UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item7.01 | Regulation FD Disclosure. |
As announced earlier today, Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients and a wholly owned subsidiary of Intrexon, will host a conference call today Tuesday, November 12th at 11:00 AM ET to provide Precigen business and pipeline updates. 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 4454504 to join the Precigen Business and Pipeline Update Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at http://investors.dna.com/events or Precigen’s website in the Presentations section at https://precigen.com/media/#id-presentations. A copy of the presentation is furnished as Exhibit 99.1 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 |
Slide presentation of Precigen, Inc., a subsidiary of Intrexon Corporation, dated November 12, 2019. | |||
| 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.
| Intrexon Corporation | ||
| By: |
/s/ Rick L. Sterling | |
| Rick L. Sterling | ||
| Chief Financial Officer | ||
Dated: November 12, 2019
Precigen Business & Pipeline Update 12 November 2019 Exhibit 99.1
Forward-looking statements Precigen, Inc. is a subsidiary of Intrexon Corporation (Nasdaq: XON). 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 Intrexon's and 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 his presentation, include statements about the timing, pace and progress of preclinical and clinical trials and discovery programs, potential benefits of Precigen’s platforms and product candidates including in comparison to competitive platforms and products, and plans to increase public disclosure regarding Precigen’s pipeline. 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) Precigen's strategy and overall approach to its business model, including its ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that Intrexon may form in the future; (ii) the ability to successfully enter new markets or develop additional products, whether with its collaborators or independently; (iii) actual or anticipated variations in operating results; (iv) actual or anticipated fluctuations in competitors' or collaborators' operating results or changes in their respective growth rates; (v) cash position; (vi) market conditions in Intrexon's and Precigen's industry; (vii) the volatility of Intrexon's stock price; (viii) the ability, and the ability of collaborators, to protect intellectual property and other proprietary rights and technologies; (ix) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies; (x) the outcomes of pending or future litigation; (xi) the rate and degree of market acceptance of any products developed; (xii) the ability to retain and recruit key personnel; (xiii) expectations related to the use of proceeds from financing efforts; and (xiv) estimates regarding expenses, future revenue, capital requirements and needs for additional financing. 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 Intrexon's Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Intrexon's subsequent filings with the Securities and Exchange Commission. All information in this presentation is as of the date its cover page, and Intrexon 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. © 2019 Precigen, Inc. All rights reserved.
Dr. Helen Sabzevari President of Precigen
CONTROL gene expression and regulation to drive safety CONSTRUCT powerful gene programs to drive efficacy DELIVER gene programs via viral and non-viral based approaches to drive lower costs Precigen’s technology platforms UltraVector® mbIL15 Sleeping Beauty system AttSiteTM recombinases AdenoVerseTM RheoSwitch® Kill switches Tissue specific promoters
Precigen’s pipeline offers rapid value creation and potential for novel combinations Precigen pipeline as of November 2019
Disrupting the market: Precigen’s transformative UltraCAR-T™ platform 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 for large patient population 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 Modified from Iyer et al., Front. Med.,2018
PRGN-3005 UltraCAR-T™, a first-in-class therapy in ovarian cancer Advanced non-viral Sleeping Beauty system to co-express CAR, mbIL15 and kill switch Advanced stage platinum resistant ovarian cancer 300k diagnosed annually1/22k in US2 Stage IV survival as low as 20%3 Mucin 16 (MUC16) protein Overexpressed on greater than 80% of ovarian tumors Limited expression found in healthy tissues PRGN-3005 optimized to preferentially target MUC16+ cancer cells Target & Design 1World Health Organization, International Agency for Research on Cancer, Global Cancer Observatory. Cancer Today, Estimated number of new cases in 2018, worldwide, both sexes, all ages. Accessed December 2018 via WHO IARC GCO website. 2American Cancer Society Ovarian Cancer Special Section. Access December 2018 via ACS website. 3American Cancer Society. Survival Rates for Ovarian Cancer, by Stage. Accessed December 2018 via ACS website. Patient Population Piché A. et al., World J Obstet Gynecol. 2016 MUC16
PRGN-3005 UltraCAR-T: Phase 1 trial is enrolling patients Clinical trial in collaboration with Uni. of WA & Fred Hutchinson Cancer Center Dose escalation study to determine safety and MTD Arm A: IP infusion Arm B: IV infusion 3x3 dose escalation for IP and IV infusion arms First cohort (dose level 1) for IP arm has completed enrollment Initial data readout from IP arm expected in 2H-2020 Arm A: Intraperitoneal (IP) infusion Arm B: Intravenous (IV) infusion
PRGN-3006 UltraCAR-T™, a first-in-class therapy in AML Relapsed or refractory acute myeloid leukemia (AML) 20k diagnosed in US in 20181 Higher risk myelodysplastic syndrome (MDS) US incidence >10k per year2 Patient Population Advanced non-viral Sleeping Beauty system to co-express CAR, mbIL15 and kill switch 1American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Accessed December 2018 via ACS website. 2American Cancer Society. Key Statistics for Myelodysplastic Syndromes. Accessed December 2018 via ACS website. Target & Design CD33 is overexpressed on myeloid leukemia cells and leukemic stem cells No expression on normal hematopoietic stem cells 85-90% of AML patients show expression of CD33 on blasts An attractive target for immunotherapy of AML www.openaccessgovernment.org/cd33-directed-therapy CD33
PRGN-3006 UltraCAR-T: Phase 1/1b trial is enrolling patients Dose escalation study to determine safety and MTD Arm 1: NO lymphodepletion Arm 2: With lymphodepletion 3x3 dose escalation design followed by dose expansion phase at MTD for each arm Study in collaboration with Moffitt Cancer Center First cohort (dose level 1) for No lymphodepletion arm has completed enrollment Initial data readout expected in 2H-2020 Arm 1: No lymphodepletion prior to UltraCAR-T infusion Arm 2: Lymphodepletion prior to UltraCAR-T infusion
PRGN-2009 off-the-shelf AdenoVerse™ immunotherapy showed robust anti-tumor activity in humanized mouse model of HPV+ head & neck cancer CD8+ T cells / mg tumor Increase in CD8+ T cell infiltration in tumor after PRGN-2009 treatment in mice PRGN-2009 immunotherapy effectively controls HPV+ head & neck cancer in mice PRGN-2009 Negative Control Vehicle PRGN-2009 Negative Control
Multifunctional therapeutics overcome tumor microenvironment immunosuppression and improve T cell function compared to anti-PD1 in preclinical mouse models PRGN-5001 exhibits superior anti-tumor effect compared to anti-PD1 in humanized mouse model of Head and Neck cancer PRGN-5002 exhibits superior anti-tumor effect compared to anti-PD1 in humanized mouse model of Cervical cancer
Portfolio Advancement in 2019 Rapidly advance preclinical and clinical programs þ þ þ þ þ Initiate PRGN-3006 UltraCAR-T TM Phase 1 trial in AML and MDS Rapidly advance PRGN-3005 UltraCAR-T TM for solid tumor Rapidly advance PRGN-2009 AdenoVerse TM immunotherapy for solid tumor Rapidly advance one infectious disease candidate Rapidly advance preclinical candidates to go/no go
