Imatinib mesylate

WOBURN, Mass., Nov. 14, 2024 /PRNewswire/ -- Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten™, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib. "Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna®, but without the fasting requirements of Tasigna," said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. "Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions." Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.1 However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.2 Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.1,3,4 Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.1,5,6 With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission.7 The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.7,8 Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. For full prescribing information including boxed warning, please visit . Azurity will offer patient support through DanzitenCONNECT™, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP). About Azurity Pharmaceuticals, Inc. Azurity specializes in providing innovative, high-quality medicines that serve overlooked patients. We supply a large number of products to treat a wide range of medical conditions. These include anti-infective, cardiovascular/cardiology, central nervous system/cerebrovascular, endocrinology, gastrointestinal, immunology, and oncology medicines. Many of our medicines are dose-form innovations for patients with needs that are not met by other available products. Our medicines have benefited millions of people. For more information, visit . Sources: DANZITEN [prescribing information]: Woburn, MA: Azurity Pharmaceuticals, Inc; 2024. Tasigna [prescribing information]: East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. Radich J, Mauro M, Jain P , et al. Population pharmacokinetic (PopPK) modeling for a novel nilotinib formulation. Presented at: SOHO 2024 Annual World; September 4-7 , 2024; Houston, TX. Tan BK, Tan SB, Chen L. Medication-related issues associated with adherence to long-term tyrosine kinase inhibitors for controlling chronic myeloid leukemia: a qualitative study . Patient Prefer Adherence. 2017;11:1027-1034. Hochhaus A, Masszi T , Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study . Leukemia. 2017;31(7):1525-1531. Hughes TP , Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123(9):1353-1360. Chronic Myeloid Leukemia. Leukemia & Lymphoma Society; 2023. Accessed October 29, 2024. Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966-984. PP-DAN-US-0080 SOURCE Azurity Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-- Transformative Financing worth up to $275 million from Top-Tier Institutional Healthcare Investors -- -- Advancement of IkT-001Pro into a Late-Stage Clinical Trial Program in Pulmonary Arterial Hypertension -- --201 Trial Results to be reported in 4Q2024 -- BOSTON and ATLANTA, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, today reported financial results for the third quarter ended September 30, 2024 and highlighted recent developments. “The financing we concluded in October was a transformational moment for Inhibikase, and positioned us to advance IkT-001Pro into a late-stage clinical trial in Pulmonary Arterial Hypertension (PAH),” said Dr. Milton Werner, President and Chief Executive of Inhibikase. “This investment, with top tier dedicated healthcare investment funds, recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. We believe IkT-001Pro, a prodrug of imatinib, has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib for the treatment of PAH more than 10 years ago. This investment further validates the Company’s innovative approach to the development of kinase inhibitor therapeutics in the non-oncology setting.” Recent Developments and Upcoming Milestones: Closed up to $275 million financing in October 2024 in support of advancing IkT-001Pro into a late-stage clinical trial in PAH Private placement of approximately $110 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately $275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and general corporate purposes. Added three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital to the Board of Directors coincident with the financing: Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals,Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBioDavid Canner, Partner at Soleus CapitalIn addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush each participated in the financing; Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board. Advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension: The Company received its Study May Proceed letter on September 9, 2024.The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that IkT-001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication.Following the Company’s pre-NDA meeting with the FDA in January 2024, Inhibikase enhanced its manufacturing process development efforts for IkT-001Pro to support late-stage clinical development. Ongoing activities include development of new dosage forms, a more efficient production process and a high throughput tableting process that will lead to dosage forms for 001Pro tablets that are differentiated from generic imatinib mesylate in alignment with FDA feedback. The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024. The trial randomized 126 patients total, 120 of which completed the 12 week double blind dosing period. Third Quarter Financial Results Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, or $0.65 per share, compared to a net loss of $4.6 million, or $0.75 per share in the quarter ended September 30, 2023. The net loss per share does not give effect to the shares issued in the October 2024 financing. R&D Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.23 million in the quarter ended September 30, 2023. SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2024 were $1.6 million compared to $1.62 million for the quarter ended September 30, 2023. Cash Position: Cash, cash equivalents and marketable securities were $3.2 million as of September 30, 2024, which does not include the gross proceeds of approximately $110 million from the October 2024 Offering. About Inhibikase (www.inhibikase.com) Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary and Neurodegenerative disease. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001Pro, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension that will deliver imatinib in a form that the Company believes will provide a better patient experience with fewer on-dosing side-effects. Inhibikase's neurodegenerative disease portfolio is led by risvodetinib, a selective c-Abl inhibitor to treat Parkinson’s and Parkinson’s-related disease. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts. Social Media Disclaimer Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use X, Facebook, LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to commence and execute a Phase 2b ‘702’ trial to evaluate IkT-001Pro as a treatment for Pulmonary Arterial Hypertension (PAH), whether our top line data from our Phase 2 201 Trial evaluating risvodetinib in untreated Parkinson’s disease will show a statistically significant clinical benefit to trial participants, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contacts: Company Contact:Milton H. Werner, PhDPresident & CEO678-392-3419info@inhibikase.com Investor Relations:Michael MoyerLifeSci Advisorsmmoyer@lifesciadvisors.com Inhibikase Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited) September 30,2024 December 31,2023 (unaudited) (Note 2)Assets ​Current assets: ​Cash and cash equivalents $913,420 $9,165,179 Marketable securities 2,330,226 4,086,873 Prepaid research and development 112,225 219,817 Deferred offering costs 553,318 — Prepaid expenses and other current assets 280,914 739,179 Total current assets 4,190,103 14,211,048 Equipment and improvements, net 53,667 73,372 Right-of-use asset 133,105 222,227 Total assets $4,376,875 $14,506,647 Liabilities and stockholders’ equity ​Current liabilities: ​Accounts payable $2,529,220 $646,767 Lease obligation, current 145,210 150,095 Accrued expenses and other current liabilities 2,161,374 2,259,955 Insurance premium financing payable 71,662 381,784 Total current liabilities 4,907,466 3,438,601 Lease obligation, net of current portion — 90,124 Total liabilities 4,907,466 3,528,725 Commitments and contingencies (see Note 13) ​Stockholders’ equity: ​ ​Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $0.001 par value; 100,000,000 shares authorized; 7,464,070 and 6,186,280 shares issued and outstanding at September 30, 2024 and December 31, 2023 7,464 6,186 Additional paid-in capital 81,748,225 77,871,584 Accumulated other comprehensive (loss) income 1,754 877 Accumulated deficit (82,288,034) (66,900,725)Total stockholders' equity (530,591) 10,977,922 Total liabilities and stockholders’ (deficit) equity $4,376,875 $14,506,647 Inhibikase Therapeutics, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenue: Grant revenue$— $79,569 $— $260,500 Total revenue — 79,569 — 260,500 Costs and expenses: Research and development 4,189,873 3,225,551 10,016,982 10,615,368 Selling, general and administrative 1,637,603 1,622,894 5,643,386 5,331,358 Total costs and expenses 5,827,476 4,848,445 15,660,368 15,946,726 Loss from operations (5,827,476) (4,768,876) (15,660,368) (15,686,226)Interest income (expense) 49,410 173,677 273,059 835,283 Net loss (5,778,066) (4,595,199) (15,387,309) (14,850,943)Other comprehensive loss, net of tax Unrealized gains (loss) on marketable securities 2,778 1,571 877 (104,861)Comprehensive Loss$(5,775,288) $(4,593,628) $(15,386,432) $(14,955,804)Net loss per share – basic and diluted$(0.65) $(0.75) $(2.03) $(2.48)Weighted-average number of common shares – basic and diluted 8,882,570 6,162,671 7,592,103 5,977,841