ATOSSA THERAPEUTICS, INC.
For the period ended Mar 31, 2026. Filed May 8, 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.
Mar 31, 2026 · Filed May 8, 2026
ATOS$2.12+5.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-276160
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-08.
0001193125-26-213423
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 100 previous paragraphs and 117 current paragraphs.
39 unchanged; 30 reworded; 46 added; 31 removed; 0 previous and 2 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 (46)
Current report
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 report
our ability to continue as a going concern;
Current report
our eligibility for, and any expected benefits of, any FDA programs or special designations, such as the Rare Pediatric Disease Priority Review Voucher (PRV) program and the orphan drug exclusivity designation;
Current report
our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD;
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other risks and uncertainties, including those discussed in the section titled "Risk Factors" herein.
Current report
(Z) endoxifen.(Z)-endoxifen is the most active metabolite of Tamoxifen, a FDA approved drug to treat and prevent breast cancer in high-risk women, and it is substantially more potent as an estrogen receptor antagonist than Tamoxifen and other approved SERMs. Unlike Tamoxifen, which requires metabolic activation through CYP2D6 and other liver enzymes, (Z)-endoxifen does not require first-pass metabolism to achieve therapeutic concentrations. As a result, its activity is not dependent on patient-specific metabolic variability.
Current report
(Z)-endoxifen is a small-molecule oral agent designed to directly inhibit estrogen receptor signaling, induce estrogen receptor degradation, and promote apoptosis in estrogen receptor positive (ER+) breast cancer cells. Preclinical and clinical data suggest that (Z)-endoxifen may retain activity against clinically relevant ESR1-mutant ER+ breast cancer models associated with aromatase inhibitor resistance. In addition to direct ER antagonism, (Z)-endoxifen may inhibit protein kinase C beta one (PKCβ1), leading to reduced AKT pathway activation and suppression of downstream cell-cycle and survival signals. This is important because AKT signaling is a key pro-growth and pro-survival pathway that can contribute to endocrine resistance. Targeting this pathway may help inhibit tumor proliferation beyond estrogen-receptor blockade alone. We are evaluating (Z)-endoxifen across multiple settings within the ER+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer treatment continuum, including neoadjuvant, adjuvant and breast density reduction indications.
Current report
In an ongoing neoadjuvant clinical study, (Z)-endoxifen has demonstrated early signs of anti-tumor activity. Reported results include one complete response and multiple responses, as well as substantial reductions in Ki-67 proliferation across dose levels. This is important because early reductions in Ki-67 during endocrine therapy are prognostic in ER+/HER2- breast cancer, and which we believe could indicate endocrine sensitivity, which has been associated with improved long-term outcomes and lower recurrence risk. Tumor shrinkage was observed by MRI imaging, which is atypical for endocrine therapies that are generally cytostatic.
Current report
We are also supporting multiple collaborative and investigator-sponsored clinical studies evaluating (Z)-endoxifen in additional breast cancer settings. These studies are not fully funded by us and are intended to further characterize clinical activity, optimize endocrine therapy strategies, and inform future regulatory pathways.
Current report
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 report
Summary of Leading Oncology Programs
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(Z)-endoxifen is currently being investigated in four Phase 2 trials:
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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 report
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 second quarter of 2026.
Current report
We expect to report top-line data from the Karisma-(Z)-endoxifen study in the first half of 2026. Further development will depend on regulatory guidance, study outcomes, and available resources.
Current report
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 report
Results from the daily 10 mg dose demonstrated excellent tolerability, with approximately 95% of patients completing at least 75% of planned therapy and showing predominantly low-grade adverse events. Biologic activity was observed across multiple measures, including reductions in the Ki-67 proliferation index, median MRI functional tumor volume reduction of approximately 72%, and the clearance of circulating tumor DNA (ctDNA) in a majority of patients who were ctDNA-positive at baseline.
Current report
(Z)-endoxifen was well tolerated in this study with the most common side effects being mild, including hot flashes, insomnia and fatigue. At baseline, the average Ki-67% was 16% with a minimum of 2% and a maximum of 60%. At week 3, this decreased to an average of 10% with a minimum of 0% and a maximum of 35%. Ki-67 decreased below 10% in a majority of participants, including some patients with Ki-67 levels below 3%. At the time of surgery, the average Ki-67% remained at 10%, and the majority of patients maintained Ki-67 levels below 10%, including certain patients with Ki-67 levels that remained below 3%. Results were similar in the postmenopausal and premenopausal groups.
Current report
Based on these findings, the study is being expanded to a 40 mg daily dose of (Z)-endoxifen in premenopausal and postmenopausal patients, targeting enhanced ERα antagonism and PKCβ1 inhibition, with or without 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 certain premenopausal patients where ovarian function suppression (OFS) treatment is required. Enrollment for the two primary arms of this expanded study using (Z)-endoxifen as a combination therapy is nearly complete and we expect to begin receiving data early in the second half of 2026. For the ongoing arms of the study involving premenopausal women, (Z)-endoxifen is being used in combination with elagolix or a GnRH Agonist. Enrollment is nearly complete for these arms, and we expect to begin receiving data in the second half of 2026.
Current report
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 report
Enrollment in this study is ongoing, and a substantial proportion of patients have elected to continue active surveillance following initial treatment and imaging assessment. These early observations support the potential of the therapy and assessment to reduce the risk of overtreatment in selected DCIS patients while maintaining oncologic safety.
Current report
Future efforts within RECAST are expected to focus on integrating advanced imaging modalities with molecular and transcriptomic biomarkers to help better predict progression risk, refine patient selection, and evaluate long-term outcomes, including invasive recurrence rates, durability of active surveillance, patient experience, and quality of life.
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EVANGELINE: EVANGELINE is a Phase 2 study evaluating (Z)-endoxifen plus OFS compared to exemestane plus OFS as a neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer.
Current report
We believe this study addresses a significant unmet need among premenopausal patients who experience poor tolerability with aromatase inhibitor-based regimens combined with OFS. Pharmacodynamic run-in data demonstrated strong early biologic activity, with approximately 86% of patients achieving a Ki-67 value of 10% or less at Week 4. These early data results supported the selection of 40 mg (Z)-endoxifen with OFS for the randomized Phase 2 portion of the study.
Current report
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.
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(Z)-Endoxifen in Rare diseases
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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 report
Duchenne muscular dystrophy: DMD is a serious, progressive neuromuscular disease that primarily affects boys, leading to loss of muscle function, loss of ambulation, and life-threatening heart and respiratory complications. We believe that (Z)-endoxifen’s direct estrogen-receptor modulation, protein kinase C inhibition, and effects on key signaling pathways could be relevant in addressing various pathologies associated with DMD, including inflammation, fibrosis, and cardiomyopathy. Through its potential ability to upregulate utrophin, (Z)-endoxifen may help stabilize muscle health, including muscle growth, repair, and fibrosis. FDA engagement commenced in Q4 2025.
Current report
In December 2025 and early in 2026, we received two FDA designations for (Z)-endoxifen for the treatment of DMD: 1) Rare Pediatric Disease designation and 2) Orphan Drug designation. We believe these designations provide us with several potential strategic benefits, including incentives, such as a potential PRV for future FDA applications, other regulatory support, and potential market exclusivity for a period of time. PRVs, which were recently reauthorized by legislation, could create significant value for the Company and could represent meaningful, non-dilutive value opportunities, either through use in another program or monetization through sale to third parties.
Current report
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 report
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. We believe that (Z)-endoxifen could prove to be an effective hormone blocker and potentially significantly reduce the effects of Precocious Puberty until young girls reach a more typical age for the onset of puberty and related developmental changes.
Current report
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 first 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 report
Reverse Stock Split
Current report
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 report
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 report
The decrease in G&A compensation expenses of $0.2 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025, was due primarily to a decrease in headcount in the current year period compared to the same period in the prior year.
Current report
Interest Income. Interest income was $0.3 million for the three months ended March 31, 2026 represented a decrease of $0.4 million compared to the prior year period. The decrease was due primarily to lower average cash balances invested in our money market account during the current year period relative to the same period in the prior year.
Current report
On June 27, 2024, our stockholders approved an amendment to our Amended and Restated Certificate of Incorporation to increase the number of authorized shares of our common stock, par value $0.18 per share, from 175,000,000 to 350,000,000. As of December 31, 2025, we are authorized to issue 350,000,000 shares of common stock, par value $0.18 per share.
Current report
an increase of $2.4 million in cash used for clinical trials and pre-clinical activities, as well as investment in drug development, process validation, and stability costs;
Current report
a decrease of $0.5 million in net cash paid to employees due to fewer employees in the current period, partially offset by employee severance payments. There were no severance related payments made during the same period in 2025;
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Removed paragraphs (31)
Previous report
our ability to successfully execute our strategy to pursue a metastatic breast cancer indication for our lead program, (Z)-endoxifen, and to develop in parallel low dose (Z)-endoxifen for breast cancer reduction;
Previous report
We are pursuing development of low dose (Z)-endoxifen for breast cancer risk reduction. On September 8, 2025, we announced that we requested a Type C meeting with the FDA to discuss a potential accelerated regulatory strategy for the development of low-dose (Z)-endoxifen for breast cancer risk reduction. This initiative followed an extensive review by external regulatory and legal experts of our clinical data and published scientific literature, which we believe supported the potential for a faster path to a New Drug Application (NDA) in the adjuvant, ductal carcinoma in situ (DCIS) and other high-risk breast cancer settings. On November 6, 2025, we received preliminary written comments from the FDA regarding the regulatory path for (Z)-endoxifen. We expect to meet with the FDA on November 17, 2025 to discuss a development plan intended to support filing an NDA, including the potential use of expedited programs where eligible. We will evaluate any implications for our plans and timelines following receipt of FDA meeting minutes, which are expected to be available in December 2025. While there can be no assurance of a favorable outcome, a successful alignment with the FDA could potentially materially shorten development timelines and reduce future clinical costs.
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In parallel, in early 2025, we made a strategic decision to pursue a metastatic breast cancer indication for our lead program, (Z)-endoxifen. We believe that this approach may offer a more streamlined regulatory pathway to deliver (Z)-endoxifen to patients with urgent unmet medical needs as the current treatment options for metastatic breast cancer often provides limited durability of response and substantial side effects. (Z)-endoxifen, a potent and well-tolerated selective estrogen receptor modulator (SERM), has shown encouraging signs in previous clinical trials, which we believe supports its potential to fill this critical treatment gap. We have received positive written feedback from the FDA regarding our proposed global Phase 2 dose optimization trial for (Z)-endoxifen in patients with ER+/HER2- metastatic breast cancer affirming key elements of Atossa's clinical development plan and paving the way for a potential IND submission targeted for the fourth quarter of 2025.
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Summary of Our Leading Programs
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The following is a summary of the status of our major clinical development programs as of the date of this Quarterly report:
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(Z)-endoxifen. (Z) endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to treat and prevent breast cancer in high-risk women. It is also referred to as a Selective Estrogen Receptor Modulator Degrader (SERM/D). We are developing a proprietary form of (Z)-endoxifen which is administered orally for the potential treatment of breast cancer and reduction of mammographic breast density. We have completed four Phase 1 clinical studies (including a study in men) and two Phase 2 clinical studies with our proprietary (Z)-endoxifen (including oral and topical formulations). We have also completed significant pre-clinical development and have developed clinical manufacturing capabilities through qualified third parties.
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(Z)-endoxifen for Women with Mammographic Breast Density. Mammographic breast density (MBD) is an emerging public health issue. Almost half of the women in the world over the age of 40 have dense breasts, and there are currently no approved treatments to reduce breast density. Elevated breast density can make a mammogram more difficult to interpret because dense breast tissue and some abnormal breast changes, such as calcifications and tumors, appear as white areas in a mammogram. Women with the highest density are four to six times more likely to develop breast cancer in their lifetime, and more likely to develop cancer between mammograms compared to those with low breast density. The latter are sometimes referred to as "interval cancers," which are often larger, more advanced, and more difficult to treat.
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In December 2021, we commenced a Phase 2 study of our proprietary oral (Z)-endoxifen. The study, known as the Karisma-(Z)-endoxifen study, was a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of our proprietary oral (Z)-endoxifen in healthy premenopausal women with measurable mammographic breast density. The primary objective of the study was to determine the dose-response relationship of daily (Z)-endoxifen on breast density reduction. Secondary endpoints assessed safety and tolerability. The study was conducted in Stockholm, Sweden and included approximately 240 participants who received daily doses of oral (Z)-endoxifen or placebo for six months after enrollment, randomized to one of three arms: placebo, 1 mg of (Z)-endoxifen, or 2 mgs of (Z)-endoxifen. The study also included an exploratory endpoint to assess twenty-four month durability of the breast density changes. Top line data for this study is expected in the first quarter of 2026.
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The study fully enrolled in November 2023 and in September 2024, the study concluded. The data showed the potential of low-dose (Z)-endoxifen to significantly reduce MBD, a key risk factor for breast cancer, with a favorable safety profile.
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Based on input from the FDA and Swedish Medical Products Agency, reduction in MBD may not be an approvable indication unless we can demonstrate that our (Z)-endoxifen also reduces the incidence of breast cancer. We may therefore conduct additional studies of (Z)-endoxifen to assess its correlation with the risk of breast cancer and/or reduction in the incidence of new breast cancers.
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(Z)-endoxifen for Ductal Carcinoma in Situ. DCIS is the presence of abnormal cells inside a milk duct in 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.
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(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 each year.
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In October 2022, we received authorization from the FDA for our Investigational New Drug (IND) application for oral (Z)-endoxifen. The study, known as "EVANGELINE" is a Phase 2 randomized study assessing (Z)-endoxifen as neoadjuvant therapy in premenopausal women with primary ER+, HER2– breast cancer. The study will enroll approximately 190 patients across up to 25 U.S. sites, and consists of two parts.
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In Part 1, a Pharmacokinetic (PK) Run-In Cohort evaluated two dose levels. A 40 mg per day cohort was initiated in February 2023 to assess if a plasma steady state concentration (Css) of 500 to 1000 ng/mL, which is required for optimal PKC-β inhibition, could be achieved. However, data showed that none of the patients in the 40 mg cohort reached the target Css. Subsequently, an 80 mg per day cohort was initiated and fully enrolled in July 2024. In this higher dose group, about 50% of patients receiving (Z)-endoxifen with goserelin and 38% of patients receiving (Z)-endoxifen alone attained the target plasma Css, with an average of 484 ng/mL. Importantly, tumor Css levels were found to be more than double the plasma levels, exceeding 500 ng/g in 90% of patients, and 85% of patients exhibited a 4-week Ki-67 response (≤10%), indicating substantial tumor suppression. (Z)-endoxifen was generally well tolerated, with no significant Grade 3 or 4 toxicities, although four gynecologic events (including one Grade 3 hemorrhagic ovarian cyst) were noted in the 80 mg group.
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In January 2025, based on adverse events reported in 80 mg/day groups, as well as the findings reported on (Z)-endoxifen tissue and plasma Css, overall tolerability, and antitumor activity, the trial will proceed based on an amended protocol as a randomized trial that compares (Z)-endoxifen 40 mg/day plus OFS to exemestane plus OFS, using the 4-week Ki-67 reduction as the primary endpoint. Part 2 is expected to compare the two treatment arms based on baseline Ki-67 levels, and the aim is to evaluate the endocrine sensitive disease rate, pathologic complete response, and other key endpoints. The Treatment Cohort was initiated in April 2025. As of September 30, 2025, seven patients were enrolled in this study.
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On October 6, 2025, we announced an amendment to our Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer. The study design has been updated to a single-arm, open-label, Phase 2 in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting. The initial EVANGELINE study design included 214 patients; and the amendment reduced the patient total to 40-65 patients. The study includes two Cohorts: Cohort A (signal-seeking), a two-stage futility design assessing the Week-4 Ki-67 ≤10% rate to allow early stop if not promising and Cohort B (estimation), assessing Week-24 objective response (RECIST 1.1, central review). The amended design will focus on objective, short-interval endpoints to inform development decisions efficiently while working to preserve patient safeguards.
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In March 2023, a second neoadjuvant Phase 2 trial investigating oral (Z)-endoxifen as a treatment for women diagnosed with locally advanced ER+/HER2- 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 EOP is a collaborative effort among academic investigators from major cancer research centers across the U.S., QLHC, the FDA, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. This study included twenty women who received 10 mg of (Z)-endoxifen orally once daily for six cycles (each cycle = 28 days) or up to 24 weeks prior to surgery. Enrollment was completed in January 2024 and 3-week preliminary data results were reported on October 31, 2024.
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On May 14, 2025 we reported updated results from this study which found that (i) 95% of participants (19/20 participants) completed at least 75% of planned dosing, (ii) median Ki-67 fell from 10.5% at baseline to 5% by Week 3, (iii) 65% of patients achieved Ki-67< 10% at Week 3 with suppression maintained at surgery, (iv) median functional tumor volume measurement (performed at baseline, Week 3, Week 12 and at surgery) decreased 77.7% from baseline to surgery, and (v) the longest tumor diameter in the participants from baseline to preoperative MRI was reduced by 36.8%. (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 occurred during this study.
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In April 2024, we announced our participation in a new study arm of the I-SPY 2 EOP which 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. In June 2024, we announced that the study had been expanded to include 80 women with newly diagnosed ER+/HER2- invasive breast cancer. Currently enrolled and newly enrolled participants are expected to transition to or be initiated on 40 mg of (Z)-endoxifen (from 80 mg) once daily in combination with 150 mg of abemaciclib twice daily for a total of 24 weeks prior to surgery. The transition to the 40 mg dose from an 80 mg dose is the result of a protocol amendment approved in January 2025. Enrollment in this study is ongoing. On July 31, 2025 we amended the study to include an additional 8 premenopausal women, increasing the total number of participants to 88.
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Commercial Lease Agreement
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On September 22, 2025, we entered into an operating lease with 1448 NW Market Street Tenant LLC for additional office space in Seattle, Washington. We agreed to pay $3 thousand per month for 13 months commencing on November 1, 2025.
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The increase in R&D compensation expenses of $0.5 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, was primarily due to an increase in headcount. R&D compensation expense remained relatively flat for the three months ended September 30, 2025, compared to the same period in 2024.
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Interest Income. Interest income was $0.6 million and $1.9 million for the three and nine months ended September 30, 2025, respectively, a decrease of $0.4 million and $1.3 million from interest income of $1.0 million and $3.2 million for the three and nine months ended September 30, 2024, respectively. The decreases were due to decreases in the average balance invested in our money market account.
Previous report
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 due to the impairment of our investment in Dynamic Cell Therapies, Inc. (DCT). Refer to Note 4“Investment in Equity Securities” to the Condensed Consolidated Financial Statements.
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an increase of $2.7 million in cash used for clinical and non-clinical trials, including drug development costs;
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an increase of $0.5 million in cash used for compensation due to an increase in full-time employees;
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an increase of $0.7 million in cash used for professional fees primarily driven by cash paid for regulatory consulting fees related to our (Z)-endoxifen program, patent protection, and investor relations, partially offset by decreases in accounting fees; and
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Net Cash Flows from Investing Activities. Net cash used in investing activities was $16 thousand and $19 thousand, for the nine months ended September 30, 2025 and 2024, respectively. Current and prior period cash used in investing activities was primarily related to purchases of new computers.
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Net Cash Flows from Financing Activities. No cash was provided by or used in financing activities for the nine months ended September 30, 2025. Net cash provided by financing activities was $0.3 million for the nine months ended September 30, 2024 and consisted of proceeds from the exercise of warrants.
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On February 21, 2025, we received a letter from Nasdaq informing us that we are not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq, because our common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. We had until August 20, 2025 to regain compliance with Nasdaq Listing Rule 5550(a)(2). On August 21, 2025, we received a letter from Nasdaq informing us that we are eligible for an additional 180 calendar day period or until February 17, 2026, to regain compliance. To regain compliance, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days, unless Nasdaq exercises its discretion to require a minimum of up to 20 consecutive business days. Subsequent to September 30, 2025, our common stock traded above the minimum closing bid price of $1.00 for 10 consecutive business days. However, Nasdaq exercised its discretion to monitor our compliance for an additional 10 consecutive business days, during which time we did not maintain our common stock bid price above $1.00, and therefore we have not yet regained compliance.
Previous report
Please refer to Note 3“Summary of Significant Accounting Policies” to the Condensed Consolidated Financial Statements.
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All statements made in this Quarterly Report on Form 10-Q (this report) that are not statements of historical fact, including statements regarding guidance, industry prospects or future results of operations or financial position, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). We have made these statements in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, which could cause actual results, outcomes and the timing of results or outcomes to differ materially from those projected or anticipated. Although we believe that our assumptions underlying our forward-looking statements are reasonable as of the date of this Quarterly Report, we cannot assure you that the forward-looking statements set out in this Quarterly Report will prove to be accurate. We may identify these forward-looking statements by the use of forward-looking words, including, but not limited to, “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “future,” “believe,” “design,” “predict,” or the negative versions of these words or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:
Current wording
All statements made in this Quarterly Report on Form 10-Q (this Quarterly Report) that are not statements of historical fact, including statements regarding guidance, industry prospects or future results of operations or financial position, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). We have made these statements in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, which could cause actual results, outcomes and the timing of results or outcomes, to differ materially from those projected or anticipated. Although we believe that our assumptions underlying our forward-looking statements are reasonable as of the date of this Quarterly Report, we cannot assure you that the forward-looking statements set forth in this Quarterly Report will prove to be accurate. We may identify these forward-looking statements by the use of forward-looking terms, including, but not limited to, "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "future," "believe," "design," "predict," or the negative versions of these words or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:
Previous wording
our ability to shorten our clinical development timelines and reduce future clinical development costs through an accelerated path to filing a New Drug Application (NDA), which is dependent on the timing and outcomes of submissions to and other interactions with the U.S. Food and Drug Administration (FDA);
Current wording
our ability to shorten our clinical development timelines and reduce future clinical development costs through an accelerated path to filing a New Drug Application, which is dependent on the timing and outcomes of submissions to and other interactions with the U.S. Food and Drug Administration (FDA);
Previous wording
the impact of general macroeconomic conditions, including the impact of inflation, high interest rates, general economic slowdown or a recession, foreign exchange rate volatility, changes in monetary policy, changes in trade policies, including tariffs or other trade restrictions or the threat of such actions, a prolonged shutdown of the U.S. federal government, and increasing geopolitical instability, including the conflict in Ukraine, the conflict in the Middle East and rising tensions between China and Taiwan, on our business, our ability to access capital markets, our operating costs and our supply chain;
Current wording
the impact of general macroeconomic conditions, including the impact of inflation, high interest rates, general economic slowdown or a recession, the availability of credit, foreign exchange rate volatility, financial institution instability, changes in monetary policy, changes in trade policies, including tariffs or other trade restrictions or the threat of such actions, and increasing geopolitical instability, including the conflict in Ukraine, the conflict in the Middle East and rising tensions between China and Taiwan and the related volatility in the price of oil and other commodity prices, on our business, our ability to access capital markets, our operating costs and our supply chain;
Previous wording
our ability to successfully initiate and complete clinical trials of our products under development, including our proprietary (Z)-endoxifen (an active metabolite of Tamoxifen);
Current wording
our ability to successfully initiate and complete clinical trials of our products under development, including our proprietary (Z)-endoxifen;
Previous wording
our ability to regain and maintain compliance with the continued listing requirements of the Nasdaq Capital Market (Nasdaq);
Current wording
our ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market (Nasdaq);
Previous wording
This Quarterly Report also contains estimates and other statistical data provided by third parties and by us relating to market size and growth, and other industry data. These and other forward-looking statements made in this Quarterly Report, unless otherwise indicated, are presented as of the date of the filing of this Quarterly Report. We have discussed certain important factors, risks and uncertainties in the cautionary statements included in this Quarterly 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 Quarterly 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 Quarterly 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, future circumstances or otherwise.
Current wording
This Quarterly Report also contains estimates and other statistical data provided by third parties and by us relating to market size and growth, and other industry data. These and other forward-looking statements made in this Quarterly Report, unless otherwise indicated, are presented as of the date of the filing of this Quarterly Report. We have discussed certain important factors, risks and uncertainties in the cautionary statements included in this Quarterly Report, particularly in the sections titled "PART II. ITEM 1A. RISK FACTORS," "PART I. ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS," and elsewhere in this Quarterly 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 Quarterly 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, future circumstances or otherwise.
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. Our lead drug candidate is oral (Z)-endoxifen, which we are developing for both the prevention and 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 (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.
Previous wording
We have been granted 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.
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 through at least November 17, 2038.
Previous wording
Our business strategy is to advance our programs through clinical studies, including potentially with partners, and opportunistically add programs in areas of high unmet medical need through acquisition, minority investment, collaboration or internal development.
Current wording
Our business strategy is to advance our programs through clinical studies, including with potential partners, and opportunistically add programs in areas of high unmet medical need through acquisition, minority investment, collaboration or internal development.
Previous wording
The 1 mg dose of (Z)-endoxifen reduced MBD by 17.3% (p<0.01), while the 2 mg dose achieved a reduction of 23.5% (p<0.01), compared to a minimal change in the placebo group of 0.27%. Plasma concentrations for (Z)-endoxifen were measured at 4.8 ng/mL and 9.7 ng/mL for the 1 mg and 2 mg arms, respectively, demonstrating the effectiveness of the lower dose in achieving significant MBD reductions. Importantly, no significant differences in adverse events were observed between the 1 mg dose and the placebo. The 2 mg dose was associated with higher rates of hot flashes, night sweats and vaginal discharge.
Current wording
The initial study data demonstrated that low-dose (Z)-endoxifen significantly reduced MBD compared to placebo. The 1 mg dose showed a mean MBD reduction of 17.3% (p<0.01) and the 2 mg dose showed a mean reduction of 23.5% (p<0.01), compared to a 0.27% change in the placebo group. Mean plasma concentrations were 4.8 ng/mL and 9.7 ng/mL in the 1 mg and 2 mg dose groups, respectively, indicating that substantial MBD reductions were achieved at relatively low systemic exposure. (Z)-endoxifen was generally well tolerated. No meaningful differences in adverse events were observed between the 1 mg dose group and placebo. The 2 mg dose group experienced higher rates of certain adverse events, including hot flashes, night sweats, and vaginal discharge.
Previous wording
In October 2023, the Quantum Leap Healthcare Collaborative (the QLHC) announced the initiation of the Phase 2 DCIS: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (the 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 are expected to 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.
Current wording
(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 are expected to be treated with (Z)-endoxifen. Early findings from RECAST suggest that this “window of opportunity” approach is feasible and well tolerated. 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.
Previous wording
We are in the research and development phase and are not currently marketing any products. We do not anticipate generating revenue until we develop and launch our pharmaceutical programs.
Current wording
We are in the research and development phase and are not currently marketing any products. We do not anticipate generating revenue unless and until we develop and launch our pharmaceutical programs.
Previous wording
There have been no material changes to our critical accounting estimates during the nine months ended September 30, 2025 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, 2024, as filed with the SEC on March 25, 2025.
Current wording
There have been no material changes to our critical accounting estimates during the three months ended March 31, 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.
Previous wording
Comparison of Three and Nine Months Ended September 30, 2025 and 2024
Current wording
Comparison of Three Months Ended March 31, 2026 and 2025
Previous wording
Revenue and Cost of Revenue. For the three and nine months ended September 30, 2025 and 2024, we had no source of revenue and no associated cost of revenue.
Current wording
Revenue and Cost of Revenue. For the three months ended March 31, 2026 and 2025, we had no source of revenue and no associated cost of revenue.
Previous wording
Operating Expenses. Total operating expenses were $9.3 million and $25.7 million for the three and nine months ended September 30, 2025, respectively, which was an increase of $2.9 million and $5.2 million from total operating expenses for the three and nine months ended September 30, 2024 of $6.4 million and $20.5 million, respectively. Factors contributing to the increased operating expenses in the three and nine months ended September 30, 2025 are explained below.
Current wording
Operating Expenses. Total operating expenses were $9.9 million for the three months ended March 31, 2026, which was an increase of $2.5 million, from total operating expenses for the three months ended March 31, 2025 of $7.4 million. Factors contributing to the increased operating expenses in the three months ended March 31, 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 nine months ended September 30, 2025 and 2024, 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 months ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
Previous wording
Clinical and non-clinical trial expenses increased $1.8 million and $3.3 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, due to increases in spend related to our (Z)-endoxifen trials, including drug development costs.
Current wording
Clinical and non-clinical trial expenses increased $1.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, due to increases in spend related to our (Z)-endoxifen trials, including drug development costs.
Previous wording
The increases in G&A compensation expenses of $0.1 million and $0.8 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, were primarily due to increases in non-cash stock-based compensation expense of $0.1 million and $0.6 million, respectively.
Current wording
The increase in R&D compensation expenses of $0.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.
Previous wording
The increases in R&D professional fees and other of $0.1 million and $0.6 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, were primarily attributable to higher regulatory consulting fees in the 2025 periods related to our (Z)-endoxifen program.
Current wording
The decreases in R&D professional fees and other of $0.4 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, were primarily attributable to lower regulatory consulting fees in the first quarter of 2026 related to our (Z)-endoxifen program as compared to the same quarter in the prior year.
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 nine months ended September 30, 2025 and 2024, 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 months ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
Previous wording
The increases in G&A professional fees and other of $0.8 million and $0.3 million for the three and nine months ended September 30, 2025, compared to the three and nine months ended September 30, 2024, were primarily due to increases in legal fees of $0.7 million and $0.5 million, respectively, related to higher patent-related activity as well as other legal matters, partially offset by decreases in investor relations costs of $0.3 million due to changes in the timing of investor outreach programs.
Current wording
The increase in G&A professional fees and other of $2.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, was due primarily to higher legal fees of $1.8 million, related to our ongoing patent litigation activity, which has subsequently been settled, as well as fees associated with management of our intellectual property portfolio and other legal matters.
Previous wording
Income Taxes. We did not record an income tax expense or benefit for the three and nine months ended September 30, 2025 and 2024 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 month months ended March 31, 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
We are authorized to issue up to 350,000,000 shares of common stock, par value $0.18 per share. On November 19, 2024, we entered into an Open Market Sale Agreement SM with Jefferies LLC. 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 $100.0 million. We did not make any sales under the at the market offering facility during the three and nine months ended September 30, 2025.
Current wording
On February 20, 2026, we entered into an At the Market Offering Agreement, dated February 20, 2026 (the Sales Agreement), with Rodman & Renshaw LLC. 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. The Sales Agreement was effective as of March 31, 2026. We did not make any sales under the Sales Agreement during the three months ended March 31, 2026, or prior to the issuance date of this report.
Previous wording
We have incurred net losses and negative operating cash flows since inception. For the nine months ended September 30, 2025, we recorded a net loss of $23.8 million and used $19.2 million of cash and cash equivalents. As of September 30, 2025, we had $51.8 million in cash and cash equivalents and working capital of $47.5 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 three months ended March 31, 2026, we recorded a net loss of $9.6 million and used $9.6 million of cash and cash equivalents in operating activities. As of March 31, 2026, we had $31.7 million in cash and cash equivalents and working capital of $29.2 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 nine months ended September 30, 2025 compared to the same period in 2024, net cash used in operating activities increased $5.2 million, primarily reflecting:
Current wording
Net Cash Flows from Operating Activities. During the three months ended March 31, 2026, compared to the same period in 2025, net cash used in operating activities increased $3.6 million due primarily to the following:
Previous wording
a decrease of $1.3 million in cash provided by interest income due to lower amounts invested in our money market account.
Current wording
a decrease of $0.4 million resulting from lower interest income due to lower average amounts invested in our money market account during the current period when compared to the same period in the prior year.
Previous wording
If we are unable to raise additional capital when needed on reasonable terms, if at all, we could be forced to curtail or cease our operations. Our future capital uses and requirements will depend on the time and expenses needed to begin and continue clinical trials for our new drug developments.
Current wording
Substantial doubt exists about our ability to continue as a going concern. If we are unable to raise additional capital when needed on reasonable terms, if at all, we could be forced to cease operations or substantially curtail our activities. Our future capital uses and requirements will depend on the time and expenses needed to begin and continue clinical trials for our new drug developments.
Previous wording
Additional funding may not be available to us on acceptable terms or at all. Continued uncertain market and macroeconomic conditions, including the impact of inflation, tariffs, high interest rates, general economic slowdown or a recession, foreign exchange rate volatility, financial institution instability, changes in monetary policy, changes in trade policies and other trade restrictions or the threat of such actions, and increasing geopolitical instability, may limit our ability to access capital. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. For example, we may raise additional funds by issuing equity securities or by equity offerings, collaboration agreements, debt financings or licensing arrangements. If adequate funds are not available, we may be required to terminate, significantly modify or delay our development programs, reduce our planned commercialization efforts, or obtain funds through collaborators that may require us to relinquish rights to our technologies or product candidates that we might otherwise seek to develop or commercialize independently. Further, we may elect to raise additional funds even before we need them if we believe the conditions for raising capital are favorable.
Current wording
Additional funding may not be available to us on acceptable terms or at all. Continued uncertain market and macroeconomic conditions, including due to inflationary pressures, high interest rates, general economic slowdown or a recession, foreign exchange rate volatility, financial institution instability, changes in monetary policy, changes in trade policies including tariffs and other trade restrictions or the threat of such actions, and increasing geopolitical instability, and the related volatility in the price of oil and other commodity prices, may limit our ability to access capital. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. For example, we may raise additional funds by issuing equity securities or by equity offerings, collaboration agreements, debt financings or licensing arrangements.
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 September 30, 2025, our estimated non-cancellable commitment was $7.8 million which will be paid over the term of the clinical trials.
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 March 31, 2026, our estimated non-cancellable commitment was $5.3 million, which will be paid over the term of the clinical trials.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Our Open Market Sale Agreement SM with Jefferies LLC, effective November 19, 2024 (the Prior ATM Facility), pursuant to which we were able to 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 $100.0 million, was cancelled on February 19, 2026. We did not make any sales under the Prior ATM Facility prior to its cancellation in 2026.
Current report — wording carried from elsewhere
If adequate funds are not available, we may be required to terminate, significantly modify or delay our development programs, reduce our planned commercialization efforts, or obtain funds through collaborators that may require us to relinquish rights to our technologies or product candidates that we might otherwise seek to develop or commercialize independently. Further, we may elect to raise additional funds even before we need them if we believe the conditions for raising capital are favorable.