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— Charcoal on clue to abide investigational new biologic appliance in 2020 for its aboriginal systemically delivered CRISPR/Cas9-based therapy, NTLA-2001, for analysis of transthyretin amyloidosis
— Expects to appoint aboriginal engineered corpuscle analysis development applicant for analysis of astute myeloid leukemia by end of 2019
— Aboriginal affirmation of CRISPR/Cas9-based, targeted admittance of a Factor 9 gene in the alarmist of non-human primates achieves accustomed circulating beastly Factor IX protein levels
— Ends division with able banknote position of $297 million
Intellia Therapeutics, Inc. (NASDAQ:NTLA), appear operational highlights and banking after-effects for the aboriginal division concluded March 31, 2019. Additionally, the Aggregation accent important accumulated milestones for 2019.
“2019 is off to a advantageous alpha in abutment of our mission to beforehand genome alteration to amusement a ambit of astringent and life-threatening diseases. We are aflame by our achievements in gene knockout and admittance beyond both our in vivo and engineered corpuscle analysis efforts. In particular, we presented abstracts at the 22 Anniversary Meeting of the American Society of Gene and Corpuscle Analysis assuming aberrant CRISPR-mediated, targeted gene admittance in the alarmist of non-human primates, accomplishing accustomed circulating beastly levels of protein production,” said Intellia President and Chief Executive Officer John Leonard, M.D. “These achievements highlight Intellia’s administering in CRISPR/Cas9 genome alteration as we beforehand our activity appear the clinic. Looking ahead, we abide on clue to book an IND appliance abutting year for NTLA-2001, our beforehand in vivo applicant for the analysis of transthyretin amyloidosis, and apprehend to appoint a development applicant in our aboriginal engineered corpuscle analysis affairs for astute myeloid leukemia by year-end.”
First Division 2019 and Added Contempo Operational Highlights
— ATTR Program: Intellia’s beforehand applicant for the analysis of transthyretin amyloidosis (ATTR), which approved an boilerplate of >95% abridgement in circulating transthyretin (TTR) protein in non-human primates (NHPs), has been nominated as the Company’s aboriginal in vivo development applicant to beforehand into Investigational New Biologic (IND)-enabling toxicology studies. Preliminary after-effects from essentially completed dose-range award (DRF) studies showed a favorable tolerability profile; and abstracts from assorted studies in NHPs approved abiding alarmist alteration with abiding abridgement of circulating TTR through 10 months of ascertainment afterward a distinct dose.
Today, Intellia appear affairs to activate IND-enabling toxicology studies of NTLA-2001 in mid-2019 and that it charcoal on clue to abide an IND appliance in 2020. NTLA-2001 is actuality co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron), with Intellia as the beforehand development and commercialization party.
— AML Program: Intellia and its analysis collaborators at IRCCS Ospedale San Raffaele presented new in vitro abstracts at the 22 Anniversary Meeting of the American Society of Gene and Corpuscle Analysis (ASGCT), assuming that CRISPR/Cas9 alteration resulted in >98% knockout of autogenous T corpuscle receptors (TCRs) followed by admittance of Wilms’ Tumor 1 (WT1)-specific TCRs into >95% of abandoned T cells. In addition, the engineered T beef were anatomic and able of accurately killing aerial levels of a console of leukemic blasts from patients that bidding the WT1 epitope. Based on these results, Intellia has articular assorted beforehand TCRs belted to the HLA-A*02:01 allele to move into anatomic testing in patient-derived xenograft models for an autologous TCR-based analysis targeting WT1 for the analysis of astute myeloid leukemia (AML). These studies are accustomed to activate in mid-2019 and will acquaint the choice of the Company’s aboriginal engineered corpuscle analysis development applicant by the end of 2019.
— In Vivo Admittance in NHPs: At the 2019 ASGCT Meeting, Intellia presented abstracts demonstrating the aboriginal CRISPR-mediated, targeted transgene admittance in the alarmist of NHPs, appliance Factor 9 (F9) as a archetypal gene. F9 is a gene that encodes for Factor IX (FIX) protein, a blood-clotting protein that is missing or abnormal in hemophilia B patients. In a accord amid Intellia and Regeneron, advisers accumulated Intellia’s lipid nanoparticle (LNP) commitment arrangement of CRISPR/Cas9 with an adeno-associated virus (AAV) absolute a proprietary bi-directional admittance template. NHP abstracts showed that a distinct administering accomplished ~3-4 Î¼g/mL of circulating beastly FIX protein at day 14 and was abiding through 28 canicule (~3-5 Î¼g/mL) of completed ascertainment in an advancing study. The levels of circulating beastly FIX protein approved in NHPs accord with the accustomed 3-5 Î¼g/mL ambit of beastly FIX protein levels (source: Amiral et al, Clin. Chem., 1984). The NHP abstracts aggregate additionally incorporates the bigger CRISPR/Cas9 LNP articular from the ATTR affairs and demonstrates the modularity of Intellia’s belvedere to administrate learnings to added programs. This abstracts expands on the clinically accordant beastly FIX protein levels accomplished in mice, aboriginal appear in October, which accept remained abiding through 10 months of observation.
— Modular In Vivo Knockout Update: Today, at the 2019 ASGCT Meeting, Intellia will present new abstracts demonstrating that absolute CRISPR-mediated knockout of anniversary of two targets of interest, either lactate dehydrogenase A (Ldha) or hydroxyacid oxidase 1 (Hao1), via the Company’s proprietary LNP commitment technology, after-effects in a durable, therapeutically accordant abridgement of oxalate elimination in a ache abrasion archetypal of primary hyperoxaluria blazon 1 (PH1).
LDHA and HAO1 are enzymes circuitous in oxalate production. In bodies with PH1, mutations in a specific alarmist agitator account the assembly of a surplus of oxalate, which can amalgamate with calcium to anatomy baffling deposits in the branch and throughout the body, arch to accident of the kidneys, heart, eyes and ashen system. An almost 30% abridgement in urinary oxalate in patients with PH1 is advised to be therapeutically accordant (source: Nephrology Dialysis Transplantation 1999; 14:2556-2558). In accord with the University of Alabama at Birmingham, Intellia advisers begin that a CRISPR-mediated knockout of the Ldha gene in a PH1 abrasion archetypal disrupts LDHA protein assembly and reduces urinary oxalate levels by 63%. Advisers additionally empiric that a CRISPR-mediated knockout of the Hao1 gene disrupts glycolate-to-glyoxylate conversion, consistent in a urinary oxalate akin abridgement of 57% in a PH1 abrasion model. In anniversary alone knockout approach, these bargain levels of urinary oxalate were abiding for at atomic 15 weeks.
Today’s presentation, blue-blooded “CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria,” is attainable through the Contest and Presentations folio of the Broker Relations area of Intellia’s website.
The Aggregation has set alternating the afterward for 2019 activity progression:
— Admit IND-enabling toxicology studies in mid-2019
— Admit IND-enabling toxicology studies in mid-2019
— Arise accomplishment of NTLA-2001 Phase 1 materials
— Admit anatomic testing in patient-derived xenograft models of assorted beforehand TCRs in mid-2019
— Admit anatomic testing in patient-derived xenograft models of assorted beforehand TCRs in mid-2019
— Appoint aboriginal engineered corpuscle analysis development applicant by the end of 2019
First Division 2019 Banking Results
— Banknote Position: Cash, banknote equivalents and bankable balance were $296.6 actor as of March 31, 2019, compared to $314.1 actor as of December 31, 2018. The abatement was apprenticed by banknote acclimated to armamentarium operations of about $29 million, which was account in allotment by $6.0 actor of allotment accustomed beneath the Novartis collaboration, $3.6 actor of net disinterestedness gain aloft from the Company’s “At the Market” (ATM) agreement, $1.5 actor of ATTR amount reimbursements fabricated by Regeneron, and $0.4 actor in gain from employee-based banal plans.
— Accord Revenue: Accord acquirement added by about $3.0 actor to $10.4 actor during the aboriginal division of 2019, compared to $7.5 actor during the aboriginal division of 2018. The admission in accord acquirement in 2019 was primarily apprenticed by amounts accustomed from the amplification of the absolute accord with Novartis, as able-bodied as by amounts accustomed beneath the Company’s ATTR Co/Co acceding with Regeneron. As ahead disclosed, Regeneron is answerable to armamentarium about 50% of the development costs for the ATTR program.
— R&D Expenses: Analysis and development costs added by $1.2 actor to $23.7 actor during the aboriginal division of 2019, compared to $22.5 actor during the aboriginal division of 2018. This admission was apprenticed primarily by the beforehand of Intellia’s analysis programs, analysis cadre beforehand to abutment these programs, as able-bodied as the amplification of the development organization.
— G&A Expenses: General and authoritative costs added by $3.1 actor to $10.5 actor during the aboriginal division of 2019, compared to $7.4 actor during the aboriginal division of 2018. This admission was apprenticed primarily by agent and bookish acreage (IP)-related costs to abutment Intellia’s growing analysis and development efforts.
— Net Loss: The Company’s net accident was $21.9 actor for the aboriginal division of 2019, compared to $21.4 actor during the aboriginal division of 2018.
Intellia expects that its cash, banknote equivalents and bankable balance as of March 31, 2019, as able-bodied as technology admission and allotment from Novartis and Regeneron, will accredit Intellia to armamentarium its advancing operating costs and basal amount requirements into the aboriginal bisected of 2021. This apprehension excludes any abeyant anniversary payments or addendum fees that could be becoming and broadcast beneath the accord agreements with Novartis and Regeneron or any cardinal use of basal not currently in the Company’s base-case planning assumptions.
Conference Alarm to Altercate Aboriginal Division 2019 Earnings
The Aggregation will altercate these after-effects on a appointment alarm today, May 2, 2019, at 8 a.m. ET. The broker presentation may be downloaded starting at 7:30 a.m. ET from the Contest and Presentations folio of the Broker Relations area of Intellia’s website at intelliatx.com.
To accompany the call:
— U.S. callers should punch 800-458-4148 and use appointment ID# 7725705, about bristles account afore the call.
— International callers should bang actuality to admission dial-in advice and use appointment ID# 7725705, about bristles account afore the call.
A epitomize of the alarm will be accessible on Intellia’s website, alpha on May 2, 2019 at 12 p.m. ET.
About Intellia Therapeutics
Intellia Analysis is a arch genome alteration aggregation focused on developing alleviative analysis appliance the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the abeyant to transform anesthetic by assuredly alteration disease-associated genes in the beastly anatomy with a distinct analysis course, and through bigger corpuscle therapies that can amusement blight and immunological diseases, or can alter patients’ afflicted cells. The aggregate of abysmal scientific, abstruse and analytic development experience, alternating with its arch bookish acreage portfolio, puts Intellia in a different position to alleviate ample ameliorative applications of the CRISPR/Cas9 technology and actualize a new chic of ameliorative products. Learn added about Intellia Analysis and CRISPR/Cas9 at intelliatx.com and chase us on Twitter @intelliatweets.
This columnist absolution contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia”) aural the acceptation of the Private Balance Litigation Reform Act of 1995. These advanced statements include, but are not bound to, accurate or adumbrated statements apropos Intellia’s adeptness to beforehand and aggrandize the CRISPR/Cas9 technology to beforehand into beastly ameliorative products, as able-bodied as our bookish acreage portfolio; our adeptness to accomplish abiding or able genome editing; our adeptness to administrate our CRISPR/Cas9 artefact candidates; the abeyant timing and beforehand of our preclinical studies, including continuing non-human abbey studies for our ATTR affairs and added programs, beastly studies for our AML program, and analytic trials; the timing and abeyant accomplishment of milestones to beforehand our activity including nominating development candidates and filing INDs; the modularity of our belvedere and our adeptness to carbon or administrate after-effects accomplished in our preclinical studies, including those in our ATTR and AML programs, in any approaching studies, including beastly analytic trials; the abeyant development of our proprietary LNP/AAV amalgam commitment arrangement to beforehand our circuitous genome alteration capabilities; the abeyant development of added in vivo or ex vivo corpuscle analysis of all types, and those targeting WT1 in AML in particular, appliance CRISPR/Cas9 technology; our adeptness to admit and conduct acknowledged IND-enabling toxicology studies of NTLA-2001, our beforehand ATTR development candidate, and after appointment an IND appliance in 2020 that will be accustomed by the authoritative agencies; our absorbed to present added abstracts apropos CRISPR-mediated knockout of anniversary of two targets of interest, Ldha and Hao1, via the Company’s proprietary LNP commitment technology, consistent in the abridgement of oxalate excretion, and added preclinical abstracts during 2019 or thereafter our affairs to arise accomplishment efforts in 2019; accomplishments by government agencies; our beforehand as a aggregation and the advancing addition of the associates of our lath of admiral and our admiral to our operations and progress; the appulse of our collaborations on our development programs; the abeyant timing of authoritative filings apropos our development programs; our expectations apropos our uses of capital, expenses, approaching accumulated arrears and added banking after-effects during the aboriginal division of 2019; and our adeptness to armamentarium operations into the aboriginal bisected of 2021.
Any advanced statements in this columnist absolution are based on management’s accepted expectations and behavior of approaching events, and are accountable to a cardinal of risks and uncertainties that could account absolute after-effects to alter materially and abnormally from those set alternating in or adumbrated by such advanced statements. These risks and uncertainties include, but are not bound to: risks accompanying to Intellia’s adeptness to assure and advance our bookish acreage position; risks accompanying to Intellia’s accord with third parties, including our licensors; risks accompanying to the adeptness of our licensors to assure and advance their bookish acreage position; uncertainties accompanying to the admission and conduct of studies and added development requirements for our artefact candidates; the accident that any one or added of Intellia’s artefact candidates will not be auspiciously developed and commercialized; the accident that the after-effects of preclinical studies will not be predictive of approaching after-effects in affiliation with approaching studies; and the accident that Intellia’s collaborations with Novartis or Regeneron or its added ex vivo collaborations will not abide or will not be successful. For a altercation of these and added risks and uncertainties, and added important factors, any of which could account Intellia’s absolute after-effects to alter from those independent in the advanced statements, see the area advantaged “Risk Factors” in Intellia’s best contempo anniversary address on Anatomy 10-K as able-bodied as discussions of abeyant risks, uncertainties, and added important factors in Intellia’s added filings with the Balance and Exchange Commission. All advice in this columnist absolution is as of the date of the release, and Intellia undertakes no assignment to amend this advice unless appropriate by law.
Jennifer Mound Smoter
Senior Vice President
External Affairs & Communications
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