ATOSSA THERAPEUTICS, INC.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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, 2026 · Filed Nov 10, 2026
ATOS$2.14+0.5%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-07.
0001193125-26-339257
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-454468
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 118 previous paragraphs and 126 current paragraphs.
73 unchanged; 44 reworded; 8 added; 1 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (8)
Current report
our ability to receive a PRV from the FDA, our ability to sell any PRV and our expectations around any PRV’s potential future value;
Current report
the number of outstanding stapled contingent value rights (Stapled CVRs) and our ability to make a payment to Stapled CVR holders, and the expected timing of such payment, if any;
Current report
Stapled Contingent Value Rights Agreement
Current report
On October 8, 2026, we entered into a Stapled Contingent Value Rights Agreement (the CVR Agreement) with VStock Transfer, LLC, as rights agent.
Current report
Each Stapled CVR entitles its holder to a pro rata share of any “CVR Payment,” which is an aggregate amount equal to 25% of the net proceeds of the sale or deemed monetization of the first priority review voucher (the “Qualifying Voucher”) awarded on or before December 31, 2036 (the “Outside Date”), which our Board of Directors may extend, in respect of the approval of a marketing application for (Z)-endoxifen for Duchenne muscular dystrophy or McCune-Albright syndrome, or any other product candidate being developed by us or our subsidiaries as of the date of the CVR Agreement. CVR Payments are capped at $50 million and will equal the lesser of 25% of the net proceeds and the unused portion of the cap. To the extent we use the Qualifying Voucher for our own application, or a change of control of the Company occurs while we hold an unsold Qualifying Voucher, such event will be treated as a deemed monetization at a fair market value determined by an independent financial advisor.
Current report
In connection with the execution of the CVR Agreement, our Board of Directors declared a dividend of one stapled contingent value right (each a Stapled CVR) for each share of our common stock outstanding at the close of business on October 19, 2026 (the Record Date). Each share of our common stock issued after the Record Date and prior to any detachment of the Stapled CVRs or the expiration of the CVR Agreement will also carry one Stapled CVR.
Current report
The Stapled CVRs will expire on the Outside Date if no Qualifying Voucher has been awarded by then. If the Qualifying Voucher is awarded on or before the Outside Date, the Stapled CVRs will remain outstanding until all CVR Payments in respect of it have been paid and no further payments are or may become payable, or until the $50 million cap has been paid in full.
Current report
Clinical and non-clinical trial expenses decreased $1.8 million and $1.4 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, due primarily to lower spend related to our ongoing (Z)-endoxifen trials for which enrollment was largely completed during the first nine months of 2026.
Removed paragraphs (1)
Previous report
Clinical and non-clinical trial expenses decreased $0.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in spend on preclinical trials that concluded in the prior period, partially offset by an increase in expense due to higher enrollment in clinical trials of $0.2 million and an increase in drug development costs of $0.3 million in the current period. Clinical and non-clinical trial expenses increased $0.4 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to an increase in expense related to clinical trial enrollments of $1.5 million and an increase in drug development costs of $0.7 million, partially offset by a $1.8 million decrease in expenses related to preclinical work completed in 2025.
Reworded paragraphs (44)
Previous wording
whether we can obtain approval from the FDA, and foreign regulatory bodies, to continue our clinical trials, including our planned (Z)-endoxifen trials, and to sell, market and distribute our therapeutics under development;
Current wording
whether we can obtain approval from the FDA, and foreign regulatory bodies, to commence clinical trials, including our planned trials for Duchenne muscular dystrophy (DMD) and McCune-Albright Syndrome (MAS), to continue our clinical trials, and to sell, market and distribute our therapeutics under development;
Previous wording
our ability to pursue a Duchenne muscular dystrophy (DMD) indication, McCune-Albright Syndrome (MAS) indication, or other indications for our lead program, (Z)-endoxifen;
Current wording
our ability to pursue a DMD indication, MAS indication, and indication for adults with dystrophinopathies such as women carriers of DMD and Becker muscular dystrophy, or other indications for our lead program, (Z)-endoxifen;
Previous wording
our ability to contract with third-party suppliers, manufacturers and service providers, including clinical research organizations, and their ability to perform adequately;
Current wording
our ability to contract with third-party suppliers, manufacturers and service providers, including clinical contract research organizations, and their ability to perform adequately;
Previous wording
We are a clinical-stage biopharmaceutical company developing proprietary innovative medicines in areas of significant unmet medical need in oncology, with a focus on breast cancer and other breast conditions, as well as certain rare diseases. Our lead drug candidate is oral (Z)-endoxifen, a selective estrogen receptor modulator (SERM)/ selective estrogen receptor degrader currently in Phase 2 clinical development. The Company is evaluating potential indications for (Z)-endoxifen based on its pharmacologic profile, including its potential for both reducing the risk of and for the treatment of breast cancer, as well as in other therapeutic areas.
Current wording
We are a clinical-stage biopharmaceutical company developing proprietary innovative medicines in areas of significant unmet medical need in oncology, with a focus on breast cancer and other breast conditions, as well as certain rare diseases. Our lead drug candidate is oral (Z)-endoxifen, a selective estrogen receptor modulator/degrader (SERM/D) currently in Phase 2 clinical development. We are evaluating potential indications for (Z)-endoxifen based on its pharmacologic profile, including its potential for both reducing the risk of and for the treatment of breast cancer, as well as in other therapeutic areas.
Previous wording
As of February 2, 2026, we have been granted seven U.S. and 16 international patents covering our proprietary (Z)-endoxifen, and we have numerous applications pending in the U.S. and in other major countries. We expect to have patent protection covering our proprietary (Z)-endoxifen in our principal areas of focus of oncology, endocrine dysfunction disorders and muscular dystrophy-related diseases through at least November 17, 2038. There have been no material changes to our patent portfolio in the three and six months ended June 30, 2026.
Current wording
As of February 2, 2026, we have been granted seven U.S. and 16 international patents covering our proprietary (Z)-endoxifen, and we have numerous applications pending in the U.S. and in other major countries. We expect to have patent protection covering our proprietary (Z)-endoxifen in our principal areas of focus of oncology, endocrine dysfunction disorders and muscular dystrophy-related diseases through at least November 17, 2038. There have been no material changes to our patent portfolio in the three and nine months ended September 30, 2026.
Previous wording
In an ongoing neoadjuvant clinical study, (Z)-endoxifen has demonstrated early signs of anti-tumor activity. Reported results include one pathological complete response and multiple responses, as well as substantial reductions in Ki-67 proliferation across dose levels. Suppression of Ki-67 during short-term endocrine treatment has been associated with endocrine responsiveness and with more favorable long-term prognosis in ER-positive breast cancer. Meaningful reductions in MRI-assessed functional tumor volume were observed, providing additional evidence of antitumor activity during therapy.
Current wording
In an ongoing neoadjuvant clinical study, (Z)-endoxifen has demonstrated early signs of anti-tumor activity, as indicated by Ki-67. Ki-67 is a nuclear protein expressed in proliferating cells and is widely used as a marker of cellular proliferation. The Ki-67 proliferation index measures the percentage of tumor cells expressing Ki-67 and provides an indication of tumor proliferative activity. Reported results include one pathological complete response and multiple responses, as well as substantial reductions in the Ki-67 proliferation index across dose levels. Suppression of Ki-67 during short-term endocrine treatment has been associated with endocrine tumor responsiveness and with a more favorable long-term prognosis in ER-positive breast cancer. Meaningful reductions in MRI-assessed functional tumor volume were observed in the clinical study, providing additional evidence of anti-tumor activity during therapy. These early findings do not establish long-term clinical benefit.
Previous wording
Based on its mechanism of action, we are exploring the potential application of (Z)-endoxifen beyond breast cancer, including gynecological cancers, endocrine resistance driven by ESR1 mutations, as well as applications in other rare disease indications, including DMD, women carriers of DMD, and MAS in girls. In preclinical models of DMD, (Z)-endoxifen demonstrated muscle-protective, anti-inflammatory, and anti-fibrotic effects. We believe similar efficacy could potentially apply to women carriers of DMD. For MAS, we believe (Z)-endoxifen could potentially be an effective hormone blocker, significantly reducing the effects of early onset puberty in young girls. We have developed a proprietary manufacturing process for (Z)-endoxifen, including defined processes for the active pharmaceutical ingredient and drug product. The drug product is available in multiple dosage strengths and is supported by qualified suppliers and manufacturing redundancies.
Current wording
Based on its mechanism of action, we are exploring the potential application of (Z)-endoxifen beyond breast cancer, including endocrine resistance driven by ESR1 mutations, as well as applications in other rare disease indications, including DMD, women carriers of DMD, Becker muscular dystrophy, and MAS mediated peripheral precocious puberty (MAS-PPP) in girls. In preclinical models of DMD, (Z)-endoxifen demonstrated muscle-protective, anti-inflammatory, and anti-fibrotic effects. We believe similar efficacy could potentially apply to symptomatic women carriers of DMD and Becker muscular dystrophy. For MAS-PPP, we believe (Z)-endoxifen could potentially be an effective hormone blocker, significantly reducing the effects of early onset puberty in young girls.
Previous wording
(Z)-endoxifen is currently being investigated in four Phase 2 trials:
Current wording
(Z)-Endoxifen is currently being investigated in four Phase 2 trials, including the completed Karisma trial:
Previous wording
Karisma-(Z)-endoxifen: We are developing our proprietary oral (Z)-endoxifen as a potential therapy to help reduce mammographic breast density (MBD). In December 2021, we initiated the Karisma-(Z)-endoxifen study, a Phase 2, randomized, double-blind, placebo-controlled, dose-response study evaluating the effect of low-dose (Z)-endoxifen on MBD in healthy premenopausal women with measurable MBD.
Current wording
Karisma-(Z)-Endoxifen [Completed]: We are developing our proprietary oral (Z)-endoxifen as a potential therapy to help reduce mammographic breast density (MBD); MBD is a recognized risk factor of future breast cancer development. In December 2021, we initiated the Karisma-(Z)-endoxifen study, a Phase 2, randomized, double-blind, placebo-controlled, dose-response study evaluating the effect of low-dose (Z)-endoxifen on MBD in healthy premenopausal women with measurable MBD.
Previous wording
The study was conducted in Stockholm, Sweden and enrolled 240 participants who were randomized to receive daily oral dosing for six months of either placebo, 1 mg of (Z)-endoxifen, or 2 mg of (Z)-endoxifen. The primary endpoint was dose-response reduction in MBD. Secondary endpoints included safety and tolerability, and an exploratory endpoint assessed durability of MBD changes over 24 months. The study was fully enrolled in November 2023 and concluded in June 2024 with database lock in September 2024. The follow up 24-month mammographic record review of participants was concluded as of March 31, 2026, and top-line durability data is expected to be received before the end of the third quarter of 2026.
Current wording
The study was conducted in Stockholm, Sweden and enrolled 240 participants who were randomized to receive daily oral dosing for six months of either placebo, 1 mg of (Z)-endoxifen, or 2 mg of (Z)-endoxifen. The primary endpoint was dose-response reduction in MBD. Secondary endpoints included safety and tolerability, and an exploratory endpoint assessed durability of MBD changes over 24 months. The study was fully enrolled in November 2023 and concluded in June 2024 with database lock in September 2024. The follow up 24-month mammographic record review of participants was concluded as of March 31, 2026, and final durability data was received during the third quarter of 2026. We are presenting this durability data at the San Antonio Breast Cancer Symposium (SABCS) in December 2026.
Previous wording
We expect to report top-line durability data from the Karisma-(Z)-endoxifen study in the third quarter of 2026. Further development will depend on regulatory guidance, study outcomes, and available resources.
Current wording
Further development will depend on regulatory guidance and available resources.
Previous wording
I-SPY 2 Endocrine Optimization Pilot (I-SPY): (Z)-endoxifen is being evaluated as a neoadjuvant therapy in patients with ER+/HER2- early breast cancer as well as in combination with other partner drugs such as CDK4/6 inhibitors and ovarian function suppression medications.
Current wording
I-SPY 2 Endocrine Optimization Pilot (I-SPY) [On-going - 100% enrolled]: (Z)-endoxifen is being evaluated as a neoadjuvant therapy in patients with ER+/HER2- early breast cancer as well as in combination with other partner drugs such as CDK4/6 inhibitors and ovarian function suppression (OFS) medications.
Previous wording
Based on these findings, the study was expanded to a 40 mg daily dose of (Z)-endoxifen in premenopausal and postmenopausal patients, targeting enhanced ERα antagonism and PKCβ1 inhibition, with combination therapy. For the expanded arms of this study, (Z)-endoxifen is being used in combination with two FDA approved drugs: 1) abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, and 2) elagolix (ORILISSA®), a prescription medicine used to treat moderate to severe pain associated with endometriosis marketed by AbbVie, Inc. More specifically, (Z)-endoxifen is being used in combination with abemaciclib in postmenopausal patients and in combination with elagolix for premenopausal patients where ovarian function suppression (OFS) treatment is required. Enrollment for all arms of this expanded study using (Z)-endoxifen as a combination therapy is complete, and we expect to begin receiving data throughout the second half of 2026.
Current wording
Based on these findings, the study was expanded to a 40 mg daily dose of (Z)-endoxifen in premenopausal and postmenopausal patients, targeting enhanced ERα antagonism and PKCβ1 inhibition, with combination therapy. For the expanded arms of this study, (Z)-endoxifen is being used in combination with two FDA approved drugs: 1) abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, and 2) elagolix (ORILISSA®), a prescription medicine used to treat moderate to severe pain associated with endometriosis marketed by AbbVie, Inc. More specifically, (Z)-endoxifen is being used in combination with abemaciclib in postmenopausal patients and in combination with elagolix for premenopausal patients where ovarian function suppression treatment is required. Enrollment for all arms of this expanded study using (Z)-endoxifen as a combination therapy is complete, and select data will be presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2026.
Previous wording
RECAST DCIS (RECAST). We are participating in RECAST, a multicenter platform study evaluating whether short-term endocrine therapy combined with MRI response assessment can identify patients with low-risk ductal carcinoma in situ (DCIS) who may safely avoid surgery and pursue long-term active surveillance.
Current wording
RECAST DCIS (RECAST) [On-going - ~50% enrolled]: We are participating in RECAST, a multicenter platform study evaluating whether short-term endocrine therapy combined with MRI response assessment can identify patients with low-risk ductal carcinoma in situ (DCIS) who may safely avoid surgery and pursue long-term active surveillance.
Previous wording
EVANGELINE: EVANGELINE is a Phase 2 study evaluating (Z)-endoxifen plus OFS as a neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer.
Current wording
EVANGELINE [On-going - enrollment complete]: EVANGELINE is a Phase 2 study evaluating (Z)-endoxifen plus OFS as a neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer.
Previous wording
The EVANGELINE study utilizes a Simon two-stage design to assess whether the regimen meets or exceeds a predefined Ki-67 response threshold of 65%. Secondary endpoints include safety and tolerability, residual cancer burden, preoperative endocrine prognostic index score, and MRI-based tumor response. Enrollment in this study was complete as of June 30, 2026.
Current wording
The EVANGELINE study utilizes a Simon two-stage design to assess whether the regimen meets or exceeds a predefined Ki-67 response threshold of 65%. Secondary endpoints include safety and tolerability, residual cancer burden, preoperative endocrine prognostic index score, and MRI-based tumor response. Enrollment in this study closed early, prior to reaching the planned enrollment target, on June 30, 2026. Top line data are expected to be received during the second quarter of 2027 upon completion of the 28-week treatment protocol by the final enrollees.
Previous wording
In addition to the oncology related indications, we believe that (Z)-endoxifen has potentially broader utility as a therapeutic platform in serious and rare diseases, many of which have significant unmet medical need. The following underscore the growing scientific evidence supporting the potential role of estrogen signaling modulation in muscle preservation and inflammation and highlight the potential versatility of our proprietary molecule beyond oncology.
Current wording
In addition to the oncology related indications, we believe that (Z)-endoxifen has potentially broader utility as a therapeutic platform in serious and rare diseases, many of which have significant unmet medical needs. The following underscores the growing scientific evidence supporting the potential role of estrogen signaling modulation in muscle preservation and inflammation and highlights the potential versatility of our proprietary molecule beyond oncology.
Previous wording
McCune-Albright Syndrome: MAS is a rare, non-inherited genetic disorder caused by a postzygotic activating mutation in GNAS, resulting in abnormal hormone signaling in affected tissues and involving bone, skin, and the endocrine system, with symptoms typically appearing in early childhood. In young girls (as early as 2 years old), early onset puberty can occur (Precocious Puberty) which can have a very significant effect on quality of life and limit growth. Because estrogen signaling contributes to peripheral precocious puberty in girls with MAS, we are evaluating whether (Z)-endoxifen could reduce estrogen-mediated manifestations, including recurrent vaginal bleeding, accelerated skeletal maturation and compromised adult height.
Current wording
McCune-Albright Syndrome: MAS is an ultra-rare, non-inherited genetic disorder caused by a postzygotic activating mutation in GNAS, resulting in abnormal hormone signaling in affected tissues and involving bone, skin, and the endocrine system, with symptoms typically appearing in early childhood. In young girls (as early as 2 years old), early onset puberty can occur (Precocious Puberty) which can have a very significant effect on quality of life and limit growth. Because estrogen signaling contributes to peripheral precocious puberty in girls with MAS, we are evaluating whether (Z)-endoxifen could reduce estrogen-mediated manifestations, including accelerated skeletal maturation and compromised adult height, as well as vaginal bleeding.
Previous wording
In May 2026, we received an additional FDA Rare Pediatric Disease designation for (Z)-endoxifen for the treatment of MAS. Additionally, given the relatively small size of this impacted population, we expect to seek Orphan Drug designation for MAS in the second half of 2026. Similarly with the potential PRV for DMD, we believe a potential PRV for MAS could provide us with several potential strategic benefits including meaningful, non-dilutive value opportunities, either through use in another program or monetization through sale to third parties.
Current wording
In May 2026, we received an additional FDA Rare Pediatric Disease designation for (Z)-endoxifen for the treatment of MAS-PPP. As with the potential PRV for DMD, we believe a potential PRV for MAS could provide us with several potential strategic benefits including meaningful, non-dilutive value opportunities, either through use in another program or monetization through sale to third parties.
Previous wording
Symptomatic women carriers of DMD:(Z)-endoxifen has also shown potential relevance in symptomatic female Duchenne and Becker muscular dystrophy carriers, an under-recognized population in which a subset may experience skeletal-muscle symptoms or develop dilated cardiomyopathy in adult life. The work done in 2025, including our manuscript entitled, “(Z)-Endoxifen as a Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy,” will continue to inform our hypotheses and potential clinical trial protocols in the remainder of 2026. Additionally, we believe this condition meets the requirements of and could qualify for Orphan Drug designation, and we intend to pursue this designation.
Current wording
Adults with Dystrophinopathies - Symptomatic women carriers of DMD and Becker muscular dystrophy:(Z)-endoxifen has also shown potential relevance in symptomatic female DMD carriers and Becker muscular dystrophy patients, an under-recognized population in which a subset may experience skeletal-muscle symptoms or develop cardiomyopathy in adult life. The work done in 2025, including our manuscript entitled, “(Z)-Endoxifen as a Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy,” will continue to inform our hypotheses and potential clinical trial protocols in the remainder of 2026. Additionally, we believe this condition meets the requirements of and could qualify for Orphan Drug designation, and we intend to pursue this designation.
Previous wording
On February 2, 2026, the Company effected a 1-for-15 reverse stock split of its issued and outstanding common stock (the Reverse Stock Split). As a result of the Reverse Stock Split, each 15 shares of common stock issued and outstanding immediately prior to February 2, 2026 were automatically converted into one new share of common stock.
Current wording
On February 2, 2026, we effected a 1-for-15 reverse stock split of our issued and outstanding common stock (the Reverse Stock Split). As a result of the Reverse Stock Split, each 15 shares of common stock issued and outstanding immediately prior to February 2, 2026 were automatically converted into one new share of common stock.
Previous wording
The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made (i) in accordance with the terms of the Company’s equity plans, to the number of shares subject to outstanding equity awards, the per share exercise price, if any, with respect to those awards and the number of shares of common stock reserved for future issuance under such plans, and (ii) in accordance with the Certificate of Designation of Preferences, Rights and Limitation of the Series B Convertible Preferred Stock (Preferred Stock), to the conversion price of the Preferred Stock and the number of shares of common stock reserved for issuance pursuant to the Preferred Stock. All applicable common stock and per share amounts have been retrospectively restated to reflect the effect of the reverse stock split.
Current wording
The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made (i) in accordance with the terms of our equity plans, to the number of shares subject to outstanding equity awards, the per share exercise price, if any, with respect to those awards and the number of shares of common stock reserved for future issuance under such plans, and (ii) in accordance with the Certificate of Designation of Preferences, Rights and Limitation of the Series B Convertible Preferred Stock (Preferred Stock), to the conversion price of the Preferred Stock and the number of shares of common stock reserved for issuance pursuant to the Preferred Stock. All applicable common stock and per share amounts have been retrospectively restated to reflect the effect of the Reverse Stock Split.
Previous wording
There have been no material changes to our critical accounting estimates during the three and six months ended June 30, 2026 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, 2025, as filed with the SEC on March 25, 2026.
Current wording
There have been no material changes to our critical accounting estimates during the three and nine months ended September 30, 2026 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, 2025, as filed with the Securities and Exchange Commission (SEC) on March 25, 2026.
Previous wording
Comparison of Three and Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of Three and Nine Months Ended September 30, 2026 and 2025
Previous wording
Revenue and Cost of Revenue. For the three and six months ended June 30, 2026 and 2025, 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, 2026 and 2025, we had no source of revenue and no associated cost of revenue.
Previous wording
Operating Expenses. Total operating expenses were $8.7 million and $18.6 million for the three and six months ended June 30, 2026, respectively, which was a decrease of $0.3 million and an increase of $2.1 million from total operating expenses for the three and six months ended June 30, 2025 of $9.0 million and $16.5 million, respectively. Factors contributing to the changes in operating expenses during the three and six months ended June 30, 2026 are explained below.
Current wording
Operating Expenses. Total operating expenses were $5.9 million and $24.5 million for the three and nine months ended September 30, 2026, respectively, which represented a decrease of $3.4 million and $1.2 million from total operating expenses for the three and nine months ended September 30, 2025, which were $9.3 million and $25.7 million, respectively. Factors contributing to the changes in operating expenses during the three and nine months ended September 30, 2026, are explained below.
Previous wording
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage 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, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
Previous wording
The increase in R&D compensation expenses of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.
Current wording
The increase in R&D compensation expense of $0.2 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, was due primarily to increases in non-cash stock-based compensation expense.
Previous wording
The decrease in R&D professional fees and other of $0.1 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was primarily attributable to a decrease in regulatory consulting fees in the 2026 periods related to our (Z)-endoxifen program as compared to the same periods in the prior year.
Current wording
The decrease in R&D professional fees and other of $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, was due primarily to lower regulatory consulting fees related to our (Z)-endoxifen programs during the current year periods.
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, 2026 and 2025, together with the dollar change and percentage 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, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
Previous wording
The decrease in G&A compensation expenses of $0.3 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
Current wording
The decrease in G&A compensation expenses of $0.3 million and $0.8 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
Previous wording
The increase in G&A professional fees and other of $0.6 million and $2.6 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to higher legal fees of $0.7 million and $2.5 million, for the three and six months ended June 30, 2026, respectively, related to our patent litigation matters, which have now been settled, as well as fees associated with management of our intellectual property portfolio and legal costs related to our SEC compliance and other stock administration matters incurred during the current year periods.
Current wording
The decrease in G&A professional fees and other of $1.0 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, was due primarily to a decrease in legal fees of $0.8 million related to the resolution of patent litigation matters during the first half of 2026. The increase in G&A professional fees and other of $1.5 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, was due primarily to higher spend on patent litigation matters during the first half of 2026, which have now been settled, and to a lesser extent, higher legal fees associated with management of our intellectual property portfolio and general legal costs related to SEC compliance and other stock administration matters incurred during the current year period.
Previous wording
Interest Income. Interest income was $0.2 million and $0.5 million for the three and six months ended June 30, 2026, respectively, and decreased $0.4 million and $0.8 million compared to the three and six months ended June 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.
Current wording
Interest Income. Interest income was $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, and decreased $0.4 million and $1.2 million compared to the three and nine months ended September 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.
Previous wording
Income Taxes. We did not record an income tax expense or benefit for the three and six months ended June 30, 2026 and 2025. We have incurred net losses since inception. Additionally, due to uncertainty regarding utilization of our net operating loss carryforwards and our history of losses, we maintain a full valuation allowance against our net deferred tax assets due to uncertainty regarding future taxable income.
Current wording
Income Taxes. We did not record an income tax expense or benefit for the three and nine months ended September 30, 2026 and 2025. We have incurred net losses since inception. Additionally, due to uncertainty regarding utilization of our net operating loss carryforwards and our history of losses, we maintain a full valuation allowance against our net deferred tax assets due to uncertainty regarding future taxable income.
Previous wording
On February 20, 2026, we entered into an At-the-Market Offering Agreement (ATM), dated February 20, 2026 (the Agreement), with Rodman & Renshaw LLC (the Sales Agent). Pursuant to the Sales Agreement, we may offer, from time to time, to sell, in an "at-the-market offering," shares of our common stock up to an aggregate offering price of up to $50.0 million. For the three months ended June 30, 2026, we received net proceeds of $21 thousand and we issued 4,300 shares of common stock under the ATM.
Current wording
On February 20, 2026, we entered into an At-the-Market Offering Agreement (ATM), dated February 20, 2026 (the Sales Agreement), with Rodman & Renshaw LLC (the Sales Agent). Pursuant to the Sales Agreement, we may offer, from time to time, to sell, in an "at-the-market offering," shares of our common stock up to an aggregate offering price of up to $50.0 million. For the three months ended September 30, 2026, no proceeds were received and no shares of common stock were issued. For the nine months ended September 30, 2026, we received net proceeds of $21 thousand and we issued 4,300 shares of common stock under the ATM.
Previous wording
We have incurred net losses and negative operating cash flows since inception. For the six months ended June 30, 2026, we recorded a net loss of $18.1 million and used $19.2 million of cash and cash equivalents in operating activities. As of June 30, 2026, we had $26.1 million in cash and cash equivalents and working capital of $25.6 million. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and allow us to continue as a going concern. Our ability to continue as a going concern is dependent on obtaining adequate capital to fund operating losses until we become profitable. We plan to obtain additional capital resources by selling our equity securities as well as short-term borrowing from banks, stockholders or other related parties, if needed. However, we cannot assure you that we will be successful in accomplishing any of these plans and, if we are unable to obtain adequate capital, we could be forced to cease operations or substantially curtail our activities. We do not anticipate any revenue until our pharmaceutical programs are developed, including receipt of all necessary regulatory approvals, and we successfully commercialize these programs. These conditions raise substantial doubt as to our ability to continue as a going concern. As of the date of filing this Quarterly Report, we expect our existing resources will likely be insufficient to fund our planned operations for the next twelve months, and additional capital resources will be needed to fund operations longer-term.
Current wording
We have incurred net losses and negative operating cash flows since inception. For the nine months ended September 30, 2026, we recorded a net loss of $23.7 million and used $24.7 million of cash and cash equivalents in operating activities. As of September 30, 2026, we had $20.6 million in unrestricted cash and cash equivalents and working capital of $20.5 million. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and allow us to continue as a going concern. Our ability to continue as a going concern is dependent on obtaining adequate capital to fund operating losses until we become profitable. We plan to obtain additional capital resources by selling our equity securities as well as short-term borrowing from banks, stockholders or other related parties, if needed. However, we cannot assure you that we will be successful in accomplishing any of these plans and, if we are unable to obtain adequate capital, we could be forced to cease operations or substantially curtail our activities. We do not anticipate any revenue until our pharmaceutical programs are developed, including receipt of all necessary regulatory approvals, and we successfully commercialize these programs. These conditions raise substantial doubt as to our ability to continue as a going concern. As of the date of filing this Quarterly Report, we expect our existing resources will likely be insufficient to fund our planned operations for the next twelve months, and additional capital resources will be needed to fund operations longer-term.
Previous wording
Net Cash Flows from Operating Activities. During the six months ended June 30, 2026, compared to the same period in 2025, net cash used in operating activities increased $6.0 million due primarily to the following:
Current wording
Net Cash Flows from Operating Activities. During the nine months ended September 30, 2026, compared to the same period in 2025, net cash used in operating activities increased $5.5 million due primarily to the following:
Previous wording
an increase of $1.5 million in cash used for clinical trials and pre-clinical activities, as well as investment in drug development, process validation, and stability costs;
Current wording
an increase of $1.8 million in cash used for clinical trials and pre-clinical activities, as well as investment in drug development, process validation, and stability costs;
Previous wording
an increase of $4.2 million in cash used related primarily to professional fees related to our settled patent litigation matters, as well as higher legal fees for intellectual property matters, SEC registrations and filings, and accounting fees, partially offset by decreases in investor relations fees and regulatory consulting fees;
Current wording
an increase of $3.2 million in cash for professional fees related to our settled patent litigation matters, as well as higher legal fees for intellectual property matters, SEC registrations and filings, and accounting fees, partially offset by decreases in investor relations fees and regulatory consulting fees;
Previous wording
a decrease of $0.5 million in net cash paid to employees due to fewer employees in the current year period, partially offset by employee severance payments. There were no severance related payments made during the same period in 2025; and
Current wording
a decrease of $0.7 million in net cash paid to employees due to fewer employees in the current year period, partially offset by employee severance payments; and
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Current report — wording carried from elsewhere
We have developed a proprietary manufacturing process for (Z)-endoxifen, including defined processes for the active pharmaceutical ingredient and drug product. The drug product is available in multiple dosage strengths and is supported by qualified suppliers and manufacturing redundancies.