8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): November 1, 2016

 

 

INTELLIA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-37766   36-4785571

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

130 Brookline Street, Suite 201,

Cambridge, Massachusetts

  02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (857) 285-6200

Not Applicable

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:

 

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))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On November 1, 2016, Intellia Therapeutics, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2016 (the “Press Release”). A copy of the Press Release is furnished herewith as Exhibit 99.1.

The information in this report furnished pursuant to Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 2.02 of this report.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

99.1    Press release dated November 1, 2016


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.

 

    Intellia Therapeutics, Inc.
Date: November 1, 2016     By:  

/s/ Nessan Bermingham

     

Nessan Bermingham, Ph.D.

President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit
Number

  

Description of Exhibit

99.1    Press release dated November 1, 2016
EX-99.1

Exhibit 99.1

 

LOGO

Intellia Therapeutics Reports Financial Results

for Third Quarter 2016

 

    

- First company to report high in vivo editing data using CRISPR/Cas9 in animal models

 

    

- Further validation of lipid nanoparticle delivery platform

 

    

- Ended quarter with $290.6 million in cash and cash equivalents

CAMBRIDGE, Mass., November 1, 2016 (GLOBE NEWSWIRE) – Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR/Cas9 technology, today reported results for the quarter ended September 30, 2016 and provided an update on recent highlights and upcoming events.

“We have demonstrated substantial progress in our research, including being the first company to present data showing high levels of in vivo editing in animal models using systemic lipid nanoparticles to deliver CRISPR/Cas9 components,” said Nessan Bermingham, Ph.D., Chief Executive Officer and Founder, Intellia Therapeutics. “We continue to make further enhancements and remain focused on advancing the development of CRISPR/Cas9-based therapeutics for patients with severe unmet medical needs.”

Recent Highlights

 

    Intellia presented preclinical data demonstrating in vivo gene editing using lipid nanoparticles (LNPs) to deliver CRISPR/Cas9. These data were presented at Genome Engineering: The CRISPR/Cas Revolution meeting in Cold Spring Harbor, New York. In several preclinical studies, the data showed:

 

    Progress in achieving in vivo editing, reporting an efficiency of approximately 60 percent in mouse liver at the transthyretin (TTR) target site after a single intravenous administration, which was consistent across different lobes of the liver. This resulted in an associated decrease in serum TTR protein levels of up to approximately 80 percent;

 

    Dose-dependent editing by LNP delivery;

 

    Undetectable Cas9 mRNA and guide RNA (gRNA) in the liver at 72 hours post administration; and

 

    Repair patterns in mouse liver cells in vivo being best predicted in vitro by primary mouse liver cells rather than cell lines.

 

    Intellia presented four posters at the recent European Society for Gene and Cell Therapy Congress (ESGCT) in Florence, Italy. The data presentations included an update on the Company’s in vivo delivery and DNA repair data and new methods for analyzing off-target activity. In its presentation on off-target analysis, Intellia described improved computational methods for readily identifying guide RNAs with zero to few off-target events, an essential step in developing CRISPR/Cas9-based therapeutics.


LOGO

 

Third Quarter 2016 Financial Results

As of September 30, 2016, Intellia had $290.6 million in cash and cash equivalents. Net loss for the third quarter 2016 was $7.5 million, compared to $3.0 million in the same period in 2015.

Collaboration revenue was $4.9 million in the third quarter 2016, compared to $1.7 million in the same period of 2015. For the Novartis collaboration, Intellia recognized $2.0 million and $1.7 million in the third quarters of 2016 and 2015, respectively. The Regeneron collaboration, announced in April 2016, for which the Company recognized $2.9 million in the third quarter of 2016, was the primary driver of the increase in collaboration revenue.

Research and development expenses in the third quarter 2016 were $7.9 million, compared to $3.5 million in the same period in 2015. This increase in expenses is primarily attributable to accelerating the development of our CRISPR/Cas9 platform and advancing our sentinel indications. These expenses include compensation and benefits for employees, including equity-based compensation, and expansion of Intellia’s facilities and laboratories.

General and administrative expenses were $4.7 million in the third quarter of 2016, compared to $1.5 million for the same period in 2015. The increase in general and administrative expenses is primarily driven by expenses to support the Company’s overall growth and costs associated with being a publicly traded company.

Upcoming Events

Intellia will present at the Fortune Brainstorm Health 2016 Conference in San Diego on November 2, 2016, the Credit Suisse Healthcare Conference in Arizona on November 7, 2016, and the Jefferies 2016 Healthcare Conference in London on November 16, 2016.

About Intellia Therapeutics

Intellia Therapeutics is a leading genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course. Our combination of deep scientific, technical and clinical development experience, along with our leading intellectual property portfolio, puts us in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Learn more about Intellia Therapeutics and CRISPR/Cas9 at intelliatx.com; Follow us on Twitter @intelliatweets.


LOGO

 

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements include, but are not limited to, statements regarding our ability to advance CRISPR/Cas9 into therapeutic products for severe and life-threatening diseases; the potential timing and advancement of our clinical trials; the impact of our collaborations with Novartis and Regeneron on our development programs; the potential indications we may pursue, including our sentinel indications; the potential timing of regulatory filings regarding our development programs; and potential commercialization opportunities for product candidates. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of our product candidates will not be successfully developed and commercialized, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving similar product candidates will not be repeated or observed in ongoing or future studies involving current product candidates, the risk that our collaboration with Novartis or Regeneron will not continue or will not be successful, and risks related to our ability to protect and maintain our intellectual property position. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia Therapeutics undertakes no duty to update this information unless required by law.


LOGO

 

INTELLIA THERAPEUTICS, INC.

CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)

(Amounts in thousands)

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
     2016      2015      2016      2015  

Collaboration revenue

   $ 4,869       $ 1,688       $ 10,852       $ 4,351   

Operating expenses:

           

Research and development

     7,861         3,458         20,509         6,795   

General and administrative

     4,705         1,531         11,680         5,474   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     12,566         4,989         32,189         12,269   

Operating loss

     (7,697      (3,301      (21,337      (7,918

Interest income

     215         —           266         —     

Loss before income taxes

     (7,482      (3,301      (21,071      (7,918

Income tax benefit

     —           282         —           766   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (7,482    $ (3,019    $ (21,071    $ (7,152
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

   $ (0.22    $ (10.27    $ (1.16    $ (48.65

Weighted average shares outstanding, basic and diluted

     34,316         294         18,098         147   

INTELLIA THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)

(Amounts in thousands)

 

     September 30,      December 31,  
     2016      2015  

Cash and cash equivalents

   $ 290,618       $ 75,816   

Total assets

     301,469         82,139   

Total liabilities

     83,345         14,783   

Convertible preferred stock

     —           88,557   

Total stockholders’ equity (deficit)

     218,124         (21,201

 

Media Contact:

 

Jennifer Mound Smoter

Chief External Affairs & Communications Officer

+1 857-706-1071

jenn.smoter@intelliatx.com

 

Investor Contacts:

 

John Graziano

Trout Group

+ 1 646-378-2942

jgraziano@troutgroup.com

 

Chad Rubin

Trout Group

+ 1 646-378-2947

crubin@troutgroup.com

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