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CAMBRIDGE, Mass., March 14, 2017 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR technology, announced financial results for the fourth quarter and full year 2016.
“2016 was a phenomenal year for Intellia. We signed a multi-year research and development collaboration with Regeneron Pharmaceuticals, our second partner, and became a publicly traded company with an upsized offering. We also presented the first in vivo CRISPR liver editing data, and significantly grew our capabilities, laboratories, and team,” said Nessan Bermingham, Ph.D., chief executive officer and founder, Intellia Therapeutics. “I am extremely pleased with the progress since forming the company in May 2014. In 2017, we expect to make meaningful steps toward our goal of bringing revolutionary therapies to patients.”
The company achieved numerous important milestones in 2016, including:
Significantly advanced the genome editing field with unprecedented liver editing and lipid nanoparticle delivery data using CRISPR/Cas9 as a potential one-time treatment.
On March 22, 2017, the company will present additional data regarding its latest in vivo liver editing data at Le Studium Conference on Messenger RNA Therapeutics in Orleans, France.
Completed a successful initial public offering, securing a strong cash position, fueling the company’s pipeline and platform studies.
Announced a multi-year, multi-target research and development collaboration with Regeneron Pharmaceuticals, representing one of the largest deals in the CRISPR/Cas9 field.
To advance the pipeline and explore the scope of genome edits with the CRISPR/Cas9 system, the company is working on four sentinel in vivo liver indications and two sentinel ex vivo programs employing different editing strategies.
Beyond providing the company multiple potential product opportunities, each of these programs potentially enable CRISPR/Cas9 translation into a broader set of disease indications requiring the same types of DNA edits.
Gained exclusive access to two leading genetic database centers that will bring critical disease insights to Intellia’s preclinical and clinical process.
Enhanced our CRISPR/Cas9 foundational and delivery intellectual property position.
Expanded our highly qualified expert leadership team by augmenting the Board of Directors and company management, while significantly growing R&D operations and laboratories, in preparation for clinical studies.
Full-Year 2016 Financial Results
Cash and cash equivalents at December 31, 2016, were $273.1 million, compared to $75.8 million at December 31, 2015. The increase in cash and cash equivalents was primarily attributable to proceeds from our initial public offering and concurrent private placements in May 2016, as well as a $75.0 million upfront payment from Regeneron in April 2016, partially offset by cash used in operations.
The company is not profitable and has incurred losses in each period since our inception. Our net loss was $31.6 million for the year ended December 31, 2016, and $10.6 million for the fourth quarter of 2016, compared to $12.4 million for the year ended December 31, 2015, and $5.2 million for the fourth quarter of 2015.
Collaboration revenue was $16.5 million for the year ended December 31, 2016, and $5.6 million for the fourth quarter of 2016, as compared to $6.0 million for the year ended December 31, 2015, and $1.7 million for the fourth quarter of 2015. The increase in collaboration revenue in 2016 was primarily driven by amounts recognized under our collaboration agreement with Regeneron, which was entered into in April 2016.
Through December 31, 2016, the company received $97.0 million in funding under our collaborations with Novartis and Regeneron, excluding amounts received for equity investments, and recorded accounts receivable of $6.5 million as of December 31, 2016. Excluding the $2.6 million of upfront payment received from Novartis that was allocated to the purchase of equity securities, we recognized $22.5 million in collaboration revenue under these agreements through December 31, 2016, and had remaining deferred revenue of $78.3 million as of December 31, 2016.
Research and development expenses increased $20.6 million to $31.8 million during the year ended December 31, 2016, as compared to $11.2 million during the year ended December 31, 2015, and increased by $6.9 million to $11.3 million during the fourth quarter of 2016, as compared to $4.4 million during the fourth quarter of 2015. This increase was primarily driven by our growth to 77 research and development employees as of December 31, 2016, from 38 research and development employees as of December 31, 2015, and the advancement of our early-stage research programs collectively resulting in increases in salaries and related compensation expenses, as well as laboratory supplies and research materials.
General and administrative expenses increased by $8.5 million to $16.8 million during the year ended December 31, 2016, as compared to $8.3 million during the year ended December 31, 2015, and increased by $2.3 million to $5.1 million during the fourth quarter of 2016, as compared to $2.8 million during the fourth quarter of 2015.
This increase was primarily related to increased salary and related headcount-based expenses, including equity-based compensation expenses, as the company grew to 27 general and administrative employees as of December 31, 2016, from 14 general and administrative employees as of December 31, 2015, as well as increased corporate insurance, legal, and other professional expenses related to our operations as a public company beginning in May 2016.
Our primary uses of capital will continue to be research and development services, compensation and related expenses, laboratory and related supplies, legal and other regulatory expenses, patent prosecution filing and maintenance costs for our licensed intellectual property, and general overhead costs.
During 2017, the company expects expenses to increase compared to prior periods in connection with our ongoing activities, particularly as research and development and preclinical activities continue, and we spend a full year occupying our new office and laboratory facility, which we began to occupy in the fourth quarter of 2016.
As of December 31, 2016, the company had an accumulated deficit of $53.6 million. We expect our losses to increase as we continue to incur significant research and development and other expenses related to our ongoing operations, seek regulatory approvals for our future product candidates, scale-up manufacturing capabilities, maintain, expand and protect our intellectual property portfolio, and hire additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems. Based on our research and development plans and expectations related to the progress of the company’s programs, we expect that cash and cash equivalents as of December 31, 2016, as well as technology access and research funding from Novartis and Regeneron, will enable Intellia to fund operating expenses and capital expenditures through mid-2019, without giving effect to any potential milestone payments or extension fees received under our collaboration agreements with Novartis and Regeneron.
The company will participate in the following upcoming investor conferences:
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.
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, express or implied 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 impact of our research relationships with Regeneron and the GENE Consortium on our ability to potentially identify disease targets and possible treatments; the future effects of our invention management agreement on our intellectual property strategy and position; the potential indications we may pursue, including our sentinel indications; the potential timing of regulatory filings regarding our development programs; potential commercialization opportunities for product candidates; our expectations regarding our uses of capital, expense, future accumulated deficient and other 2017 financial results; and our expectations regarding our ability to fund operations through mid-2019. 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 that positive results from a preclinical or clinical study may not necessarily be predictive of the results of future preclinical or clinical studies, 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, including our upcoming Annual Report on Form 10-K for the year ended December 31, 2016. 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.
|INTELLIA THERAPEUTICS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended |
|Twelve Months Ended |
|Research and development||11,331||4,375||31,840||11,170|
|General and administrative||5,118||2,809||16,798||8,283|
|Total operating expenses||16,449||7,184||48,638||19,453|
|Loss before income taxes||(10,563||)||(5,491||)||(31,634||)||(13,409||)|
|Income tax benefit||-||246||-||1,012|
|Net loss per share, basic and diluted||$||(0.31||)||$||(9.57||)||$||(1.42||)||$||(51.02||)|
|Weighted average shares outstanding, basic and diluted||34,507||548||22,222||243|
|INTELLIA THERAPEUTICS, INC.|
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|December 31, |
|December 31, |
|Cash and cash equivalents||$||273,064||$||75,816|
|Convertible preferred stock||-||88,557|
|Total stockholders' equity (deficit)||209,837||(21,201||)|
Intellia Contacts: Media Contact: Jennifer Mound Smoter Senior Vice President, External Affairs & Communications +1 857-706-1071 firstname.lastname@example.org Investor Contact: Graeme Bell Executive Vice President, Chief Financial Officer +1 857-706-1081 email@example.comNEXT ARTICLE
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