Itraconazole

Enters into Strategic Transaction, unlocking $100 million in value Sharpens focus on Orphan Drug candidates to address unmet medical needs NASHVILLE, Tenn., May 5, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders' equity. "We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company's evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders." RECENT COMPANY DEVELOPMENTS INCLUDE: Strategic Transaction Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland's portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders' approval and certain other customary closing conditions. This transaction is designed to unlock value and sharpen Cumberland's focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland's products will create more critical mass to support patient care and expand product distribution. Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future. Development Pipeline In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential. Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval. During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland's ifetroban candidate product for DMD patients. This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA. In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results. Cumberland's third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending. FINANCIAL RESULTS: Net Revenue: For first quarter of 2026, the Company's net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ® in China. Cumberland's branded portfolio revenue included $1.0 million for Kristalose®, $2.9 million for Sancuso®, $2.1 million for Vibativ®, $1.0 million for Caldolor® and $1.9 million for Talicia.® Operating Expenses: Total operating expenses for the quarter were $12.3 million. Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million. Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share. Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company's credit facility. Total shareholders' equity was $21.6 million on March 31, 2026. EARNINGS REPORT CALL: A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is . Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: . ABOUT CUMBERLAND PHARMACEUTICALS: Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote ® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor ® (ibuprofen) injection, for the treatment of pain and fever; Kristalose ® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso ® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol ® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia ® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at . About Acetadote ® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit . About Caldolor ® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Kristalose ® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit . About Sancuso ® ( granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit . About Vaprisol ® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit . About Vibativ ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit . About Talicia ® Talicia® is an FDA approved oral capsule for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection of the stomach and leading risk factor for gastric cancer. Talicia is listed as a first line option in the 2024 ACG Guideline for the treatment of H. pylori and features three key advantages: 1) high eradication rates - >90% in confirmed adherent patients, 2) the simplicity of an all-in-one capsule, and 3) low resistance to the two antibiotics - amoxicillin and rifabutin. For more information, please visit . FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "goal", "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include risks and uncertainties related to the strategic transaction, risks related to our ability to develop our pipeline of new product candidates, macroeconomic conditions, including changes in interest rates, inflation, tariffs, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization of intangible and right-of-use assets, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): Net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. (b) Represents the straight line reduction in carrying value of right-of-use assets. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo

Company outlines near-term pharmacokinetic milestones, highlights amorphous formulation strategy, and announces planned global patent filing TAMPA, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- Inhibitor Therapeutics, Inc. (OTCQB: INTI) ("Inhibitor" or the "Company"), today provided an update on its ongoing pharmacokinetic (PK) clinical program supporting the treatment of surgically eligible basal cell carcinomas (BCCs) in Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome, and announced plans to file a new global patent application covering its proprietary itraconazole formulation. Inhibitor's comparative PK, safety and tolerability study is being conducted in healthy adult subjects under fasting conditions in Malaysia and is designed as a three-way crossover study against a reference listed drug. The study is being executed in collaboration with Avior Bio, Inc. The Company’s collaboration with Avior Bio, spanning formulation development through clinical execution, has proceeded in line with planned timelines and budget and is intended to support the Company's regulatory strategy under the FDA's 505(b)(2) pathway. The study is currently progressing through its crossover dosing periods, with Period 2 scheduled for April 10, 2026, and Period 3 scheduled for April 24, 2026. Following the final PK sampling in Period 3, plasma samples are expected to be shipped for bioanalysis on or about May 1, 2026. Bioanalytical work is expected to require approximately two weeks, followed by approximately two additional weeks of statistical analysis. The Company expects to receive top-line comparative PK and relative bioavailability results in advance of the full Clinical Study Report, which will follow completion of the final study documentation. Based on the Company's current development plan, Inhibitor believes this PK study is expected to represent the final clinical study required prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for its BCCNS program. A key differentiating feature of the Company's program is its proprietary amorphous formulation approach. In its conventional crystalline form, itraconazole is known to present significant solubility limitations, which can contribute to variability in absorption and systemic exposure. Inhibitor's formulation strategy is designed to address those limitations by incorporating itraconazole in an amorphous morphology, which is intended to enhance solubility and dissolution behavior by reducing particle agglomeration and improving dispersion. This approach may support improved intestinal absorption and more consistent, predictable pharmacokinetic performance. The Company's Investigational Medicinal Product Dossier (IMPD) characterizes the underlying challenges associated with itraconazole and supports the scientific rationale for the formulation strategy. While the bulk drug substance is described as crystalline and practically insoluble in water, the formulated product candidate evaluated in the dossier was shown by X-ray diffraction to be amorphous, without detectable crystalline peaks, and was developed with the intent of suppressing crystallization and improving intestinal solubility and absorption. In parallel with clinical advancement, Inhibitor is preparing a new patent application directed to the composition of its proprietary formulation. The Company expects to seek global patent protection for the formulation and, if granted, the patent would be owned by Inhibitor Therapeutics without any ongoing royalty obligations. The Company believes this planned filing has the potential to materially strengthen its intellectual property estate by expanding protection around the formulation itself, complementing its existing portfolio related to the use of itraconazole in oncology indications. If granted, the Company believes such patent protection could enhance the strategic value of the BCCNS program as it advances toward potential NDA submission, commercialization and broader partnering discussions. Gorlin Syndrome is a rare hereditary disorder characterized by the development of multiple basal cell carcinomas over a patient's lifetime. Inhibitor is developing itraconazole for surgically eligible BCCs in BCCNS as a differentiated therapeutic approach intended to address a significant unmet need for patients who often face repeated surgical procedures and associated morbidity. About Inhibitor Therapeutics Inhibitor Therapeutics, Inc. is a publicly traded, clinical-stage pharmaceutical development company (OTCQB: INTI) focused on developing and commercializing innovative therapies using repurposed, already approved active pharmaceutical ingredients that have clinical value and are patent protected. The Company's lead program is itraconazole for the treatment of surgically eligible basal cell carcinomas (BCCs) in Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. For more information, visit the Company's website at www.inhibitortx.com. Forward-Looking Statements This press release contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Investor Relations Contact Simon Bettink VP of Operations Inhibitor Therapeutics, Inc. sbettink@inhibitortx.com Released March 31, 2026