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Skye Bioscience, Inc.

For the period ended Sep 30, 2025. Filed Nov 10, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 10, 2025

SKYE$0.99-4.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-07.

0001516551-25-000049

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

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-10.

0001628280-25-051031

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

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 122 previous paragraphs and 126 current paragraphs.

50 unchanged; 52 reworded; 24 added; 17 removed; 3 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 9 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 (24)

Current report

In October 2025, we reported the following 26 week topline data from our ongoing CBeyond study:

Current report

•In CBeyond, the nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo (-1.52% vs. -0.26 for placebo, mITT). Preliminary pharmacokinetic analysis showed an association between exposure and response, suggesting that the 200 mg, subcutaneous weekly dose was suboptimal as a monotherapy.

Current report

•At the tested dose and exposure levels, nimacimab 200 mg demonstrated a favorable safety profile with placebo-like tolerability. In combination with semaglutide, there was no increase in gastrointestinal (GI) adverse events. Importantly, there were no increases in neuropsychiatric adverse events reported resulting from treatment with nimacimab.

Current report

•In the combination arm, nimacimab 200 mg, subcutaneous weekly dose plus semaglutide demonstrated a clinically meaningful magnitude of weight loss compared to semaglutide alone (-13.2% vs -10.25%, p=0.0372, mITT), with no plateau being observed through Week 26. In the combination arm, 100% of patients achieved greater than 5% weight loss (vs. 85% with semaglutide alone) and 67% achieved greater than 10% weight loss (vs. 50% with semaglutide alone) based on the per protocol analysis. This finding supports potential further studies to evaluate combinations of nimacimab and incretin-based therapies. Other findings in the combination arm included:

Current report

◦Nimacimab plus semaglutide showed a change of -11.26cm (1.16cm) in waist circumference versus -8.09cm (1.2cm) for semaglutide alone, resulting in a difference of -3.17cm (1.59cm) (p=0.0492, using least-squares mean (LSM)).

Current report

◦An improvement in lean mass to fat mass ratio was observed at week 26 when comparing the nimacimab plus semaglutide combination arm to the placebo arm (0.26 vs. 0.02, p <0.0001), and the combination arm compared to semaglutide alone (0.26 vs. 0.13, p = 0.0126).

Current report

◦A decrease in rebound weight gain in an analysis of participants 12 weeks post-treatment when nimacimab 200 mg (subcutaneous, weekly) was combined with semaglutide when compared to semaglutide alone (18.1% versus 49.8% weight rebound). Moreover, at 12 weeks post-treatment, the nimacimab plus semaglutide group maintained significant weight loss compared to the placebo group (p=0.006), while the semaglutide alone group lost significance over the placebo group (p=0.12) and followed a trajectory of rebound weight gain consistent with previously reported data (Wilding et al., 2022, STEP-1 Trial Extension), which demonstrated that patients will gain a majority of weight back within 1-year of stopping treatment with semaglutide.

Current report

Patients who completed 26 weeks of treatment in the primary phase of the study were eligible to enroll in a 26-week extension for a potential full treatment duration of 52 weeks with a 13-week follow-up period. In September 2025, we completed the enrollment in the extension study. A total of 43 patients were enrolled, with 19 and 24 patients in the combination and monotherapy cohorts, respectively. In the combination arms, patients will continue with blinded treatment with nimacimab or placebo and will continue receiving semaglutide (Wegovy®). Patients in the monotherapy arm will receive nimacimab 300 mg during the extension. Enrollment for the extension is complete. Skye expects to report data from the extension study in Q1 2026.

Current report

We believe multiple factors support evaluation of nimacimab at higher doses, including the combination of preclinical toxicology safety margins and modeling; preclinical pharmacology data showing dose-dependent increases in weight loss with nimacimab monotherapy and GLP-1 combinations; and the notable safety profile in the Phase 2a study. However, there can be no assurance that nimacimab at higher doses will result in the desired end points.

Current report

•Quality assurance costs increased by $100,653 from routine vendor site audits.

Current report

•Consulting, advisory and professional fees decreased by $496,410 primarily due to the timing of tax accounting services and financial advisory services.

Current report

•Investor relations, marketing and communications expenses increased by $50,022 primarily due to additional content creation and digital marketing expenses.

Current report

•Recruiting fees decreasedby$272,699 primarily due to the one time cost to hire an executive in the prior period.

Current report

•Legal and professional fees increased by $171,707 due to increased patent prosecution activity and litigation defense costs.

Current report

Total change in estimate for legal contingencies for the three months ended September 30, 2025 and for the same period in 2024:

Current report

For the three months ended September 30, 2024, we recorded a change in estimate for legal contingencies (as defined in Note 7 to the accompanying Unaudited Condensed Consolidated Financial Statements) based on changes after September 30, 2024 to the facts and circumstances related to our legal proceedings that existed as of the balance sheet date.

Current report

•Increased interest income of $90,766 due to the reversal of accrued interest on the legal judgment, which was vacated in the prior year.

Current report

•Professional, consulting and advisory fees decreased by $518,287 primarily due to the decrease in professional fees from tax and financial advisory services.

Current report

•Recruiting fees expenses decreased by $219,935 due to the one time cost to hire an executive in the prior period.

Current report

Total change in estimate for legal contingencies for the nine months ended September 30, 2025 and for the same period in 2024:

Current report

For the nine months ended September 30, 2024, we recorded a change in estimate for legal contingencies (as defined in Note 7 to the accompanying Unaudited Condensed Consolidated Financial Statements) based on changes after September 30, 2024 to the facts and circumstances related to our legal proceedings that existed as of the balance sheet date.
Removed paragraphs (17)

Previous report

This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1943, as amended (the "Exchange Act") that involve substantial risks and uncertainties. The words “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “may,” “will,” “should,” “could,” “target,” “strategy,” “intend,” “project,” “guidance,” “likely,” “usually,” “potential,” or the negative of these words or variations of such words, similar expressions, or comparable terminology are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. A further list and description of risks, uncertainties and other factors that could cause actual results or events to differ materially from the forward-looking statements that we make is included in the cautionary statements herein and in our other filings with the SEC, including those set forth under Part I, Item 1A, Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024. Our forward-looking statements do not reflect the potential impact of any future acquisitions,

Previous report

mergers, dispositions, joint ventures or investments that we may make.

Previous report

We have based the forward-looking statements included in this Quarterly Report on Form 10-Q on information available to us on the date of this quarterly report, and we assume no obligation to update any such forward-looking statements, other than as required by law. Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, you are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.

Previous report

To obtain 52 weeks of treatment data, we are enrolling a Phase 2a trial extension that increases the originally planned 26 weeks of treatment in the CBeyond study to provide a longer-term assessment of safety, tolerability and efficacy. The protocol extension provides for continued assessment of nimacimab as a monotherapy and in combination with a GLP-1 receptor agonist.

Previous report

The Data Safety Monitoring Committee for the CBeyond study has completed four regularly scheduled reviews and has recommended that the CBeyond study continue in accordance with the study protocol.

Previous report

We recently shared new data from a preclinical diet induced obesity (DIO) mouse model which provides further evidence for the potential combination of nimacimab with incretins and demonstrated the potential durability of response with nimacimab as a monotherapy or maintenance therapy post-incretin treatment. The preclinical DIO study demonstrated that at day 25 the combination of nimacimab and a suboptimal tirzepatide dose (3nmol/kg daily) yielded 44% vehicle-adjusted weight loss

Previous report

(29.6% weight loss with an average of 30g mice). The combination outperformed either agent alone with nimacimab demonstrating 21.5% vehicle-adjusted weight loss (7.1% weight loss with an average of 40g mice) and the suboptimal tirzepatide dose demonstrating 29.7% vehicle-adjusted weight loss (15.4% weight loss with an average of 36g mice). The combination efficacy also exceeded an optimal dose of tirzepatide (10 nmol/kg), which resulted in 38.9% vehicle-adjusted weight loss (24.6% weight loss with 32g mice). The preclinical DIO study also demonstrated that, when used as a monotherapy, nimacimab-driven weight loss persisted for about 20 days after treatment cessation, while mice treated with tirzepatide alone regained most of their lost weight within a week post-treatment. Lastly, the preclinical DIO study demonstrated that when nimacimab alone was used after an initial tirzepatide or combination treatment in the preclinical DIO mouse model, it reduced rebound weight gain in these groups of mice.

Previous report

•Consulting and advisory fees increased by $276,812 from the use of finance consultants and board member compensation.

Previous report

•General business expenses decreased by $371,633 primarily due to the one time cost of uplisting to Nasdaq in the prior period.

Previous report

•Increased gain from the sale of asset of $89,363 during the period ended June 30, 2025 from the collection of amounts due from the sale of real estate.

Previous report

•Consulting and advisory fees increased by $378,083 from the use of finance consultants, and fees associated with the Company's annual general meeting of stockholders.

Previous report

•Human resources related expenses increased by $52,764 due to increased hiring activity.

Previous report

•General business expenses decreased by $358,592 due to the one time cost of uplisting to Nasdaq in the prior period and one-time fees related to SEC filings in the prior period offset by increased software costs.
Reworded paragraphs (52)

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements (unaudited) for the three and six months ended June 30, 2025 and 2024, together with the notes thereto and the consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on March 20, 2025.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements (unaudited) for the three and nine months ended September 30, 2025 and 2024, together with the notes thereto and the consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on March 20, 2025.

Previous wording

We are a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors ("GPCRs") to treat obesity, overweight, and related conditions. Our lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting the CB1 receptor—a key GPCR involved in metabolic regulation.

Current wording

We are a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors ("GPCRs") to treat obesity, overweight, and related conditions. Our lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting the CB1 receptor.

Previous wording

We are conducting CBeyond TM, a Phase 2a proof-of-concept clinical trial of nimacimab administered as a subcutaneous injectable for the treatment of obesity and overweight in the United States. The CBeyond study is also assessing the combination of nimacimab and a GLP-1 receptor agonist. We anticipate providing a top-line readout from the CBeyond study late in the third quarter or early in the fourth quarter of 2025.

Current wording

We are conducting CBeyond TM, a Phase 2a proof-of-concept clinical trial of nimacimab administered as a subcutaneous injectable for the treatment of obesity and overweight in the United States. The randomized, placebo- and active-controlled, double-blind CBeyond Phase 2a trial enrolled 136 adults with obesity or overweight, including individuals with a BMI ≥27 kg/m² with at least one comorbidity. Patients were randomized across four arms, 2:2:1:1 to arms with weekly nimacimab 200 mg subcutaneously, placebo, nimacimab 200 mg plus semaglutide (Wegovy®), or placebo plus semaglutide, and were dosed weekly for 26 weeks. Patients not participating in a 26-week extension were monitored for 13 weeks post-treatment.

Previous wording

We were incorporated under the laws of the State of Nevada on March 16, 2011, and our headquarters are based in San Diego, CA. We also maintain administrative office space in San Francisco, CA. Since our incorporation, we have devoted substantially all of our efforts to building our product portfolio through the acquisition of clinical assets and licensing agreements, carrying out research and development, building infrastructure and raising capital.

Current wording

We were incorporated under the laws of the State of Nevada on March 16, 2011. Our headquarters are based in San Diego, CA, and we also maintain administrative office space in San Francisco, CA. Since our incorporation, we have devoted substantially all of our efforts to building our product portfolio through the acquisition of clinical assets and licensing agreements, carrying out research and development, building infrastructure and raising capital.

Previous wording

During the three and six months ended June 30, 2025, we incurred $14,337,753 and $21,535,010 in research and development expenses primarily related to our Phase 2a clinical trial of nimacimab for obesity and the manufacturing costs associated with future trials. During the three and six months ended June 30, 2024, we incurred $4,078,751 and $6,025,201 in research and development expense primarily related to our efforts in conducting our Phase 2a clinical trial for SBI-100 OE and costs related to our Phase 2a clinical trial for nimacimab for obesity.

Current wording

During the three and nine months ended September 30, 2025, we incurred $9,357,444 and $30,892,454 in research and development expenses primarily related to our Phase 2a clinical trial of nimacimab for obesity and the manufacturing costs associated with future trials. During the three and nine months ended September 30, 2024, we incurred $4,883,337 and $10,908,538 in research and development expense primarily related to our efforts in conducting our Phase 2a clinical trial for SBI-100 OE and costs related to our Phase 2a clinical trial for nimacimab for obesity.

Previous wording

The estimate for legal contingencies and related expenses relates to a litigation matter that related to a former employee of the Company. As of December 31, 2023, we had posted an appellate bond that was collateralized by an irrevocable letter of credit equal to, $9,080,202, approximately 150% of the liability recorded on our balance sheet. As of December 31, 2024, we were successful in our appeal of the judgement in the Ninth Circuit Court of Appeals and the case was remanded back to the District Court for a new trial, as a result of which we reduced the estimated legal contingency based on new key assumptions. The final amount of the loss and loss recoveries remains uncertain. We believe that it is at least reasonably possible that the estimated amount of the potential loss may change in the near term. As of June 30, 2025, the estimated legal contingency, including accrued legal expenses, is $1,806,065.

Current wording

The estimate for legal contingencies and related expenses relates to a litigation matter that related to a former employee of the Company. As of December 31, 2023, we had posted an appellate bond that was collateralized by an irrevocable letter of credit equal to, $9,080,202, approximately 150% of the liability recorded on our balance sheet. As of December 31, 2024, we were successful in our appeal of the judgment in the Ninth Circuit Court of Appeals and the case was remanded back to the District Court for a new trial, as a result of which we reduced the estimated legal contingency based on new key assumptions. The final amount of the loss and loss recoveries remains uncertain. We believe that it is at least reasonably possible that the estimated amount of the potential loss may change in the near term. As of September 30, 2025, the estimated legal contingency, including accrued legal expenses, is $2,054,357.

Previous wording

Other expense primarily includes a gain from the sale of the Avalite Sciences, Inc. ("AVI") building (the "AVI building") in the first quarter of 2024, and interest expense. These expenses are offset by interest income earned on our cash balances and investments.

Current wording

Other (income) expense primarily includes a gain from the sale of the Avalite Sciences, Inc. ("AVI") building (the "AVI building") in the first quarter of 2024, and interest expense. These expenses are offset by interest income earned on our cash and cash equivalent balances and short term investments.

Previous wording

There have been no material changes in our Critical Accounting Estimates from the information provided in the "Critical Accounting Estimates" section of "Item 7- Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, except, for the addition of our critical accounting estimate related to the estimate for accrued legal contingencies and related expenses and loss recoveries.

Current wording

There have been no material changes in our Critical Accounting Estimates from the information provided in the "Critical Accounting Estimates" section of "Item 7- Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Previous wording

Research and development expenses for the three months ended June 30, 2025, increased by$10,259,002 as compared to the same period in 2024. The net increase in research and development expenses was primarily due to:

Current wording

Research and development expenses for the three months ended September 30, 2025, increased by$4,474,107 as compared to the same period in 2024. The net increase in research and development expenses was primarily due to:

Previous wording

•Clinical trial costs increased by $3,625,342 due to increased site and patient costs related to our extended Nimacimab Phase 2a clinical study, offset by a decrease in costs to complete our glaucoma study.

Current wording

•Clinical trial costs increased by $578,014 due to increased site and patient costs related to our Phase 2a clinical study for nimacimab.

Previous wording

•Contract manufacturing costs increased by $9,149,873 from drug substance, product, labeling and packaging costs related to resupplying our extended Phase 2a clinical study of nimacimab, manufacturing in anticipation for our Phase 2b clinical study for nimacimab, and process intensification and dose optimization work.

Current wording

•Contract manufacturing costs increasedby $2,704,671 from drug substance, product, labeling and packaging costs related to resupplying our extended Phase 2a clinical study for nimacimab, manufacturing in anticipation for our clinical study of nimacimab, and process intensification and dose optimization work.

Previous wording

•Discovery research and development increased $721,676 from increased work to interrogate nimacimab's mechanism of action and for life cycle management.

Current wording

•Discovery research and development costs increased $479,430 from increased work to interrogate nimacimab's mechanism of action and for life cycle management.

Previous wording

•Salaries and stock-based compensation increased by$563,161 due to increased headcount.

Current wording

•Salaries and stock-based compensation increased by$387,000 due to increased headcount.

Previous wording

•General business expenses decreased by $263,555 due to the non-recurrence of fees associated with eliminating our glaucoma program.

Current wording

•General business expenses decreased by $139,664 due to the non-recurrence of fees associated with eliminating our glaucoma program.

Previous wording

•Consulting costs increased by $142,092 to support our nimacimab program.

Current wording

•Consulting, advisory and professional fees increased by $353,956 to support our nimacimab program.

Previous wording

•Depreciation expense on equipment increased by $94,809 due to the depreciation of manufacturing equipment.

Current wording

•Depreciation expense on equipment increased by $59,243 due to the depreciation of manufacturing equipment.

Previous wording

General and administrative expenses for the three months ended June 30, 2025, decreased by$420,648 as compared to the same period in 2024. The decrease in general and administrative expenses was primarily due to:

Current wording

General and administrative expenses for the three months ended September 30, 2025, decreased by$731,837 as compared to the same period in 2024. The decrease in general and administrative expenses was primarily due to:

Previous wording

•Salaries, benefits and other direct employee related costs increased by $289,007 primarily due to higher headcount.

Current wording

•Salaries, benefits and other direct employee related costs decreased by $209,163 primarily due to lower headcount and timing of new hires.

Previous wording

For the three months ended June 30, 2025, we had an increase of other (income) expense of$111,627 as compared to the same period in 2024 primarily due to:

Current wording

For the three months ended September 30, 2025, we had an decrease of other income of$560,625 as compared to the same period in 2024 primarily due to:

Previous wording

•Decreases in interest income and other income of $428,147 due to decreased interest from our cash equivalents and short-term investments yields as a result of the decrease in cash equivalents and short-term investments on hand.

Current wording

•Decreases in interest income and other income of $489,223 due to decreased interest from our cash equivalents and short-term investments yields as a result of the decrease in cash equivalents and short-term investments on hand.

Previous wording

Below is a summary of our research and development expenses during the six months ended June 30, 2025 and for the same period in 2024:

Current wording

Below is a summary of our research and development expenses during the nine months ended September 30, 2025, and for the same period in 2024:

Previous wording

Research and development expenses for thesix months ended June 30, 2025, increased by$15,509,809 as compared to the same period in 2024. The net increase in research and development expenses was primarily due to:

Current wording

Research and development expenses for thenine months ended September 30, 2025, increased by$19,983,916 as compared to the same period in 2024. The net increase in research and development expenses was primarily due to:

Previous wording

•Clinical trial costs increased by $2,358,832 due to increased site and patient costs related to our Nimacimab Phase 2a clinical study, offset by a decrease in costs to complete our glaucoma study.

Current wording

•Clinical trial costs increased by $4,203,355 due to increased site and patient costs related to our the extension of the Phase 2a clinical study of nimacimab, offset by a decrease in costs to complete our glaucoma study.

Previous wording

•Contract manufacturing costs increased by $6,617,742 from drug substance, product, labeling and packaging costs related to resupplying our extended Phase 2a study for nimacimab, manufacturing in anticipation for our Phase 2b clinical study for nimacimab, and process intensification and dose optimization work.

Current wording

•Contract manufacturing costs increased by $11,854,544 from drug substance, product, labeling and packaging costs related to resupplying the extension of our Phase 2a clinical study of nimacimab, manufacturing drug substance for the next CBeyond clinical study for nimacimab, and process intensification and dose optimization work.

Previous wording

•Discovery research and development increased $1,344,695 from increased work to interrogate nimacimab's mechanism of action, potency and for life cycle management.

Current wording

•Discovery research and development increased $1,824,126 from increased work to interrogate nimacimab's mechanism of action, potency and for life cycle management.

Previous wording

•Salaries, benefits and stock-based compensation increased by$1,089,121 due to increased headcount.

Current wording

•Salaries, benefits and stock-based compensation increased by$1,476,121 due to increased headcount.

Previous wording

•Consulting costs increased by $292,071 to support our nimacimab program.

Current wording

•Consulting, advisory and professional fees increased by $603,719 to support our nimacimab program.

Previous wording

•General business expenses decreased by $262,745 due to the non-recurrence of fees associated with eliminating our glaucoma program.

Current wording

•General business expenses decreased by $402,409 due to the non-recurrence of fees associated with eliminating our glaucoma program.

Previous wording

•Depreciation expense on equipment increased by $189,844 due to the depreciation of manufacturing equipment.

Current wording

•Depreciation expense on equipment increased by $249,087 due to the depreciation of manufacturing equipment.

Previous wording

Below is a summary of our general and administrative expenses during the six months ended June 30, 2025, and for the same period in 2024:

Current wording

Below is a summary of our general and administrative expenses during the nine months ended September 30, 2025, and for the same period in 2024:

Previous wording

General and administrative expenses for thesix months ended June 30, 2025, decreased by$64,143 as compared to the same period in 2024. The decrease in general and administrative expenses was primarily due to:

Current wording

General and administrative expenses for thenine months ended September 30, 2025, decreased by$795,980 as compared to the same period in 2024. The decrease in general and administrative expenses was primarily due to:

Previous wording

•Salaries, benefits and other direct employee related costs increased by $152,870 primarily due to higher headcount.

Current wording

•Salaries, benefits and other direct employee related costs decreased by $56,293 primarily due to lower headcount and timing of new hires.

Previous wording

•Investor relations, marketing and communications expenses increased by $565,089 due to primarily to a market evaluation study for nimacimab and increased investor communications activities.

Current wording

•Investor relations, marketing and communications expenses increased by $615,111 due primarily to a market evaluation study for nimacimab and increased investor communications activities.

Previous wording

•Legal and professional fees decreased by $862,862 due to decreases in litigation, one-time fees related to SEC filings in the prior period, decreases in external legal costs and decreased financial advisory services.

Current wording

•Legal and professional fees decreased by $291,197 due to decreases in litigation, one-time fees related to SEC filings in the prior period, decreases in external legal costs and decreased financial advisory services.

Previous wording

Below is a summary of our other (income) expense for the six months ended June 30, 2025 and for the same period in 2024:

Current wording

Below is a summary of our other (income) expense for the nine months ended September 30, 2025 and for the same period in 2024:

Previous wording

For thesix months ended June 30, 2025, we had a reduction of other (income) expense of$364,849 as compared to the same period in 2024 primarily due to:

Current wording

For thenine months ended September 30, 2025, we had a reduction of other (income) expense of$925,474 as compared to the same period in 2024 primarily due to:

Previous wording

•Gain on sale of asset decreased by $1,055,645, due to the one-time sale of real estate.

Current wording

•Gain on sale of asset decreased by $1,037,215, due to the one-time sale of real estate during the nine months ended September 30, 2024.

Previous wording

•Decreased interest expense of $450,052 due to the reduction of debt.

Current wording

•Decreased interest expense of $796,222 due to the reduction of debt.

Previous wording

•Decreased interest income and other income of $197,458 due to the decreased interest from our cash equivalents and short-term investments yields as a result of the decrease in cash equivalents and short-term investments on hand.

Current wording

•Decreased interest income and other income of $686,681 due to the decreased interest from our cash and cash equivalents and short-term investments yields as a result of the decrease in cash equivalents and short-term investments on hand.

Previous wording

We have incurred operating losses and negative cash flows from operations since our inception, and as of June 30, 2025, we had working capital of $42,270,810, an accumulated deficit of $159,677,863, and stockholders’ equity of $43,676,709. We had unrestricted cash and cash equivalents and short-term investments in the amount of $48,585,283 as of June 30, 2025, as compared to $68,415,741 as of December 31, 2024. For the six months ended June 30, 2025 and 2024, the Company incurred losses from operations of $30,003,487 and $14,557,821, respectively. For the six months ended June 30, 2025 and 2024, the Company incurred net losses of $28,728,191 and $12,922,347, respectively.

Current wording

We have incurred operating losses and negative cash flows from operations since our inception, and as of September 30, 2025, we had working capital of $31,556,897, an accumulated deficit of $172,432,523, and stockholders’ equity of $32,836,185. We had unrestricted cash and cash equivalents and short-term investments in the amount of $35,312,308 as of September 30, 2025, as compared to $68,415,741 as of December 31, 2024. For the nine months ended September 30, 2025 and 2024, the Company incurred losses from operations of $43,268,021 and $19,526,617, respectively. For the nine months ended September 30, 2025 and 2024, the Company incurred net losses of $41,482,851 and $16,820,644, respectively.

Showing the first 40 of 52 pairs. Open the source sections for the rest.

Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

•Investor relations, marketing and communications expenses increased by $191,519 primarily due to to a market evaluation study for nimacimab and increased investor outreach activities.

Previous report — wording carried elsewhere

•Legal and professional fees decreased by $854,783 due to decreases in litigation, one-time fees related to filings with the SEC in the prior period, and decreases in external legal costs and decreased financial advisory services.

Previous report — wording carried elsewhere

•Decreased interest expense of $886,988 due to the reduction of debt.