Skye Bioscience, Inc.
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
SKYE$0.99-4.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001628280-26-033417
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001628280-26-056968
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 109 previous paragraphs and 125 current paragraphs.
35 unchanged; 30 reworded; 49 added; 40 removed; 4 previous and 11 current paragraphs rearranged.
Tables are not compared: 4 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 (49)
Current report
Results of CBeyond Phase 2a Proof-of-Concept Trial
Current report
We believe multiple factors may have resulted in the lower than anticipated weight loss results for nimacimab as a monotherapy, including a lower systemic exposure than originally modeled, and a better understanding of tissue exposure required to drive weight loss with peripheral CB1 inhibition.
Current report
Recent Developments
Current report
Termination of CBeyond Study
Current report
With recent approvals of oral versions of GLP-1 receptor agonists (WEGOVY and FOUNDAYO), combined with continued development GLP-1, GIP, glucagon triple agonists, such as retatrutide demonstrating greater than 25% weight loss, Skye management determined that nimacimab's current target product profile which included at least a 600mg once-weekly dose, or 6 mL weekly injection, may not significantly penetrate the increasingly competitive anti-obesity medicine market. As a result, the Company terminated all clinical activities related to CBeyond, including enrollment for the CBeyond expansion (Part C) study, and paused all R&D activities associated with nimacimab in order to evaluate strategic options. In addition, the Company instituted multiple cost-cutting measures, including but not limited to, a reduction in workforce and termination of certain vendor contracts and licensing agreements.
Current report
Transaction with Redx Pharma Limited
Current report
On August 14, 2026, we entered into a transaction agreement (“Transaction Agreement”) with Redx Pharma Limited with registered number 07368089 (“Redx”), a private limited company incorporated in England and Wales. Pursuant to the Transaction Agreement, and subject to the terms and conditions set forth therein, we will acquire the entire issued and to be issued share capital of Redx pursuant to a scheme of arrangement under Part 26 of the United Kingdom Companies Act 2006 (the “Scheme of Arrangement” and such transaction, the “Transaction”). Upon the consummation of the Transaction, the combined company will be led by the Redx management team and plans to operate under the name Fibrx Therapeutics, Inc. The Transaction Agreement was unanimously approved by our board of directors and is subject to certain customary closing conditions, including the approval by the stockholders of each company. See Note 11 Subsequent Events for additional information.
Current report
Company Contingent Value Rights Agreement
Current report
Immediately prior to the Effective Time, the Company and a rights agent are expected to enter into a contingent value rights agreement (the “Legacy CVR Agreement”), pursuant to which holders of record of Common Stock as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one contingent value right for each outstanding share of Common Stock held as of such date. Pursuant to the Legacy CVR Agreement, each Company Legacy CVR holder will be entitled to receive their pro rata share of an aggregate cash payment equal to 90% of the net proceeds, if any, received by the Company as a result of payments made to the Company of any upfront, milestone, royalty and other payments received under any disposition agreement related to certain of the Company’s pre-Transaction assets (the “Legacy Assets”).
Current report
The foregoing summary of the Legacy CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the form of the Legacy CVR Agreement, which is filed herewith as Exhibit 10.1 and is incorporated by reference herein.
Current report
Redx Contingent Value Rights Agreement
Current report
Immediately prior to the Effective Time, Redx and a rights agent are expected to enter into a contingent value rights agreement (the “Redx CVR Agreement”), pursuant to which holders of record of Redx ordinary shares as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one contingent value right for each outstanding Redx ordinary share held as of such date. Pursuant to the Redx CVR Agreement, each Redx Legacy CVR holder will be entitled to receive, in the form of shares of common stock of the Company, their pro rata share of an aggregate cash payment equal to 100% of the net proceeds, if any, received by the Company as a result of payments made to the Company of any upfront, milestone, royalty and other payments received under any disposition agreement related to certain of Redx’s pre-Transaction assets.
Current report
The foregoing summary of the Redx CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the form of the Redx CVR Agreement, which is filed herewith as Exhibit 10.2 and is incorporated by reference herein.
Current report
Concurrent Financing
Current report
Concurrently with entering into the Transaction Agreement, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain accredited investors (the “Investors”). Pursuant to the Securities Purchase Agreement, and subject to the terms and conditions therein, the Company agreed to sell, and the Investors agreed to purchase, immediately after to the Effective Time, shares of Common Stock for an aggregate purchase price of $67.9 million, which may increase to up to
Current report
$72.9 million, subject to certain conditions (the “Concurrent Financing”). The closing of the Concurrent Financing is anticipated to occur immediately after the Closing on the Closing Date, subject to the satisfaction of customary closing conditions.
Current report
Additionally, Redx entered into subscription agreements with new and existing Redx investors, including Redx's existing major shareholder, Redmile, for a Series A private placement of $36.0 million in gross proceeds (the “Series A Financing” and, together with the Concurrent Financing, the “Financing”). The Series A Financing has been approved by the Redx board of directors and, subject to Redx shareholder approval, is expected to close shortly after the execution of the Transaction Agreement. The Financing is expected to provide the combined company with an aggregate total gross proceeds of approximately $103.9 million, which may increase to up to $108.9 million, subject to certain conditions set forth in the Side Letter (the “Concurrent Financing”). See Note 11 Subsequent Events for additional information.
Current report
Equity Line of Credit and Warrant
Current report
Concurrently with entering into the Transaction Agreement, the Company entered in a binding term sheet (the “Term Sheet”) with a fund affiliated with Redmile Group, LLC (“Redmile”), pursuant to which, and subject to the terms and conditions therein, the Company and Redmile agreed to enter into definitive documentation with respect to an equity line of credit (the “ELOC”) and the Warrant (as defined below) within seven days of the date of the Term Sheet. Pursuant to the Term Sheet, the ELOC will be effective for a period of three years following the closing of the Concurrent Financing and obligate the Company to sell shares of Common Stock and/or Non-Voting Common Stock having an aggregate purchase price of up to $22.0 million to Redmile from time to time, subject to cetain volume limitations, at a purchase price set in accordance with the terms therein. In addition, pursuant to the Term Sheet, the Company agreed to issue to Redmile at the Closing Time, a warrant to purchase up to $5.0 million of shares of Common Stock and/or Non-Voting Common Stock in accordance with the terms set forth therein (the “Warrant”).
Current report
Termination of Halozyme License Agreement
Current report
In December 2025, the Company entered into a Non-exclusive Global Collaboration and License Agreement (the “Halozyme License Agreement”) with Halozyme, Inc. (“Halozyme”).
Current report
Under the terms of the Halozyme License Agreement, Halozyme granted the Company a non-exclusive license to Halozyme’s ENHANZE® drug delivery technology for the development of a subcutaneous co-formulation with nimacimab (such combination, the “Product”). Halozyme will also be the Company’s exclusive supplier of clinical and commercial supplies of the active pharmaceutical ingredient ("API") for Halozyme’s rHuPH20 bulk drug product.
Current report
On August 11, 2026, the Company notified Halozyme of its intent to terminate the Halozyme License Agreement.
Current report
To date, we have not commercialized any products and have never generated revenue from the commercialization of any product. If we are unable to complete the proposed transaction with Redx, we may need to raise additional capital. There can be no assurances, however, that additional funding will be available on terms acceptable to us, or at all.
Current report
As a result of terminating the CBeyond trial and any other research and development expenses associated with nimacimab, including workforce reduction, vendor contracts and license agreements, we expect research and development expenses in the future will be significantly reduced until the completion of the proposed transaction with Redx.
Current report
•Clinical trial costs decreased by $2,025,003 due to the termination of all clinical activities related to CBeyond, including enrollment for the CBeyond expansion (Part C) study, and the pausing of all R&D activities associated with nimacimab in order to evaluate strategic options.
Current report
•Contract manufacturing costs decreasedby $7,885,849 due to the termination of all clinical activities related to CBeyond, including enrollment for the CBeyond expansion (Part C) study, and the pausing of all R&D activities associated with nimacimab in order to evaluate strategic options.
Current report
•Discovery research and development costs decreased $555,674 primarily due to the pausing of all R&D activities and cost-cutting measures implemented as the Company evaluates strategic options.
Current report
•Quality assurance costs decreased by $21,480 primarily due to the pausing of all R&D activities and cost-cutting measures implemented as the Company evaluates strategic options.
Current report
•Consulting, advisory and professional fees decreased by $59,191 primarily due to the pausing of all R&D activities associated with nimacimab and cost-cutting measures implemented as the Company evaluates strategic options.
Current report
•Legal fees increased by $1,549,769 due to costs associated with the strategic alternatives process and negotiation of the proposed Transaction Agreement and litigation defense costs.
Current report
Change in Estimate for Legal Contingencies
Current report
Total change in estimate for legal contingencies for the three months ended June 30, 2026, and for the same period in 2025:
Current report
For the three months ended June 30, 2026, we recorded a change in estimate for legal contingencies (as defined in Note 9 to the accompanying Unaudited Condensed Consolidated Financial Statements) based on changes after June 30, 2026, to the facts and circumstances related to our legal proceedings that existed as of the balance sheet date.
Current report
For the six months ended June 30, 2026 and 2025
Current report
Research and development expenses for thesix months ended June 30, 2026, decreased by$9,657,398 as compared to the same period in 2025. The net decrease in research and development expenses was primarily due to:
Current report
◦Clinical trial costs decreased by $1,837,419 due to the termination of all clinical activities related to CBeyond, including enrollment for the CBeyond expansion (Part C) study, and the pausing of all R&D activities associated with nimacimab in order to evaluate strategic options.
Current report
◦Contract manufacturing costs decreasedby$7,681,937 due to the termination of all clinical activities related to CBeyond, including enrollment for the CBeyond expansion (Part C) study, and the pausing of all R&D activities associated with nimacimab in order to evaluate strategic options.
Current report
◦Discovery research and development costs decreased by $724,061 primarily due to the pausing of all R&D activities and cost-cutting measures implemented as the Company evaluates strategic options.
Current report
◦Quality assurance costs decreased by $86,376 primarily due to the pausing of all R&D activities and cost-cutting measures implemented as the Company evaluates strategic options.
Showing the first 40 of 49 passages. Open the source sections for the rest.
Removed paragraphs (40)
Previous 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, like semaglutide or tirzepatide. Other findings in the combination arm included:
Previous 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)).
Previous 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).
Previous 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 (17.8% versus 37.3% 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.
Previous report
Topline data from our CBeyond Phase 2a study was presented at ObesityWeek medical conference in November 2025.
Previous report
Summary of Phase 2a Extension Study
Previous report
In February 2026, we reported the following interim results from the combination cohort of our Phase 2a extension study:
Previous report
•19 participants in the combination cohorts completed week 26 were eligible for, and enrolled in the extension study, which continued in a blinded manner for 26 weeks, maintaining their original treatment assignment (10 nimacimab plus semaglutide; 9 placebo plus semaglutide). An additional 22 participants completed week 26 and were either ineligible for the extension or chose not to join the extension study and continued on post-treatment follow-up (11 nimacimab plus semaglutide; 11 placebo plus semaglutide).
Previous 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.
Previous report
We have received comments from the agency regarding our Type C meeting request in which they responded to our proposed Phase 2b clinical trial design, we intend to use data from the CBeyond trial, including the CBeyond expansion study (Part C), to inform the design of a potential Phase 2b study and potential registration path for nimacimab as a combination therapy with GLP-1s. Key design elements under evaluation include patient selection, dose selection, treatment duration, and endpoints. Final trial design and timing remain subject to ongoing data analysis, regulatory feedback and capital considerations.
Previous report
We were incorporated under the laws of the State of Nevada on March 16, 2011. Our headquarters are based in San Diego, 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 report
To date, we have not generated any revenue. We do not expect to receive any revenue from our drug candidate, nimacimab, or any future drug candidates that we develop unless and until we obtain regulatory approval for, and commercialize, nimacimab or future drug candidates or generate revenue from collaborative agreements with third parties.
Previous report
Research and Development Expenses
Previous report
We expect that our ongoing research and development expenses will consist of costs incurred for the development of our drug candidate, nimacimab, or any future drug candidates, including but not limited to:
Previous report
• employee-related expenses, which include salaries, benefits and stock-based compensation;
Previous report
• payments to third party contract research organizations and investigative sites;
Previous report
• payments to third party manufacturing organizations and consultants; and
Previous report
• payments to third parties related to our discovery research and development efforts to build our pipeline.
Previous report
We expect to incur future research and development expenditures to support our preclinical, nonclinical, and clinical studies. Preclinical and nonclinical activities include early discovery efforts with novel molecules, laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess safety and efficacy.
Previous report
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time consuming and the successful development of our drug candidate, nimacimab, and any future drug candidate is highly uncertain. Our future research and development expenses will depend on the clinical success of nimacimab and any future drug candidates as well as ongoing assessments of the commercial potential of such drug candidates. In addition, we cannot forecast with any degree of certainty whether nimacimab or any future drug candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. We expect to incur increased research and development expenses in the future as we continue our efforts towards advancing our lead program for nimacimab.
Previous report
General and Administrative Expenses
Previous report
Other (Income) Expense
Previous report
Research and Development Expenses
Previous report
•Clinical trial costs increased by $190,765 due to increased site and patient costs related to our Phase 2a clinical study for nimacimab.
Previous report
•Contract manufacturing costs increasedby $203,916 from drug substance, product, labeling and packaging costs related to resupplying our extended Phase 2a clinical study for nimacimab, manufacturing in anticipation for our expansion study of nimacimab, and process intensification and dose optimization work.
Previous report
•Discovery research and development costs decreased $168,387 primarily due to a reduction in work for life cycle management partially offset by increased work to interrogate nimacimab's mechanism of action.
Previous report
•Quality assurance costs decreased by $64,896 from routine vendor site audits.
Previous report
•Consulting, advisory and professional fees increased by $216,413 to support our nimacimab program.
Previous report
General and Administrative Expenses
Previous report
•Legal fees increased by $988,624 due to increased patent prosecution activity and litigation defense costs.
Previous report
Other (Income) Expense
Previous report
As of March 31, 2026, management estimates that we have sufficient capital to continue our operations through the fourth quarter of 2026, excluding the anticipated clinical cost of a proposed Phase 2b study and additional anticipated drug manufacturing costs to supply any such Phase 2b study. However, our continued operations beyond the fourth quarter of 2026 will depend on our ability to successfully raise additional capital through various potential sources, such as equity and/or debt financings, or strategic relationships. Our ability to access the capital markets is expected to be extremely limited. If we seek additional financing to fund our operations and there remains substantial doubt about our ability to continue as a going concern, our financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all. In addition, the uncertainty as to the resolution of the Cunning Lawsuit could limit our ability to raise new capital from investors to operate our business. If adequate funds are not available to us when needed we will be required to curtail or perhaps cease our operations which would, in turn, further raise substantial doubt about our ability to continue as a going concern. Refer to "Risks Related to Our Limited Operating History, Financial Position and Capital Requirements — Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, and if we are unable to continue, you may lose your entire investment" in our Annual Report on Form 10-K for additional information.
Previous report
•the scope, rate of progress, results and costs of our clinical trials, preclinical studies and other related activities;
Previous report
•our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;
Previous report
•the timing of, and the costs involved in, obtaining regulatory approvals for nimacimab or any future drug candidates;
Previous report
•the number and characteristics of the drug candidates we seek to develop or commercialize;
Previous report
•the cost of manufacturing clinical supplies, and establishing commercial supplies of our drug candidates;
Previous report
•the cost of commercialization activities if our current or future drug candidates are approved for sale, including marketing, sales and distribution costs;
Previous report
•the expenses needed to attract and retain skilled personnel;
Previous report
$12,802,650 in short-term investments.
Reworded paragraphs (30)
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 months ended March 31, 2026 and 2025, 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, 2025, which was filed with the Securities and Exchange Commission (SEC) on March 10, 2026.
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 six months ended June 30, 2026 and 2025, 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, 2025, which was filed with the Securities and Exchange Commission (SEC) on March 10, 2026.
Previous wording
We are a clinical stage biotechnology company pioneering 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 cannabinoid receptor 1 ("CB1")—a key GPCR involved in metabolic regulation that is administered as a subcutaneous injectable initially for the treatment of obesity and overweight.
Current wording
We are a clinical stage company with lead clinical candidate, nimacimab, a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 ("CB1")—a key GPCR involved in metabolic regulation that is administered as a subcutaneous injectable initially for the treatment of obesity and overweight.
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 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.
Current wording
We completed 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
In October 2025, we announced topline results from our CBeyond 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. We reported the following 26 week data from the CBeyond Phase 2a study:
Current wording
In October 2025, we announced topline results from our CBeyond 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. 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 suggested an association between exposure and response, indicating that the 200 mg, subcutaneous weekly dose was suboptimal as a monotherapy. 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. 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.
Previous wording
•Of the 10 participants in the nimacimab plus semaglutide arm who joined the extension study, the mean weight loss at 26 weeks was 14.4%. 7 participants completed the additional 26 weeks of treatment and lost an additional 7.9% of weight, resulting in a mean weight loss of 22.3% after 52 weeks of treatment. According to initial results in this limited cohort, the combination therapy remained safe and well tolerated. No SAEs or AESIs were reported during the extension period.
Current wording
19 participants in the combination cohorts completed week 26 were eligible for, and enrolled in the extension study. Seven participants in the combination group completed the additional 26 weeks of treatment lost an additional 7.9% of weight, resulting in a mean weight loss of 22.3% . According to initial results in this limited cohort, the combination therapy remained safe and well tolerated. No SAEs or AESIs were reported during the extension period. Moreover, the 7 participants in the semaglutide-alone group completed treatment of the additional 26 weeks and lost an additional -5.8% of weight during the extension period, resulting in a mean weight loss of -19.7%. Full topline reporting of the CBeyond Phase 2a extension data including nimacimab monotherapy data and 13-week off-therapy follow-up has not yet been reported.
Previous wording
In March 2026, we initiated an expansion study (Part C) of the CBeyond Phase 2a trial to assess preliminary safety and pharmacokinetic (PK) profile of nimacimab administered intravenously (IV). The expansion study will comprise two cohortsof nimacimab monotherapy (400 mg IV and 600 mg IV) compared to placebo administered weekly over 15 weeks (16 doses), with a 12 week follow up period, to generate preliminary monotherapy safety, PK, and exploratory efficacy data. Within each dose cohort, 8 participants will be randomized in a 3:1 ratio to nimacimab (n=6) or placebo (n=2). We expect to report topline data from the expansion study in the fourth quarter of 2026.
Current wording
In March 2026, we initiated an expansion study (Part C) of the CBeyond Phase 2a trial to assess preliminary safety and pharmacokinetic (PK) profile of nimacimab administered intravenously (IV). The expansion study comprised of two cohortsof nimacimab monotherapy (400 mg IV and 600 mg IV) compared to placebo administered weekly over 15 weeks (16 doses), with a 12 week follow up period, to generate preliminary monotherapy safety, PK, and exploratory efficacy data. Within each dose cohort, 8 participants will be randomized in a 3:1 ratio to nimacimab (n=6) or placebo (n=2). On May 20, 2026 we announced that the Cohort Review Committee (CRC) responsible for reviewing safety data generated from the CBeyond Part C Expansion Study, and for approving the opening of enrollment in Cohort 2 has unanimously approved opening the second cohort of the CBeyond Part C Expansion study.
Previous wording
During the three months ended March 31, 2026, we incurred $7,935,680 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 months ended March 31, 2025, we incurred $7,197,257 in research and development expense primarily related to our efforts in conducting our Phase 2a clinical trial related to our Phase 2a clinical trial for nimacimab for obesity.
Current wording
During the three and six months ended June 30, 2026, we incurred $3,941,932 and $11,877,612 in research and development expenses, respectively, 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, 2025, we incurred $14,337,753 and $21,535,010 in research and development expense, respectively, primarily related to our efforts in conducting our Phase 2a clinical trial related to our Phase 2a clinical trial for nimacimab for obesity.
Previous wording
Our general and administrative expenses have fluctuated year-over-year as we have entered into various strategic acquisitions to restructure and reposition our company. Additionally, as a business in the early stages of drug development we are continually evaluating our operations and infrastructure to identify areas where we can increase efficiencies. As a public company, we expect to incur additional expenses related to insurance, investor relations activities, legal and other administration and professional services to comply with the rules and regulations of the SEC, the Financial Industry Regulatory Authority ("FINRA") and Nasdaq. Other significant costs are expected to include legal fees relating to patent and corporate matters, business development costs and fees for consulting services. To incentivize our employees and be competitive to retain strong talent we issued additional equity awards in 2026 and 2025 and we repriced certain options in the first quarter of 2026, which have resulted in increased stock-based compensation expense. We also expect that certain general and administrative expenses which are commensurate with headcount, will continue to increase in the future in order to support our expected increase in research and development activities, including increased salaries, technology, facilities and other related costs.
Current wording
Our general and administrative expenses have fluctuated year-over-year as we have entered into various strategic acquisitions to restructure and reposition our company. Additionally, as a business in the early stages of drug development we are continually evaluating our operations and infrastructure to identify areas where we can increase efficiencies. As a public company, we expect to incur additional expenses related to insurance, investor relations activities, legal and other administration and professional services to comply with the rules and regulations of the SEC, the Financial Industry Regulatory Authority ("FINRA") and Nasdaq. Other significant costs are expected to include legal fees relating to patent and corporate matters, business development costs and fees for consulting services. To incentivize our employees and be competitive to retain strong talent we issued additional equity awards in 2026 and 2025 and we repriced certain options in the first quarter of 2026, which have resulted in increased stock-based compensation expense. We expect general and administrative expenses to reduce in the future resulting from workforce reduction activities and will continue to reduce until the proposed transaction with Redx is complete.
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 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 recovered the appellate bond and 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 March 31, 2026, the estimated legal contingency, including accrued legal expenses, is $2,574,759, an increase of $505,692 from December 31, 2025, due to accrual adjustments for services by legal firms in relation to the ongoing Cunning litigation.
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 recovered the appellate bond and reduced the estimated legal contingency based on new key assumptions. As of June 30, 2026, the estimated legal contingency, including accrued legal expenses, is $5,417,250, an increase of $3,348,183 from December 31, 2025. The increase primarily reflects a $3,250,000 change in the estimated legal contingency recognized during the second quarter of 2026, as well as changes in accrued legal expenses. 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.
Previous wording
Other (income) expense primarily includes interest income earned on our cash and cash equivalent balances and short term investments.
Current 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 income earned on our cash and cash equivalent balances and short term investments.
Previous wording
Research and development expenses for the three months ended March 31, 2026, increased by$738,423 as compared to the same period in 2025. The net increase in research and development expenses was primarily due to:
Current wording
Research and development expenses for the three months ended June 30, 2026, decreased by$10,395,821 as compared to the same period in 2025. The net decrease in research and development expenses was primarily due to:
Previous wording
•Salaries and stock-based compensation increasedby $375,048 primarily due to severance for one employee and incremental expenses form the stock option repricing.
Current wording
•Salaries and stock-based compensation increasedby $236,291 primarily due to severance for one employee and incremental expenses form the stock option repricing.
Previous wording
General and administrative expenses for the three months ended March 31, 2026, increased by$176,381 as compared to the same period in 2025. The decrease in general and administrative expenses was primarily due to:
Current wording
General and administrative expenses for the three months ended June 30, 2026, decreased by$36,801 as compared to the same period in 2025. The decrease in general and administrative expenses was primarily due to:
Previous wording
•Salaries, benefits and other direct employee related costs decreased by $275,661 primarily due to lower headcount and timing of new hires.
Current wording
•Salaries, benefits and other direct employee related costs decreased by $1,416,005 primarily due to lower headcount.
Previous wording
•Consulting, advisory and professional fees decreased by $28,245 primarily due to the timing of tax accounting services and financial advisory services.
Current wording
•Consulting, advisory and professional fees increased by $158,060 primarily due to the timing of tax accounting services and financial advisory services.
Previous wording
•Investor relations, marketing and communications expenses decreased by $335,032 primarily due to reductions in content creation and digital marketing expenses.
Current wording
•Investor relations, marketing and communications expenses decreased by $212,353 primarily due to reductions in content creation and digital marketing expenses.
Previous wording
•Recruiting fees decreasedby$33,750 primarily due to the one time cost to hire an executive in the prior period.
Current wording
•Recruiting fees decreasedby$50,000 primarily due to the one time cost to hire an executive in the prior period.
Previous wording
•General business expenses decreased $139,555 primarily due to headcount reductions and associated travel and entertainment expenses, as compared to the same period in the prior year.
Current wording
•General business expenses decreased $66,272 primarily due to headcount reductions and associated travel and entertainment expenses, as compared to the same period in the prior year.
Previous wording
For the three months ended March 31, 2026, other income decreased$493,238 as compared to the same period in 2025 primarily due to:
Current wording
For the three months ended June 30, 2026, other income decreased$344,344 as compared to the same period in 2025 primarily due to:
Previous wording
•Decreases in interest income and other income, net of $449,439 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, net of $429,882 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
We have incurred operating losses and negative cash flows from operations since our inception. We expect to continue to incur significant losses and negative cash flows from operations through 2026 and into the foreseeable future. We anticipate that we will continue to incur net losses in order to advance and develop potential drug candidates into preclinical and clinical development activities and support our corporate infrastructure, which includes the costs associated with being a public company. Historically, we have funded our operations primarily through issuance of equity securities, borrowings from a related party and strategic transactions.
Current wording
We have incurred operating losses and negative cash flows from operations since our inception. We expect to continue to incur significant losses and negative cash flows from operations through 2026 and into the foreseeable future. Historically, we have funded our operations primarily through issuance of equity securities, borrowings from a related party and strategic transactions. We have not commercialized any products and have never generated revenue from the commercialization of any product. If we are unable to complete the proposed transaction with Redx, we may need to raise additional capital. There can be no assurances, however, that additional funding will be available on terms acceptable to us, or at all.
Previous wording
As of March 31, 2026, we had working capital of $8,162,037, an accumulated deficit of $199,383,847, and stockholders’ equity of $9,011,804. We had unrestricted cash and cash equivalents and short-term investments in the amount of $17,108,629 as of March 31, 2026, as compared to $25,737,221 as of December 31, 2025. For the three months ended March 31, 2026 and 2025, the Company incurred losses from operations of $12,674,366 and $11,759,562, respectively. For the three months ended March 31, 2026 and 2025, the Company incurred net losses of $12,509,361 and $11,103,319, respectively.
Current wording
As of June 30, 2026, we had working capital deficit of $572,215, an accumulated deficit of $210,170,441, and stockholders’ deficit of $497,307. We had unrestricted cash and cash equivalents and short-term investments in the amount of $10,064,141 as of June 30, 2026, as compared to $25,737,221 as of December 31, 2025. For the three months ended June 30, 2026 and 2025, the Company incurred losses from operations of $11,061,303 and $18,243,925, respectively. For the six months ended June 30, 2026 and 2025, the Company incurred losses from operations of $23,735,669 and $30,003,487, respectively. For the three months ended June 30, 2026 and 2025, the Company incurred net losses of $10,786,594 and $17,624,872, respectively. For the six months ended June 30, 2026 and 2025, the Company incurred net losses of $23,295,955 and $28,728,191, respectively.
Previous wording
Our independent registered public accounting firm issued a report on our audited consolidated financial statements as of and for the year ended December 31, 2025 that included an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern due to our recurring operating losses. Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business. Our accompanying condensed consolidated financial statements do not include any adjustments to the carrying amounts or classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.
Current wording
Our independent registered public accounting firm issued a report on our audited consolidated financial statements as of and for the year ended December 31, 2025, that included an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern due to our recurring operating losses. Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business. Our accompanying condensed consolidated financial statements do not include any adjustments to the carrying amounts or classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Refer to "Risks Related to Our Limited Operating History, Financial Position and Capital Requirements — Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, and if we are unable to continue, you may lose your entire investment" in our Annual Report on Form 10-K for additional information.
Previous wording
•the amount of revenue, if any, received from commercial sales of our drug candidates, should any of our drug candidates receive marketing approval;
Current wording
•the amount of revenue, if any, received from the monetization of the Company Legacy CVR, commercial sales of our drug candidates, should any of our drug candidates receive marketing approval;
Previous wording
Cash used in operating activities of $8,557,917 during thethree months ended March 31, 2026, reflected a net loss of $12,509,361, partially offset by aggregate non-cash charges of $1,677,490 and included a$2,273,954 net cash inflow in our operating assets and liabilities.
Current wording
Cash used in operating activities of $15,679,591 during thesix months ended June 30, 2026, reflected a net loss of $23,295,955, partially offset by aggregate non-cash charges of $6,767,758 and included a$848,606 net cash inflow in our operating assets and liabilities.
Previous wording
Non-cash charges included$1,496,989 for stock-based compensation expense primarily attributable to the recognition of current period expense on prior grants and$172,886 in depreciation and amortization. The net change in our operating assets and liabilities included a$220,450 cash inflow from thedecreasein our prepaid expenses and other current assets, a$38,381 net cash outflow from decrease in our accrued expenses and other current liabilities and a$1,903,517 cash inflow from theincrease of our accounts payable.
Current wording
Non-cash charges included a$3,250,000 change in estimate for legal contingencies,$2,768,199 for stock-based compensation expense primarily attributable to the recognition of current period expense on prior grants,$597,275 loss on disposal of assets, and$330,484 in depreciation and amortization. The net change in our operating assets and liabilities included a$784,043 cash inflow from thedecreasein our prepaid expenses and other current assets, a$2,396,394 net cash outflow from decrease in our accrued expenses and other current liabilities and a$2,244,988 cash inflow from theincrease of our accounts payable.
Previous wording
Cash used in operating activities of 9,185,480 during thethree months ended March 31, 2025, reflected a net loss$11,103,319, partially offset by aggregate non-cash charges of$2,379,288 and included a$461,449 net cash outflow in our operating assets and liabilities.
Current wording
Cash used in operating activities of 19,931,667 during thesix months ended June 30, 2025, reflected a net loss$28,728,191, partially offset by aggregate non-cash charges of$4,510,100 and included a$4,286,424 net cash outflow in our operating assets and liabilities.
Previous wording
During the three months ended March 31, 2026, our cash provided by investing activities related primarily to the maturity, of $10,895,109 in short-term investments.
Current wording
During the six months ended June 30, 2026, our cash provided by investing activities related primarily to the maturity, of $17,858,939 in short-term investments.
Previous wording
During the three months ended March 31, 2025, our cash used in investing activities related primarily to the purchase of
Current wording
During thesix months ended June 30, 2025, our cash used in investing activities related primarily to the purchase of$24,747,039 in short-term investments and$89,363 in net proceeds from the sale of the AVI building.
Previous wording
During the three months ended March 31, 2026, cash used in financing activities included $71,525 in repayments on the our insurance premium loan payable.
Current wording
During the six months ended June 30, 2026, cash used in financing activities included $178,813 in repayments on the our insurance premium loan payable.
Rearranged current paragraphs (11)
Current report — wording carried from elsewhere
Below is a summary of our research and development expenses during the six months ended June 30, 2026 and for the same period in 2025:
Current report — wording carried from elsewhere
◦Salaries and stock-based compensation increasedby $611,340 primarily due to severance for seven employees and incremental expenses form the stock option repricing.
Current report — wording carried from elsewhere
Below is a summary of our general and administrative expenses during the six months ended June 30, 2026, and for the same period in 2025:
Current report — wording carried from elsewhere
◦Salaries, benefits and other direct employee related costs decreased by $1,691,664 primarily due to lower headcount.
Current report — wording carried from elsewhere
◦Consulting, advisory and professional fees increased by $129,815 primarily due to the timing of tax accounting services and financial advisory services.
Current report — wording carried from elsewhere
◦Investor relations, marketing and communications expenses decreased by $547,385 primarily due to reductions in content creation and digital marketing expenses.
Current report — wording carried from elsewhere
◦Recruiting fees decreasedby$83,750 primarily due to the one time cost to hire an executive in the prior period.
Current report — wording carried from elsewhere
◦General business expenses decreased $205,829 primarily due to headcount reductions and associated travel and entertainment expenses, as compared to the same period in the prior year.
Current report — wording carried from elsewhere
Below is a summary of our other (income) expense for the six months ended June 30, 2026 and for the same period in 2025:
Current report — wording carried from elsewhere
For thesix months ended June 30, 2026, other income decreased$837,582 as compared to the same period in 2025 primarily due to:
Current report — wording carried from elsewhere
◦Decreases in interest income and other income, net of $918,510 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.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
•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 suggested an association between exposure and response, indicating that the 200 mg, subcutaneous weekly dose was suboptimal as a monotherapy.
Previous report — wording carried elsewhere
•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.
Previous report — wording carried elsewhere
•Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was -13.9%. 7 participants completed treatment of the additional 26 weeks and lost an additional -5.8% of weight during the extension period, resulting in a mean weight loss of -19.7% after 52 weeks of treatment.
Previous report — wording carried elsewhere
Full topline reporting of the CBeyond Phase 2a extension data including nimacimab monotherapy data and 13-week off-therapy follow-up is expected to take place in the third quarter of 2026.