What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2020-11-05 compared with 2020-08-06 · 91 added, 87 removed, 293 unchanged (38% of the section changed)

7 unchanged sentences

Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

the anticipated timing of the initiation of our clinical studies for NTLA-2001, our program for the treatment of transthyretin amyloidosis;

the anticipated timing of preclinical studies, manufacturing activities and our investigational new drug application or equivalent regulatory filing for NTLA-5001, our program for the treatment of acute myeloid leukemia;

the anticipated timing of preclinical studies, manufacturing activities and our investigational new drug application or equivalent regulatory filing for NTLA-2002, our program for the treatment of hereditary angioedema;

our ability to execute our clinical study strategy for NTLA-2001, our program for the treatment of transthyretin amyloidosis;

the anticipated timing of preclinical studies, manufacturing activities and our investigational new drug application (“IND”) or equivalent regulatory filing for NTLA-5001, our program for the treatment of acute myeloid leukemia;

the anticipated timing of preclinical studies, manufacturing activities and our IND application or equivalent regulatory filing for NTLA-2002, our program for the treatment of hereditary angioedema;

our ability to use a modular platform capability or other strategy to efficiently discover and develop product candidates, including by applying learnings from one program to other programs;

11 unchanged sentences

our ability to acquire and maintain relevant intellectual property licenses and rights, and the scope and terms of such rights;

our plans to negotiate, and ability to agree to terms with Caribou Biosciences, Inc.

(“Caribou”) in accordance with the September 2019 interim award issued by the arbitration panel in our arbitration against Caribou (the “Caribou Arbitration”), including the scope of such arrangement and the timing and amount of payment under any such arrangement as well as the potential to initiate additional arbitration or legal proceedings if negotiations are not successful;

t he potential implications and impact the interim award in the Caribou Arbitration may have on any other intellectual property rights, as well as Caribou’s potential to compete with us in the field of human therapeutics;

developments relating to our licensors, licensees, third-parties from which we derive rights, collaborators, competitors and our industry;

the effect of the coronavirus disease 2019 (“COVID-19”) pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations;

our ability to agree to terms with Caribou Biosciences, Inc.

other risks and uncertainties, including those listed under the caption “Risk Factors.”

7 unchanged sentences

Intellia Therapeutics, Inc.

(“we,” “us,” “our,” “Intellia,” or the “Company”) is a leading genome editing company focused on developing curative therapeutics utilizing a biological tool known as CRISPR/Cas9, which stands for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”) /CRISPR associated 9 (“Cas9”).

(“we,” “us,” “our,” “Intellia,” or the “Company”) is a leading genome editing company, focused on the development of proprietary, potentially curative therapeutics utilizing a biological tool known as CRISPR/Cas9, which stands for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”) /CRISPR associated 9 (“Cas9”).

This is a technology for genome editing, the process of altering selected sequences of genomic deoxyribonucleic acid (“DNA”).

We believe that CRISPR/Cas9 technology has the potential to transform medicine by editing disease-associated genes with a single treatment course, and that it also can be used to create novel engineered cell therapies that can replace a patient’s diseased cells or effectively target various cancers and autoimmune diseases.

We are leveraging our leading scientific expertise, clinical development experience and intellectual property (“IP”) position to unlock a broad set of therapeutic applications for CRISPR/Cas9 genome editing and to develop a potential new class of therapeutic products .

We believe that CRISPR/Cas9 technology has the potential to transform medicine by both producing therapeutics that permanently edit and/or correct disease-associated genes in the human body with a single treatment course, and creating enhanced engineered cells that can treat oncological and immunological diseases.

Our combination of deep scientific, technical and clinical development experience, along with our intellectual property (“IP”) portfolio, puts us in a position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create new classes of therapeutic products .

Our management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared by us in accordance with accounting principles generally accepted in the United States of America (“U.S.

11 unchanged sentences

All of our revenue to date has been collaboration revenue .

Since our inception and through June 3 0 , 20 20 , we have raised an aggregate of approximately $ 889.

8 million to fund our operations, of which $ 268.8 million was through our collaboration agreements, $170.5 million was from our initial public offering and concurrent private placements, $ 2 4 9.

Since our inception and through September 3 0 , 20 20 , we have raised an aggregate of approximately $ 8 93.6 million to fund our operations, of which $ 272.6 million was through our collaboration agreements, $170.5 million was from our initial public offering and concurrent private placements, $ 2 4 9.

1 million was from follow-on offering s , $ 1 1 6.

4 unchanged sentences

We have assembled multiple in vivo and engineered cell therapy capabilities into a pipeline that reflects our full-spectrum approach and leverages the modularity inherent in our platform .

Our diversified pipeline includes in vivo development programs targeting genetic diseases, including transthyretin amyloidosis (“ATTR”), which we are co-developing with Regeneron Pharmaceuticals, Inc.

Our diversified pipeline includes in vivo development programs targeting genetic diseases, including transthyretin amyloidosis (“ATTR”), hemophilia A and hemophilia B, which we are co-developing with Regeneron Pharmaceuticals, Inc.

(“Regeneron”), and hereditary angioedema (“ HAE ”) .

34 unchanged sentences

The data from our various NHP studies has also demonstrated the transient nature of our proprietary modular LNP delivery system, which was rapidly cleared from circulation, with all CRISPR/Cas9 complex undetectable in blood and liver within ten days of administration.

Our lead candidate, NTLA-2001, applies an in vivo liver knockout approach for the treatment of ATTR.

We have manufactured clinical-scale materials for a Phase 1 study of NTLA-2001 and announced that we have submitted our first Clinical Trial Application (“CTA”) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) and are executing on our clinical plans to initiate a global Phase 1 study of NTLA-2001.

Pending approval of our CTA and subject to the impact of COVID-19, we plan to dose the first patient by the end of 2020.

Our lead candidate, NTLA-2001, applies an in vivo liver gene knockout approach for the treatment of ATTR.

In October 2020, we announced the authorization of our Clinical Trial Application (“CTA”) by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) to initiate our Phase 1 study to evaluate NTLA-2001 for the treatment of hATTR-PN.

Subject to the potential impact of the COVID-19 pandemic, we expect to dose the first patient in this Phase 1 trial during the fourth quarter of 2020.

In addition, we are submitting additional regulatory applications to enable enrollment in other countries as part of our global clinical development plans.

The Phase 1 study will be a two-part, open label, multi-center study in adults with hATTR-PN to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NTLA-2001, which will include the measurement of serum TTR levels following a single intravenous infusion.

NTLA-2001 is part of a co-development and co-promotion (“Co/Co”) agreement directed to our first collaboration target with Regeneron, ATTR (the “ATTR Co/Co”), for which we are the clinical and commercial Lead Party and Regeneron is the Participating Party (see Note 7 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further detail).

18 unchanged sentences

On May 7, 2020, we announced a development candidate for the treatment of HAE, NTLA-2002 , a wholly owned program .

As part of an ongoing durability study of our lead LNP formulation in support of NTLA-2002, we ha ve now demonstrated ten months of sustained therapeutically relevant reduction of serum kallikrein levels and activity following a single dose in NHPs .

We expect to submit an IND or IND-equivalent for NTLA-2002 in the second half of 2021.

We have completed a NHP durability study of our lead LNP formulation in support of NTLA-2002, which resulted in a year-long therapeutically relevant reduction of serum kallikrein protein levels and activity following a single dose.

In addition, during the third quarter of 2020 we have initiated Good Laboratory Practices ( “ GLP ” ) toxicology studies in preparation for an IND or IND-equivalent regulatory submission for NTLA-2002 in the second half of 2021.

Ex Vivo Programs

27 unchanged sentences

Importantly, chromosomal translocations (i.e., undesired chromosomal rearrangements) were similar to background levels in untreated cells.

We continue to advance IND-enabling activities, including process development to support clinical T cell manufacturing.

We are on track to submit an IND or IND-equivalent for NTLA-5001 in the first half of 2021.

We continue to advance IND-enabling activities and we are on track to submit an IND or IND-equivalent for NTLA-5001 in the first half of 2021.

Research Collaboration with Novartis

5 unchanged sentences

As a result of meeting this milestone, we recognized a $5.0 million milestone payment that was previously constrained as collaboration revenue within the condensed consolidated statement of operations and comprehensive loss.

Novartis is currently actively recruiting patients for its Phase 1/2 study of QTQ923 and HIX763, both candidates which were developed under the research collaboration.

For more information regarding our collaboration with Novartis, see the section below entitled “Collaborations - Novartis.”

2 unchanged sentences

Within our in vivo research efforts, we continue to work on programs such as primary hyperoxaluria Type 1, alpha-1 antitrypsin deficiency, hemophilia A and hemophilia B which leverage our capabilities to knockout, insert and make consecutive edits to the genome.

In September 2020, we presented data that showed the persistence of in vivo CRISPR/Cas9 edits in regenerated liver tissue, both knockout and insertion, and corresponding durability of effect following a partial hepatectomy (“PHx”) and liver regrowth in a murine model.

Unlike traditional gene therapy, for which a significant loss (over 80%) in transgene expression was observed in the insertion PHx model, our targeted gene insertion approach yielded durable edits, with no significant loss in expression.

We are also investigating delivery strategies that target tissues outside of the liver.

16 unchanged sentences

The 2020 Regeneron Amendment also grants Regeneron rights to develop products for five additional in vivo CRISPR/Cas-based therapeutic liver targets and non-exclusive rights to independently develop and commercialize up to 10 ex vivo gene edited products made using certain defined cell types.

Through June 3 0 , 20 20 , excluding amounts allocated to Regeneron’s purchase of our common stock, we have recorded $ 145.0 million in upfront payment s under the 2016 Regeneron Agreement and the 2020 Regeneron Amendment and $ 32.

6 million for research and development services primarily under the ATTR Co/Co agreement, a s described in Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q .

Through June 3 0 , 20 20 , we have recognized $ 9 4.4 million of collaboration revenue under all arrangements , including $ 16.3 million and $ 24.2 million during the three and six months ended June 30, 2020 and $6.3 million and $12.0 million during the three and six months ended June 30, 2019, respectively , in the condensed consolidated statements of operations and comprehensive loss .

Through September 3 0 , 20 20 , excluding amounts allocated to Regeneron’s purchase of our common stock, we have recorded $ 145.0 million in upfront payment s under the 2016 Regeneron Agreement and the 2020 Regeneron Amendment and $ 3 3 .

8 million primarily for research and development services under the ATTR Co/Co agreement, a s described in Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q .

Through September 3 0 , 20 20 , we have recognized $ 116.

7 million of collaboration revenue under all arrangements , including $ 22.

2 million and $ 46.

4 million during the three and nine months ended September 30, 2020 and $ 5.8 million and $1 7.8 million during the three and nine months ended September 30, 2019, respectively , in the condensed consolidated statements of operations and comprehensive loss .

This includes $ 1 .

8 million and $ 8.6 million during the three and six months ended June 30, 2020, respectively, and $3.2 million and $5.8 million during the three and six months ended June 30, 2019 , respectively, primarily representing payments due from Regeneron pursuant to the ATTR Co / Co a greement , which is accounted for under Accounting Standards Codification 808 , Collaborative Arrangements .

As of June 3 0 , 20 20 and December 31, 201 9 , we had accounts receivable of $ 3.9 million and $ 3 .6 million, respectively, and deferred revenue of $ 1 0 0.7 million and $ 28.8 million , respectively, related to th ese a r range ment s .

2 million and $ 9 .

8 million during the three and nine months ended September 30, 2020, respectively, and $ 2.6 million and $ 8.4 million during the three and nine months ended September 30, 2019 , respectively, primarily representing payments due from Regeneron pursuant to the ATTR Co / Co a greement , which is accounted for under Accounting Standards Codification 808 , Collaborative Arrangements .

As of September 3 0 , 20 20 and December 31, 201 9 , we had accounts receivable of $ 1 .

2 million and $ 3 .6 million, respectively, and deferred revenue of $ 79.6 million and $ 28.8 million , respectively, related to th ese a r range ment s .

As described in Note 7, “Collaborations—Novartis Institutes for BioMedical Research, Inc.,” to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, i n December 2014, we entered into a strategic collaboration agreement with Novartis (the “2014 Novartis Agreement”), primarily focused on the development of new ex vivo CRISPR/Cas9-edited therapies using CAR-T cells and HSCs.

The agreement was amended in December 2018 (the “Novartis Amendment”) to also include research on OSCs.

Through June 30, 2020, excluding amounts allocated to Novartis’ purchase of the Company’s Class A-1 and Class A-2 Preferred Units, we had recorded a total of $62.4 million in cash under the 2014 Novartis Agreement and the Novartis Amendment.

Through June 30, 2020, we have recognized $62.4 million of collaboration revenue, including $5.0 million related to a development milestone that was recognized in the first quarter of 2020 and $4.8 million and $9.5 million in the three and six months ended June 30, 2019, respectively.

No collaboration revenue was recorded during the three months ended June 30, 2020, related to the 2014 Novartis Agreement and the Novartis Amendment.

As of June 30, 2020, we had no accounts receivable related to the 2014 Novartis Agreement and the Novartis Amendment.

Through September 30, 2020, excluding amounts allocated to Novartis’ purchase of the Company’s Class A-1 and Class A-2 Preferred Units, we had recorded a total of $62.4 million in cash under the 2014 Novartis Agreement and the Novartis Amendment.

Through September 30, 2020, we have recognized $62.4 million of collaboration revenue, including $5.0 million related to a development milestone that was recognized in the first quarter of 2020 and $4.8 million and $14.3 million in the three and nine months ended September 30, 2019, respectively.

No collaboration revenue was recorded during the three months ended September 30, 2020, related to the 2014 Novartis Agreement and the Novartis Amendment.

As of September 30, 2020, we had no accounts receivable related to the 2014 Novartis Agreement and the Novartis Amendment.

As of December 31, 2019, we had accounts receivable of $1.0 million related to the 2014 Novartis Agreement and the Novartis Amendment.

As of June 30, 2020 and December 31, 2019, we had no deferred revenue related to the 2014 Novartis Agreement and the Novartis Amendment.

As of September 30, 2020 and December 31, 2019, we had no deferred revenue related to the 2014 Novartis Agreement and the Novartis Amendment.

Financial Overview

10 unchanged sentences

The following discussion of the financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and the related footnotes thereto.

Comparison of Three Months Ended June 30 , 2020 and 2019

The following table summarizes our results of operations for the three months ended June 30, 2020 and 2019:

Three Months Ended June 30,

Comparison of Three Months Ended September 30 , 2020 and 2019

The following table summarizes our results of operations for the three months ended September 30, 2020 and 2019:

Three Months Ended September 30,

Period Change

7 unchanged sentences

Collaboration Revenue

Collaboration revenue increased $5.1 million to $16.3 million during the three months ended June 30, 2020, as compared to $11.1 million during the three months ended June 30, 2019.

The increase in collaboration revenue during the three months ended June 30, 2020 is primarily caused by an $8.4 million one-time cumulative catch-up adjustment related to the modification of the 2016 Regeneron Agreement.

Refer to Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q f or further details.

Collaboration revenue increased $11.6 million to $22.2 million during the three months ended September 30, 2020, as compared to $10.6 million during the three months ended September 30, 2019.

The increase in collaboration revenue during the three months ended September 30, 2020 is primarily due to the Company recording $15.3 million related to the transfer of control of the license to develop the Factor VIII target for hemophilia A, partially offset by a decrease in revenue related to the Novartis collaboration.

Refer to Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further details.

Research and Development

Research and development expenses increased by $12.3 million to $37.8 million during the three months ended June 30, 2020, as compared to $25.5 million during the three months ended June 30, 2019.

The following table summarizes our research and development expenses for the three months ended June 30, 2020 and 2019, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended June 30,

Research and development expenses increased by $12.2 million to $39.8 million during the three months ended September 30, 2020, as compared to $27.5 million during the three months ended September 30, 2019.

The following table summarizes our research and development expenses for the three months ended September 30, 2020 and 2019, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended September 30,

Period Change

5 unchanged sentences

Total research and development expenses

The increase in research and development expenses for the three months ended June 30, 2020 compared to the three months ended June 30, 2019 was primarily attributable to:

approximately $8.7 million in increased pipeline and platform development expenses driven by increased manufacturing and related costs as we prepared to file our CTA and began preparations to enter the clinic for NTLA-2001, increased pre-clinical studies for NTLA-2002 and NTLA-5001, and an upfront payment associated with a research collaboration and licensing agreement;

The increase in research and development expenses for the three months ended September 30, 2020 compared to the three months ended September 30, 2019 was primarily attributable to:

approximately $7.4 million in increased pipeline and platform development expenses driven by increased costs as we prepared to enter the clinic for NTLA-2001, increased preclinical studies for NTLA-2002 and NTLA-5001, and an upfront payment associated with a research collaboration and licensing agreement;

approximately $ 2.9 million in employee - related expenses driven by an increase in the size of our workforce due to the advancement of our programs ;

1 unchanged sentence

approximately $1.3 million in increased stock-based compensation driven by our larger workforce.

Through 2020, we expect research and development expenses to increase as we continue to grow our development team and advance our ATTR, AML and HAE programs towards clinical development.

Through 2020, we expect research and development expenses to increase as we continue to grow our development team, execute clinical trials for ATTR and advance our AML and HAE programs towards clinical development.

General and Administrative

General and administrative expenses decreased by approximately $1.6 million to $11.5 million during the three months ended June 30, 2020, compared to $13.1 million during the three months ended June 30, 2019.

This decrease was primarily related to a $3.1 million decrease in legal expenditures, which were principally related to a decrease in certain activities related to IP matters.

The decrease was offset in part by an increase in employee related expenses, including stock-based compensation, of $1.3 million.

General and administrative expenses increased by approximately $2.1 million to $10.6 million during the three months ended September 30, 2020, compared to $8.4 million during the three months ended September 30, 2019.

This increase was primarily related to employee related expenses, including stock-based compensation, of $2.0 million.

Interest Income

Interest income decreased by approximately $1.1 million to $0.6 million during the three months ended June 30, 2020 as compared to $1.8 million during the three months ended June 30, 2019.

This decrease was due to a decline in investment income due to market performance.

Comparison of Six Months Ended June 30 , 2020 and 2019

The following table summarizes our results of operations for the six months ended June 30, 2020 and 2019:

Six Months Ended June 30,

Interest income decreased by approximately $1.4 million to $0.3 million during the three months ended September 30, 2020 as compared to $1.7 million during the three months ended September 30, 2019.

This decrease was due to a decline in investment income due to market conditions.

Comparison of Nine Months Ended September 30 , 2020 and 2019

The following table summarizes our results of operations for the nine months ended September 30, 2020 and 2019:

Nine Months Ended September 30,

Period Change

7 unchanged sentences

Collaboration Revenue

Collaboration revenue increased approximately $7.6 million to $29.2 million during the six months ended June 30, 2020, as compared to $21.6 million during the six months ended June 30, 2019.

The increase in collaboration revenue during the six months ended June 30, 2020 is primarily caused by an $8.4 million one-time cumulative catch-up adjustment related to the modification of the 2016 Regeneron Agreement.

Collaboration revenue increased approximately $19.2 million to $51.4 million during the nine months ended September 30, 2020, as compared to $32.2 million during the nine months ended September 30, 2019.

The increase in collaboration revenue during the nine months ended September 30, 2020 is primarily caused by an $8.4 million one-time cumulative catch-up adjustment related to the modification of the 2016 Regeneron Agreement as well as $15.3 million recorded due to the transfer of control of the license to develop the Factor VIII target for hemophilia A, partially offset by a decrease in revenue related to the Novartis collaboration.

Refer to Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further details.

Research and Development

Research and development expenses increased by approximately $23.3 million to $72.4 million during the six months ended June 30, 2020, as compared to $49.2 million during the six months ended June 30, 2019.

The following table summarizes our research and development expenses for the six months ended June 3 0 , 2020 and 2019, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended June 30,

Research and development expenses increased by approximately $35.5 million to $112.2 million during the nine months ended September 30, 2020, as compared to $76.7 million during the nine months ended September 30, 2019.

The following table summarizes our research and development expenses for the nine months ended September 3 0 , 2020 and 2019, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Nine Months Ended September 30,

Period Change

5 unchanged sentences

Total research and development expenses

The increase in research and development expenses for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 was primarily attributable to:

approximately $14.8 million in increased pipeline and platform development expenses driven by increased manufacturing and related costs as we prepared to file our CTA and began preparations to enter the clinic for NTLA-2001, increased pre-clinical studies for NTLA-2002 and NTLA-5001, and an upfront payment associated with a research collaboration and licensing agreement;

The increase in research and development expenses for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019 was primarily attributable to :

approximately $22.2 million in increased pipeline and platform development expenses driven by increased manufacturing and related costs as we prepared to file our CTA and enter the clinic for NTLA-2001, increased preclinical studies for NTLA-2002 and NTLA-5001, and upfront payments associated with a research collaboration and licensing agreement;

approximately $8.9 million in employee-related expenses driven by an increase in the size of our workforce due to the advancement of our programs;

1 unchanged sentence

approximately $1.9 million in increased stock-based compensation driven by our larger workforce.

Through 2020, we expect research and development expenses to increase as we continue to grow our development team and advance our ATTR, AML and HAE programs towards clinical development.

General and Administrative

General and administrative expenses decreased by approximately $0.8 million to $22.8 million during the six months ended June 30, 2020, compared to $23.7 million during the six months ended June 30, 2019.

This decrease was primarily related to a $2.7 million decrease in legal expenditures, which were principally related to a decrease in certain activities related to IP matters.

The decrease was offset in part by an increase in employee related expenses, including stock-based compensation, of $1.2 million.

General and administrative expenses increased by approximately $1.3 million to $33.4 million during the nine months ended September 30, 2020, compared to $32.1 million during the nine months ended September 30, 2019.

This increase was primarily related to a $3.2 million increase in employee-related expenses offset by a decrease in legal expenses of $2.3 million.

Interest Income

Interest income decreased by approximately $1.8 million to $1.9 million during the six months ended June 30, 2020 as compared to $3.6 million during the six months ended June 30, 2019.

This decrease was due to a decline in investment income due to market performance.

Interest income decreased by approximately $3.2 million to $2.1 million during the nine months ended September 30, 2020 as compared to $5.3 million during the nine months ended September 30, 2019.

This decrease was due to a decline in investment income due to market conditions.

Liquidity and Capital Resources

Since our inception through June 30, 2020, we have raised an aggregate of $889.8 million to fund our operations, of which $268.8 million was through our collaboration agreements, $170.5 million was from our initial public offering and concurrent private placements, $249.1 million was from follow-on public offerings, $116.4 million was from at-the-market offerings and $85.0 million was from the sale of convertible preferred stock.

As of June 3 0 , 20 20 , we had $ 4 36.8 million in cash, cash equivalents and marketable securities.

Since our inception through September 30, 2020, we have raised an aggregate of $893.6 million to fund our operations, of which $272.6 million was through our collaboration agreements, $170.5 million was from our initial public offering and concurrent private placements, $249.1 million was from follow-on public offerings, $116.4 million was from at-the-market offerings and $85.0 million was from the sale of convertible preferred stock.

As of September 3 0 , 20 20 , we had $ 4 07.9 million in cash, cash equivalents and marketable securities.

We are entitled to receive research payments under our collaboration with Novartis and are also eligible to earn a significant amount of milestone payments and royalties, in each case, on a per-product basis under our collaboration with Novartis and on a per-target basis under our collaboration with Regeneron.

17 unchanged sentences

During the year ended December 31, 2019, we issued 287,231 shares of our common stock, in a series of sales, at an average price of $ 16.48 per share, in accordance with the 2019 Sales Agreement for aggregate net proceeds of $ 4.4 million, after payment of cash commissions to Jefferies and approximately $0.2 million related to legal, accounting and other fees in connection with the sales .

During the six months ended June 30, 2020, we issued 1,107,100 shares of our common stock in a series of sales at an average price of $13.78 per share in accordance with the 2019 Sales Agreement, for aggregate net proceeds of $14.7 million after payment of cash commissions to Jefferies and approximately $0.1 million related to legal, accounting and other fees in connection with the sales.

As of June 30, 2020, $130.0 million in shares of common stock remain eligible for sale under the 2019 Sales Agreement.

During the nine months ended September 30, 2020, we issued 1,107,100 shares of our common stock in a series of sales at an average price of $13.78 per share in accordance with the 2019 Sales Agreement, for aggregate net proceeds of $14.7 million after payment of cash commissions to Jefferies and approximately $0.1 million related to legal, accounting and other fees in connection with the sales.

As of September 30, 2020, $130.0 million in shares of common stock remain eligible for sale under the 2019 Sales Agreement.

Funding Requirements

1 unchanged sentence

During 2020, we expect our expenses to increase compared to prior periods in connection with our ongoing activities, as we continue to grow our research and development team and begin clinical development.

Because our lead programs are still in preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of any future product candidates or whether, or when, we may achieve profitability.

Because our lead programs are still in the discovery, preclinical or early clinical stage and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of any future product candidates or whether, or when, we may achieve profitability.

Until such time as we can generate substantial product revenues, if ever, we expect to finance our ongoing cash needs through equity financings and collaboration arrangements.

5 unchanged sentences

If we are unable to raise additional funds through equity financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Based on our research and development plans and our expectations related to the progress of our programs, we expect that our cash, cash equivalents and marketable securities as of June 30, 2020, as well as research and cost reimbursement funding from Regeneron, will enable us to fund our ongoing operating expenses and capital expenditure requirements at least through the next twenty-four months, excluding any potential mile stone payments or extension fees that could be earned and distributed under the collaboration agreements with Regeneron and Novartis or any strategic use of capital not currently in the base case planning assumptions.

Based on our research and development plans and our expectations related to the progress of our programs, we expect that our cash, cash equivalents and marketable securities as of September 30, 2020, as well as research and cost reimbursement funding from Regeneron, will enable us to fund our ongoing operating expenses and capital expenditure requirements at least through the next twenty-four months, excluding any potential mile stone payments or extension fees that could be earned and distributed under the collaboration agreements with Regeneron and Novartis or any strategic use of capital not currently in the base case planning assumptions.

We have based this estimate on current assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect.

12 unchanged sentences

and attracting, hiring, and retaining qualified personnel .

The following is a summary of cash flows for the six months ended June 30, 2020 and 2019:

Six Months Ended June 30,

The following is a summary of cash flows for the nine months ended September 30, 2020 and 2019:

Nine Months Ended September 30,

(In thousands)

Net cash provided by (used in) operating activities

Net cash provided by investing activities

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net cash provid ed by ( used in ) operating activities

Net cash provided by operating activities of $18.9 million during the six months ended June 30, 2020 primarily reflects the receipt of a $70.0 million up-front payment and $8.4 million in additional payments under our collaboration with Regeneron and $6.0 million in payments from Novartis, offset in part by increased spend in our research and development activities.

Net cash used in operating activities of $49.1 million during the six months ended June 30, 2019 primarily reflects increased spend in our research and development and general administrative activities, offset in part by the receipt of $7.0 million and $4.1 million in payments from our collaboration partners, Novartis and Regeneron, respectively, during those periods.

Net cash provided by investing activities

During the six months ended June 30, 2020 and 2019, our investing activities provided net cash of $150.4 million and $28.9 million, respectively.

The increase in the six months ended June 30, 2020 is primarily due to an increase of $152.3 million from marketable securities activity during the period, as $183.5 million in marketable securities matured and $31.2 million in marketable securities were purchased.

The increase in the six months ended June 30, 2019 is primarily due to an increase of $31.4 million from marketable securities activity during the period, as $214.0 million in marketable securities matured and $182.6 million in marketable securities were purchased.

These increases in cash provided by investing activity were offset in part by the use of $1.9 million and $2.5 million related to purchases of property and equipment in the six months ended June 30, 2020 and 2019, respectively.

Net cash used in operating activities

Net cash used in operating activities of $9.7 million during the nine months ended September 30, 2020 primarily reflects the receipt of a $70.0 million up-front payment and $12.2 million in additional payments under our collaboration with Regeneron and $6.0 million in payments from Novartis, offset in part by increased spend in our research and development activities.

Net cash used in operating activities of $74.6 million during the nine months ended September 30, 2019 primarily reflects increased spend in our research and development and general administrative activities, offset in part by the receipt of $8.0 million and $7.3 million in payments from our collaboration partners, Novartis and Regeneron, respectively, during those periods.

Net cash used in investing activities

During the nine months ended September 30, 2020 and 2019, our investing activities used net cash of $3.6 million and $2.7 million, respectively.

The decrease in the nine months ended September 30, 2020 is primarily related to the use of $2.6 million in cash for the purchase of property and equipment and a decrease of $1.0 million from marketable securities activity during the period, as $243.8 million in marketable securities matured and $244.8 million in marketable securities were purchased.

The decrease in the nine months ended September 30, 2019 is primarily related to the use of $4.2 million in cash for the purchase of property and equipment, offset in part by an increase of $1.5 million from marketable securities activity during the period, as $265.5 million in marketable securities matured and $264.0 million in marketable securities were purchased.

Net cash provided by financing activities

Net cash provided by financing activities of $137.1 million during the six months ended June 30, 2020 includes $107.7 million in net proceeds from a follow-on offering, $14.7 million in net proceeds from at-the-market offerings, $12.6 million in proceeds from the issuance of common stock to Regeneron in a private placement, $1.4 million in cash received from the exercise of stock options and $0.7 in cash received from the issuance of shares through our employee stock purchase plan.

Net cash provided by financing activities of $10.5 million during the six months ended June 30, 2019 includes $7.9 million in net proceeds from at-the-market offerings, $2.0 million in cash received from the exercise of stock options and $0.5 million in cash received from the issuance of shares through our employee stock purchase plan.

Net cash provided by financing activities of $137.7 million during the nine months ended September 30, 2020 includes $107.7 million in net proceeds from a follow-on offering, $14.7 million in net proceeds from at-the-market offerings, $12.6 million in proceeds from the issuance of common stock to Regeneron in a private placement, $2.0 million in cash received from the exercise of stock options and $0.7 million in cash received from the issuance of shares through our employee stock purchase plan.

Net cash provided by financing activities of $56.9 million during the nine months ended September 30, 2019 includes $54.1 million in net proceeds from at-the-market offerings, $2.2 million in cash received from the exercise of stock options and $0.5 million in cash received from the issuance of shares through our employee stock purchase plan.

Critical Accounting Policies

8 unchanged sentences

The Second Amendment extends the term of the 130 Brookline Lease by approximately six years through January 31, 2031.

This extended term is included as part of the lease liability and right-of-use asset at June 30, 2020.

This extended term is included as part of the lease liability and right-of-use asset at September 30, 2020.

The Second Amendment also provides an option to extend the lease for two consecutive five-year terms.

The Company recognized a right-of-use asset and lease liability of approximately $7.3 million related to the Second Amendment.

We recognized a right-of-use asset and lease liability of approximately $7.3 million related to the Second Amendment.

In March 2020, we entered into an agreement to lease approximately 39,000 square feet of office and laboratory space at 281 Albany Street in Cambridge, Massachusetts under an operating lease agreement (the “281 Albany Lease”).

The 281 Albany Lease is expected to commence on October 1, 2020, and our obligation to pay rent will start on the date that is six months after the commencement date or the date on which we occupy the premises, whichever occurs earlier (the “Rent Commencement Date”).

Our obligation to pay rent on the 281 Albany Lease will start on the date that is six months after the commencement date or the date on which we occupy the premises, whichever occurs earlier (the “Rent Commencement Date”).

The initial term of the 281 Albany Lease is ten years following the Rent Commencement Date.

The base rent under the 281 Albany Lease is $99.00 per square foot per year during the first year of the term, which is subject to scheduled annual increases up to $128.87 per square foot per year during the last year of the initial term, plus certain operating expenses and taxes.

In addition, the landlord will contribute an aggregate of $4.4 million toward the cost of construction and tenant improvements for the premises.

In addition, the landlord will contribute an

aggregate of $4.4 million toward the cost of construction and tenant improvements for the p remises.

We have the option to extend the 281 Albany Lease for two successive five-year terms .

T here were no other material changes to our contractual obligations during the six months ended June 3 0 , 20 20 .

There were no other material changes to our contractual obligations during the nine months ended September 30, 2020.

For a complete discussion of our contractual obligations, please refer to our Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report for the year ended December 31, 2019.

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis