make important advances this year in our mission to improve patient care through innovative gene and cell therapies,” said Dr. Sabzevari. “We enter 2020 with cash resources that we believe are sufficient for us to deliver on several value-creating milestones during the year across our clinical pipeline. At the same time, we are laser-focused on aligning our portfolio, streamlining operations and maximizing organizational structures to improve operational efficiency going forward.”
Fourth Quarter 2019 Financial Results Compared to Prior Year Period
Total revenues decreased $24.2 million from the quarter ended December 31, 2018. Collaboration and licensing revenues decreased $24.6 million, or 103%, from the quarter ended December 31, 2018 primarily due to the reacquisition of rights previously licensed to some of Precigen’s collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Additionally, collaboration and licensing revenues from collaborations with other collaborators decreased due to lower demand for research and development services in the current year period.
Research and development expenses decreased $252.2 million, or 92%. The 2018 amounts include a $228.0 million expense related to in-process research and development reacquired from former collaborators. Selling, general and administrative (SG&A) expenses increased $6.3 million, or 28% which was primarily attributable to increased compensation expenses related to performance and retention incentives for SG&A employees, partially offset by (i) decreased share-based compensation expense which arose primarily from the departure of former employees during the first half of the current year; and (ii) fewer legal fees associated with the Company’s Trans Ova subsidiary. The Company also recorded a $29.6 million goodwill impairment charge in the fourth quarter of 2019 related to its Trans Ova subsidiary.
Full Year 2019 Financial Results Compared to Prior Year Period
Total revenues decreased $60.5 million from the year ended December 31, 2018. Collaboration and licensing revenues decreased $55.5 million, or 80%, from the year ended December 31, 2018 primarily due to the reacquisition of rights previously licensed to some of Precigen’s collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Additionally, in 2018, the Company recognized additional revenues from the acceleration of previously deferred revenue upon mutual termination of certain collaborations. Product revenues decreased $4.7 million, or 17%, primarily due to lower customer demand in the beef and dairy industries resulting in fewer sales of pregnant cows and calf products. Gross margin on products also declined in the current period as a result of fewer products sold.
Research and development expenses decreased $264.4 million, or 72%. The 2018 amounts include $236.7 million of expenses related to in-process research and development reacquired from former collaborators. SG&A expenses decreased $24.9 million, or 20%. SG&A salaries, benefits, and other personnel costs decreased $14.9 million primarily due to decreased share-based compensation expense as a result of the reversal of previously recognized expense for unvested options granted to former employees as well as the conclusion of the vesting period for other previously granted stock options. Legal and professional fees decreased $6.1 million primarily due to fewer legal fees associated with the Company’s Trans Ova subsidiary. The Company also recorded a $29.6 million goodwill impairment charge in the fourth quarter of 2019 related to its Trans Ova subsidiary.
Conference Call and Webcast
Precigen will host a conference call today Monday March 2nd at 5:30 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), and 1-412-317-6061 (International) and providing the number 4230814 to join the Precigen Conference Call. Participants may also access the live webcast through Precigen’s website in the Events section at https://investors.precigen.com/press-events/event-calendar.
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, UltraCAR-T, 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 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 and clinical trials and discovery programs, the promise of the Company’s portfolio of therapies, the Company’s refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company’s non-healthcare businesses. 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.
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) |
December 31, 2019 | December 31, 2018 | ||||||
| Assets |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 65,793 | $ | 96,876 | ||||
| Restricted cash |
— | 6,987 | ||||||
| Short-term investments |
9,260 | 119,614 | ||||||
| Equity securities |
— | 384 | ||||||
| Receivables |
||||||||
| Trade, net |
20,650 | 21,179 | ||||||
| Related parties, net |
600 | 4,129 | ||||||
| Other, net |
4,978 | 1,257 | ||||||
| Inventory |
16,097 | 20,575 | ||||||
| Prepaid expenses and other |
6,444 | 5,327 | ||||||
| Current assets held for sale |
110,821 | 9,155 | ||||||
|
|
|
|
|
|||||
| Total current assets |
234,643 | 285,483 | ||||||
| Equity securities, noncurrent |
— | 640 | ||||||
| Property, plant and equipment, net |
60,969 | 86,896 | ||||||
| Intangible assets, net |
68,346 | 88,962 | ||||||
| Goodwill |
63,754 | 93,627 | ||||||
| Investments in affiliates |
1,461 | 2,139 | ||||||
| Right-of-use assets |
25,228 | — | ||||||
| Other assets |
1,362 | 2,069 | ||||||
| Noncurrent assets held for sale |
— | 156,361 | ||||||
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|
|||||
| Total assets |
$ | 455,763 | $ | 716,177 | ||||
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|||||
| Current liabilities |
||||||||
| Accounts payable |
$ | 5,917 | $ | 11,973 | ||||
| Accrued compensation and benefits |
14,091 | 9,955 | ||||||
| Other accrued liabilities |
12,049 | 19,005 | ||||||
| Deferred revenue |
5,697 | 11,088 | ||||||
| Lines of credit |
1,922 | 466 | ||||||
| Current portion of long-term debt |
31,670 | 479 | ||||||
| Current portion of lease liabilities |
4,182 | — | ||||||
| Related party payables |
51 | 256 | ||||||
| Current liabilities held for sale |
47,333 | 8,340 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
122,912 | 61,562 | ||||||
| Long-term debt, net of current portion |
186,321 | 211,216 | ||||||
| Deferred revenue, net of current portion |
48,136 | 46,728 | ||||||
| Lease liabilities, net of current portion |
23,849 | — | ||||||
| Deferred tax liabilities, net |
2,834 | 3,856 | ||||||
| Other long-term liabilities |
— | 3,135 | ||||||
| Long-term liabilities held for sale |
— | 10,958 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
384,052 | 337,455 | ||||||
|
|
|
|
|
|||||
| Commitments and contingencies |
||||||||
| Total equity |
||||||||
| Common stock |
— | — | ||||||
| Additional paid-in capital |
1,752,048 | 1,722,012 | ||||||
| Accumulated deficit |
(1,652,869 | ) | (1,330,545 | ) | ||||
| Accumulated other comprehensive loss |
(27,468 | ) | (28,612 | ) | ||||
|
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|
|
|||||
| Total Precigen shareholders’ equity |
71,711 | 362,855 | ||||||
| Noncontrolling interests |
— | 15,867 | ||||||
|
|
|
|
|
|||||
| Total equity |
71,711 | 378,722 | ||||||
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|
|
|
|
|||||
| Total liabilities and total equity |
$ | 455,763 | $ | 716,177 | ||||
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|
|
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Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
| (Amounts in thousands, except share and per share data) | Three months ended | Year ended | ||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues |
||||||||||||||||
| Collaboration and licensing revenues |
$ | (658 | ) | $ | 23,947 | $ | 14,059 | $ | 69,540 | |||||||
| Product revenues |
5,297 | 4,974 | 23,780 | 28,486 | ||||||||||||
| Service revenues |
12,096 | 12,040 | 51,803 | 52,419 | ||||||||||||
| Other revenues |
267 | 231 | 1,080 | 733 | ||||||||||||
|
|
|
|
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|
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|
|||||||||
| Total revenues |
17,002 | 41,192 | 90,722 | 151,178 | ||||||||||||
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|
|
|||||||||
| Operating Expenses |
||||||||||||||||
| Cost of products |
7,800 | 7,531 | 31,930 | 35,087 | ||||||||||||
| Cost of services |
7,611 | 6,462 | 29,471 | 27,589 | ||||||||||||
| Research and development |
21,035 | 273,229 | 101,879 | 366,248 | ||||||||||||
| Selling, general and administrative |
28,358 | 22,089 | 100,844 | 125,751 | ||||||||||||
| Impairment loss |
30,184 | — | 30,810 | — | ||||||||||||
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|
|
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|
|
|||||||||
| Total operating expenses |
94,988 | 309,311 | 294,934 | 554,675 | ||||||||||||
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|
|
|
|||||||||
| Operating loss |
(77,986 | ) | (268,119 | ) | (204,212 | ) | (403,497 | ) | ||||||||
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|
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| Other Income (Expense), Net |
||||||||||||||||
| Unrealized and realized appreciation (depreciation) in fair value of equity securities and preferred stock, net |
5,221 | (2,255 | ) | 8,291 | (28,273 | ) | ||||||||||
| Interest expense |
(4,542 | ) | (4,307 | ) | (17,666 | ) | (8,473 | ) | ||||||||
| Interest and dividend income |
603 | 1,758 | 3,871 | 19,017 | ||||||||||||
| Other income (expense), net |
2,774 | (65 | ) | 3,445 | 470 | |||||||||||
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| Total other income (expense), net |
4,056 | (4,869 | ) | (2,059 | ) | (17,259 | ) | |||||||||
| Equity in net loss of affiliates |
(473 | ) | (913 | ) | (2,416 | ) | (8,986 | ) | ||||||||
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|
|||||||||
| Loss from continuing operations before income taxes |
(74,403 | ) | (273,901 | ) | (208,687 | ) | (429,742 | ) | ||||||||
| Income tax benefit (expense) |
905 | (686 | ) | 930 | 15,425 | |||||||||||
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|
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| Loss from continuing operations |
$ | (73,498 | ) | $ | (274,587 | ) | $ | (207,757 | ) | $ | (414,317 | ) | ||||
| Loss from discontinued operations, net of income tax benefit |
(95,717 | ) | (67,135 | ) | (116,159 | ) | (100,389 | ) | ||||||||
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|
|
|
|
|
|
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| Net loss |
$ | (169,215 | ) | $ | (341,722 | ) | $ | (323,916 | ) | $ | (514,706 | ) | ||||
| Net loss attributable to the noncontrolling interests |
— | 1,257 | 1,592 | 5,370 | ||||||||||||
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| Net loss attributable to Precigen |
$ | (169,215 | ) | $ | (340,465 | ) | $ | (322,324 | ) | $ | (509,336 | ) | ||||
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| Amounts Attributable to Precigen |
||||||||||||||||
| Net loss from continuing operations attributable to Precigen |
$ | (73,498 | ) | $ | (273,330 | ) | $ | (206,165 | ) | $ | (408,947 | ) | ||||
| Net loss from discontinued operations attributable to Precigen |
(95,717 | ) | (67,135 | ) | (116,159 | ) | (100,389 | ) | ||||||||
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| Net loss attributable to Precigen |
$ | (169,215 | ) | $ | (340,465 | ) | $ | (322,324 | ) | $ | (509,336 | ) | ||||
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| Net Loss per Share |
||||||||||||||||
| Net loss from continuing operations attributable to Precigen per share, basic and diluted |
$ | (0.47 | ) | $ | (2.08 | ) | $ | (1.34 | ) | $ | (3.16 | ) | ||||
| Net loss from discontinued operations attributable to Precigen per share, basic and diluted |
(0.62 | ) | (0.51 | ) | (0.75 | ) | (0.77 | ) | ||||||||
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| Net loss attributable to Precigen per share, basic and diluted |
$ | (1.09 | ) | $ | (2.59 | ) | $ | (2.09 | ) | $ | (3.93 | ) | ||||
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| Weighted average shares outstanding, basic and diluted |
155,230,741 | 131,532,851 | 154,138,774 | 129,521,731 | ||||||||||||
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Precigen 4Q-2019 Business Update 2 March 2020 Exhibit 99.2
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,” “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) ongoing transition efforts following the company’s recent divestment of several assets and businesses, (ii) 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; (iii) 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, whether with its collaborators or independently; (iv) the ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that it may form in the future; (v) the ability to hold or generate significant operating capital, including through partnering, asset sales and operating cost reductions; (vi) actual or anticipated variations in operating results; (vii) actual or anticipated fluctuations in competitors’ or collaborators’ operating results or changes in their respective growth rates; (viii) cash position; (ix) market conditions in the company’s industry; (x) the volatility of Precigen’s stock price; (xi) the ability, and the ability of collaborators, to protect Precigen’s intellectual property and other proprietary rights and technologies; (xii) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies; (xiii) outcomes of pending and future litigation; (xiv) the rate and degree of market acceptance of any products developed by Precigen, its subsidiaries, collaborations or joint ventures; (xv) the ability to retain and recruit key personnel; (xvi) expectations related to the use of proceeds from public offerings and other financing efforts; (xvii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and (xviii) 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 information in this presentation is as of the date its cover page, and Precigen undertakes no duty to update this information unless required by law. 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.
Precigen: Setting the Stage for Success Ziopharm licensing agreement Merck KGaA agreement PRGN-3006 IND clearance PRGN-3005 IND clearance Intrexon Health formed Manufacturing facility opened First patient dosed for PRGN-3006 First patient dosed for PRGN-3005 Announced completion of dosing of first cohorts and manufacturing success for PRGN-3005 and PRGN-3006 Intrexon renamed Precigen Dr. Sabzevari named President & CEO Several Non-HC assets divested Balance sheet strengthened 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20
Adhering to Operating Principles to Deliver Value to All Stakeholders PRECIGEN’S VISION FOR PATIENTS Develop life-saving and cost-conscious therapies utilizing our cutting-edge platform technologies for patients with unmet need FISCAL STRENGTH Responsible capital allocation to ensure runway for maximum value creation ACTIVE PORTFOLIO MANAGEMENT Continuous evaluation of portfolio based on data to make rapid go/no go decisions STRATEGIC PARTNERSHIPS Seek strategic partnerships to maximize value generation RAPID EXECUTION Focus on rapid execution of priority programs with the highest probability of success
Our Non-Healthcare Asset Strategy MBP Titan Significantly reduce cash requirement Increase operational efficiencies Support partnering discussions Trans Ova Genetics Continue to evaluate strategic alternatives Increase operational efficiencies Contribute cash to Precigen
One Precigen: Deploying Novel Approaches to Address Unmet Healthcare Needs Therapeutic gene(s) inserted Non-viral multi-gene delivery Non-exhausted, stem-like T cell phenotype Higher antigen-specific expansion Enhanced in vivo persistence Ability to deplete with kill switch Overnight manufacturing process Large payload capacity Low seroprevalence in humans Ability for repeat administration Durable antigen-specific immune response Highly productive manufacturing process Food-grade bacteria, L. lactis Long history of safe use in humans Easy genetic manipulation Cost-effective and scalable manufacturing Convenient oral or topical delivery Local expression of genes at disease site UltraCAR-T AdenoVerse Immunotherapy ActoBiotics
PRODUCT PLATFORM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 STATUS / MILESTONES PARTNER PRECIGEN AG019 ActoBiotics Type 1 Diabetes Interim data in 3Q20 PRGN-3005 UltraCAR-T Ovarian Cancer Initial data in 2H20 PRGN-3006 UltraCAR-T AML, MDS Initial data in 2H20 INXN-4001 Non-viral UltraVector Heart Failure Phase 1 data in 2020 PRGN-2009 OTS AdenoVerse Immunotherapy HPV+ Solid Tumors Initiate Phase 1 in 2020 PARTNERED FCX-007 Fibroblast Cell Therapy RDEB Pivotal Phase 3 initiated AG013 ActoBiotics Oral Mucositis Phase 2 interim data in 1H20 CGF166 Gene Therapy Hearing Loss Phase 1/2 ongoing FCX-013 Fibroblast Cell Therapy Localized Scleroderma Phase 1/2 is enrolling Robust Pipeline with Many Milestones to Drive Value
Our UltraCAR-T™ Platform Promises a More Effective Way to Treat Patients Reliance on viral vectors Complexity of manufacturing viral vectors Long and complex CAR-T cell manufacturing process Long delays for patients High cost of manufacturing Exhausted T cell phenotype Major challenges in solid tumor treatment Non-viral gene delivery Simplified manufacturing of Plasmid DNA Overnight UltraCAR-T manufacturing process No ex vivo expansion necessary Reduced manufacturing cost Stem-like memory T cell phenotype Enhanced potential for expansion and persistence Conventional CAR-T Viral vectors and ex vivo expansion result in long delays for patient treatment and high cost UltraCAR-T™ Overnight non-viral gene transfer eliminates long delays for patient treatment and lower manufacturing cost 1 2 5 6 7 8 3 4
PRGN-3005, a first-in-class therapy in ovarian cancer Phase 1 trial is ongoing Arm A: Intraperitoneal (IP) infusion; Arm B: Intravenous (IV) infusion Second cohort for IP arm currently enrolling patients 100% manufacturing success to date Encouraging preliminary findings of UltraCAR-T kinetics Initial data readout from IP arm expected in 2H20 PRGN-3005 UltraCAR-T Infusion of PRGN-3005 UltraCAR-T into intraperitoneal cavity allows for direct access to tumor antigen expressed on cancer cells MUC16 CAR mbIL15 Kill Switch
PRGN-3006, a first-in-class therapy in AML Phase 1/1b trial is ongoing Arm 1: No Lymphodepletion ; Arm 2: With Lymphodepletion Second cohort for Arm 1 and First cohort for Arm 2 currently enrolling 100% manufacturing success to date Encouraging preliminary findings of UltraCAR-T kinetics Initial data readout expected in 2H20 PRGN-3006 UltraCAR-T CD33 CAR mbIL15 Kill Switch
Multiple Milestones to Drive Value in 2020 and Beyond Initial data from IP arm of PRGN-3005 UltraCAR-T™ Phase 1 trial in Ovarian Cancer Initial data from PRGN-3006 UltraCAR-T™ Phase 1 trial in AML and MDS Interim data from Phase 2 trial of AG013 in Oral Mucositis Interim data from Phase 1b/2a trial of AG019 in Type 1 Diabetes Phase 1 data completion of INXN-4001 in Heart Failure patients with LVAD Initiate Phase 1 trial of PRGN-2009 off-the-shelf AdenoVerse™ immunotherapy in HPV+ cancers
