Cerenome Reports Third Quarter 2026 Financial Results and Business Highlights Featuring REYOBIQ ReSPECT- LM Data and CNSide Commercial and Reimbursement Progress

On November 13, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted radiopharmaceuticals, and artificial intelligence, reported financial results for the third quarter ended September 30, 2026, and provides an overview of recent business progress.

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"Recognition of our first quarter of CNSide diagnostic revenue and commercial payments beginning in October is a tremendous landmark," said Marc H. Hedrick, M.D., Cerenome’s President and Chief Executive Officer. "Furthermore, our payer universe continues to expand with now about 80% of U.S. private payers representing approximately 190 million covered lives. Most recently, with Aetna coverage, it gives physicians an in-network option for both tumor cell enumeration and molecular profiling. In parallel, our growing commercial team is focused on helping more cancer centers use our test in patient care. In therapeutics, we materially advanced our two key programs by completing enrollment in our Phase 2 trial in adults with recurrent glioblastoma, opening up higher dose cohorts in the repeat dosing of REYOBIQ in patients with leptomeningeal metastases and reporting interim data in that trial."

Q3 2026 AND RECENT HIGHLIGHTS

Corporate

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During the quarter, Plus Therapeutics rebranded as Cerenome, and on August 3 its common stock began trading on Nasdaq under the symbol CNSY. The new name and brand reflect the Company’s focus on integrating CNS diagnostics, therapeutics, and data.
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In November, Ron Andrews was appointed as Chief Business Officer to advance CNSide commercial adoption and strategic partnerships. Mr. Andrews continues to serve on the Company’s Board of Directors.
CNSide CSF Assay Platform

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The company submitted billing claims for approximately $1.55 million in gross billings at list prices and recognized $0.7 million in net diagnostic revenue in the quarter after estimated payer adjustments and price concessions.
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Contracted coverage was expanded through agreements with Medical Mutual, Health Care Service Corporation and Blue Cross Blue Shield of Michigan.
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Secured in-network agreements were also made with Florida Blue and Aetna. The Aetna agreement, effective November 1, is the first national CNSide payer agreement to include both tumor cell enumeration and molecular profiling. The Company’s aggregate contracted footprint now represents approximately 190 million covered lives.
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The company entered into a collaboration with Genomic Testing Cooperative to add DNA and RNA profiling to CNSide. In July, the Company also highlighted updated NCCN CNS Cancers Guidelines recognizing a role for CSF analysis in the assessment of LM.
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XiFin was selected for revenue cycle management and clearinghouse services, and Samantha Fowlkes was appointed as Vice President and Head of Commercial Sales for CNSide Diagnostics.
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The Company is on track for Medicare reimbursement in 1st half of 2027 and is separately pursuing a coverage determination from Novitas Solutions.
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CNSide CSF Molecular Profile tests were launched for solid tumors and hematologic malignancies. The test was available to order beginning October 12, providing DNA and RNA profiling from cerebrospinal fluid (CSF). CNSide can be ordered independently or alongside tumor cell enumeration.

REYOBIQ Development

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The company presented interim Phase 1 ReSPECT-LM (multi-dose) findings at the Society of Neuro Oncology Annual meeting in November. The first 10 patients have been treated with repeated intraventricular doses of REYOBIQ, with no dose-limiting toxicities or treatment discontinuations due to adverse events reported. This highlights the potential for REYOBIQ to safely administer higher dose of tumor-destroying radiation (compared to single-dose study). Dose escalation is ongoing to identify a recommended multiple-dose regimen for a follow-on randomized study.
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Also, enrollment was completed in the Phase 2 ReSPECT-GBM study in recurrent glioblastoma in October. Cerenome expects topline data in mid-2027 following additional patient follow-up, and plans to hold an End-of-Phase 2 meeting with the FDA thereafter.
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Investigators reported preclinical data at the Rivkin Ovarian Cancer Research Symposium in October showing the active agent in REYOBIQ was associated with a new mechanism of action, namely positively impacting the tumor environment. The net effect described by investigators was administering REYOBIQ along with anti-PD-1 checkpoint blockade enhanced antitumor activity in these preclinical studies, opening up the possibility of novel combination therapies.
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Investigators presented pharmacokinetic, dosimetry, and safety observations from the ReSPECT-LM program at the SNO/ASCO CNS Metastases Conference in August. A separate presentation examined the potential health economic impact of earlier detection of leptomeningeal metastases (LM) using CNSide.

THIRD QUARTER 2026 FINANCIAL RESULTS

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Cash, cash equivalents and investments totaled $4.9 million as of September 30, 2026, compared with $8.6 million as of June 30, 2026. In September, the Company announced closing a senior secured financing facility up to $20 million with royalty-based repayments. In addition, the Company raised $3.8M under the Equity Distribution Agreement subsequent to the end of the quarter.
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Total revenue was $0.7 million, consisting entirely of net diagnostic revenue.
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Cost of revenue was $0.9 million. Research and development expense was $2.1 million, compared with $2.4 million a year earlier. Selling, general and administrative expense was $5.2 million, compared with $3.4 million a year earlier.
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Operating loss was $7.5 million, compared with $4.5 million a year earlier. Net loss was $8.7 million, or $1.14 per share, compared with $4.4 million, or $1.03 per share, a year earlier.
ANTICIPATED MILESTONES AND OUTLOOK FOR 2027

CNSide Commercial Rollout

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Expand CNSide adoption across cancer centers, build-out the field sales team, enhance the testing menu and build on existing payer collection experience across the CNSide test menu.
REYOBIQ Clinical Program

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Continue dose escalation in LM Multi-dose study and follow patients in ReSPECT-GBM for the anticipated mid-2027 topline readouts from both trials.
Conference Call and Webcast

Cerenome will host a conference call and webcast Monday, November 16, 2026, at 8:30 a.m. Eastern Time to discuss third quarter results and provide a business update.

Webcast and Conference Call

Date/Time: Monday, November 16, 2026 at 8:30 AM ET

Webcast: View Source

Dial-in: U.S.: 833-862-0853 International: 412-317-6789

Please dial in 15 minutes before the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

About Leptomeningeal metastases (LM)

Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with

breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Cerenome, NOV 13, 2026, View Source [SID1234674748])

BeyondSpring Reports Third-Quarter 2026 Financial Results and Provides Corporate Update

On November 13, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended September 30, 2026, and provided a corporate update highlighting regulatory and strategic progress for Plinabulin and its global Phase 3 DUBLIN-4 trial.

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"The third quarter marked an important regulatory and strategic step forward for Plinabulin," said Min Qiu, Chief Executive Officer of BeyondSpring. "The FDA’s Fast Track designation underscores the significant unmet need for new treatment options for NSCLC patients without AGA and progressing after immune checkpoint inhibitor therapy, where docetaxel is still the standard of care. Plinabulin has been shown to improve the tolerability and dose intensity of docetaxel and demonstrated a long-term survival benefit in the previous successful DUBLIN-3 study in second- and third-line EGFR wild-type NSCLC, published in The Lancet Respiratory Medicine in 2024."

Mr. Qiu continued, "With an FDA-aligned Phase 3 design and a strategic transaction with Biolin to support approximately half of DUBLIN-4’s planned 442-patient enrollment, generating quality data from China, we remain focused on advancing the study toward its prespecified interim analysis at 221 progression-free survival events. We believe positive interim results could represent a significant value inflection point for BeyondSpring, as we continue to pursue financing and strategic opportunities to support global execution."

Recent Regulatory, Clinical and Corporate Highlights

FDA Fast Track designation for Plinabulin plus docetaxel in post-ICI non-squamous NSCLC

The Company announced that the U.S. Food and Drug Administration granted Fast Track designation to Plinabulin plus docetaxel for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), following prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
The designated population corresponds to the second- or third-line patient population targeted in the global DUBLIN-4 trial. Fast Track designation may facilitate more frequent FDA interactions and, if applicable criteria are met, rolling review of a future application.
Strategic transaction to fund half of DUBLIN-4’s planned patient enrollment

The Company completed the sale of BeyondSpring Ltd., its wholly owned subsidiary that indirectly held the majority equity interest in Dalian Wanchunbulin Pharmaceuticals Ltd. ("Bulin"), to Biolin Investment Limited ("Biolin") on September 30, 2026, pursuant to a definitive agreement among the parties.
As non-cash consideration, Biolin will support the funding of DUBLIN-4 clinical development activities conducted by Bulin at participating sites in China, which are expected to include enrollment of approximately 221 patients, or approximately half of the planned 442-patient global enrollment. BeyondSpring will receive access to clinical data generated from the China portion of the trial.
Third Quarter Financial Results

Continuing operations:

Research and development (R&D) expenses were $1.1 million for the quarter ended September 30, 2026, compared to $1.0 million for the quarter ended September 30, 2025. The increase of $0.1 million was primarily due to a $0.3 million increase in preclinical expenses related to Plinabulin treatment combination research in support of strategic business development and partnership initiatives, partially offset by lower patent-related legal services and drug manufacturing costs.
General and administrative (G&A) expenses were $1.0 million for the quarter ended September 30, 2026, compared to $0.7 million for the quarter ended September 30, 2025. The increase of $0.3 million was primarily due to an increase in legal fees related to financing activities and higher consulting expenses related to accounting advisory and audit services, partially offset by lower personnel-related and travel expenses.
Net loss was $2.1 million for the quarter ended September 30, 2026, compared to $1.6 million for the quarter ended September 30, 2025.
Cash, cash equivalents, and short-term investments were $0.6 million as of September 30, 2026, compared to $4.0 million as of December 31, 2025.
Year-to-Date Financial Results

Continuing operations:

Research and development (R&D) expenses were $3.1 million for the nine months ended September 30, 2026, compared to $2.7 million for the nine months ended September 30, 2025. The increase of $0.4 million was primarily due to expanded drug manufacturing activities and increased preclinical Plinabulin treatment combination research, partially offset by lower patent-related legal services and personnel-related expenses.
General and administrative (G&A) expenses were $2.7 million for the nine months ended September 30, 2026, compared to $3.2 million for the nine months ended September 30, 2025. The decrease of $0.5 million was primarily due to lower personnel-related expenses, mainly from lower incentive compensation and share-based compensation, as well as lower professional service expenses in legal advisory and lower travel and entertainment expenses.
Net loss was $5.7 million for the nine months ended September 30, 2026, compared to $5.8 million for the nine months ended September 30, 2025.

(Press release, BeyondSpring Pharmaceuticals, NOV 13, 2026, View Source [SID1234674747])

AIM ImmunoTech Approaches Major Clinical Inflection Point with Phase 2 Pancreatic Cancer Data Expected Q1 2027; Reports Third Quarter 2026 Financial Results

On November 13, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported financial results for the third quarter ended September 30, 2026, and provided a business update on its lead Ampligen (rintatolimod) program in metastatic pancreatic cancer.

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AIM is evaluating Ampligen’s potential role in an evolving pancreatic cancer treatment landscape, including the emergence of RAS-targeted therapies such as Revolution Medicines’ daraxonrasib. Ampligen is a selective Toll-like receptor 3 (TLR3) agonist designed to stimulate immune responses, with repeated clinical success in killer T-cell activation in the tumor microenvironment. AIM believes that its mechanism may offer opportunities for investigation alongside RAS-targeted therapies that depend on killer T-cell activation.

AIM recently outlined the scientific rationale for exploring Ampligen alongside RAS inhibition. The potential complementary role of immune modulation and RAS-targeted treatment represents an additional area of scientific interest for AIM as it evaluates future development strategies. Such combinations remain exploratory, and their safety and efficacy have not been established.

Professor Dr. C.H.J. van Eijck, Erasmus Medical Center, and AIM’s Consulting Oncologist, states, "KRAS and RAS inhibition may leave important immune barriers intact. T-cells entering the tumor can become exhausted or be suppressed by other immune cells. Combining daraxonrasib or MRTX1133 with CTLA-4 checkpoint blockade improved tumor control in pancreatic cancer models. This demonstrates that an immune treatment can improve targeted therapy in experimental settings and provides a rationale for investigating other complementary immune approaches. The proposed combination has a specific rationale: KRAS or RAS inhibition could reduce tumor burden and make surviving cancer cells more vulnerable, while Ampligen could help activate the immune response needed to control those cells. This may be particularly relevant when RAS targeted treatment recruits immune cells but does not sufficiently activate them against the cancer. Ampligen, a Toll-like receptor 3 agonist, is an ideal candidate for such investigation because it can stimulate dendritic-cell and T-cell responses. In a study of patients with advanced pancreatic cancer, Ampligen treatment was associated with changes consistent with activation of these immune cells. Higher post-treatment levels of selected dendritic-cell and CD4 T-cell populations correlated with better clinical outcomes. These observations support biological activity in patients, although only a focused future clinical trial can establish that Ampligen, in combination or as a maintenance therapy, will cause better outcomes."

AIM Chief Executive Officer Thomas K. Equels states, "I believe that Revolution Medicines’ daraxonrasib will be the first-line therapy for metastatic pancreatic cancer in the near future, and I believe Ampligen’s immune-modulating mechanism offers a compelling scientific rationale for further investigation in this setting. Importantly, as the pancreatic cancer treatment landscape evolves with the emergence of RAS-targeted therapies, we also see opportunities to explore how Ampligen could potentially complement these advances. We believe the upcoming Phase 2 DURIPANC clinical trial results will be an important step in determining how best to advance this strategy toward pivotal development. We intend to design our Phase 3 to be relevant as a maintenance therapy based upon the first-line therapies we expect in the near future – not just FOLFIRINOX."

Third Quarter 2026 Accomplishments and Other Recent Corporate Highlights

Ampligen dosing is concluded in the Phase 2 clinical trial ("DURIPANC") evaluating the drug in combination with AstraZeneca’s anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab) in patients with metastatic pancreatic cancer whose disease stabilized following first-line FOLFIRINOX chemotherapy. AIM anticipates topline clinical benefit results in Q1 2027 and survival results analyses in Q3 2027, both of which will inform next steps as AIM moves forward with the design of a pivotal Phase 3 trial in pancreatic cancer

Equels continues, "We are entering one of the most consequential periods in AIM’s pancreatic cancer development program. DURIPANC’s Ampligen dosing is complete and analysis of the clinical benefit endpoint is imminent, in Q1 2027. In mid-year 2027 we will be able to calculate median overall survival, which is viewed as the ‘gold standard’ for approval by the FDA. Our focus has been on disciplined execution and advancing Ampligen toward the clinical evidence needed to support its next stage of development. The upcoming readout represents an important milestone in AIM’s pancreatic cancer development strategy, providing an opportunity to evaluate whether Ampligen-based immunotherapy can help sustain disease control in a patient population facing limited treatment options."

DURIPANC year-end results, together with additional median overall survival and immune-response analyses expected mid-year 2027, are anticipated to inform the design of a potential pivotal Phase 3 trial. The approaching data readout will build on earlier exploratory clinical observations from the Dutch government-approved Named Patient Program. In a subgroup of 39 Ampligen-treated patients post-chemotherapy (including either FOLFIRINOX or Gemcitabine) with a baseline neutrophil-to-lymphocyte ratio below 4.5, median overall survival was 34.8 months, measured from initiation of chemotherapy.

Advanced Phase 2 DURIPANC toward near-term results. Completed enrollment and Ampligen dosing, with primary endpoint analysis expected to begin in December 2026 and topline clinical benefit results anticipated in Q1 2027.
Continued preparations for potential pivotal development. Maintained focus on advancing the clinical evidence needed to inform a pivotal Phase 3 study, supported by prior engagement with Thermo Fisher Scientific’s PPD clinical research business.
Expanded Ampligen’s strategic development opportunities. Released a new investor presentation outlining the potential scientific rationale for evaluating Ampligen alongside emerging RAS-targeted therapies in pancreatic cancer.
Ongoing ovarian cancer analysis. We are analyzing mechanism of action data from a clinical trial in advanced recurrent ovarian cancer, with publication expected soon.
Strengthened intellectual property protection. Announced a U.S. patent covering Ampligen in combination with pembrolizumab for cancer treatment, with protection extending to December 2039. AIM also announced patent protection for Ampligen’s use in Long COVID across Europe and the United Kingdom, expected to extend through June 2041.
Advanced manufacturing readiness. Entered into an agreement with Sterling Pharma Solutions to manufacture additional batches of two polynucleotide precursors used in Ampligen production.
Satisfied outstanding promissory note. In September 2026, satisfied the February 2024 promissory note with Streeterville Capital, LLC in full.
Third Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities totaled approximately $6.9 million as of September 30, 2026, compared with approximately $3.0 million at December 31, 2025.
Research and Development: R&D expenses were approximately $846,000, compared with $607,000 in the prior-year period, primarily reflecting manufacturing costs associated with Ampligen precursors.
General and Administrative: G&A expenses were approximately $2.1 million, compared with $1.8 million in the third quarter of 2025, primarily due to salary obligations and fees that had been waived in the prior-year period.
Net Loss: Net loss was approximately $3.1 million, compared with $3.3 million in the third quarter of 2025.
Complete financial results and related disclosures are available in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.

(Press release, AIM ImmunoTech, NOV 13, 2026, View Source [SID1234674746])

Sol-Gel Reports Third Quarter 2026 Financial Results and Provides Corporate Updates

On November 12, 2026 Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

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Q3 2026 and Recent Corporate Developments

On September 17, 2026, Sol-Gel announced that the last patient had completed the last scheduled study visit in its pivotal Phase 3 clinical trial (SGT-610-01) of SGT-610 (patidegib gel, 2%) for the prevention of basal cell carcinoma (BCC) lesions in adult patients with Gorlin syndrome. Of the 113 patients enrolled in the randomized, double-blind, vehicle-controlled study, 102 completed the study, a completion rate of approximately 90%. The primary endpoint of the study is the number of new BCCs on the face at month 12 after twice-daily treatment. Secondary endpoints include the number of new surgically eligible BCCs (SEBs). Top-line results are expected in late November 2026.
On October 14, 2026, Sol-Gel hosted a KOL Investor Event in New York featuring Ervin Epstein Jr., MD (Alta Bates Summit Medical Center), Kavita Sarin, MD, PhD (Stanford Cancer Institute), Elizabeth M. Billingsley, MD (Penn State College of Medicine) and Julie Breneiser, PA-C (Gorlin Syndrome Alliance). The event addressed the disease burden of Gorlin syndrome, the limitations of current surgical and off-label systemic management, and the potential role of SGT-610 in preventing the development of new basal cell carcinomas (BCCs), with the goal of reducing the need for repeated surgical interventions. A replay of the webcast and the presentation materials are available on the Investor Relations section of the Company’s website.
Sol-Gel continues to advance its U.S. commercial readiness activities for SGT-610. If approved, the Company intends to retain full U.S. commercial rights and to commercialize SGT-610 through a cost-effective model utilizing an experienced third-party commercialization services organization, reaching the concentrated Gorlin syndrome treating population through a small, focused field organization supported by outsourced commercial infrastructure. Market access, distribution, patient support and medical affairs planning are progressing in preparation for a potential U.S. launch.
Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "The third quarter brought us to the threshold of the most important moment in Sol-Gel’s history. Reaching last patient last visit in September marked the culmination of the patient treatment and follow-up phase of our pivotal Phase 3 trial of SGT-610, with 102 of 113 patients completing the study, representing a completion rate of approximately 90%, exceeding our original expectations for patient retention. That is a credit to the patients, investigators and site teams who stayed with us. We expect to report top-line results in late November. In parallel, we continue to advance our U.S. commercial readiness activities so that, subject to positive clinical results, we can move efficiently toward a regulatory submission and commercialization."

Mr. Arkin further commented: "We also continue to pursue the broader opportunities for hedgehog pathway inhibition that we outlined last quarter. The studies of topical patidegib as a neo-adjuvant ahead of Mohs surgery, and for the prevention of high-frequency BCC (HF-BCC) which we announced in August, respond to interest we hear directly from surgeons, and we continue to evaluate an intra-cystic injectable for odontogenic keratocysts, a manifestation of Gorlin syndrome that often requires repeated surgical interventions. Our immediate priority remains maximizing the commercial potential of Gorlin syndrome therapy, while these additional programs are intended to expand the therapeutic applications of hedgehog pathway inhibition."

Financial Results for the Third Quarter 2026

Revenue for the third quarter was nominal, compared to revenue of $0.4 million for the same period in 2025.

Research and development expenses were $5.1 million compared to $5.7 million for the same period in 2025. The decrease of $0.6 million was primarily attributed to a decrease in clinical trial expenses related to SGT-610.

General and administrative expenses were $1 million compared to $1 million for the same period in 2025.

Sol-Gel reported a net loss of $5.6 million for the third quarter of 2026 and loss of $1.7 per basic and diluted share, compared to a net loss of $5.9 million and loss of $2.1 per basic and diluted share for the same period in 2025.

As of September 30, 2026, Sol-Gel had $14.4 million in cash, cash equivalents, and deposits and $31.3 million in marketable securities for a total balance of $45.7 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2028.

(Press release, Sol-Gel Technologies, NOV 12, 2026, View Source [SID1234674729])

Artelo Biosciences Provides Business Update and Reports 2026 Third Quarter Financial Results

On November 12, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company"), a clinical stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, obesity, dermatologic, ophthalmic, and neurological conditions, reported a business update and announced its financial and operational results for the third quarter ended September 30, 2026.

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Business Highlights

ART27.13:

Expanding Development Opportunities in Obesity: New nonclinical findings demonstrated approximately 20% weight loss with ART27.13 monotherapy, comparable to semaglutide, and approximately 40% weight loss when combined with semaglutide in a diet-induced obesity animal model. The combination also further improved oral glucose tolerance and increased bone mineral density, effects not observed in any other treatment group. The results support ART27.13’s potential as a treatment for obesity, both independently and in combination with GLP-1 therapies, expanding beyond cancer supportive care towards a total weight management solution.
Strengthening Intellectual Property and Clinical Potential: Artelo filed a provisional patent application covering ART27.13 for obesity and combination use with GLP-1 receptor agonists. Artelo also received Notices of Allowance in the U.S. and Japan for patent claims covering the intended commercial formulation of ART27.13. The U.S. patent, once issued, is expected to extend protection through 2041. The Company continues to pursue multiple indications, supported by previously reported Phase 2 CAReS interim findings demonstrating improvements in body weight, lean body mass and physical activity in patients experiencing cancer-related anorexia and weight loss.
Second Phase 2 Study Initiated in Glaucoma: Enrollment is already underway for the investigator-led DREAM trial, a Phase 2 study evaluating whether oral daily treatment with ART27.13 can lower intraocular pressure in people with glaucoma or ocular hypertension.

ART26.12:

Advancing First-in-Human FABP5 Inhibitor for Non-Opioid Pain Treatment: Plans for ART26.12, the first selective fatty acid binding protein 5 (FABP5) inhibitor evaluated in humans, anticipate a Phase 1 multiple ascending dose (MAD) study to initiate in the fourth quarter of 2026. Previously reported single ascending dose results demonstrated favorable safety and tolerability, predictable pharmacokinetics and exposure levels supporting further clinical development.
Strengthening Scientific Evidence and Industry Engagement: Artelo presented ART26.12 data at the International Association for the Study of Pain (IASP) 2026 World Congress on Pain and at BIO-Europe 2026, highlighting its differentiated mechanism of action and potential to address significant unmet needs in chronic pain. Reported nonclinical findings indicate ART26.12’s potential across multiple pain indications, including chemotherapy-induced peripheral neuropathy, spinal cord injury and osteoarthritis, where it achieved pain relief levels comparable to naproxen with significantly less gastric tissue damage.

"We are gratified that our programs are moving closer to key clinical milestones and revealing new development opportunities," said Gregory D. Gorgas, President and Chief Executive Officer. "Our immediate priority is advancing ART26.12 into its next stage of clinical testing, where we aim to amplify the encouraging results observed to date. At the same time, the expanding potential of ART27.13 is generating opportunities with potential strategic partners in significant new therapeutic markets."

Q3 2026 Financial Results

R&D Expenses: Research and development expenses were $0.8 million for the quarter ended September 30, 2026, compared to $1.3 million for the quarter ended September 30, 2025.
G&A Expenses: General and administrative expenses were $1.0 million for the quarter ended September 30, 2026, compared to $1.8 million in the quarter ended September 30, 2025.
Net Loss: For the quarter ended September 30, 2026, net loss was $1.8 million, or $3.19 per basic and diluted common share, compared to a net loss of $3.1 million for the quarter ended September 30, 2025.
Cash and Investments: Cash totaled $4.4 million as of September 30, 2026.

(Press release, Artelo Biosciences, NOV 12, 2026, View Source [SID1234674728])