hERG

New preclinical data on PRMT5-MTA inhibitor program will also be presented NEW YORK, NY, USA I October 23, 2024 I Schrödinger (Nasdaq: SDGR) today announced new preclinical data on SGR-3515, its investigational Wee1/Myt1 inhibitor, during a poster session at the 36th EORTC-NCI-AACR Symposium (ENA 2024). The data demonstrate that in preclinical models, treatment with SGR-3515 results in synergistic anti-tumor activity that leads to deeper and more durable responses compared to inhibitors that target only Wee1 or Myt1. The preclinical data also show that SGR-3515 has a favorable pharmacological profile and dosing schedule that supports evaluating intermittent dosing in patients. Wee1 and Myt1 kinases regulate the cell cycle and DNA damage response, allowing time for DNA repair before cell division takes place. Concurrent loss of function or inhibition of Wee1 and Myt1 confers selective vulnerability in cancer cells, a mechanism referred to as synthetic lethality, which has become an emerging therapeutic strategy for a range of cancers. A Phase 1 dose-escalation study of SGR-3515 in patients with advanced solid tumors is ongoing in the U.S. and Canada, and initial data from the clinical study is expected in the second half of 2025. Schrödinger will also present preclinical data from its PRMT5-MTA program during a poster session on October 25. Schrödinger scientists have identified a novel series of selective, potent PRMT5-MTA inhibitors and are optimizing lead compounds for use in peripheral and brain tumors. “We are pleased to share these encouraging preclinical data on SGR-3515, a potential best-in-class treatment for patients with a broad range of solid tumors, including uterine and ovarian cancers, two patient populations with high unmet need,” stated Karen Akinsanya, Ph.D., president of R&D therapeutics at Schrödinger. “We also look forward to presenting preclinical data on the discovery of a novel series of compounds for our PRMT5-MTA inhibitor program. These programs highlight how we are deploying our computational platform at scale to discover highly optimized molecules to address diseases with significant medical need, and we believe the future of our therapeutics portfolio is very promising.” SGR-3515 Data at ENA 2024 The presentation (Abstract # 147), “Discovery of SGR-3515, a first-in-class Wee1/Myt1 inhibitor with differentiated pharmacological properties in xenograft tumor models,” includes preclinical data demonstrating superior anti-tumor activity of SGR-3515 compared to inhibitors of Wee1 or Myt1 alone due to strong target engagement of both Wee1 and Myt1. The data show that SGR-3515 is a more potent co-inhibitor of both Wee1 and Myt1 than previously disclosed inhibitors of either target. These data are consistent with prior preclinical observations demonstrating that SGR-3515 has a unique and differentiated pharmacological profile that supports evaluating an intermittent dosing schedule of three days on and 11 days off, as well as five days on and nine days off, which maintained anti-tumor activity while allowing recovery from any mechanism-based hematological toxicity in preclinical models. The preclinical data also demonstrate superior kinase selectivity and in vitro cell potency of SGR-3515 across a broad cell line panel compared to other known Wee1 and Myt1 inhibitors. These new data suggest that SGR-3515 is significantly more selective than existing compounds with low potential for drug-drug interaction. PRMT5-MTA Data at ENA 2024 Additionally, Schrödinger will present new preclinical data on its PRMT5-MTA inhibitor program at a poster session during the meeting on October 25 from 9:00 a.m. – 3:00 p.m. CEST. The presentation (Abstract # 372), “Discovery of a highly MTA-synergistic series of PRMT5 inhibitors for the treatment of MTAP-deficient tumors by virtual screening technology,” will include preclinical data on the discovery of highly selective PRMT5-MTA inhibitors. The poster will describe how Schrödinger’s virtual screening platform facilitated the identification of structurally distinct chemical matter with a high degree of MTA-synergy for compounds within a novel chemical series in vitro and in cellular contexts. Schrödinger has identified a novel series of selective, potent PRMT5-MTA inhibitors that did not show major off-target liabilities such as hERG inhibition in preclinical studies and may be suitable for use in combinations across tumor types. About Schrödinger Schrödinger is transforming the way therapeutics and materials are discovered. Schrödinger has pioneered a physics-based computational platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at lower cost compared to traditional methods. The computational platform is licensed by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. Schrödinger’s multidisciplinary drug discovery team also leverages the software platform to advance a portfolio of collaborative and proprietary programs to address unmet medical needs. Founded in 1990, Schrödinger has approximately 850 employees and is engaged with customers and collaborators in more than 70 countries. To learn more, visit www.schrodinger.com , follow us on LinkedIn , or visit our blog, Extrapolations.com . SOURCE: Schrödinger

Company to host conference call on August 15, 2024 at 8:00 a.m. ETBOSTON and ATLANTA, Aug. 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 Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today reported financial results for the second quarter ended June 30, 2024 and highlighted recent developments. “The first half of 2024 has showcased the strength of our pipeline through the continued execution of key milestones for both risvodetinib (risvo) and IkT-001Pro,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “We completed enrollment of The 201 Trial evaluating risvo in untreated Parkinson’s disease, and anticipate the last patient exiting the study in September, 2024. We anticipate reporting topline data in November, 2024. Additionally, 001Pro has advanced as a potential treatment for Pulmonary Arterial Hypertension (PAH). We have filed our IND and we intend to ramp up the 702 trial following IND clearance. Finally, the manufacturing requirements for 001Pro necessary for potential approval is advancing with the on-going development of a scalable process.” Recent Developments and Upcoming Milestones: Completed enrollment of the Phase 2 ‘201’ trial evaluating risvodetinib in untreated Parkinson’s disease: On June 17, 2024, Inhibikase announced that the final participant had been enrolled in The 201 Trial evaluating the safety and tolerability of risvodetinib as a treatment in untreated Parkinson’s patients. The trial has enrolled and randomized 126 patients total. The last patient will exit the trial in September, 2024. As of July 29, 2024, 84 participants have completed the 12-week dosing period. There have been 41 mild and 8 moderate adverse events observed that may be related to risvo treatment. Six people withdrew from the trial without completing 12 weeks of treatment. Forty-six people have agreed to participate in biomarker studies of the change in synuclein aggregate deposition in the skin and seven have agreed to biomarker studies of the status of synuclein aggregate in the spinal fluid.Expanded Pipeline with advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension: Following receipt of final meeting minutes from Inhibikase’s pre-IND meeting with the FDA in May 2024, the Company submitted its IND to the FDA and plans to begin ramp-up of the Phase 2 702 trial to evaluate IkT-001Pro as a treatment for PAH, subject to receipt of the Study May Proceed letter from the FDA. In the final meeting minutes, the FDA stated that Inhibikase had built a bridge between imatinib’s use in blood and gastrointestinal cancers and PAH and that the Company’s Phase 2 design, to be known as the 702 trial, was reasonable. The Company has completed the requested pre-clinical hERG safety study showing that IkT-001Pro does not inhibit hERG and therefore is unlikely to induce QTcF prolongation in treated patients. Imatinib has previously been shown to induce QTcF prolongation in some patients.The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that 001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication with high unmet need valued at $7.66 billion in 2023 according to global sales data from Evaluate Pharma.Scaled manufacturing of IkT-001Pro: Following the Company’s pre-NDA meeting with the U.S. FDA in January 2024, Inhibikase scaled its process development efforts for IkT-001Pro to support late-stage clinical development and NDA batch requirements. 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.Successfully raised $4.0 Million in a registered direct offering and concurrent private placement: In May 2024, Inhibikase raised $4 million in aggregate gross proceeds from its registered direct offering and concurrent private placement. The Company is using the net proceeds from the offering to progress risvodetinib towards its planned Phase 3 trials in 2025 and completed pre-clinical studies requested by the FDA that enabled the IND filing for 001Pro in PAH. Second Quarter Financial Results Net Loss: Net loss for the quarter ended June 30, 2024, was $5.0 million, or $0.66 per share, compared to a net loss of $5.8 million, or $0.94 per share in the quarter ended June 30, 2023. The net loss per share for the three and six months ended June 30, 2023, was adjusted to show an improvement from ($1.11) to ($0.94) and from ($2.09) to ($1.74), respectively. R&D Expenses: Research and development expenses were $3.1 million for the quarter ended June 30, 2024 compared to $4.5 million in the quarter ended June 30, 2023. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 and a net decrease of $0.1 million in other research and development expenses. SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2024 were $2.0 million compared to $1.8 million for the quarter ended June 30, 2023. The $0.2 million increase was primarily driven by a $0.4 million increase legal and consulting fees partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses. Cash Position: Cash, cash equivalents and marketable securities were $7.9 million as of June 30, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into December, 2024. Conference Call InformationThe conference call is scheduled to begin at 8:00am ET on August 15, 2024. Participants should dial 1-877-407-0789 (United States) or 1-201-689-8562 (International). A live webcast may be accessed using the link HERE or by visiting the investors section of the Company's website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase's website for approximately 90 days after the call. About Inhibikase (www.inhibikase.com) Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program Risvodetinib, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects for the treatment of certain hematological or gastrointestinal cancers and in cardiopulmonary disease. The Company's RAMP™ medicinal chemistry program has identified several follow-on compounds to Risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts. Social Media DisclaimerInvestors 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 StatementsThis 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 enroll and complete the 201 Trial evaluating Risvodetinib in untreated Parkinson’s disease, to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications, to successfully conduct clinical trials that are statistically significant and whether results from our animal studies may be replicated in humans, 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:Alex LoboPrecision AQAlex.lobo@precisionaq.com Inhibikase Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited) June 30,2024 December 31,2023 (unaudited) Assets ​Current assets: ​Cash and cash equivalents $3,086,455 $9,165,179Marketable securities 4,853,559 4,086,873Prepaid research and development 306,300 219,817Prepaid expenses and other current assets 356,487 739,179Total current assets 8,602,801 14,211,048Equipment and improvements, net 60,235 73,372Right-of-use asset 163,762 222,227Total assets $8,826,798 $14,506,647Liabilities and stockholders’ equity ​Current liabilities: ​Accounts payable $1,340,538 $646,767Lease obligation, current 152,224 150,095Accrued expenses and other current liabilities 2,034,525 2,259,955Insurance premium financing payable 177,256 381,784Total current liabilities 3,704,543 3,438,601Lease obligation, net of current portion 25,606 90,124Total liabilities 3,730,149 3,528,725Commitments and contingencies ​Stockholders’ equity: ​ ​Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2024 and December 31, 2023 — —Common stock, $0.001 par value; 100,000,000 shares authorized; 7,216,145 and 6,186,280 shares issued and outstanding at June 30, 2024 and December 31, 2023 7,216 6,186Additional paid-in capital 81,600,425 77,871,584Accumulated other comprehensive (loss) income (1,024) 877Accumulated deficit (76,509,968) (66,900,725Total stockholders' equity 5,096,649 10,977,922Total liabilities and stockholders’ equity $8,826,798 $14,506,647 Inhibikase Therapeutics, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenue: Grant revenue$— $116,410 $— $180,931 Total revenue — 116,410 — 180,931 Costs and expenses: Research and development 3,075,830 4,535,698 5,827,109 7,389,817 Selling, general and administrative 1,974,705 1,783,113 4,005,786 3,708,464 Total costs and expenses 5,050,535 6,318,811 9,832,895 11,098,281 Loss from operations (5,050,535) (6,202,401) (9,832,895) (10,917,350)Interest income (expense) 90,927 424,435 223,652 661,606 Net loss (4,959,608) (5,777,966) (9,609,243) (10,255,744)Other comprehensive income, net of tax Unrealized (loss) gains on marketable securities 776 (167,536) (1,901) (106,432)Comprehensive Loss$(4,958,832) $(5,945,502) $(9,611,144) $(10,362,176)Net loss per share – basic and diluted$(0.66) $(0.94) $(1.38) $(1.74)Weighted-average number of common shares – basic and diluted 7,535,667 6,162,280 6,939,779 5,883,895

Aug. 08, 2024 -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations. Oragenics conducted hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia. “We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials,” stated Michael Redmond, President of Oragenics. “Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients.” Concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes of cocussions include falls, motor vehicle accidents, and contact sports. According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion. This includes $10.1 billion covered by private insurance, $22.5 billion by Medicare, and $8 billion by Medicaid. Concussions have been associated with other neurological disorders, such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability. Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com. The content above comes from the network. if any infringement, please contact us to modify.