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SOUTH SAN FRANCISCO, CA, USA I October 30, 2024 I TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced that the first patient has been dosed with BBO-10203 in the BREAKER-101 trial. BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors, without directly inhibiting the catalytic activity of PI3Kα. “I am thrilled to partner with BBOT to bring a potentially transformable new therapeutic to the clinic,” said Dr. Minal Barve, Chief Medical Officer and Principal Investigator at Mary Crowley Cancer Research, Dallas, TX. “BBO-10203 represents a first-in-class drug with potential to address high unmet medical needs and change the landscape of cancer care. We look forward to evaluating BBO-10203 in the BREAKER-101 trial.” BBO-10203 was designed to bind covalently and selectively to the RAS-binding domain (RBD) of PI3Kα. This selective inhibition is agnostic to the mutational status of PI3Kα and RAS, and in preclinical models, results in complete inhibition of RAS-driven pAKT signal at single digit nanomolar concentration. Additionally, no hyperglycemia was observed in preclinical species treated with BBO-10203. The discovery of BBO-10203 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT. “BBO-10203 is a first-in-class program that inhibits the interaction of the two most mutated oncogenes in human cancer, and it will allow us to test, for the first time, the importance of RAS-coordinated activation of the MAPK and AKT signaling pathways,” said Pedro Beltran, PhD, Chief Scientific Officer of BBOT. “The discovery of BBO-10203 was made possible by the dedicated collaboration between academic, national laboratory, and industry experts that synergized to advance medicines for patients suffering from cancer.” The BREAKER-101 trial will enroll patients globally with locally advanced or metastatic HER2-positive breast cancer, HR-positive/HER2-negative breast cancer, KRAS mutant advanced colorectal cancer, and KRAS mutant advanced non-small cell lung cancer. “There is a tremendous opportunity to improve the standard of care in oncology by inhibiting oncogenic pAKT signaling without the metabolic side effects observed with kinase inhibitors, and the initiation of the Phase 1 study of BBO-10203 marks an important milestone in this regard,” said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. “The second IND within six months of establishing BBOT clearly demonstrates our team’s capability in advancing our novel programs into the clinic. This novel mechanism and scientific rationale behind it will allow tremendous combination opportunities that optimally inhibit both pAKT and pERK – an approach we hope will bring unprecedented benefit to patients with RAS-driven cancers.” About TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT) BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit bridgebiooncology.com . SOURCE: BridgeBio Oncology Therapeutics

MIAMI, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced the successful completion of long-term chronic toxicity studies in both rats and dogs with its lead candidate PAS-004, currently being investigated in a Phase 1 clinical trial in advanced cancer patients. Results show that once daily treatment with PAS-004 for 6-months in rats and 9-months in dogs at different dose levels confirms the observations of prior 28-day toxicity studies and indicates a similar safety profile following long-term dosing in both species. Further, the 9-month study in dogs established 0.5 mg/kg as the no adverse effect level (NOAEL) in dogs, the most sensitive species. PAS-004 demonstrated a consistent safety profile at doses that correlate with significant pathway engagement and will likely produce significant pERK reduction when dosed below the NOAEL. Completion of this milestone is planned to support chronic patient dosing. For the chronic toxicity studies, PAS-004 was administered in crystalline form and demonstrated a similar adverse event profile and equivalent NOAEL in dogs as compared to the original amorphous formulation. The Company is using a crystalline form of PAS-004 in its human clinical trials. “It is our belief that the ability to titrate to and obtain sustained Mitogen Associated Protein kinase (MAPK) pathway suppression over a prolonged period will lead to enhanced efficacy with a more manageable side effect profile and less toxicity than that observed with other MEK inhibitors. The results of these long-term chronic toxicity studies further demonstrates PAS-004 safety profile and highlight PAS-004’s potential as a best-in-class MEK inhibitor. We look forward to sharing additional data on PAS-004, including initial interim pharmacokinetic (PK) and pharmacodynamic (PD) data from our first-in-human Phase 1 clinical study later this quarter.” commented Dr. Tiago Reis Marques, CEO of Pasithea. About Pasithea Therapeutics Corp. Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS). Forward Looking Statements This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include all statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, preclinical and clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Pasithea Therapeutics ContactPatrick GaynesCorporate Communicationspgaynes@pasithea.com

LA JOLLA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual meeting 2024 held May 31- June 4th in Chicago, IL. The highlights of presentation entitled “Phase 1b/2a study evaluating the combination of MN-166 (ibudilast) and temozolomide (TMZ) in patients with newly diagnosed and recurrent glioblastoma (GBM) (Abstract # 2016)“ are as follows: The clinical study enrolled a total of 62 patients, including 36 with newly diagnosed GBM patients and 26 with recurrent GBM. The primary endpoints were safety and tolerability of MN-166 and TMZ combination treatment and the efficacy of combination treatment. The recommended Phase 2-dose (R2PD) of MN-166 is 50 mg BID. The combination of Temozolomide (TMZ) and MN-166 was safe and well tolerated. No unexpected adverse effects were observed in both new GBM and recurrent GBM patients. Most reported adverse events were Lymphopenia, Leukopenia, Thrombocytopenia and Neutropenia. Progression Free Survival at 6 months (PFS6) was 44% (new GBM) and 31% (recurrent GBM), respectively. PFS6 in recurrent GBM was higher than historical control. Median PFS was 8.7 months in new GBM and 2.4 months in recurrent GBM. Median Overall Survival (OS) was 21 months in new GBM and 8.6 months in recurrent GBM. Neither were higher than historical data. Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at initial surgery or biopsy to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74 The intra-tumoral CD3 expression was significantly higher in the patients had disease progression within 5 months of treatment initiation compared to patients that had no disease progression over 5 months, whereas the expression of MIF, CD74 (MIF receptor), Ki67 (proliferation index), and CD11b (marker expressed on myeloid-derived suppressor cells and macrophages, among other cell types) were not different between these 2 subgroups of patients. Preclinical data has shown improved survival with the combination of Ibudilast and PD-1 or PD-L1 antibody therapy compared to treatment with ibudilast alone or PD-1/PD-L1 antibody alone, suggesting a potential promising therapeutic benefit of this combination. Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer of MediciNova, Inc., commented, “First, we wish to express our sincere thanks to the study participants, their familys, the investigators, and their staff for their dedication and courage to conduct and volunteer for this trial. We are very pleased to have the opportunity to present our positive safety and efficacy results from the clinical trial of MN-166 in the treatment of GBM at the most prestigious clinical oncology conference. GBM’s rapid progression and resistance to therapy poses a serious challenge to the medical community. Evaluation of MN-166 (ibudilast) as an adjuvant therapy with TMZ in GBM patients was generally safe and well tolerated. For the PFS6 primary efficacy endpoint, recurrent GBM patients showed a higher PFS6 rate compared to most historical studies. Moreover, the preclinical studies data from 2 different research groups presented at this meeting support our postulation that adding MN-166 (ibudilast) to existing immunotherapy, i.e. anti-PD1 or anti-PD-L1, improves survival more than the individual therapies alone. We are eager to evaluate MN-166 (ibudilast) in combination with anti-PD1 and anti-PD-L1 therapies in a future clinical trial.” About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety pro MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova also has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D. Chief Business Officer MediciNova, Inc info@medicinova.com