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Athira Pharma Inc

For the period ended Jun 30, 2024. Filed Aug 1, 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 1, 2024

LONA$4.42+1.7%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 2024-05-15.

0000950170-24-060482

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

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-01.

0000950170-24-089304

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 161 previous paragraphs and 164 current paragraphs.

135 unchanged; 20 reworded; 3 added; 5 removed; 1 previous and 6 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 (3)

Current report

anticipated milestone timelines, such as the timing of data releases, and our ability to meet such timelines;

Current report

Research and development expenses increased by $0.5 million, from $42.9 million for the six months ended June 30, 2023 to $43.4 million for the six months ended June 30, 2024. The increase was driven primarily by an increase in ATH-1105 program costs of $3.3 million associated with the Phase 1 clinical trial, which commenced in the second quarter of 2024. This increase was partially offset by decreases in fosgonimeton program costs of $1.4 million and preclinical and other direct costs of $1.2 million, and to a lesser extent, a decrease in personnel-related expenses. The decrease in fosgonimeton program costs of $1.4 million was driven by a decrease in contract manufacturing costs of $2.4 million, and decreases in contract research organization and clinical site visit costs for our Phase 2/3 LIFT-AD clinical trial and the corresponding open-label extension for our Phase 2 ACT-AD and Phase 2/3 LIFT-AD clinical trials of $1.8 million, partially offset by an increase in program consulting costs of $3.0 million.
Removed paragraphs (5)
Reworded paragraphs (20)

Previous wording

Our lead drug candidate, fosgonimeton, is a potentially first-in-class, small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurological disorders. The effects of fosgonimeton in its primary target indication, Alzheimer's disease, or AD, are currently being evaluated in multiple clinical trials.

Current wording

Our lead drug candidate, fosgonimeton, is a potentially first-in-class, small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases. The effects of fosgonimeton in its primary target indication, Alzheimer's disease, or AD, were previously evaluated in our ACT-AD clinical trial and are currently being evaluated in our LIFT-AD clinical trial.

Previous wording

ACT-AD 1 was a randomized, double-blind, placebo-controlled, parallel-group 26-week exploratory Phase 2 clinical trial in mild-to-moderate AD, with event-related potential, or ERP, P300 latency as the primary endpoint. Initiated in November 2020, the trial was designed to better characterize the overall effects of fosgonimeton on working memory processing speed and cognitive measures and inform the Phase 2/3 LIFT-AD trial. Topline results for this exploratory Phase 2 ACT-AD trial were announced in June 2022, and the primary and all secondary endpoints were not met by protocoled analysis. However, a post hoc analysis of results from ACT-AD in a pre-specified subgroup suggested positive effects on measures of cognition, function and neurodegeneration in participants taking fosgonimeton alone without background acetylcholinesterase inhibitors, or AChEIs. Additionally, data from post hoc analysis of plasma biomarkers from participants on fosgonimeton without background AChEIs showed descriptive improvements (non-statistically significant) in markers of neuroinflammation and AD-specific protein pathologies when compared to placebo. Fosgonimeton was generally well tolerated in the ACT-AD study, with a favorable safety profile, and there were no treatment related serious adverse events or deaths observed.

Current wording

ACT-AD 1 was a randomized, double-blind, placebo-controlled, parallel-group 26-week exploratory Phase 2 clinical trial with fosgonimeton in mild-to-moderate AD, with event-related potential, or ERP, P300 latency as the primary endpoint. Initiated in November 2020, the trial was designed to better characterize the overall effects of fosgonimeton on working memory processing speed and cognitive measures and inform the Phase 2/3 LIFT-AD trial. Topline results for this exploratory Phase 2 ACT-AD trial were announced in June 2022, and the primary and all secondary endpoints were not met by protocoled analysis. However, a post hoc analysis of results from ACT-AD in a pre-specified subgroup suggested positive effects on measures of cognition, function and neurodegeneration in participants taking fosgonimeton alone without background acetylcholinesterase inhibitors, or AChEIs. Additionally, data from post hoc analysis of plasma biomarkers from participants on fosgonimeton without background AChEIs showed descriptive improvements (non-statistically significant) in markers of neuroinflammation and AD-specific protein pathologies when compared to placebo. Fosgonimeton was generally well tolerated in the ACT-AD study, with a favorable safety profile, and there were no treatment-related serious adverse events or deaths observed. While we have completed the ACT-AD trial, its open-label extension is ongoing.

Previous wording

LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group 26-week Phase 2/3 clinical trial with fosgonimeton for the treatment of mild-to-moderate AD. The primary endpoint for the Phase 2/3 LIFT-AD trial will be measured by the Global Statistical Test, or GST, which combines the scores from the co-key secondary endpoints of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale, or ADAS-Cog11) and function (Alzheimer’s Disease Cooperative Study-Activities of Daily Living, or ADCS-ADL23), and which we believe is a comprehensive measure of overall disease burden. Guided by the results from the completed exploratory ACT-AD Phase 2 trial, in September 2022, we proactively amended LIFT-AD to focus on participants not on background AChEIs, and in May 2023, we further amended LIFT-AD to focus on 40 mg dosing, which we have selected for further development and as the potential dose for regulatory approval of fosgonimeton in this indication. In January 2024 we announced the completion of enrollment with a total of approximately 315 patients randomized in the primary analysis population. We expect to report topline LIFT-AD results in the second half of 2024.

Current wording

LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group 26-week Phase 2/3 clinical trial with fosgonimeton in mild-to-moderate AD. The primary endpoint for the Phase 2/3 LIFT-AD trial is the Global Statistical Test, or GST, which combines the scores from the co-key secondary endpoints of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale, or ADAS-Cog11) and function (Alzheimer’s Disease Cooperative Study-Activities of Daily Living, or ADCS-ADL23), and which we believe is a comprehensive measure of overall disease burden. Guided by the results from the completed exploratory ACT-AD Phase 2 trial, in September 2022, we proactively amended LIFT-AD to focus on participants not on background AChEIs, and in May 2023, we further amended LIFT-AD to focus on 40 mg dosing, which we have selected for further development and as the potential dose for regulatory approval of fosgonimeton in this indication. In January 2024, we announced the completion of enrollment with a total of approximately 315 patients randomized in the primary analysis population. In July 2024, we announced the completion of dosing for the last patient in LIFT-AD and that we are targeting to report topline LIFT-AD results by the end of the third quarter of 2024.

Previous wording

To date, we have funded our operations primarily through proceeds from the sale of equity securities, including proceeds from the sale and issuance of common stock in our IPO and in a subsequent follow-on public offering, the sale and issuance of convertible preferred stock, common stock warrants, and convertible notes, and to a lesser extent from grant income and stock option exercises. From inception to March 31, 2024, we have raised aggregate net cash proceeds of approximately $407.4 million primarily from the issuance of our common stock (excluding option exercises), convertible preferred stock, common stock warrants, and convertible notes. We have incurred significant operating losses to date. Our net losses were $26.3 million and $27.8 million for the three months ended March 31, 2024 and 2023, respectively. As of

Current wording

To date, we have funded our operations primarily through proceeds from the sale of equity securities, including proceeds from the sale and issuance of common stock in our IPO and in a subsequent follow-on public offering, the sale and issuance of convertible preferred stock, common stock warrants, and convertible notes, and to a lesser extent from grant income and stock option exercises. From inception to June 30, 2024, we have raised aggregate net cash proceeds of approximately $407.4 million primarily from the issuance of our common stock (excluding option exercises), convertible preferred stock, common stock warrants, and convertible notes. We have incurred significant operating losses to date. Our net losses were $53.2 million and $57.4 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $362.4 million and cash, cash equivalents and investments of $91.8 million.

Previous wording

We will require substantial additional funding to support our continuing operations and further the development of our drug candidates. Until such time as we can generate significant revenue from drug product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaboration, licensing or similar arrangements, for the foreseeable future. Adequate funding may not be available when needed or on terms acceptable to us, or at all. If we are unable to raise additional capital as needed, we may have to significantly delay, scale back or discontinue development of our drug candidates. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our drug product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to drug candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities. Based upon our current operating plan, we estimate that our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the date of this report.

Current wording

We will require substantial additional funding to support our continuing operations and further the development of our drug candidates. Until such time as we can generate significant revenue from drug product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaboration, licensing or similar arrangements, for the foreseeable future. Adequate funding may not be available when needed or on terms acceptable to us, or at all. If we are unable to raise additional capital as needed, we may have to significantly delay, scale back or discontinue development of our drug candidates. Our ability to raise additional funds may be negatively impacted by potential adverse global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our drug product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to drug candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities. Based upon our current operating plan, we estimate that our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the date of this report.

Previous wording

Research and development expenses decreased by $0.1 million, from $21.3 million for the three months ended March 31, 2023 to $21.2 million for the three months ended March 31, 2024. The decrease was driven primarily by a decrease in ATH-1020 program expenses of $0.1 million, and to lesser extents, decreases in personnel-related expenses, fosgonimeton program costs, and preclinical and other direct costs, partially offset by an increase in other indirect costs of $0.1 million. The overall decrease in fosgonimeton program costs of less than $0.1 million was driven by decreases in manufacturing costs of $2.0 million and contract research organization expenses of $1.0 million, offset by increases in program consulting costs of $2.0 million, and clinical site visit costs for our Phase 2/3 LIFT-AD clinical trial and the corresponding open-label extension for our Phase 2 ACT-AD and Phase 2/3 LIFT-AD clinical trials of $1.0 million.

Current wording

Research and development expenses increased by $0.6 million, from $21.6 million for the three months ended June 30, 2023 to $22.2 million for the three months ended June 30, 2024. The increase was driven primarily by an increase in ATH-1105 program costs of $3.3 million associated with the Phase 1 clinical trial, which commenced in the second quarter of 2024. This increase was partially offset by decreases in fosgonimeton program costs of $1.4 million and preclinical and other direct costs of $1.2 million, and to a lesser extent, a decrease in personnel-related expenses. The decrease in fosgonimeton program costs of $1.4 million was driven by decreases in contract research organization and clinical site visit costs for our Phase 2/3 LIFT-AD clinical trial and the corresponding open-label extension for our Phase 2 ACT-AD and Phase 2/3 LIFT-AD clinical trials of $2.0 million and a decrease in contract manufacturing costs of $0.4 million, partially offset by an increase in program consulting costs of $1.2 million.

Previous wording

Other income, net, decreased by $0.4 million, from $1.8 million for the three months ended March 31, 2023 to $1.4 million for the three months ended March 31, 2024 due to lower income from accretion of discounts on debt securities purchased below par value and held to maturity, and lower interest income earned on our available-for-sale securities. These decreases resulted from lower balances of available-for-sale securities held during the three months ended March 31, 2024 compared to the three months ended March 31, 2023.

Current wording

Other income, net, decreased by $0.8 million, from $2.0 million for the three months ended June 30, 2023 to $1.2 million for the three months ended June 30, 2024 due to lower income from accretion of discounts on debt securities purchased below par value and held to maturity and lower interest income earned on our available-for-sale securities. These decreases resulted from lower balances of available-for-sale securities held during the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

Previous wording

General and administrative expenses decreased by $2.0 million, from $8.5 million for the three months ended March 31, 2023 to $6.5 million for the three months ended March 31, 2024. The decrease was primarily due to a decrease in legal costs of $0.6 million, a decrease in business development expenses of $0.5 million, a decrease in professional services expenses of $0.4 million, a decrease in personnel-related costs of $0.3 million, and a decrease in other general corporate expenses of $0.2 million.

Current wording

General and administrative expenses decreased by $6.2 million, from $18.5 million for the six months ended June 30, 2023 to $12.3 million for the six months ended June 30, 2024. The decrease was primarily due to a decrease in legal costs of $2.4 million, a decrease in business development expenses of $1.8 million, a decrease in professional services expenses of $1.1 million, a decrease in other general corporate expenses of $0.6 million, and a decrease in personnel-related costs of $0.4 million.

Previous wording

Grant income recognized during the three months ended March 31, 2023 of $0.2 million represented the remaining balance of the total $15.2 million approved grant amount available at the beginning of the quarter. There was no grant income recognized during the three months ended March 31, 2024.

Current wording

Grant income recognized during the six months ended June 30, 2023 of $0.2 million represented the remaining balance of the total $15.2 million approved grant amount available at the beginning of the quarter. There was no grant income recognized during the six months ended June 30, 2024.

Previous wording

Since our inception, we have funded our operations primarily with proceeds from the sale and issuance of common stock, convertible preferred stock, common stock warrants, and convertible notes, and to a lesser extent from grant income and stock option exercises. From our inception through March 31, 2024, we have raised aggregate net cash proceeds of $407.4 million primarily from the issuance of our common stock (excluding option exercises), convertible preferred stock, common stock warrants, and convertible notes.

Current wording

Since our inception, we have funded our operations primarily with proceeds from the sale and issuance of common stock, convertible preferred stock, common stock warrants, and convertible notes, and to a lesser extent from grant income and stock option exercises. From our inception through June 30, 2024, we have raised aggregate net cash proceeds of

Previous wording

As of March 31, 2024, we had $122.1 million in cash, cash equivalents and investments and have not generated positive cash flows from operations. Since our inception, we have devoted substantially all of our resources to our research and development efforts such as small molecule compound discovery, nonclinical studies and clinical trials, as well as manufacturing activities, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Current wording

As of June 30, 2024, we had $91.8 million in cash, cash equivalents and investments and have not generated positive cash flows from operations. Since our inception, we have devoted substantially all of our resources to our research and development efforts such as small molecule compound discovery, nonclinical studies and clinical trials, as well as manufacturing activities, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Previous wording

Our material cash requirements include our operating leases for laboratory and office facilities. As of March 31, 2024, we had lease payment obligations of $1.7 million, with $0.5 million payable within 12 months. For additional information regarding our lease commitments, see Note 7 to our unaudited condensed consolidated financial statements included elsewhere in this report. We are contingently committed to $0.9 million of potential future milestone payments, in addition to sales-based payments and royalties, under our license agreement with WSU. Payments generally are due and payable only upon achievement of certain developmental, regulatory, and sales milestones for which the specific timing cannot be predicted. Refer to Note 6 to our unaudited condensed consolidated financial statements for additional information regarding the WSU license agreement. Additionally, we have purchase obligations and open purchase orders that support normal operations and are primarily due in the next 12 months. These purchase obligations and open purchase orders are generally cancellable in full or in part through the contractual provisions. We also anticipate that our research and development expenses and our general and administrative expenses will increase over at least the near-term as we advance our clinical development and our drug candidates through clinical trials, adjust our headcount to support our operations, and incur legal and other professional expenses related to our ongoing legal proceedings. We cannot predict with certainty the amount and timing of these increased expenses.

Current wording

Our material cash requirements include our operating leases for laboratory and office facilities. As of June 30, 2024, we had lease payment obligations of $1.6 million, with $0.5 million payable within 12 months. For additional information regarding our lease commitments, see Note 7 to our unaudited condensed consolidated financial statements included elsewhere in this report. We are contingently committed to $0.9 million of potential future milestone payments, in addition to sales-based payments and royalties, under our license agreement with WSU. Payments generally are due and payable only upon achievement of certain developmental, regulatory, and sales milestones for which the specific timing cannot be predicted. Refer to Note 6 to our unaudited condensed consolidated financial statements for additional information regarding the WSU license agreement. Additionally, we have purchase obligations and open purchase orders that support normal operations and are primarily due in the next 12 months. These purchase obligations and open purchase orders are generally cancellable in full or in part through the contractual provisions. We also anticipate that our research and development expenses and our general and administrative expenses will increase over at least the near-term as we advance our clinical development and our drug candidates through clinical trials, adjust our headcount to support our operations, and incur legal and other professional expenses related to our ongoing legal proceedings. We cannot predict with certainty the amount and timing of these increased expenses.

Previous wording

Based upon our current operating plan, we estimate that our $122.1 million of cash, cash equivalents and investments at March 31, 2024 will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the date of this report. We will need to raise substantial additional capital to fund the development of our drug candidates. Until such time as we can generate significant revenue from drug product sales, we expect to finance our operations through the sale of equity securities, debt financings, or other capital, which could include income from collaboration, licensing or similar arrangements with third parties, or receiving research contributions, or grants. For example, in January 2023, we entered into a sales agreement with Cantor Fitzgerald and BTIG to sell shares of our common stock having aggregate sales proceeds of up to $75.0 million, from time to time, through an ATM equity offering program under which Cantor Fitzgerald and BTIG are acting as sales agents. As of the date of this report, we have not sold any securities pursuant to this ATM offering. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us or may reduce the value of our common stock. Adequate funding may not be available when needed or on terms acceptable to us, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our drug product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to drug candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flows from operating activities.

Current wording

Based upon our current operating plan, we estimate that our $91.8 million of cash, cash equivalents and investments at June 30, 2024 will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the date of this report. We will need to raise substantial additional capital to fund the development of our drug candidates. Until such time as we can generate significant revenue from drug product sales, we expect to finance our operations through the sale of equity securities, debt financings, or other capital, which could include income from collaboration, licensing or similar arrangements with third parties, or receiving research contributions, or grants. For example, in January 2023, we entered into a sales agreement with Cantor Fitzgerald and BTIG to sell shares of our common stock having aggregate sales proceeds of up to $75.0 million, from time to time, through an ATM equity offering program under which Cantor Fitzgerald and BTIG are acting as sales agents. As of the date of this report, we have not sold any securities pursuant to this ATM offering. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us or may reduce the value of our common stock. Adequate funding may not be available when needed or on terms acceptable to us, or at all. Our ability to raise additional funds may be negatively impacted by potential adverse global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our drug product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to drug candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flows from operating activities.

Previous wording

the number of trials required for regulatory approval, in particular with respect to fosgonimeton for the treatment of mild-to-moderate AD;

Current wording

the number of trials required for regulatory approval, in particular with respect to fosgonimeton for the treatment of mild-to-moderate AD (including any potential confirmatory or Phase 3 registrational trials);

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $25.8 million. This consisted primarily of a net loss of $26.3 million, partially offset by non-cash charges of $2.7 million, and an increase in our net operating assets of $2.2 million. The non-cash charges primarily consisted of stock-based compensation expense, depreciation expense, and amortization of premiums and accretion of discounts on available-for-sale securities. The increase in our net operating assets was primarily due to a decrease in accounts payable and accrued expenses, partially offset by a decrease in prepaid expenses and other assets.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $48.1 million. This consisted primarily of a net loss of $53.2 million, partially offset by non-cash charges of $6.1 million, and an increase in our net operating assets of $1.0 million. The non-cash charges primarily consisted of stock-based compensation expense, depreciation expense, and amortization of premiums and accretion of discounts on available-for-sale securities. The increase in our net operating assets was primarily due to a decrease in accounts payable and accrued expenses, partially offset by a decrease in prepaid expenses and other assets.

Previous wording

During the three months ended March 31, 2023, net cash used in operating activities was $26.2 million. This consisted primarily of a net loss of $27.8 million, partially offset by non-cash charges of $2.7 million, and an increase in our net operating assets of $1.1 million. The non-cash charges primarily consisted of stock-based compensation expense, depreciation expense, and amortization of premiums and accretion of discounts on available-for-sale securities. The increase in our net operating assets was primarily due to an increase in prepaid expenses and other current assets and a decrease in accounts payable, partially offset by a decrease in unbilled grant receivable, and an increase in accrued expenses.

Current wording

During the six months ended June 30, 2023, net cash used in operating activities was $50.5 million. This consisted primarily of a net loss of $57.4 million, partially offset by non-cash charges of $5.7 million and a decrease in our net operating assets of $1.2 million. The non-cash charges primarily consisted of stock-based compensation expense, amortization of premiums and accretion of discounts on available-for-sale securities, and depreciation expense. The decrease in our net operating assets was primarily due to a decrease in unbilled grant receivable and an increase in accrued expenses, partially offset by a decrease in accounts payable and an increase in prepaid expenses and other current assets.

Previous wording

During the three months ended March 31, 2024, net cash provided by investing was $13.0 million. This consisted of maturities of available-for-sale securities of $18.9 million, partially offset by purchases of available-for-sale securities of $5.9 million.

Current wording

During the six months ended June 30, 2024, net cash provided by investing was $39.6 million. This consisted of maturities of available-for-sale securities of $51.0 million, partially offset by purchases of available-for-sale securities of $11.3 million.

Previous wording

During the three months ended March 31, 2023, net cash provided by investing was $35.5 million. This consisted of maturities of available-for-sale securities of $45.5 million, partially offset by purchases of available-for-sale securities of $9.7 million and property and equipment of $0.2 million.

Current wording

During the six months ended June 30, 2023, net cash provided by investing was $68.0 million. This consisted of maturities of available-for-sale securities of $93.2 million, partially offset by purchases of available-for-sale securities of $24.9 million and property and equipment of $0.3 million.

Previous wording

During the three months ended March 31, 2023, net cash provided by financing activities was $0.1 million, consisting of proceeds received from exercises of stock options.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities was $0.1 million, consisting of proceeds received from the issuance of common stock under our employee stock purchase plan.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies, Significant Judgments and Use of Estimates” in our Annual Report on Form 10-K filed with the SEC on February 22, 2024 and Note 2 to our unaudited condensed consolidated financial statements included in “Part I, Item 1—Financial Statements (Unaudited)” of this report. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:

Current wording

During the six months ended June 30, 2024, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies, Significant Judgments and Use of Estimates” in our Annual Report on Form 10-K filed with the SEC on February 22, 2024 and Note 2 to our unaudited condensed consolidated financial statements included in “Part I, Item 1—Financial Statements (Unaudited)” of this report. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:
Rearranged current paragraphs (6)

Current report — wording carried from elsewhere

General and administrative expenses decreased by $4.1 million, from $10.0 million for the three months ended June 30, 2023 to $5.9 million for the three months ended June 30, 2024. The decrease was primarily due to a decrease in legal costs of $1.8 million, a decrease in business development expenses of $1.3 million, a decrease in professional services expenses of $0.6 million, and a decrease in other general corporate expenses of $0.4 million.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the periods presented:

Current report — wording carried from elsewhere

The following table shows the primary components of our research and development expenses for the periods presented:

Current report — wording carried from elsewhere

Other income, net, decreased by $1.3 million, from $3.8 million for the six months ended June 30, 2023 to $2.5 million for the six months ended June 30, 2024 due to lower income from accretion of discounts on debt securities purchased below par value and held to maturity and lower interest income earned on our available-for-sale securities. These decreases resulted from lower balances of available-for-sale securities held during the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

Current report — wording carried from elsewhere

$407.4 million primarily from the issuance of our common stock (excluding option exercises), convertible preferred stock, common stock warrants, and convertible notes.

Current report — wording carried from elsewhere

During the six months ended June 30, 2023, net cash provided by financing activities was $0.3 million, consisting of proceeds received from exercises of stock options and the issuance of common stock under our employee stock purchase plan.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

March 31, 2024, we had an accumulated deficit of $335.5 million and cash, cash equivalents and investments of $122.1 million.