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 May 6, 2020, reporting its financial results for the quarter ended March 31, 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 May 6, 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 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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| 99.3 |
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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: May 6, 2020
Exhibit 99.1
Precigen Reports First Quarter 2020 Financial Results
– Achieves significant progress in streamlining healthcare operations and reducing operating costs –
– Maintains guidance for clinical readouts in 2020 –
– Completes reduction in force at MBP Titan to focus resources on healthcare –
– Received FDA clearance of PRGN-2009 to initiate a Phase 1/2 trial in HPV-positive solid tumors –
GERMANTOWN, MD, May 6, 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 first quarter financial results for 2020.
First Quarter Business Highlights:
| • | PRGN-2009 AdenoVerse™ Immunotherapy: Precigen announced that the US Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application to initiate a Phase 1/2 trial for PRGN-2009, a first-in-class, off-the-shelf investigational immunotherapy utilizing the AdenoVerse™ platform and designed to activate the immune system to recognize and target HPV-positive solid tumors. The Phase 1 portion of the study will follow a 3+3 dose escalation design to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase 2 dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers; |
| • | PRGN-3005 UltraCAR-T®: Dosing in the second dose level of the intraperitoneal (IP) arm of the Phase 1 trial of PRGN-3005 UltraCAR-T was completed; |
| • | PRGN-3006 UltraCAR-T®: Enrollment of patients in the non-lymphodepletion and lymphodepletion arms of the Phase 1 trial of PRGN-3006 UltraCAR-T, has been unaffected by the COVID-19 pandemic to date. The IND has been amended, and the FDA has allowed for concurrent dosing of patients in both arms; and |
| • | In order to further Precigen’s efforts to focus resources on its healthcare programs and as a result of market uncertainty driven by the COVID-19 pandemic and the current state of the energy sector, MBP Titan LLC, a wholly-owned subsidiary of Precigen focused on methane bioconversion, has significantly reduced its resource requirements through a workforce reduction. These actions will significantly decrease cash burn while maintaining intellectual property. |
First Quarter 2020 Financial Highlights:
| • | Total revenues of $29.8 million; |
| • | Net loss from continuing operations attributable to Precigen of $29.9 million, or $(0.19) per basic share, of which $8.7 million was for non-cash charges; and |
| • | Cash, cash equivalents, and short-term investments totaled $149.2 million at March 31, 2020. |
“This is the first full quarter operating as the new Precigen, and we have made tremendous progress in consolidating operations and adhering to our operating priniciples to deliver value to all stakeholders,” said Helen Sabzevari, PhD, President and CEO of Precigen. “From a clinical perspective, we are incredibly pleased to receive the third IND clearance for a Precigen asset in just over one year. From an operational perspective, we’ve achieved significant progress in streamlining our healthcare operations. This helps us focus our capital allocation to ensure that we have a solid runway for maximum value creation.”
First Quarter 2020 Financial Results Compared to Prior Year Period
Total revenues increased $7.3 million over the quarter ended March 31, 2019. Collaboration and licensing revenues increased $4.8 million, or 80%, over the quarter ended March 31, 2019 primarily due to the accelerated recognition of previously deferred revenue upon the mutual termination of a collaboration with Fibrocell Science, Inc., in February 2020. This increase was partially offset by a decrease in collaboration revenues related to programs that were paused in 2019. Service revenues increased $2.6 million, or 23%, over the quarter ended March 31, 2019 primarily due to increased service revenues at Precigen’s subsidiary, Trans Ova Genetics L.C., due to an increase in services performed for new and existing customers and the expansion of its commercial dairy business.
Research and development expenses decreased $8.0 million, or 30%. Salaries, benefits and other personnel costs decreased $2.1 million, and contract research organization costs and lab supplies decreased $5.1 million as Precigen narrowed its focus on its primary healthcare programs. Selling, general and administrative expenses decreased $8.0 million, or 26%. Salaries, benefits and other personnel costs decreased $4.8 million primarily due to a reduction of corporate employees in the first quarter of 2020 as Precigen scaled down its corporate functions. Additionally, professional fees decreased $3.6 million primarily due to the expiration of the services agreement with Third Security, LLC on December 31, 2019.
More information on Precigen’s first quarter financial results will be available in our Quarterly Report on Form 10-Q, which we expect to file by May 11, 2020.
Conference Call and Webcast
Precigen will host a conference call today Wednesday, May 6th at 4:15 PM ET to discuss the results and provide a general business update. The conference call may be accessed by dialing 1-833-646-0488 (US/Canada toll-free) or 1-918-922-6615 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/events/event-details/precigen-first-quarter-2020-financial-results-conference-call.
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, AdenoVerse, 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 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) |
March 31, 2020 | December 31, 2019 | ||||||
| Assets |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 37,840 | $ | 65,793 | ||||
| Short-term investments |
111,332 | 9,260 | ||||||
| Receivables |
||||||||
| Trade, net |
19,376 | 20,650 | ||||||
| Related parties, net |
252 | 600 | ||||||
| Other |
351 | 4,978 | ||||||
| Inventory |
14,636 | 16,097 | ||||||
| Prepaid expenses and other |
5,596 | 6,444 | ||||||
| Current assets held for sale |
— | 110,821 | ||||||
|
|
|
|
|
|||||
| Total current assets |
189,383 | 234,643 | ||||||
| Property, plant and equipment, net |
59,627 | 60,969 | ||||||
| Intangible assets, net |
65,489 | 68,346 | ||||||
| Goodwill |
63,703 | 63,754 | ||||||
| Investments in affiliates |
1,108 | 1,461 | ||||||
| Right-of-use assets |
24,036 | 25,228 | ||||||
| Other assets |
1,326 | 1,362 | ||||||
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|||||
| Total assets |
$ | 404,672 | $ | 455,763 | ||||
|
|
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|
|
|||||
| Current liabilities |
||||||||
| Accounts payable |
$ | 4,777 | $ | 5,917 | ||||
| Accrued compensation and benefits |
7,209 | 14,091 | ||||||
| Other accrued liabilities |
9,972 | 12,049 | ||||||
| Deferred revenue |
11,141 | 5,697 | ||||||
| Lines of credit |
1,205 | 1,922 | ||||||
| Current portion of long-term debt |
31,886 | 31,670 | ||||||
| Current portion of lease liabilities |
4,308 | 4,182 | ||||||
| Related party payables |
139 | 51 | ||||||
| Current liabilities held for sale |
— | 47,333 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
70,637 | 122,912 | ||||||
| Long-term debt, net of current portion |
188,730 | 186,321 | ||||||
| Deferred revenue, net of current portion |
32,877 | 48,136 | ||||||
| Lease liabilities, net of current portion |
22,414 | 23,849 | ||||||
| Deferred tax liabilities |
2,785 | 2,834 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
317,443 | 384,052 | ||||||
|
|
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|
|
|||||
| Commitments and contingencies |
||||||||
| Total shareholders’ equity |
||||||||
| Common stock |
— | — | ||||||
| Additional paid-in capital |
1,797,450 | 1,752,048 | ||||||
| Accumulated deficit |
(1,708,867 | ) | (1,652,869 | ) | ||||
| Accumulated other comprehensive loss |
(1,354 | ) | (27,468 | ) | ||||
|
|
|
|
|
|||||
| Total shareholders’ equity |
87,229 | 71,711 | ||||||
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|
|
|
|
|||||
| Total liabilities and shareholders’ equity |
$ | 404,672 | $ | 455,763 | ||||
|
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Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
| Three months ended | ||||||||
| March 31, | ||||||||
| (Amounts in thousands, except share and per share data) |
2020 | 2019 | ||||||
| Revenues |
||||||||
| Collaboration and licensing revenues |
$ | 10,721 | $ | 5,971 | ||||
| Product revenues |
4,961 | 4,837 | ||||||
| Service revenues |
13,946 | 11,383 | ||||||
| Other revenues |
210 | 394 | ||||||
|
|
|
|
|
|||||
| Total revenues |
29,838 | 22,585 | ||||||
|
|
|
|
|
|||||
| Operating Expenses |
||||||||
| Cost of products |
6,089 | 7,722 | ||||||
| Cost of services |
7,536 | 7,092 | ||||||
| Research and development |
18,891 | 26,938 | ||||||
| Selling, general and administrative |
23,018 | 31,049 | ||||||
|
|
|
|
|
|||||
| Total operating expenses |
55,534 | 72,801 | ||||||
|
|
|
|
|
|||||
| Operating loss |
(25,696 | ) | (50,216 | ) | ||||
|
|
|
|
|
|||||
| Other Expense, Net |
||||||||
| Unrealized and realized appreciation in fair value of equity securities and preferred stock, net |
— | 449 | ||||||
| Interest expense |
(4,592 | ) | (4,305 | ) | ||||
| Interest and dividend income |
673 | 1,361 | ||||||
| Other income, net |
64 | 546 | ||||||
|
|
|
|
|
|||||
| Total other expense, net |
(3,855 | ) | (1,949 | ) | ||||
| Equity in net loss of affiliates |
(351 | ) | (748 | ) | ||||
|
|
|
|
|
|||||
| Loss from continuing operations before income taxes |
(29,902 | ) | (52,913 | ) | ||||
| Income tax benefit (expense) |
(40 | ) | 13 | |||||
|
|
|
|
|
|||||
| Loss from continuing operations |
$ | (29,942 | ) | $ | (52,900 | ) | ||
| Loss from discontinued operations, net of income taxes |
(26,056 | ) | (9,236 | ) | ||||
|
|
|
|
|
|||||
| Net loss |
$ | (55,998 | ) | $ | (62,136 | ) | ||
| Net loss attributable to the noncontrolling interests |
— | 1,427 | ||||||
|
|
|
|
|
|||||
| Net loss attributable to Precigen |
$ | (55,998 | ) | $ | (60,709 | ) | ||
|
|
|
|
|
|||||
| Amounts Attributable to Precigen |
||||||||
| Net loss from continuing operations attributable to Precigen |
$ | (29,942 | ) | $ | (51,473 | ) | ||
| Net loss from discontinued operations attributable to Precigen |
(26,056 | ) | (9,236 | ) | ||||
|
|
|
|
|
|||||
| Net loss attributable to Precigen |
$ | (55,998 | ) | $ | (60,709 | ) | ||
|
|
|
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|
|||||
| Net Loss per Share |
||||||||
| Net loss from continuing operations attributable to Precigen per share, basic and diluted |
$ | (0.19 | ) | $ | (0.34 | ) | ||
| Net loss from discontinued operations attributable to Precigen per share, basic and diluted |
(0.16 | ) | (0.06 | ) | ||||
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|
|
|
|
|||||
| Net loss attributable to Precigen per share, basic and diluted |
$ | (0.35 | ) | $ | (0.40 | ) | ||
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|
|
|
|
|||||
| Weighted average shares outstanding, basic and diluted |
160,338,743 | 152,948,058 | ||||||
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Precigen, Inc. 1Q-2020 Business Update 6 May 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,” “seek,” “expect,” “believe,” “anticipate,” “intend,” “continue,” “opportunity,” “groundwork,” “poised,” “future,” “update” and similar expressions. Examples of forward-looking statements in his 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 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. 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.
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
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
Our Non-Healthcare Asset Strategy MBP Titan Significantly reduced cash requirement Steps to secure IP and technology Support partnering discussions Trans Ova Genetics Increase operational efficiencies On-track to contribute cash to Precigen Continue to evaluate strategic alternatives
PRODUCT PLATFORM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MILESTONES AG019 ActoBiotics Type 1 Diabetes Interim data 3Q20 PRGN-3005 UltraCAR-T Ovarian Cancer Initial data 2H20 PRGN-3006 UltraCAR-T AML, MDS Initial data in 2H20 INXN-4001 Non-viral UltraVector Heart Failure Top line data 2H20 PRGN-2009 OTS AdenoVerse Immunotherapy HPV+ Solid Tumors Initiate Phase 1 2020 Robust Pipeline with Many Milestones to Drive Value
PRGN-2009, a first-in-class off-the-shelf AdenoVerse™ immunotherapy for HPV+ cancers PRGN-2009 AdenoVerse Immunotherapy 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 Development through a CRADA with NCI
PRGN-2009 AdenoVerse Immunotherapy: Phase 1 trial design Phase 1 study will evaluate safety and response of PRGN-2009 alone and in combination with M7824 (bintrafusp alfa) in patients with HPV-associated cancers Clinical development under CRADA with NCI Dr. Julius Strauss as Principal Investigator Arm A: PRGN-2009 monotherapy dose escalation Arm B: PRGN-2009 in combination with M7824 Phase 1, Arm A Phase 1, Arm B
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 Dosing in Dose Level 2 of IP arm completed 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 Direct 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
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-3006, 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 kinetics Initial data readout expected in 2H20 PRGN-3006 UltraCAR-T CD33 CAR mbIL15 Kill Switch
PRODUCT PLATFORM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MILESTONES AG019 ActoBiotics Type 1 Diabetes Interim data 3Q20 PRGN-3005 UltraCAR-T Ovarian Cancer Initial data 2H20 PRGN-3006 UltraCAR-T AML, MDS Initial data in 2H20 INXN-4001 Non-viral UltraVector Heart Failure Top line data 2H20 PRGN-2009 OTS AdenoVerse Immunotherapy HPV+ Solid Tumors Initiate Phase 1 2020 Robust Pipeline with Many Milestones to Drive Value
Upcoming 2020 Clinical Milestones 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 1b/2a trial of AG019 in Type 1 Diabetes Top line data from Phase 1 trial of INXN-4001 in Heart Failure patients with LVAD Initiate Phase 1 trial of PRGN-2009 off-the-shelf AdenoVerse™ immunotherapy in HPV+ cancers
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 three months ended March 31, 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 three months ended March 31, 2020 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 EndedMarch 31, 2020 2019 Segment Adjusted EBITDA for reportable segments $,-20,210 $,-20,282 All Other Segment Adjusted EBITDA 492 -1,238 Remove cash paid for capital expenditures and investments in affiliates 2,741 3,512 Add recognition of previously deferred revenue associated with upfront and milestone payments 12,473 4,612 Other expenses: Interest expense -4,592 -4,305 Depreciation and amortization -4,810 -5,344 Stock-based compensation expense -5,718 -8,248 Adjustment for accrued bonuses paid in equity awards 2,833 0 Equity in net loss of affiliates -,351 -,748 Other 9 0 Unallocated corporate costs ,-10,182 ,-18,022 Eliminations -2,587 -2,850 Consolidated net loss from continuing operations before income taxes $,-29,902 $,-52,913