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Intellia Therapeutics Inc

For the period ended Jun 30, 2024. Filed Aug 8, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 8, 2024

NTLA$11.35+2.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-09.

0000950170-24-057046

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0000950170-24-093907

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 121 previous paragraphs and 130 current paragraphs.

68 unchanged; 39 reworded; 14 added; 11 removed; 3 previous and 9 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (14)

Current report

We plan to initiate a pivotal Phase 3 trial of NTLA-2001 as a single-dose treatment for hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”) by year-end. As previously announced, the study is expected to be a small, placebo-controlled trial of approximately 50 patients conducted in ex-U.S. regions with limited or no access to TTR-silencers.

Current report

In June 2024, we presented positive long-term data from the ongoing Phase 1 study. Eight of 10 patients remained completely attack-free following the 16-week primary observation period. These patients have experienced ongoing attack-free durations of greater than 18 months after a single-dose treatment, with the longest ongoing individual attack-free duration reaching over 26 months. Across all patients, NTLA-2002 led to a 98% mean reduction in monthly HAE attack rate. Consistent with previously reported results, NTLA-2002 was well-tolerated, and the majority of adverse events were mild in severity through the latest follow-up. These interim data were presented at the European Academy of Allergy and Clinical Immunology (“EAACI”) Congress 2024 in Valencia, Spain.

Current report

In January 2024, we announced that enrollment and dosing was completed in the Phase 2 portion of the study. In August 2024, we announced positive topline results from the Phase 2 study of NTLA-2002 in patients with HAE. The clinical trial met its primary efficacy and all secondary endpoints in the 16-week primary observation period, with a single 25 mg or 50 mg dose leading to deep reductions in attacks. No new safety findings were observed. We have selected the 50 mg dose for further evaluation in the global pivotal Phase 3 study based upon the greater number of patients with complete attack elimination and greater kallikrein protein reduction compared to the 25 mg dose observed in the Phase 2 study, which is consistent with the previously reported Phase 1 results. We plan to present the detailed Phase 2 data at an upcoming medical meeting in the fourth quarter of this year.

Current report

In August 2024, we also announced the successful completion of an end-of-Phase 2 meeting with the FDA supporting our Phase 3 plans for NTLA-2002. The Phase 3 study is on track to initiate in the second half of 2024, subject to regulatory feedback.

Current report

In July 2024, we announced the authorization of our Clinical Trial Application by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) to initiate a first-in-human study of NTLA-3001. We expect to dose the first patient in the Phase 1/2 study of NTLA-3001 in the second half of 2024. The Phase 1/2 study will be a two-part, open-label, multi-center study with up to 30 patients to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NTLA-3001.

Current report

In June 2024, we presented positive clinical proof-of-concept data that redosing with CRISPR, utilizing our proprietary non-viral, LNP-based delivery platform, enabled an additive pharmacodynamic effect. In the three patients who previously received the lowest dose of 0.1 mg/kg in the Phase 1 dose-escalation study of NTLA-2001, follow-on dosing with a 55 mg dose of NTLA-2001 led to a deeper protein reduction. Median reduction in serum TTR was 90% at day 28 after redosing. The corresponding reduction from original baseline levels was a 95% median reduction in serum TTR. NTLA-2001 was generally well tolerated across all patients after receiving the follow-on dose. While redosing is not planned for the NTLA-2001 program in ATTR amyloidosis, a redosing option could be an important advantage of our LNP-based delivery platform for future investigational therapies where a target additive effect is desired. These data were presented at the Peripheral Nerve Society (“PNS”) Annual Meeting in Montreal, Canada.

Current report

Collaboration revenue decreased by $6.6 million during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023. The decrease in collaboration revenue is primarily due to a reduction in revenue under the AvenCell license and collaboration agreement (the “AvenCell LCA”).

Current report

Research and development expenses decreased by $1.1 million during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023.

Current report

Research and development expenses increased by $13.7 million to $226.1 million during the six months ended June 30, 2024, as compared to $212.4 million during the six months ended June 30, 2023.

Current report

a $0.9 million decrease in research materials and contracted services primarily driven by a decrease in internal R&D expenses, offset in part by an increase in drug component spend;

Current report

General and administrative expenses increased by $4.8 million to $62.9 million during the six months ended June 30, 2024, compared to $58.1 million during the six months ended June 30, 2023. This increase was primarily related to an increase in stock-based compensation of $5.1 million.
Removed paragraphs (11)

Previous report

In January 2024, we announced that enrollment and dosing was completed in the Phase 2 portion of the study. Data from the Phase 2 study will inform the dose of NTLA-2002 selected for the pivotal Phase 3 study. We expect to initiate the global pivotal Phase 3 study, including U.S. patients, in the second half of 2024, subject to regulatory feedback.

Previous report

We plan to present updated data from the Phase 1 study at the European Academy of Allergy and Clinical Immunology (“EAACI”) Congress 2024, taking place May 31 – June 3 in Valencia, Spain. Long-term data from the Phase 1 portion of the Phase 1/2 study will include safety, kallikrein reduction and attack rate data, including number of patients who continue to be completely attack free through the latest follow-up. Additionally, we plan to report topline results from the Phase 2 portion in mid-2024 and present full results at a medical meeting in the second half of 2024.

Previous report

Research and development expenses increased by $14.7 million, or 15%, during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023.
Reworded paragraphs (39)

Previous wording

our ability to execute our clinical study strategy for NTLA-2001, our program for the treatment of transthyretin (“ATTR”) amyloidosis, including the ability to successfully complete our global Phase 3 study, or the success of such program;

Current wording

our ability to execute our clinical study strategy for NTLA-2001, our program for the treatment of transthyretin (“ATTR”) amyloidosis, including the ability to successfully complete our global Phase 3 study for ATTR amyloidosis with cardiomyopathy (“ATTR-CM”), to initiate and complete our global Phase 3 study for hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”), or the success of such program;

Previous wording

our ability to execute our clinical study strategy for NTLA-2002, our program for the treatment of hereditary angioedema (“HAE”), including the ability to successfully complete our Phase 1/2 study and determine a recommended dose that can be advanced into later-stage studies, or the success of such program;

Current wording

our ability to execute our clinical study strategy for NTLA-2002, our program for the treatment of hereditary angioedema (“HAE”), including the ability to successfully initiate and complete our global Phase 3 study, file a biologics license application (“BLA”) or comparable marketing application within a certain time period, or the success of such program;

Previous wording

our ability to execute our clinical study strategy for NTLA-3001, our program for the treatment of alpha-1 antitrypsin deficiency (“AATD”)-associated lung disease, including the ability to successfully initiate our Phase 1 study, or the success of such program;

Current wording

our ability to execute our clinical study strategy for NTLA-3001, our program for the treatment of alpha-1 antitrypsin deficiency (“AATD”)-associated lung disease, including the ability to successfully initiate our Phase 1 study and dose the first patient in 2024, or the success of such program;

Previous wording

Our strategy is to advance our full-spectrum gene editing company, focused on developing and commercializing curative CRISPR/Cas9-based therapeutics, by leveraging our modular platforms. All of our revenue to date has been collaboration revenue. Since our inception and through March 31, 2024, we have raised an aggregate of approximately $2,598.3 million to fund our operations through our initial public offering (“IPO”) and concurrent private placements, follow-on public offerings, at-the-market offerings, and the sale of convertible preferred stock, as well as through our collaboration agreements.

Current wording

Our strategy is to advance our full-spectrum gene editing company, focused on developing and commercializing curative CRISPR/Cas9-based therapeutics, by leveraging our modular platforms. All of our revenue to date has been collaboration revenue. Since our inception and through June 30, 2024, we have raised an aggregate of approximately $2,666.7 million to fund our operations through our initial public offering (“IPO”) and concurrent private placements, follow-on public offerings, at-the-market offerings, and the sale of convertible preferred stock, as well as through our collaboration agreements.

Previous wording

NTLA-2001 is an investigationalin vivo CRISPR-based therapy designed to inactivate the transthyretin (“TTR”) gene in the liver and thereby prevent the production of TTR protein for the treatment of ATTR amyloidosis. NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose.

Current wording

NTLA-2001, now known as nexiguran ziclumeran (“nex-z”), is an investigationalin vivo CRISPR-based therapy designed to inactivate the transthyretin (“TTR”) gene in liver cells, thereby preventing the production of TTR protein for the treatment of ATTR amyloidosis. NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose.

Previous wording

The global, pivotal Phase 3 MAGNITUDE trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of NTLA-2001 in adults with ATTR-CM. The primary endpoint of the study is a composite of cardiovascular (“CV”)-related mortality and events. Patients will be randomized 2:1 NTLA-2001:placebo, with a single 55 mg infusion of NTLA-2001 administered. We are actively enrolling patients, and in March 2024, the first patients in the U.S. and globally were dosed. Enrollment is currently tracking well ahead of our initial projections, with over 30 patients dosed to date and more than 40 additional patients in screening. Many additional sites are expected to open in the weeks and months ahead to further accelerate enrollment.

Current wording

The pivotal Phase 3 MAGNITUDE trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of NTLA-2001 in adults with ATTR-CM. The primary endpoint of the study is a composite of cardiovascular (“CV”)-related mortality and events. Patients will be randomized 2:1 NTLA-2001:placebo, with a single 55 mg infusion of NTLA-2001 administered. In March 2024, the first patients in the U.S. and globally were dosed. The trial is currently enrolling and continues to track ahead of our initial projections. During the second quarter, we received approval for our application under the new European Union Clinical Trials Regulation, which enables the Phase 3 trial to proceed in Denmark, Germany, France, Italy, Spain and Sweden.

Previous wording

Today, we announced alignment with the U.S. Food and Drug Administration (“FDA”) on a pivotal Phase 3 trial design to support a biologics license application (“BLA”) filing for NTLA-2001 as a single-dose treatment for people living with ATTR amyloidosis with polyneuropathy (“ATTRv-PN”), subject to review of an investigational new drug (“IND”) application. The study is expected to be a small, placebo-controlled trial conducted at ex-U.S. sites with approximately 50 ATTRv-PN patients. We plan to initiate the study by year-end.

Current wording

In May 2024, we announced alignment with the U.S. Food and Drug Administration (“FDA”) on a pivotal Phase 3 trial design to support a biologics license application (“BLA”) filing for NTLA-2001 as a single-dose treatment for people living with ATTRv-PN, subject to review of its investigational new drug (“IND”) application.

Previous wording

We plan to present updated data from the ongoing Phase 1 study in ATTR-CM and ATTRv-PN patients in the second half of 2024.

Current wording

We plan to present updated data from the ongoing Phase 1 study in ATTR-CM and ATTRv-PN patients in the second half of 2024, including safety, TTR reduction and other clinical endpoint data from both arms of the Phase 1 study.

Previous wording

Our multi-national Phase 1/2 study is evaluating the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of NTLA-2002 in adults with Type I or Type II HAE. This includes the measurement of kallikrein protein levels and activity, as well as HAE attack rate. The Phase 1 portion of the study was an open-label, single-ascending dose design. Two dose levels of NTLA-2002 were identified from Phase 1 for further evaluation in the Phase 2, randomized, placebo-controlled portion of the study.

Current wording

Our multi-national Phase 1/2 study is evaluating the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of NTLA-2002 in adults with Type I or Type II HAE. This includes the measurement of kallikrein protein levels and activity, as well as HAE attack rate. The Phase 1 portion of the study was an open-label, single-ascending dose design. Two dose levels of NTLA-2002 were identified from Phase 1 for further evaluation in the Phase 2, randomized, double-blind, placebo-controlled portion of the study.

Previous wording

In January 2024, we also announced that positive interim results from the Phase 1 portion of the Phase 1/2 study were published in the New England Journal of Medicine.

Current wording

In January 2024, we announced that positive interim results from the Phase 1 portion of the Phase 1/2 study were published in the New England Journal of Medicine.

Previous wording

NTLA-3001 is our wholly owned, first-in-class CRISPR-mediatedin vivo targeted gene insertion development candidate for the treatment of AATD-associated lung disease. It is designed to precisely insert the wild-type SERPINA1 gene, which encodes the alpha-1 antitrypsin (“AAT”) protein, with the potential to restore permanent expression of fully functional AAT protein to normal levels after a single dose. We expect to dose the first patient in a Phase 1 study of NTLA-3001 in 2024.

Current wording

NTLA-3001 is our wholly owned, first-in-class CRISPR-mediatedin vivo targeted gene insertion development candidate for the treatment of AATD-associated lung disease and our first wholly owned gene insertion program. It is designed to precisely insert the wild-type SERPINA1 gene, which encodes the alpha-1 antitrypsin (“AAT”) protein, with the potential to restore permanent expression of fully functional AAT protein to normal levels after a single dose.

Previous wording

We are advancing multiple programs, wholly owned and in collaboration with partners, utilizing our allogeneic platform for the treatment of immuno-oncology and autoimmune diseases. Our proprietary allogeneic cell engineering platform avoids both T cell- and natural killer (“NK”) cell-mediated rejection in preclinical models, a key unsolved challenge with other investigational allogeneic approaches. Cell therapies engineered with our allogeneic platform, combined with edits to enhance cell function, offer a new approach to target solid tumors.

Current wording

We are advancing multiple programs, wholly owned and in collaboration with partners, utilizing our allogeneic platform for the treatment of immuno-oncology and autoimmune diseases. Our proprietary allogeneic cell engineering platform avoids both T cell- and natural killer (“NK”) cell-mediated rejection in preclinical models, a key unsolved challenge with other investigational allogeneic approaches. Cell therapies engineered with our allogeneic platform, combined with edits to enhance cell function, offer a new approach to target both hematological and solid tumors.

Previous wording

Our revenue consists of collaboration revenue, including amounts recognized related to upfront technology access payments for licenses, technology access fees, research materials shipped, research funding and milestone payments earned under our collaboration and license agreements.

Current wording

Our revenue consists of collaboration revenue, including amounts recognized related to upfront technology access payments for licenses, technology access fees, research materials shipped, research funding and milestone payments earned under our license and collaboration agreements.

Previous wording

During the three months ended March 31, 2024, other income (expense), net consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities and change in the fair value of our investments. During the three months ended March 31, 2023, other income (expense), net consisted of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities, loss from equity method investment and change in fair value of contingent consideration.

Current wording

During the three and six months ended June 30, 2024, other income (expense), net consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities and change in the fair value of our investments. During the three months ended June 30, 2023, other income (expense), net consisted of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities and loss from our equity method investment. During the six months ended June 30, 2023, other income (expense), net consisted of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities, loss from our equity method investment and change in fair value of contingent consideration.

Previous wording

The following table summarizes our results of operations for the three months ended March 31, 2024 and 2023:

Previous wording

The following table summarizes our research and development expenses for the three months ended March 31, 2024 and 2023, together with the changes in those items in dollars and the respective percentages of change:

Current wording

The following table summarizes our research and development expenses, together with the changes in those items in dollars and the respective percentages of change:

Previous wording

The increase in research and development expenses for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 was primarily attributable to:

Current wording

The decrease in research and development expenses for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was primarily attributable to:

Previous wording

a $4.6 million increase in external costs related to the development of NTLA-2002, primarily due to an increase in spend on drug components and contracted services;

Current wording

a $3.2 million increase in external costs related to the development of NTLA-2002, primarily due to an increase in spend on drug components and contracted services;

Previous wording

a $0.3 million decrease in external costs related to the development of NTLA-3001, primarily due to a decrease in spend on drug components, offset in part by an increase in spend on contracted services;

Current wording

a $2.6 million decrease in external costs related to the development of NTLA-3001, primarily due to a decrease in spend on drug components, offset in part by an increase in spend on contracted services;

Previous wording

a $1.3 million increase in research materials and contracted services primarily driven by an increase in spend on drug components, offset in part by a decrease in internal research and development expenses and contracted services;

Current wording

a $2.2 million decrease in research materials and contracted services primarily driven by a decrease in drug component and internal research and development spend, offset in part by an increase in contracted services;

Previous wording

a $0.8 million increase in facility-related expenses primarily related to depreciation and technology expense allocated to research and development; and

Current wording

a $1.4 million increase in facility-related expenses primarily related to depreciation, technology expense allocated to research and development and rent; and

Previous wording

General and administrative expenses increased by approximately $3.6 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023. This increase was primarily related to an increase in stock-based compensation of $3.7 million.

Current wording

General and administrative expenses increased by approximately $1.1 million during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023. This increase was primarily related to an increase in stock-based compensation of $1.4 million.

Previous wording

Collaboration revenue increased by $16.3 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023. The increase in collaboration revenue is primarily due to the recognition of $21.0 million of previously eliminated intra-entity profit under the AvenCell license and collaboration agreement. See Note 7, “Collaborations and Other Arrangements” of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further details.

Current wording

Collaboration revenue increased by $9.7 million to $35.9 million during the six months ended June 30, 2024, as compared to $26.2 million during the six months ended June 30, 2023. The increase in collaboration revenue during the six months ended June 30, 2024 is primarily due to the recognition of $21.0 million of previously eliminated intra-entity profit under the AvenCell LCA, offset in part by a $10.7 million reduction in revenue related to the AvenCell LCA. Refer to Note 7 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further details.

Previous wording

a $3.9 million increase in external costs related to the development of NTLA-2001, our lead product candidate, primarily due to an increase in spend on drug components and contracted services;

Current wording

a $7.9 million increase in external costs related to the development of NTLA-2002, primarily due to an increase in spend on drug components and contracted services;

Previous wording

a $2.6 million increase in employee-related expenses primarily driven by a one-time charge related to a workforce reduction in January 2024, offset in part by a decrease in salary costs;

Current wording

a $2.6 million decrease in employee-related expenses, primarily driven by a workforce reduction in January 2024;

Previous wording

The decrease in other income (expense), net of $2.3 million is primarily related to $6.1 million in expense due to the change in fair value of our investments in Kyverna and AvenCell, offset by a $3.0 million change related to our equity method loss recorded in the first quarter of 2023, and a $0.7 million increase in interest income, driven by an increase in market rates.

Current wording

The decrease in other income (expense), net of $18.9 million is primarily related to $26.4 million in expense due to the change in fair value of our investments in Kyverna and AvenCell, offset by a $7.0 million change related to our equity method loss recorded in the first half of 2023 and a $0.4 million increase in interest income, driven by an increase in market rates.

Previous wording

Since our inception through March 31, 2024, we have raised an aggregate of $2,598.3 million to fund our operations through our collaboration agreements, our initial public offering and concurrent private placements, follow-on public offerings, at-the-market offerings and the sale of convertible preferred stock.

Current wording

Since our inception through June 30, 2024, we have raised an aggregate of $2,666.7 million to fund our operations through our collaboration agreements, our initial public offering and concurrent private placements, follow-on public offerings, at-the-market offerings and the sale of convertible preferred stock.

Previous wording

As of March 31, 2024, we had $953.4 million in cash, cash equivalents and marketable securities.

Current wording

As of June 30, 2024, we had $939.9 million in cash, cash equivalents and marketable securities.

Previous wording

In March 2022, we entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies LLC (“Jefferies”), under which Jefferies is able to offer and sell, from time to time in “at-the-market” offerings, shares of our common stock having aggregate gross proceeds of up to $400.0 million. In February 2024, we entered into an amendment to the 2022 Sale Agreement (the “2022 Sale Agreement, as amended”) to increase the size of the at-the-market offering program from $400.0 million to $750.0 million. We agreed to pay cash commissions of up to 3.0% of the gross proceeds of sales of common stock under the 2022 Sale Agreement, as amended.

Current wording

In March 2022, we entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies LLC (“Jefferies”), under which Jefferies is able to offer and sell, from time to time in “at-the-market” offerings, shares of our common stock having aggregate gross proceeds of up to $400.0 million. In February 2024, we entered into an amendment to the 2022 Sale Agreement (the “2022 Sale Agreement, as amended”) to increase the size of the at-the-market offering program from $400.0 million to $750.0 million. We agreed to pay cash commissions of up to 3.0% of the gross proceeds of sales of common stock under the 2022 Sale Agreement, as amended. Through June 30, 2024 we have issued 11,320,924 shares of our common stock under the 2022 Sale Agreement, as amended.

Previous wording

During the three months ended March 31, 2024, we issued 2,209,938 shares of our common stock, in a series of sales, at an average price of $26.19 per share, in accordance with the 2022 Sale Agreement, as amended, for aggregate net proceeds of $56.0 million, after payment of cash commissions and approximately $0.2 million related to legal, accounting and other fees in connection with the sales.

Current wording

During the six months ended June 30, 2024, we issued 3,802,761 shares of our common stock, in a series of sales, at an average price of $25.58 per share, in accordance with the 2022 Sale Agreement, as amended, for aggregate net proceeds of $94.4 million, after payment of cash commissions and approximately $0.2 million related to legal, accounting and other fees in connection with the sales.

Previous wording

As of March 31, 2024, $371.1 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement, as amended.

Current wording

As of June 30, 2024, $331.7 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement, as amended.

Previous wording

The following is a summary of cash flows for the three months ended March 31, 2024 and 2023:

Previous wording

Net cash used in operating activities of $120.7 million during the three months ended March 31, 2024 primarily consists of a net loss of $107.4 million, further reduced by changes in operating assets and liabilities of $29.7 million, including the receipt of $5.9 million in payments from our collaboration partners during that period, and the non-cash recognition of $21.0 million of previously eliminated intra-entity profit recorded within “collaboration revenue,” offset in part by non-cash charges of $6.1 million of net adjustments to the fair value of our investments in Kyverna and AvenCell, stock-based compensation of $34.2 million and depreciation of $2.5 million.

Current wording

Net cash used in operating activities of $178.8 million during the six months ended June 30, 2024 primarily consists of a net loss of $254.4 million, further reduced by the non-cash recognition of $21.0 million of previously eliminated intra-entity profit recorded within “collaboration revenue,” accretion of investment discounts and premiums of $9.9 million and net changes in operating assets and liabilities of $0.1 million. These decreases are offset in part by stock-based compensation of $75.0 million, $26.4 million in net adjustments to the fair value of our investments in Kyverna and AvenCell and depreciation of $5.1 million.

Previous wording

Net cash used in operating activities of $109.3 million during the three months ended March 31, 2023 primarily reflects the increased spend in our research and development activities, offset in part by the receipt of $3.4 million in payments from our collaboration partners during that period.

Current wording

Net cash used in operating activities of $199.7 million during the six months ended June 30, 2023 primarily reflects the increased spend in our research and development activities, offset in part by the receipt of $8.0 million in payments from our collaboration partners during that period.

Previous wording

During the three months ended March 31, 2024, our investing activities provided cash of $5.9 million. The increase in the three months ended March 31, 2024 is primarily due to $268.0 million of marketable securities maturing, offset in part by $259.6 million in marketable securities purchased and $2.5 million in cash for the purchase of property and equipment.

Current wording

During the six months ended June 30, 2024, we used $18.3 million of net cash in investing activities. The decrease in the six months ended June 30, 2024 is primarily due to $14.8 million in marketable securities purchased (net of maturities) and $3.5 million in cash for the purchase of property and equipment.

Previous wording

During the three months ended March 31, 2023 our investing activities used cash of $122.2 million. The decrease in the three months ended March 31, 2023 is primarily due to $382.0 million in marketable securities purchased, offset in part by $263.6 million of marketable securities maturing, and $3.8 million in cash for the purchase of property and equipment.

Current wording

During the six months ended June 30, 2023 we used cash of $156.8 million in investing activities. The decrease in the six months ended June 30, 2023 is primarily due to $148.6 million in marketable securities purchased (net of maturities) and $8.1 million in cash for the purchase of property and equipment.

Previous wording

Net cash provided by financing activities of $60.0 million during the three months ended March 31, 2024 includes $58.0 million in net proceeds from at-the-market offerings and $2.0 million in cash received from the exercise of stock options.

Current wording

Net cash provided by financing activities of $101.2 million during the six months ended June 30, 2024 includes $96.4 million in net proceeds from at-the-market offerings, $3.1 million in cash received from the exercise of stock options and $1.7 million in cash received from the issuance of shares through our employee stock purchase plan.

Previous wording

Net cash provided by financing activities of $2.2 million during the three months ended March 31, 2023 includes $1.5 million in net proceeds from at-the-market offerings and $0.8 million in cash received from the exercise of stock options.

Current wording

Net cash provided by financing activities of $4.7 million during the six months ended June 30, 2023 includes $2.1 million in cash received from the issuance of shares through our employee stock purchase plan, $1.5 million in net proceeds from at-the-market offerings and $1.2 million in cash received from the exercise of stock options.
Rearranged current paragraphs (9)

Current report — wording carried from elsewhere

a $1.3 million increase in external costs related to the development of NTLA-2001, our lead product candidate, primarily due to an increase in spend on contracted services, offset in part by a decrease in drug components;

Current report — wording carried from elsewhere

a $5.2 million decrease in employee-related expenses driven by a workforce reduction in January 2024;

Current report — wording carried from elsewhere

The decrease in other income (expense), net of $16.6 million is primarily related to $20.4 million in expense due to the change in fair value of our investment in Kyverna, offset in part by a $4.0 million change related to our equity method loss recorded in the second quarter of 2023.

Current report — wording carried from elsewhere

The following table summarizes our results of operations:

Current report — wording carried from elsewhere

The following table summarizes our research and development expenses, together with the changes in those items in dollars and the respective percentages of change:

Current report — wording carried from elsewhere

The increase in research and development expenses for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily attributable to:

Current report — wording carried from elsewhere

a $5.2 million increase in external costs related to the development of NTLA-2001, our lead product candidate, primarily due to an increase in spend on contracted services, offset in part by a decrease in drug components;

Current report — wording carried from elsewhere

a $2.9 million decrease in external costs related to NTLA-3001, primarily related to a decrease in spend on drug components, offset in part by an increase in spend on contracted services;

Current report — wording carried from elsewhere

a $2.2 million increase in facility-related expenses primarily related to depreciation, technology expense allocated to research and development, and rent; and
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

our ability to initiate and complete our Phase 3 study for NTLA-2002 for HAE and file a biologics license application or comparable marketing application within a certain time period;

Previous report — wording carried elsewhere

a $3.2 million increase in stock-based compensation.

Previous report — wording carried elsewhere

Through March 31, 2024 we have issued 9,728,101 shares of our common stock under the 2022 Sale Agreement, as amended.