Precigen Reports First Quarter 2020 Financial Results

GERMANTOWN, Md., May 6, 2020 /PRNewswire/ -- 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((TM)) 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((TM)) 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 6(th) 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

Precigen: Advancing Medicine with Precision((TM))

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 or follow us on Twitter @Precigen and LinkedIn.


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:       
              Corporate Contact:

     Steven Harasym                     
     Marie Rossi, PhD

     Vice President, Investor Relations 
     Vice President, Communications

     Tel: +1 (301) 556-9850             
     Tel: +1 (301) 556-9850


               Precigen, Inc. and Subsidiaries

               Consolidated Balance Sheets


                (Amounts in thousands)     March 31, 2020                                  December 31,



         Current assets

         Cash and cash equivalents                                                    $
              37,840                $

         Short-term investments                                                                  111,332                           9,260


         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

         Total assets                                                                $
              404,672               $


         Current liabilities

         Accounts payable                                                              $
              4,777                 $

         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

         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

          Total liabilities and shareholders' equity                                  $
              404,672               $


        Precigen, Inc. and Subsidiaries

        Consolidated Statements of Operations


                (Amounts in thousands, except share and per share data)                                                                                   Three months ended


                                                                                                                                                        2020                      2019


       Collaboration and licensing revenues                                                                                                                   $
              10,721          $

       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)      $

       Loss from discontinued operations, net of income taxes                                                                                                           (26,056)                (9,236)

       Net loss                                                                                                                                             $
              (55,998)      $

       Net loss attributable to the noncontrolling interests                                                                                                                                      1,427

       Net loss attributable to Precigen                                                                                                                    $
              (55,998)      $

                Amounts Attributable to Precigen

       Net loss from continuing operations attributable to Precigen                                                                                         $
              (29,942)      $

       Net loss from discontinued operations attributable to Precigen                                                                                                   (26,056)                (9,236)

       Net loss attributable to Precigen                                                                                                                    $
              (55,998)      $

                Net Loss per Share

       Net loss from continuing operations attributable to Precigen per share, basic and diluted                                                              $
              (0.19)        $

       Net loss from discontinued operations attributable to Precigen per share, basic and diluted                                                                        (0.16)                 (0.06)

       Net loss attributable to Precigen per share, basic and diluted                                                                                         $
              (0.35)        $

       Weighted average shares outstanding, basic and diluted                                                                                                        160,338,743             152,948,058


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