Intellia Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout 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.
Sep 30, 2024 · Filed Nov 7, 2024
NTLA$11.35+2.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-123276
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 130 previous paragraphs and 133 current paragraphs.
78 unchanged; 43 reworded; 11 added; 8 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (11)
Current report
In November 2024, we announced that the U.S. Food and Drug Administration (“FDA”) has cleared our nex-z Investigational New Drug (“IND”) application to initiate the MAGNITUDE-2 pivotal Phase 3 trial for ATTRv-PN. MAGNITUDE-2 is an international, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of nex-z in 50 adults with ATTRv-PN. Patients will be randomized 1:1 to receive a single 55 mg infusion of nex-z or placebo. Patients randomized to the placebo arm will be eligible for optional crossover to receive nex-z. The primary endpoints are the change from baseline in modified Neuropathy Impairment Score +7 (mNIS+7) at month 18 and serum TTR at day 29. The mNIS+7 scale is a validated measure specifically designed to assess and quantify polyneuropathy impairment, including muscle weakness, muscle stretch reflexes, sensory loss and autonomic impairment. We expect to initiate patient enrollment in the MAGNITUDE-2 study at ex-U.S. sites by year-end.
Current report
We will be presenting new data from the ongoing Phase 1 study in ATTR-CM patients at the 2024 American Heart Association (“AHA”) Scientific Sessions in November. The presentation will include safety, reduction in serum TTR and biomarkers of disease progression and functional capacity data in patients with ATTR-CM.
Current report
In October 2024, we announced the initiation of the HAELO Phase 3 study of NTLA-2002. HAELO is a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of NTLA-2002 in 60 adults with Type I or Type II HAE. Patients will be randomized 2:1 to receive a single 50 mg infusion of NTLA-2002 or placebo. Patients randomized to the placebo arm will be eligible for optional crossover to NTLA-2002 at week 28. The primary endpoint is the change in number of HAE attacks from week 5 through week 28. We are actively screening patients in the HAELO Phase 3 study and plan to submit a biologics license application (“BLA”) or comparable marketing application in 2026.
Current report
In October 2024, we presented positive Phase 2 data from the ongoing Phase 1/2 study, with results continuing to support the potential of NTLA-2002 to be a functional cure for HAE. Eight of 11 patients in the 50 mg arm ceased having any attacks during the 16-week primary observation period after a single dose of NTLA-2002. These eight patients continue to be attack-free through the latest follow-up and no subsequent treatment has been required. NTLA-2002 was well tolerated. The most frequent adverse events (“AEs”) were headache, fatigue and nasopharyngitis. There have been no serious AEs, and all AEs were either Grade 1 or 2. These interim data were published in The New England Journal of Medicine and presented at the 2024 American College of Allergy, Asthma & Immunology (“ACAAI”) Scientific Meeting in Boston, Massachusetts.
Current report
Other Income (Expense), Net
Current report
a $3.0 million increase in stock-based compensation.
Current report
Other Income, Net
Current report
Research and development expenses increased by $23.3 million to $349.4 million during the nine months ended September 30, 2024, as compared to $326.1 million during the nine months ended September 30, 2023.
Current report
a $9.3 million increase in stock-based compensation.
Current report
Other Income, Net
Current report
Net cash used in operating activities of $301.0 million during the nine months ended September 30, 2023 primarily consists of a net loss of $349.0 million, further reduced by changes in operating assets and liabilities of $55.6 million, including the receipt of $12.6 million in payments from our collaboration partners during that period and offset in part by non-cash charges of stock-based compensation of $99.0 million, loss on equity method investment of $17.5 million and depreciation of $6.5 million.
Removed paragraphs (8)
Previous 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.
Previous report
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 report
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 report
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 report
a $3.1 million increase in stock-based compensation.
Previous 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.
Previous report
a $6.3 million increase in stock-based compensation.
Previous report
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.
Reworded paragraphs (43)
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 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;
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 complete our global Phase 3 study, generate results supporting the potential of NTLA-2002 to be a functional cure for HAE, file a biologics license application (“BLA”) or comparable marketing application within a certain time period, 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 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.
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 September 30, 2024, we have raised an aggregate of approximately $2,758.3 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.
Previous 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.
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. Nex-z 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 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.
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 target enrollment 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
NTLA-2001 is the subject of a co-development and co-promotion (“Co/Co”) arrangement directed to our first collaboration target with Regeneron Pharmaceuticals, Inc. (“Regeneron”), ATTR (the “ATTR Co/Co”), for which we are the clinical and commercial lead party and Regeneron is the participating party. Regeneron shares in approximately 25% of worldwide development costs and commercial profits for the ATTR program. For more information regarding our collaboration with Regeneron, see Note 7, “Collaborations and Other Arrangements” of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Current wording
NTLA-2001 is the subject of a co-development and co-promotion (“Co/Co”) arrangement with Regeneron Pharmaceuticals, Inc. (“Regeneron”), ATTR (the “ATTR Co/Co”), for which we are the clinical and commercial lead party and Regeneron is the participating party. Regeneron shares in approximately 25% of worldwide development costs and commercial profits for the ATTR program. For more information regarding our collaboration with Regeneron, see Note 7, “Collaborations and Other Arrangements” of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
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, double-blind, placebo-controlled portion of the study.
Current wording
Our Phase 1/2 trial of NTLA-2002 evaluated safety, tolerability, activity, pharmacokinetics, and pharmacodynamics. 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 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 wording
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 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.
Previous wording
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 wording
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 compared to baseline. 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.
Previous wording
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 wording
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.
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 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.
Current wording
NTLA-3001 is a 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
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 wording
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 by year-end. 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.
Previous 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.
Current wording
During the three and nine months ended September 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 September 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 nine months ended September 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
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 wording
Collaboration revenue decreased by $2.9 million during the three months ended September 30, 2024, as compared to the three months ended September 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”).
Previous 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:
Current wording
The increase in research and development expenses for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily attributable to:
Previous wording
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 wording
a $6.4 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;
Previous 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;
Current wording
a $6.9 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 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 $6.8 million decrease in external costs related to the development of NTLA-3001, primarily due to a decrease in spend on drug components and contracted services;
Previous wording
a $5.2 million decrease in employee-related expenses driven by a workforce reduction in January 2024;
Current wording
a $2.7 million decrease in employee-related expenses driven by a workforce reduction in January 2024;
Previous 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;
Current wording
a $1.8 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 contracted services and internal research and development spend;
Previous wording
a $1.4 million increase in facility-related expenses primarily related to depreciation, technology expense allocated to research and development and rent; and
Current wording
a $1.0 million increase in facility-related expenses primarily related to depreciation, facilities maintenance costs, technology expense allocated to research and development, and rent; and
Previous 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.
Current wording
General and administrative expenses increased by $1.1 million during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023. This increase was primarily related to an increase in stock-based compensation of $1.3 million.
Previous wording
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 wording
The increase in other income, net of $0.2 million is primarily related to a $3.9 million change related to our equity method loss recorded in the third quarter of 2023, offset in part by $3.1 million in expense due to the change in fair value of our investment in Kyverna and a $0.6 million decrease in interest income.
Previous wording
Comparison of Six Months Ended June 30, 2024 and 2023
Current wording
Comparison of Nine Months Ended September 30, 2024 and 2023
Previous 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.
Current wording
Collaboration revenue increased by $6.8 million to $45.0 million during the nine months ended September 30, 2024, as compared to $38.2 million during the nine months ended September 30, 2023. The increase in collaboration revenue during the nine months ended September 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 $12.4 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
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 wording
The increase in research and development expenses for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily attributable to:
Previous wording
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 wording
an $11.7 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 and consulting fees, offset in part by a decrease in drug components;
Previous 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;
Current wording
a $14.7 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 $2.9 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 wording
a $9.7 million decrease in external costs related to NTLA-3001, primarily related to a decrease in spend on drug components and internal research costs, offset in part by an increase in spend on contracted services;
Previous wording
a $2.6 million decrease in employee-related expenses, primarily driven by a workforce reduction in January 2024;
Current wording
a $5.3 million decrease in employee-related expenses, primarily driven by a workforce reduction in January 2024;
Previous wording
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 wording
a $0.9 million increase in research materials and contracted services primarily driven by an increase in drug component spend, offset in part by a decrease in internal R&D expenses;
Previous wording
a $2.2 million increase in facility-related expenses primarily related to depreciation, technology expense allocated to research and development, and rent; and
Current wording
a $3.3 million increase in facility-related expenses primarily related to depreciation, facility maintenance costs, technology expense allocated to research and development, and rent; and
Previous wording
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.
Current wording
General and administrative expenses increased by $5.9 million to $93.4 million during the nine months ended September 30, 2024, compared to $87.5 million during the nine months ended September 30, 2023. This increase was primarily related to an increase in stock-based compensation of $6.3 million.
Previous 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.
Current wording
The decrease in other income, net of $18.7 million is primarily related to $29.5 million in expense due to the change in fair value of our investments in Kyverna and AvenCell and a $0.2 million decrease in interest income, offset in part by a $10.9 million change related to our equity method loss recorded in the nine months ended September 30, 2023.
Previous 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.
Current wording
Since our inception through September 30, 2024, we have raised an aggregate of $2,758.3 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.
Previous wording
As of June 30, 2024, we had $939.9 million in cash, cash equivalents and marketable securities.
Current wording
As of September 30, 2024, we had $944.7 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. Through June 30, 2024 we have issued 11,320,924 shares of our 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 September 30, 2024 we have issued 14,522,533 shares of our common stock under the 2022 Sale Agreement, as amended.
Previous 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.
Current wording
During the nine months ended September 30, 2024, we issued 7,004,370 shares of our common stock, in a series of sales, at an average price of $25.68 per share, in accordance with the 2022 Sale Agreement, as amended, for aggregate net proceeds of $174.9 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 June 30, 2024, $331.7 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement, as amended.
Current wording
As of September 30, 2024, $249.1 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement, as amended.
Previous 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.
Current wording
Net cash used in operating activities of $263.7 million during the nine months ended September 30, 2024 primarily consists of a net loss of $390.1 million, further reduced by the non-cash recognition of $21.0 million of previously eliminated intra-entity profit recorded within “collaboration revenue” and accretion of investment discounts and premiums of $14.2 million. These decreases are offset in part by stock-based compensation of $114.7 million, $29.5 million in net adjustments to the fair value of our investments in Kyverna and AvenCell, net changes in operating assets and liabilities of $9.8 million and depreciation of $7.7 million.
Previous 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.
Current wording
During the nine months ended September 30, 2024, we used $26.0 million of net cash in investing activities. The decrease in the nine months ended September 30, 2024 is primarily due to $21.2 million in marketable securities purchased (net of maturities) and $4.8 million in cash for the purchase of property and equipment.
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Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Research and development expenses increased by $9.7 million during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.