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Washington, D.C. 20549



Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 9, 2022

Precigen, Inc.

(Exact name of registrant as specified in its charter)


Virginia   001-36042   26-0084895

(State or other jurisdiction

of incorporation)



File Number)


(I.R.S. Employer

Identification No.)

20374 Seneca Meadows Parkway, Germantown, Maryland 20876

(Address of principal executive offices) (Zip Code)

(301) 556-9900

(Registrant’s telephone number, including area code)


(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to 12(b) of the Act:


Title of each class  




Name of each exchange

on which registered

Common Stock, No Par Value   PGEN   Nasdaq Global Select Market


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 May 9, 2022, reporting its financial results for the quarter ended March 31, 2022.


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.




99.1   Press release dated May 9, 2022
104   Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101)





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.

/s/ Donald P. Lehr 

    Donald P. Lehr
    Chief Legal Officer

Dated: May 9, 2022



Exhibit 99.1



Precigen Reports First Quarter 2022 Financial Results and Business Updates


Fast Track designation received for PRGN-3006 UltraCAR-T®, an important milestone for patients with relapsed or refractory acute myeloid leukemia, a rapidly progressing disease with limited treatment options –

Phase 1b expansion arm initiated for PRGN-3006 UltraCAR-T® at Dose Level 3 with lymphodepletion –

Dosing initiated in patients at Dose Level 3 via intravenous infusion with lymphodepletion in the PRGN-3005 UltraCAR-T® Phase 1 study –

Phase 2 study initiated for PRGN-2012 AdenoVerse Immunotherapy as an adjuvant treatment in patients with recurrent respiratory papillomatosis

Cash, cash equivalents, short-term and long-term investments totaled $142.1 million as of March 31, 2022 –

Company to host a pipeline update call in the coming months –


GERMANTOWN, MD, May 9, 2022Precigen, 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 2022 financial results and business updates.


“Precigen's portfolio has been prioritized based on the positive preliminary data we have seen for key programs and we are exploring potential rapid paths to licensure with the FDA for programs with compelling data in diseases that have a high unmet medical need. The FDA Fast Track designation recently received for PRGN-3006 UltraCAR-T will help facilitate development and expedite the review process and is an important milestone for patients with relapsed or refractory acute myeloid leukemia,” said Helen Sabzevari, PhD, President and CEO of Precigen. “As a result of these advancements, we look forward to hosting a call to provide pipeline updates in the coming months.”


“We remain focused on enhancing our financial position, expanding our financial flexibility, and extending our cash runway to help Precigen achieve our near-term objectives,” said Harry Thomasian Jr., CFO of Precigen. “As the year progresses, we intend to expound on these initiatives.”


Key Business Highlights


·PRGN-3006 UltraCAR-T® in Acute Myeloid Leukemia (AML)

oIn April 2022, Precigen announced that the US Food and Drug Administration (FDA) granted Fast Track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory (r/r) AML. Fast Track designation facilitates development and expedites the review process for drugs that address serious conditions and high unmet medical needs, such as r/r AML.

oEnrollment and dosing were completed in the dose escalation phase of the Phase 1 PRGN-3006 UltraCAR-T clinical trial for both the lymphodepletion and non-lymphodepletion cohorts.

oThe Phase 1b expansion arm was initiated and the first patient was dosed at Dose Level 3 with lymphodepletion. The Company plans to incorporate repeat dosing in 2022.

·PRGN-3005 UltraCAR-T® in Ovarian Cancer

oEnrollment and dosing was completed in the dose escalation phase of both the intraperitoneal (IP) and intravenous (IV) arms of the Phase 1 clinical trial.

oDosing was initiated in patients at Dose Level 3 with lymphodepletion prior to IV administration of PRGN-3005 UltraCAR-T.

oThe Company plans to initiate a Phase 1b expansion arm and incorporate repeat dosing in 2022.

·Next Generation UltraCAR-T® Platform

oAn abstract titled, Incorporation of intrinsic checkpoint blockade enhances functionality of multigenic autologous UltraCAR-T® cells manufactured using non-viral gene delivery and rapid manufacturing process, was presented as a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022. The poster highlighted preclinical data showcasing the advancement of the UltraCAR-T platform to simultaneously express CAR, membrane bound IL-



  15 (mbIL15), a kill switch, and address the inhibitory tumor microenvironment by incorporating a novel mechanism for intrinsic downregulation of one or more checkpoint inhibitor genes.

·PRGN-2012 AdenoVerseImmunotherapy in Recurrent Respiratory Papillomatosis (RRP)

oEnrollment was completed in the dose escalation and expansion cohorts of the Phase 1 study.

oThe first patient was dosed in the Phase 2 study of PRGN-2012 in adult patients with RRP (clinical trial identifier: NCT04724980).

oThe Company plans to seek FDA guidance on a rapid regulatory strategy for licensure given the high unmet medical need for this patient population.

·PRGN 2009 AdenoVerseImmunotherapy in Human Papillomavirus (HPV)-associated Cancers

oEnrollment in the Phase 1 monotherapy arm was completed in patients with recurrent or metastatic HPV-associated cancers (clinical trial identifier: NCT04432597).

oEnrollment is ongoing in the Phase 1 combination arm in patients with recurrent or metastatic HPV-associated cancers. The Company expects to complete enrollment in the Phase 1 combination arm in the second quarter of 2022.

oEnrollment is ongoing in the Phase 2 monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients.


First Quarter 2022 Financial Highlights 


·Net cash used in operating activities of $18.7 million in 2022 compared to $16.4 million in 2021. This increase was primarily due to the acceleration of the Company’s pipeline programs;

·Cash, cash equivalents, short-term and long-term investments totaled $142.1 million as of March 31, 2022; and

·Total revenues of $32.0 million in 2022 compared to $24.5 million in 2021.


First Quarter 2022 Financial Results Compared to Prior Year Period


Total revenues increased $7.5 million, or 31%, from the quarter ended March 31, 2021. Product and service revenues generated by Trans Ova and Exemplar increased $7.6 million primarily due to higher customer demand for animals and services as a result of stronger beef and dairy industries in the current year as well as an increase in services performed at Exemplar, offset by a $0.1 million reduction in collaboration and license revenue from the quarter ended March 31, 2021.


Gross margin on products and services improved as a result of the increased revenues, a change in pricing structure for certain customers, and operational efficiencies that have been gained through improved inventory management offset by increased costs for supplies, drugs, and personnel costs.


Research and development expenses increased $2.2 million, or 21%, from the quarter ended March 31, 2021. Contract research organization costs and lab supplies increased $1.6 million with the advancement of the Company’s clinical and preclinical programs.


Selling, general and administrative (SG&A) expenses increased $0.9 million, or 5%, over the three months ended March 31, 2021. Professional fees increased $1.6 million, primarily due to increased legal fees associated with certain litigation matters. This increase was partially offset with a decrease in salaries, benefits, and other personnel costs of $1.3 million primarily due to reduced stock compensation in 2022 and reduced head count.


Loss from continuing operations was $19.3 million, or $(0.10) per basic share, compared to loss from continuing operations of $21.8 million, or $(0.11) per basic share, in 2021.




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 the most 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 therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen, LinkedIn or YouTube.




Precigen, UltraCAR-T, AdenoVerse 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 studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. 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, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, 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.


Investor Contact: 

Steven Harasym 

Vice President, Investor Relations 

Tel: +1 (301) 556-9850 



Media Contacts: 

Donelle M. Gregory 



Glenn Silver 

Lazar-FINN Partners 





Precigen, Inc. and Subsidiaries

Consolidated Balance Sheets


(Amounts in thousands)  March 31, 2022  December 31, 2021  
Current assets          
Cash and cash equivalents  $40,321   $42,920 
Short-term investments   71,821    72,240 
Trade, net   24,308    20,832 
Related parties, net   15    73 
Other   543    566 
Inventory   12,730    13,261 
Prepaid expenses and other   5,199    6,736 
Total current assets   154,937    156,628 
Long-term investments   29,914    48,562 
Property, plant and equipment, net   33,583    34,315 
Intangible assets, net   51,427    54,115 
Goodwill   53,613    54,148 
Right-of-use assets   10,963    10,900 
Other assets   1,131    1,188 
Total assets  $335,568   $359,856 
Liabilities and Shareholders’ Equity          
Current liabilities          
Accounts payable  $4,415   $5,405 
Accrued compensation and benefits   6,052    11,223 
Other accrued liabilities   10,494    11,595 
Deferred revenue   2,669    4,442 
Current portion of long-term debt   355    402 
Current portion of lease liabilities   1,590    1,551 
Related party payables   26    27 
Total current liabilities   25,601    34,645 
Long-term debt, net of current portion   201,112    182,749 
Deferred revenue, net of current portion   23,023    23,023 
Lease liabilities, net of current portion   9,508    9,502 
Deferred tax liabilities   2,438    2,539 
Other long-term liabilities   50    50 
Total liabilities   261,732    252,508 
Commitments and contingencies          
Shareholders’ equity          
Common stock        
Additional paid-in capital   1,991,670    2,022,701 
Accumulated deficit   (1,916,135)   (1,915,556)
Accumulated other comprehensive (loss) income   (1,699)   203 
Total shareholders’ equity   73,836    107,348 
Total liabilities and shareholders’ equity  $335,568   $359,856 




Precigen, Inc. and Subsidiaries

Consolidated Statements of Operations


(Amounts in thousands, except share  Three months ended March 31,  
and per share data)  2022    2021  
Collaboration and licensing revenues  $   $66 
Product revenues   8,724    6,381 
Service revenues   23,209    17,931 
Other revenues   88    133 
Total revenues   32,021    24,511 
Operating Expenses          
Cost of products   7,510    5,574 
Cost of services   9,589    7,402 
Research and development   12,760    10,521 
Selling, general and administrative   19,576    18,702 
Impairment of goodwill   482     
Total operating expenses   49,917    42,199 
Operating loss   (17,896)   (17,688)
Other Expense, Net          
Interest expense   (2,069)   (4,539)
Interest income   434    392 
Other income (expense), net   223    (58)
Total other expense, net   (1,412)   (4,205)
Equity in net loss of affiliates   (1)   (3)
Loss from continuing operations before income taxes   (19,309)   (21,896)
Income tax benefit   58    52 
Loss from continuing operations  $(19,251)  $(21,844)
Income (loss) from discontinued operations, net of income taxes       4,526 
Net loss  $(19,251)  $(17,318)
Net Loss per Share          
Net loss from continuing operations per share, basic and diluted  $(0.10)  $(0.11)
Net income (loss) from discontinued operations per share, basic and diluted       0.02 
Net loss per share, basic and diluted  $(0.10)  $(0.09)
Weighted average shares outstanding, basic and diluted   199,629,218    193,499,546