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Precigen Reports First Quarter 2021 Financial Results

- Company on track to achieve stated 2021 milestones -

- Initiated Phase 2 clinical trial of PRGN-2009 AdenoVerse™ immunotherapy -

- Initiated Phase 1 clinical trial of PRGN-2012 AdenoVerse immunotherapy in patients with recurrent respiratory papillomatosis (RRP) -

- Upcoming presentation at FOCIS Virtual Annual Meeting to provide clinical progress for AG019 ActoBiotics™ in Type 1 diabetes (T1D) -

GERMANTOWN, Md., May 10, 2021 /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 2021 financial results.

"In the first quarter of 2021, our portfolio, including our most advanced clinical programs, has progressed consistent with guidance," said Helen Sabzevari, PhD, President and CEO of Precigen. "Our UltraCAR-T trials for PRGN-3005 in ovarian cancer and PRGN-3006 in acute myeloid leukemia as well as the PRGN-2009 trial in HPV-associated cancers continue to progress according to plan. We were pleased to initiate the first-in-human Phase 1 study of PRGN-2012, Precigen's first off-the-shelf AdenoVerse immunotherapy targeting infectious disease to enter the clinic, and receive orphan drug designation from the US FDA in patients with RRP. We look forward to upcoming presentations of new clinical data for AG019 at FOCIS and the current trial status for PRGN-2009 at ASCO and we anticipate multiple data readouts from our portfolio in the coming months, meeting our stated milestones."   

Business Highlights:

PRGN-3005 UltraCAR-T®

PRGN-3006 UltraCAR-T®

AG019 ActoBiotics™

PRGN-2009 AdenoVerse™ Immunotherapy

PRGN-2012 AdenoVerse™ Immunotherapy

First Quarter 2021 Financial Highlights

  • Net cash used in operating activities of $16.4 million in 2021 compared to $27.7 million in 2020;
  • Cash, cash equivalents, short-term and long-term investments totaled $209.3 million as of March 31, 2021; and
  • Total revenues of $24.5 million in 2021 compared to $29.8 million in 2020.

First Quarter 2021 Financial Results Compared to Prior Year Period
Research and development expenses decreased $0.8 million, or 7%, from the quarter ended March 31, 2020.  Salaries, benefits, and other personnel costs decreased $0.7 million in 2021 as the Company scaled down certain research and development functions in the first quarter of 2020 as a result of certain programs being previously deprioritized. Selling, general and administrative expenses decreased $2.8 million, or 13%. Salaries, benefits, and other personnel costs decreased $1.0 million in 2021 primarily due to a reduced headcount as the Company scaled down its corporate functions to support its more streamlined organization and reduced stock compensation costs for previously granted awards that became fully vested in early 2021. Professional fees decreased $1.0 million primarily due to a decrease in legal fees associated with certain litigation matters that were settled in the second half of 2020. Net loss from continuing operations was $21.8 million, or $(0.11) per basic share, of which $9.7 million was for non-cash charges in 2021 compared to net loss from continuing operations of $20.8 million, or $(0.13) per basic share, of which $7.7 million was for non-cash charges in 2020.

Total revenues decreased $5.3 million, or 18%, from the quarter ended March 31, 2020. Collaboration and licensing revenues decreased $10.7 million primarily due to the recognition of previously deferred revenue upon the mutual termination of one of its collaboration agreements in February 2020. Product and service revenues generated by Trans Ova and Exemplar increased $5.4 million primarily due to higher customer demand for Trans Ova's products and services as a result of stronger beef and dairy industries in the current year, as well as increased services provided by Exemplar to new and existing customers. 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 reductions in workforce and improved inventory management.

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 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, UltraPorator, UltraCAR-T, ActoBiotics, 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 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 studies, clinical trials, discovery programs and related milestones, and the promise of the Company's portfolio of therapies, and in particular its CAR-T therapies. 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 clinical trials, businesses, operating results, cash flows and/or financial condition, (ii) Precigen's strategy and overall approach to its health-focused business model; (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, including any delays or potential delays as a result of the COVID-19 pandemic, 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 Precigen'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, including federal, state, and local government responses to the COVID-19 pandemic; (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; and (xvii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing. 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.

Investor Contact:

Steven Harasym

Vice President, Investor Relations

Tel: +1 (301) 556-9850

[email protected]

Media Contact:

Glenn Silver

Lazar-FINN Partners

[email protected]

Precigen, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)


(Amounts in thousands)


March 31, 2021



December 31, 2020

Assets








Current assets








Cash and cash equivalents


$

27,355



$

51,792

Short-term investments



78,331




48,325

Receivables








Trade, net



20,790




16,487

Related parties, net



12




19

Notes



—




3,689

Other



555




232

Inventory



10,637




11,359

Prepaid expenses and other



6,430




7,192

Current assets held for sale or abandonment



8




9,853

Total current assets



144,118




148,948

Long-term investments



103,610




—

Property, plant and equipment, net



33,716




34,924

Intangible assets, net



61,230




65,396

Goodwill



54,238




54,363

Right-of-use assets



8,639




9,353

Other assets



1,433




1,603

Total assets


$

406,984



$

314,587





Liabilities and Shareholders' Equity








Current liabilities








Accounts payable


$

4,295



$

4,598

Accrued compensation and benefits



6,425




8,097

Other accrued liabilities



7,437




9,549

Deferred revenue



3,845




2,800

Current portion of long-term debt



359




360

Current portion of lease liabilities



2,658




2,657

Related party payables



52




19

Current liabilities held for sale or abandonment



172




14,047

Total current liabilities



25,243




42,127

Long-term debt, net of current portion



174,158




171,522

Deferred revenue, net of current portion



23,023




23,023

Lease liabilities, net of current portion



6,943




7,744

Deferred tax liabilities



2,722




2,897

Other long-term liabilities



100




100

Total liabilities



232,189




247,413

Commitments and contingencies








Shareholders' equity








Common stock



—




—

Additional paid-in capital



2,013,757




1,886,567

Accumulated deficit



(1,840,708)




(1,823,390)

Accumulated other comprehensive income



1,746




3,997

Total shareholders' equity



174,795




67,174

Total liabilities and shareholders' equity


$

406,984



$

314,587

Precigen, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)


(Amounts in thousands, except share and per share data)



Three months ended




March 31,




2021



2020










Revenues








Collaboration and licensing revenues


$

66


$

10,721


Product revenues



6,381



4,961


Service revenues



17,931



13,946


Other revenues



133



210


Total revenues



24,511



29,838










Operating Expenses








Cost of products



5,574



6,089


Cost of services



7,402



7,536


Research and development



10,521



11,327


Selling, general and administrative



18,702



21,486


Total operating expenses



42,199



46,438


Operating loss



(17,688)



(16,600)










Other Expense, Net








Interest expense



(4,539)



(4,592)


Interest income



392



673


Other income (expense), net



(58)



64


Total other expense, net



(4,205)



(3,855)


Equity in net loss of affiliates



(3)



(351)


Loss from continuing operations before income taxes



(21,896)



(20,806)


Income tax benefit (expense)



52



(40)


Loss from continuing operations


$

(21,844)


$

(20,846)


Income (loss) from discontinued operations, net of income taxes



4,526



(35,152)


Net loss


$

(17,318)


$

(55,998)


Net Loss per Share








Net loss from continuing operations per share, basic and diluted


$

(0.11)


$

(0.13)


Net income (loss) from discontinued operations per share, basic and diluted



0.02



(0.22)


Net loss per share, basic and diluted


$

(0.09)


$

(0.35)


Weighted average shares outstanding, basic and diluted



193,499,546



160,338,743


SOURCE Precigen, Inc.

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