ATOSSA THERAPEUTICS INC
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
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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 12, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-12.
0000950170-24-095102
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0000950170-24-124668
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 81 previous paragraphs and 84 current paragraphs.
56 unchanged; 25 reworded; 3 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 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
our ability to successfully deploy artificial intelligence (“AI”) in our or our collaborators’ product candidates;
Current report
In November 2024, a preliminary data analysis from this study showed positive topline data in premenopausal women with MBD. The preliminary report showed low doses of (Z)-endoxifen significantly reduced MBD and was generally well tolerated. The prevention trial included healthy women, randomized to daily placebo, 1 mg and 2 mg of (Z)-endoxifen. There were 80 women in each study arm (240 in total) and the study lasted six months. Measurements at six months or early terminations were compared to baseline density. The study demonstrated MBD reductions of 19.3 percent and 26.5 percent in the 1 mg and 2 mg treatment arms, respectively, compared to placebo, over a six-month period. No changes in hematological safety tests or vital signs were noted during the trial period. The number of women that discontinued the study because of side effects related to the drug were 4, 5 and 11 in the placebo, 1 mg and 2 mg arms, respectively. Vasomotor symptoms were not reported as a reason for discontinuation.
Current report
A preliminary data analysis from this study, which included 20 women with ER+/HER2- breast cancer who received 10mg of (Z)-endoxifen orally once daily for six cycles (each cycle = 28 days), showed that (Z)-endoxifen met the primary endpoint with 95 percent (19/20 patients) receiving > 75 % of planned treatment. The data also demonstrated (Z)-endoxifen activity in rapidly reducing key biomarkers such as Ki-67 by 69 percent from baseline and a 30.4 percent reduction in functional tumor volume (FTV) from baseline after 3 weeks of treatment. FTV is a quantitative measurement of tumor burden that can be used to assess treatment response for breast cancer. (Z)-endoxifen was well tolerated in this study with the most common side effects being mild, including hot flashes, insomnia, and fatigue. No dose reductions or discontinuations due to treatment related adverse events were observed in this study. Surgical Ki-67 values and 24-week imaging will be analyzed in the future.
Reworded paragraphs (25)
Previous wording
These and other forward-looking statements made in this report are presented as of the date of the filing of this report. We have discussed certain important factors, risks and uncertainties in the cautionary statements included in this report, particularly in the sections titled “ITEM 1A. RISK FACTORS,” “ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS,” and elsewhere in this report, that we believe could cause our actual results, events or outcomes, or the timing of these results or outcomes, to differ materially from our anticipated results, events or outcomes, or the anticipated timing of these results or outcomes. Our forward-looking statements do not reflect the potential impact of any new information, future events or circumstances that may affect our business after the date of this report. Except as required by law, we expressly disclaim any intent to update any forward-looking statements after the date on which the statement is made, whether as a result of new information, future events or future circumstances or otherwise.
Current wording
These and other forward-looking statements made in this report are presented as of the date of the filing of this report. We have discussed certain important factors, risks and uncertainties in the cautionary statements included in this report, particularly in the sections titled “ITEM 1A. RISK FACTORS,” “ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS,” and elsewhere in this report, that we believe could cause our actual results, events or outcomes, or the timing of these results or outcomes, to differ materially from our anticipated results, events or outcomes, or the anticipated timing of these results or outcomes, including any variation between interim or preliminary and final clinical results or analysis. Our forward-looking statements do not reflect the potential impact of any new information, future events or circumstances that may affect our business after the date of this report. Except as required by law, we expressly disclaim any intent to update any forward-looking statements after the date on which the statement is made, whether as a result of new information, future events or future circumstances or otherwise.
Previous wording
We have been granted three U.S. patents and one international patent covering our proprietary (Z)-endoxifen, and we have numerous applications pending in the U.S. and in other major countries. We have patent protection covering our proprietary (Z)-endoxifen through November 17, 2038.
Current wording
We have been granted multiple U.S. and international patents covering our proprietary (Z)-endoxifen, and we have numerous applications pending in the U.S. and in other major countries. We have patent protection covering our proprietary (Z)-endoxifen through at least November 17, 2038.
Previous wording
(Z)-endoxifen for Women with Mammographic Breast Density. Mammographic breast density (MBD) is an emerging public health issue affecting over 10 million women in the U.S. alone. Dense breast tissue makes mammography less effective. When women with MBD are diagnosed with breast cancer, it is often later stage, which makes treatment outcomes suboptimal. Studies conducted by others have also shown that MBD increases the risk of developing breast cancer and that reducing MBD may reduce the incidence of breast cancer.
Current wording
(Z)-endoxifen for Women with Mammographic Breast Density. Mammographic breast density (MBD) is an emerging public health issue affecting over 20 million women in the U.S. alone. Dense breast tissue makes mammography less effective. When women with MBD are diagnosed with breast cancer, it is often later stage, which makes treatment outcomes suboptimal. Studies conducted by others have also shown that MBD increases the risk of developing breast cancer and that reducing MBD may reduce the incidence of breast cancer.
Previous wording
In December 2021, we commenced a Phase 2 study of our proprietary oral (Z)-endoxifen. The study, known as the Karisma-(Z)-endoxifen study, is a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of our proprietary oral (Z)-endoxifen in healthy premenopausal women with measurable breast density. The primary objective of the study is to determine the dose-response relationship of daily (Z)-endoxifen on breast density reduction. Secondary endpoints will assess safety and tolerability. The study also includes an exploratory endpoint to assess durability of the breast density changes. The study is being conducted in Stockholm, Sweden and includes approximately 240 participants, at full enrollment, who receive daily doses of oral (Z)-endoxifen or placebo for six months after they enroll. The study fully enrolled in November 2023 and we expect primary data in the second half of 2024.
Current wording
In December 2021, we commenced a Phase 2 study of our proprietary oral (Z)-endoxifen. The study, known as the Karisma-(Z)-endoxifen study, is a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of our proprietary oral (Z)-endoxifen in healthy premenopausal women with measurable breast density. The primary objective of the study is to determine the dose-response relationship of daily (Z)-endoxifen on breast density reduction. Secondary endpoints will assess safety and tolerability. The study also includes an exploratory endpoint to assess durability of the breast density changes. The study is being conducted in Stockholm, Sweden and includes approximately 240 participants, at full enrollment, who receive daily doses of oral (Z)-endoxifen or placebo for six months after they enroll. The study fully enrolled in November 2023.
Previous wording
(Z)-endoxifen for Ductal Carcinoma In Situ. Ductal carcinoma in situ (DCIS) is a pre-cancerous lesion of the breast. It rarely produces symptoms, or a breast lump one can feel, typically being detected through screening mammography. In some cases, DCIS may become invasive and spread to other tissues, but there is no way of determining which lesions will remain stable without treatment, and which will go on to become invasive. This uncertainty can result in aggressive and unnecessary treatment approaches that can have harmful side effects without significant benefit.
Current wording
(Z)-endoxifen for Ductal Carcinoma In Situ. Ductal carcinoma in situ (DCIS) is a pre-cancerous lesion of the breast. Each year, approximately 60,000 new cases of DCIS are diagnosed in the United States. It rarely produces symptoms, or a breast lump one can feel, typically being detected through screening mammography. In some cases, DCIS may become invasive and spread to other tissues, but there is no way of determining which lesions will remain stable without treatment, and which will go on to become invasive. This uncertainty can result in aggressive and unnecessary treatment approaches that can have harmful side effects without significant benefit.
Previous wording
In October 2023, Quantum Leap Healthcare Collaborative (QLHC) announced the initiation of the Phase 2 DCIS: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (RECAST) study. (Z)-endoxifen is being investigated as part of this platform trial, which offers women with DCIS six months of neoadjuvant treatment with the intent of determining their suitability for long-term active surveillance without surgery. Approximately 100 patients will be treated with (Z)-endoxifen. The study incorporates both a neoadjuvant therapy phase, with patients at high risk for progression to invasive disease proceeding to surgery, followed by an extended surveillance phase for low-risk patients.
Current wording
In October 2023, Quantum Leap Healthcare Collaborative (QLHC) announced the initiation of the Phase 2 DCIS: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (RECAST) study. (Z)-endoxifen is being investigated as part of this platform trial, which offers women with DCIS six months of neoadjuvant treatment with the intent of determining their suitability for long-term active surveillance without surgery. Approximately 100 patients will be treated with (Z)-endoxifen. The study incorporates both a neoadjuvant therapy phase, with patients at high risk for progression to invasive disease proceeding to surgery, followed by an extended surveillance phase for low-risk patients. Enrollment in this study is ongoing.
Previous wording
(Z)-endoxifen for Neoadjuvant Treatment of Breast Cancer. We are also developing (Z)-endoxifen to treat estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer in the neoadjuvant setting, which is the administration of a therapy before the main treatment, which is usually surgery. Although there are neoadjuvant treatments for breast cancers that are not ER+, there are few neoadjuvant treatments for ER+ breast cancer which comprises about 78% of all breast cancers.
Current wording
(Z)-endoxifen for Neoadjuvant Treatment of Breast Cancer. We are also developing (Z)-endoxifen to treat estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer in the neoadjuvant setting, which is the administration of a therapy before the main treatment, which is usually surgery. Although there are neoadjuvant treatments for breast cancers that are not ER+, there are few neoadjuvant treatments for ER+ breast cancer which comprises approximately 240,000 new cases or 78% of all breast cancers.
Previous wording
The study is expected to enroll approximately 180 patients at up to 25 sites. EVANGELINE is a two-part study consisting of a PK Run-in Cohort and a Treatment Cohort. The primary objective of the Treatment Cohort is to evaluate the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen compared to treatment with current standard of care, exemestane + goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, also called ovarian function suppression.
Current wording
The study is expected to enroll approximately 180 patients at up to 25 sites. EVANGELINE is a two-part study consisting of a PK Run-in Cohort and a Treatment Cohort. The PK Run-in Cohort was fully enrolled in July 2024. The primary objective of the Treatment Cohort is to evaluate the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen compared to treatment with current standard of care, exemestane + goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, also called ovarian function suppression. Initiation of the Treatment Cohort is expected in the fourth quarter of 2024.
Previous wording
In March 2023, a second Phase 2 trial investigating oral (Z)-endoxifen as a neoadjuvant treatment for women diagnosed with locally advanced ER+ breast cancer was initiated. This trial is a study arm in the ongoing I‑SPY 2 clinical trial. The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the U.S., QLHC, the U.S. FDA, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients are being treated with (Z)-endoxifen for up to 24 weeks prior to surgery. Enrollment was completed in January 2024 for the Phase 2 I-SPY clinical trial.
Current wording
In March 2023, a second Phase 2 trial investigating oral (Z)-endoxifen as a neoadjuvant treatment for women diagnosed with locally advanced ER+ breast cancer was initiated. This trial is a study arm in the ongoing I‑SPY 2 Endocrine Optimization Pilot (I-SPY 2 EOP). The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the U.S., QLHC, the U.S. FDA, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. 20 patients were treated with (Z)-endoxifen for up to 24 weeks prior to surgery. Enrollment was completed in January 2024 for the Phase 2 I-SPY clinical trial.
Previous wording
On April 15, 2024, we announced that a new study was initiated to evaluate our proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. This trial is a study arm of the I-SPY 2 Endocrine Optimization Pilot (I-SPY 2 EOP). The I-SPY 2 EOP trial is a collaborative effort among academic investigators from major cancer research centers across the U.S., QLHC, the FDA, and the FNIH. On June 28, 2024, we announced that the study has been expanded to include 80 women with newly diagnosed ER+ / HER2- invasive breast cancer. Participants are expected to receive 80mg (Z)-endoxifen once daily in combination with 150mg abemaciclib twice daily for a total of 24 weeks prior to surgery.
Current wording
On April 15, 2024, we announced that a new study was initiated to evaluate our proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. This trial is a study arm of the I-SPY 2 EOP. On June 28, 2024, we announced that the study has been expanded to include 80 women with newly diagnosed ER+ / HER2- invasive breast cancer. Participants are expected to receive 80mg (Z)-endoxifen once daily in combination with 150mg abemaciclib twice daily for a total of 24 weeks prior to surgery. Enrollment in this study is ongoing.
Previous wording
There have been no material changes to our critical accounting estimates during the six months ended June 30, 2024 from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on April 1, 2024.
Current wording
There have been no material changes to our critical accounting estimates during the nine months ended September 30, 2024 from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on April 1, 2024.
Previous wording
Comparison of Three and Six Months Ended June 30, 2024 and 2023
Current wording
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Previous wording
Revenue and Cost of Revenue. For the three and six months ended June 30, 2024 and 2023, we had no source of revenue and no associated cost of revenue.
Current wording
Revenue and Cost of Revenue. For the three and nine months ended September 30, 2024 and 2023, we had no source of revenue and no associated cost of revenue.
Previous wording
Operating Expenses. Total operating expenses were $7.1 million and $14.1 million for the three and six months ended June 30, 2024, respectively, which was a decrease of $0.7 million and $0.8 million, respectively, from total operating expenses for the three and six months ended June 30, 2023 of $7.8 million and $14.9 million, respectively. Factors contributing to the decrease in operating expenses in the three and six months ended June 30, 2024 are explained below.
Current wording
Operating Expenses. Total operating expenses were $6.4 million and $20.5 million for the three and nine months ended September 30, 2024 which was a decrease of $1.1 million and $1.9 million, from total operating expenses for the three and nine months ended September 30, 2023 of $7.5 million and $22.4 million, respectively. Factors contributing to the decrease in operating expenses in the three and nine months ended September 30, 2024 are explained below.
Previous wording
R&D Expenses. The following table provides a breakdown of major categories within R&D expense for the three and six months ended June 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Current wording
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and nine months ended September 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Previous wording
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and six months ended June 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Current wording
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and nine months ended September 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Previous wording
Interest Income. Interest income was $1.1 million and $2.2 million for the three and six months ended June 30, 2024, respectively, an increase of $0.1 million and $0.4 million, respectively, from interest income of $1.0 million and $1.8 million for the three and six months ended June 30, 2023, respectively. The increase was due to a change in the mix of our money market accounts which yielded a higher rate of return in 2024.
Current wording
Interest Income. Interest income of $1.0 million for the three months ended September 30, 2024 represented a decrease of $0.3 million compared to the prior year period, and was primarily due to a decrease in funds invested in the money market account. Interest income of $3.2 million for the nine months ended September 30, 2024 represented an increase of $0.1 million compared to the prior year period, and was primarily due to a change in the mix of our money market accounts which yielded a higher rate of return in 2024.
Previous wording
Impairment Charge on Investment in Equity Securities. For the three and six months ended June 30, 2024, there were no impairment charges related to our investment in equity securities. For the three and six months ended June 30, 2023, we wrote down our investment in equity securities by $3.0 million due to impairment of our investment in DCT. Refer to Note 4“Investment in Equity Securities” to the Condensed Consolidated Financial Statements.
Current wording
Impairment Charge on Investment in Equity Securities. For the nine months ended September 30, 2024, we wrote down our Investment in equity securities by $1.7 million and for the nine months ended September 30, 2023, we wrote down our Investment in equity securities by $3.0 million due to impairment of our investment. Refer to Note 4“Investment in Equity Securities” to the Condensed Consolidated Financial Statements.
Previous wording
Income Taxes. We did not record an income tax expense or benefit for the three and six months ended June 30, 2024 and 2023 due to uncertainty regarding utilization of our net operating loss carryforwards and our history of losses.
Current wording
Income Taxes. We did not record an income tax expense or benefit for the three and nine months ended September 30, 2024 and 2023 due to uncertainty regarding utilization of our net operating loss carryforwards and our history of losses.
Previous wording
We have incurred net losses and negative operating cash flows since inception. For the six months ended June 30, 2024, we recorded a net loss of $11.9 million and used $9.2 million of cash in operating activities. As of June 30, 2024, we had $79.5 million in cash and cash equivalents and working capital of $76.0 million. We believe we have sufficient cash on hand to fund our projected operating requirements for at least the next 12 months.
Current wording
We have incurred net losses and negative operating cash flows since inception. For the nine months ended September 30, 2024, we recorded a net loss of $19.2 million and used $14.0 million of cash in operating activities. As of September 30, 2024, we had $74.8 million in cash and cash equivalents and working capital of $71.3 million. We believe we have sufficient cash on hand to fund our projected operating requirements for at least the next 12 months.
Previous wording
Net Cash Flows from Operating Activities. Net cash used in operating activities was $9.2 million for the six months ended June 30, 2024, compared to net cash used in operating activities of $11.5 million for the same period in 2023, a decrease of $2.3 million compared to the prior year period. Cash used in operating activities for the six months ended June 30, 2024 primarily consisted of our net loss of $11.9 million adjusted for non-cash items, including non-cash stock-based compensation expense of $0.8 million, and net cash inflows from a change in our operating assets and liabilities of $2.0 million. Cash used in operating activities for the six months ended June 30, 2023 primarily consisted of our net loss of $16.1 million, adjusted for non-cash stock-based compensation expense of $3.2 million, and net cash outflows from a change in our operating assets and liabilities of $1.5 million.
Current wording
Net Cash Flows from Operating Activities. Net cash used in operating activities was $14.0 million for the nine months ended September 30, 2024, compared to net cash used in operating activities of $15.4 million for the same period in 2023, a decrease of $1.4 million compared to the prior year period. Cash used in operating activities for the nine months ended September 30, 2024 primarily consisted of our net loss of $19.2 million adjusted for non-cash impairment on our investment in equity securities of $1.7 million, non-cash stock-based compensation expense of $1.5 million, and net cash inflows from a change in our operating assets and liabilities of $1.9 million. Cash used in operating activities for the nine months ended September 30, 2023 primarily consisted of our net loss of $22.3 million, adjusted for non-cash impairment on our investment in equity securities of $3.0 million, non-cash stock-based compensation expense of $4.1 million, and net cash outflows from a change in our operating assets and liabilities of $0.1 million.
Previous wording
Net Cash Flows from Investing Activities. Net cash used in investing activities was $9 thousand and $13 thousand for the six months ended June 30, 2024 and 2023, respectively, primarily related to purchases of computers.
Current wording
Net Cash Flows from Investing Activities. Net cash used in investing activities was $19 thousand and $14 thousand for the nine months ended September 30, 2024 and 2023, respectively, and was primarily related to our purchases of computers.
Previous wording
Net Cash Flows from Financing Activities. Net cash provided by financing activities was $0.3 million for the six months ended June 30, 2024 and primarily consisted of proceeds from warrants exercised during the period. No cash was used or provided in financing activities during the six months ended June 30, 2023.
Current wording
Net Cash Flows from Financing Activities. Net cash provided by financing activities was $0.3 million for the nine months ended September 30, 2024 and primarily consisted of proceeds from warrants exercised during the period. Net cash used in financing activities was $1,475 for the nine months ended September 30, 2023 and primarily consisted of the repurchase of common stock under the Share Repurchase Program.
Previous wording
Our contractual obligations represent our future cash commitments and liabilities under agreements with third-party clinical trial service providers. Apart from contracts with one third party clinical trial service provider, such agreements are cancellable upon written notice by us. The non-cancellable contracts expire upon completion of the clinical trial and release of the final report, or the contract may be terminated by the clinical trial service provider, by the FDA or another governmental agency. As of June 30, 2024, our estimated non-cancellable commitment was $7.6 million which will be paid over the term of the clinical trials which are expected to be complete in 2025.
Current wording
Our contractual obligations represent our future cash commitments and liabilities under agreements with third-party clinical trial service providers. Apart from contracts with one third party clinical trial service provider, such agreements are cancellable upon written notice by us. The non-cancellable contracts expire upon completion of the clinical trial and release of the final report, or the contract may be terminated by the clinical trial service provider, by the FDA or another governmental agency. As of September 30, 2024, our estimated non-cancellable commitment was $10.5 million which will be paid over the term of the clinical trials.
Previous wording
In June 2023, our Board of Directors (the Board) authorized a program to repurchase up to $10.0 million of our common stock (the Share Repurchase Program). The Share Repurchase Program does not obligate us to acquire any specific number of shares. Under the Share Repurchase Program, shares of common stock may be repurchased using a variety of methods, including privately negotiated and/or open market transactions, including under plans complying with Rule 10b5-1 under the Exchange Act, as part of accelerated share repurchases and other methods. The timing, manner, price and amount of any repurchases are determined by the Board in its discretion and depend on a variety of factors, including legal requirements, price and economic and market conditions. During the three and six months ended June 30, 2024, no shares were repurchased. Please refer to Note 10“Stockholders’ Equity”to the Condensed Consolidated Financial Statements.
Current wording
In June 2023, our Board of Directors (the Board) authorized a program to repurchase up to $10.0 million of our common stock (the Share Repurchase Program). The Share Repurchase Program does not obligate us to acquire any specific number of shares. Under the Share Repurchase Program, shares of common stock may be repurchased using a variety of methods, including privately negotiated and/or open market transactions, including under plans complying with Rule 10b5-1 under the Exchange Act, as part of accelerated share repurchases and other methods. The timing, manner, price and amount of any repurchases are determined by the Board in its discretion and depend on a variety of factors, including legal requirements, price and economic and market conditions. During the three and nine months ended September 30, 2024, no shares were repurchased. Please refer to Note 10“Stockholders’ Equity”to the Condensed Consolidated Financial Statements.