A Novel Strategy Combined Regional Anticoagulation in Membrane Oxygenator and Low-intensity of Systemic Anticoagulation Applied in Management of Extracorporeal Membrane Oxygenation

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

Start Date01 Nov 2024

Sponsor / Collaborator

Beijing Chao-Yang Hospital

NCT06500793 / Not yet recruitingPhase 1

A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered with Nafamostat As a Combination IR Solution and ER Capsule Formulation in Healthy Subjects

A single and multiple-dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.

Start Date01 Nov 2024

Sponsor / Collaborator

Ensysce Biosciences, Inc.

[+1]

ChiCTR2400083973 / SuspendedPhase 1IIT

Regional citrate anticoagulation versus nafamostat mesylate for continuous renal replacement therapy in patients at high risk of bleeding: a prospective randomized study

Start Date13 May 2024

Sponsor / Collaborator-

100 Clinical Results associated with Nafamostat Mesilate

100 Translational Medicine associated with Nafamostat Mesilate

100 Patents (Medical) associated with Nafamostat Mesilate

835

Literatures (Medical) associated with Nafamostat Mesilate

26 Nov 2024·Zhonghua yi xue za zhi

[Proposal of anticoagulant strategies in continuous renal replacement therapy].

Article

Author: Sun, X F

Anticoagulant therapy is an important component of continuous renal replacement therapy (CRRT). This article is based on evidence-based medicine and systematically summarizes the status and issues of anticoagulant regimens such as unfractionated heparin, regional heparinization, low molecular weight heparin, regional citrate anticoagulation, agatroban, nafamostat mesylate, and prostacyclin during CRRT in patients with or without high-risk bleeding, heparin induced thrombocytopenia or liver dysfunction, and provides recommendations, aiming to guide clinicians in the rational selection of anticoagulant regimens for CRRT.

01 Nov 2024·EUROPEAN JOURNAL OF PHARMACOLOGY

Harringtonine metabolites: 5'-de-O-methylharringtonine and cephalotaxine, targeting spike protein and TMPRSS2 to double block membrane fusion of SARS-CoV-2 and its variants

Article

Author: Zhang, Yuxiu ; Ma, Xiaoyu ; Ma, Weina ; Lei, Panpan ; He, Langchong ; Ren, Bingxi ; Hu, Shiling ; Gao, Jiapan

Membrane fusion is the main pathway for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to invade host cells. Harringtonine (HT), derived from cephalotaxus fortunei Hook. f., has been recognized as an effective antagonist of SARS-CoV-2. It can directly block the active binding of spike (S) protein to host angiotensin converting enzyme 2 (ACE2), as well as hinder the enzymolysis of transmembrane serine proteases 2 (TMPRSS2). This study examined the potential of HT metabolites, 5'-de-O-methylharringtonine and cephalotaxine, as the membrane fusion inhibitors for SARS-CoV-2. 5'-De-O-methylharringtonine was synthesized and subsequently characterized by high resolution mass spectrometry and nuclear magnetic resonance to be structurally consistent, with a purity of 92.677% determined by reverse phase high performance liquid chromatography. Both 5'-de-O-methylharringtonine and cephalotaxine can specifically bind to SARS-CoV-2 S protein and TMPRSS2 using cell membrane chromatography. They can form hydrogen bonds with key sites that correlated highly with the enhanced binding affinity of SARS-CoV-2 and its variants to ACE2 or nafamostat to TMPRSS2. Moreover, 5'-de-O-methylharringtonine and cephalotaxine can inhibit pseudotyped virus entry and membrane fusion in a dose-dependent manner, with enhanced effectiveness upon elevated expression of TMPRSS2. Importantly, they displayed low cytotoxic effects on human normal cell lines. Our study suggested that 5'-de-O-methylharringtonine and cephalotaxine were of low toxicity and safety for humans as potential antagonists of SARS-CoV-2 and its variants, which deserve further validation in a biosafety level 3 facility.

01 Oct 2024·Journal of intensive medicine

Pathophysiological dynamics in the contact, coagulation, and complement systems during sepsis: Potential targets for nafamostat mesilate

Review

Author: Zhong, Ming ; Qian, Yiqi ; Wei, Yilin ; He, Qiaolan

Sepsis is a life-threatening syndrome resulting from a dysregulated host response to infection. It is the primary cause of death in the intensive care unit, posing a substantial challenge to human health and medical resource allocation. The pathogenesis and pathophysiology of sepsis are complex. During its onset, pro-inflammatory and anti-inflammatory mechanisms engage in intricate interactions, possibly leading to hyperinflammation, immunosuppression, and long-term immune disease. Of all critical outcomes, hyperinflammation is the main cause of early death among patients with sepsis. Therefore, early suppression of hyperinflammation may improve the prognosis of these patients. Nafamostat mesilate is a serine protease inhibitor, which can inhibit the activation of the complement system, coagulation system, and contact system. In this review, we discuss the pathophysiological changes occurring in these systems during sepsis, and describe the possible targets of the serine protease inhibitor nafamostat mesilate in the treatment of this condition.

News (Medical) associated with Nafamostat Mesilate

13 Nov 2024

·www.prnewswire.com

Talphera Announces Third Quarter 2024 Financial Results and Provides Corporate Update

Five sites actively screening with multiple patients having completed the study; two additional institutions expected to begin screening in the fourth quarter totaling seven active sites Cash and investments at September 30, 2024 of $11.1 million Conference call and webcast to be held Wednesday, November 13, 2024 at 4:30 pm ET SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced third quarter 2024 financial results and provided a corporate update. "Our NEPHRO CRRT study has gained momentum, with activated study sites now screening patients and two additional sites to begin screening in the fourth quarter. We're actively engaged with new high-volume sites we expect to further contribute to enrollment rates in the first half of 2025. While we are not providing specific guidance on the study completion date, with execution of our plan to improve enrollment rates and activation of additional study sites, we anticipate the study to be completed next year," stated Vince Angotti, Talphera Chief Executive Officer. "As a reminder, this is not a prolonged study as the primary endpoint is measured at 24 hours with a patient completing the study at 72 hours," continued Angotti. Dr. Shakil Aslam, Talphera Chief Medical Officer, added, "I remain convinced that nafamostat, if approved, will provide the first FDA-approved regional anticoagulant for CRRT, potentially avoiding the risks of systemic anticoagulation that occurs with heparin. After engagement and discussion with numerous clinicians and the NEPHRO investigators, we have identified opportunities to further improve patient screening and enrollment for a timely completion of the study." Third quarter 2024 and recent highlights The first patient was enrolled in the NEPHRO CRRT study in August 2024. Five clinical sites have been activated and are screening patients, with multiple patients now having completed the study. Two additional large-volume clinical sites are expected to be screening patients in the fourth quarter. The NEPHRO CRRT study will enroll 166 patients undergoing continuous renal replacement therapy (CRRT) at up to 14 clinical sites across the United States. The primary endpoint of the study is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours. In October, we met with several physicians, nurses and NEPHRO CRRT study principal investigators at the American Society of Nephrology's Kidney Week 2024 in San Diego, confirming dissatisfaction with the current anticoagulants and validating the target product profile of nafamostat and its potential as a much-needed alternative anticoagulant for CRRT. Third Quarter 2024 Financial Information The cash, cash equivalents and investments balance was $11.1 million as of September 30, 2024. Combined R&D and SG&A expenses for the third quarter of 2024 totaled $3.7 million compared to $3.4 million for the third quarter of 2023. Excluding non-cash stock-based compensation expense, these amounts were $3.5 million for the third quarter of 2024, compared to $3.0 million for the third quarter of 2023. The increase in combined R&D and SG&A expenses in the third quarter of 2024 was primarily due to an increase in costs associated with the NEPHRO study, partially offset by lower SG&A expenses. For the third quarter of 2024, the Company recognized net loss from continuing operations of $3.4 million, as compared to net loss of $1.4 million for the third quarter of 2023, largely due to the change in fair value of the Company's warrant liability. The divestment of DSUVIA represents a discontinued operation; accordingly, all historical operating results for the business are reflected within discontinued operations. There were no DSUVIA related expenses in the third quarter of 2024. Net loss attributable to common shareholders for the third quarter of 2024 was $3.4 million, or $0.13 per basic and diluted share, compared to a net loss of $1.4 million, or $0.08 per basic and diluted share, for the third quarter of 2023. Conference Call and Webcast Information Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Standard Time/1:30 p.m. Pacific Standard Time to discuss the results and provide an update on the Company's business. Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada. The conference ID is 89949. The webcast can be accessed here or by visiting the Investors section of the Company's website at and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit . About Niyad and nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT ( Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation that the NEPHRO study enrollment rates will increase, additional study sites will be activated allowing the study to be completed by the end of 2025, that nafamostat, if approved, will potentially avoid the risks of systemic anticoagulation, the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, the potential advantage of having Breakthrough Device Designation, and potential FDA approval of the nafamostat product candidate. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. SOURCE Talphera, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 3Breakthrough TherapyClinical Study

12 Nov 2024

·ir.ensysce.com

Ensysce Biosciences Reports Third Quarter 2024 Financial Results

Awarded $14 Million Multi-Year NIH Grant and Initiated Second Clinical Trial for Breakthrough Therapy PF614-MPAR Submitted Pivotal PF614 Phase 3 Protocol to the FDA for Review SAN DIEGO, CA / ACCESSWIRE / November 12, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today reported financial and operational results for the third quarter ended September 30, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made significant progress in the third quarter, and we have line of sight to meaningful clinical initiatives to close out the year. The highlight of the third quarter was NIH's recognition of the potential value provided by our overdose protection technology MPAR®, by awarding Ensysce with a $14 million multi-year grant to further the clinical development of PF614-MPAR. The support from the NIH allows the completion of a second Phase 1b trial, PF614-MPAR-102. We believe the data from this study will cement PF614-MPAR as the first opioid with oral overdose protection, a game-changer for those suffering with severe pain while mitigating potential abuse and overdose." Dr. Kirkpatrick continued, "We also built on FDA feedback from our End of Phase 2 meeting in February to complete our Phase 3 protocol and have submitted it to the FDA. We expect FDA feedback by the end of November to allow us to complete plans to execute the study over the coming year. Our August financing transaction that raised $5 million in gross proceeds allows us to advance to clinical site selection for our pivotal Phase 3 trial for PF614, and the $14 million MPAR® grant has allowed us to rapidly initiate our second trial for PF614-MPAR. We anticipate the results from these clinical studies will continue to build on our prior positive safety data to bring our innovative and premium pain products to market. Lastly, we are applying our TAAP and MPAR technology to our opioid use disorder program and look forward to moving the lead agent into clinical development in the coming years." TAAPTM (Opioid Abuse Deterrent Program) Update Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company's TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614's TAAPTM modification makes it inactive until it is swallowed and exposed to the body's own trypsin in the small intestine to activate or "switch on" to release oxycodone. During the third quarter, the Company submitted to the FDA for regulatory review the protocol and statistical analysis plan for its anticipated final Phase 3 study, PF614-301. The study is entitled "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update PF614-MPAR, designed to treat severe pain with added oral overdose protection, is a combination product of the TAAPTM prodrug PF614 with a trypsin inhibitor. MPAR® (Multi-Pill Abuse Resistance) reduces or "switches off" the release of the opioid only in an overdose situation, providing an additional layer of protection to Ensysce's TAAP™ medications. The clinical data from the first clinical trial, PF614-101, demonstrated that the MPAR® technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose, leading to the FDA's Breakthrough Therapy designation in January of this year. During the third quarter, the Company received approval from the Investigational Review Board ("IRB") of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' The Site Initiation Visit has been undertaken and the study is on track to initiate subject dosing this quarter. To execute this study, Ensysce has continued its collaboration with Quotient Sciences to use their Translational Pharmaceutics® platform to perfect the drug product. As reported in August, the Company received a $14 million multi-year grant from the NIH, National Institute of Drug Abuse (NIDA) to fund this clinical study as well as the necessary non-clinical studies to support an NDA (New Drug Application) for PF614-MPAR. Opioid Use Disorder (OUD) Program Update The Company recently announced the selection of its lead OUD drug candidate PF9001 that has been designed using Ensysce's TAAPTM platform. The intent of the program is to reduce both the abuse profile and the cardiovascular side effects associated with traditional methadone OUD treatments. The program is finalizing required studies supported by a multi-year Helping to End Addiction Long-Term (HEAL) award of up to $15 million granted by the NIH and NIDA and anticipates advancing to Investigational New Drug (IND) enabling studies in the coming year. Q3 2024 Financial Results Cash - Cash and cash equivalents were $4.2 million as of September 30, 2024, compared to $1.1 million as of December 31, 2023. A key driver for the increase in cash was cumulative net proceeds of $8.5 million from equity financings in February and August 2024. Stockholders' Equity - Stockholders' equity was $6.6 million as of September 30, 2024, a level compliant with the $2.5 million stockholders' equity requirement set forth in Nasdaq Listing Rule 5550(b)(1). Federal Grants - Funding under federal grants totaled $3.4 million for the third quarter of 2024 compared to $0.4 million in the comparable year ago quarter. The increase is due to the timing of research activities eligible for funding, with increased activities under the OUD grant following the selection of a lead drug candidate in June. Funding under the current phase of the OUD grant was completed in August 2024. Also contributing to the increase is the recently awarded MPAR grant, with payments for clinical activities for PF614-MPAR initiated during the quarter. With the completion of the OUD grant, funding under federal grants is expected to decline in coming quarters from the level of the third quarter of 2024. Research & Development Expenses - R&D expenses were $1.7 million for the third quarter of 2024 compared to $1.9 million for the same period in 2023. The decrease of $0.2 million was primarily the result of reduced external research and development costs related to clinical and pre-clinical programs for PF614 in the 2024 period. Increased activities on the OUD and MPAR programs are expected to result in higher research and development expenses in coming quarters. General & Administrative Expenses - G&A expenses were $1.1 million in the third quarter of 2024, compared to $1.2 million for the third quarter of 2023, a slight decrease of $0.1 million. G&A expenses are expected to approximate current levels in the coming quarters. Other Income (Expense) - Total other income (expense), net, was consistent with income of $17,023 for the third quarter of 2024 compared to income of $16,508 for the same period of 2023. Net Income (Loss) - Net income attributable to common stockholders for the third quarter of 2024 was $0.7 million compared to a net loss of $2.7 million for the third quarter of 2023. The Company recorded net income in the third quarter due to the timing of federal grant funding received, with the completion of funding under the OUD grant and the start of funding under the MPAR grant both occurring during the quarter. With only the MPAR grant moving forward, net income for the third quarter is expected to be a one-time event and we do not anticipate net income in coming quarters. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future. About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com. Definitions TAAP™: trypsin activated abuse protection - designed to protect against prescription drug abuse. MPAR®: multi-pill abuse resistance - designed to protect against abuse and accidental overdose. Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D.Chief Executive Officer(858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon DevineMZ North AmericaMain: 203-741-8811ENSC@mzgroup.us Ensysce Biosciences, Inc.Condensed Consolidated Statements of Operations(Unaudited) 2024 2023 2024 2023 $ 3,418,853 $ 435,380 $ 3,906,372 $ 1,715,488 1,690,674 1,914,970 3,416,807 5,354,713 1,083,433 1,227,724 3,643,223 3,923,277 2,774,107 3,142,694 7,060,030 9,277,990 644,746 (2,707,314 ) (3,153,658 ) (7,562,502 ) 17,023 16,508 (1,268,929 ) 440,588 $ 661,769 $ (2,690,806 ) $ (4,422,587 ) $ (7,121,914 ) - 1,235 (216 ) 198 $ 661,769 $ (2,689,571 ) $ (4,422,803 ) $ (7,121,716 ) $ 0.07 $ (0.87 ) $ (0.57 ) $ (3.32 ) Ensysce Biosciences, Inc.Condensed Consolidated Statements of Cash Flows(Unaudited) Nine Months Ended September 30, 2024 2023 $ (6,738,610 ) $ (8,978,107 ) 9,768,598 7,294,786 3,029,988 (1,683,321 ) 1,123,604 3,147,702 $ 4,153,592 $ 1,464,381 Ensysce Biosciences, Inc.Condensed Consolidated Balance Sheets(Unaudited) September 30, December 31, 2024 2023 $ 4,153,592 $ 1,123,604 4,936,915 1,165,264 9,090,507 2,288,868 294,217 419,217 $ 9,384,724 $ 2,708,085 $ 1,967,573 $ 1,936,007 447,035 542,260 387,176 854,697 2,801,784 3,332,964 3,213 26,388 2,804,997 3,359,352 6,579,727 (651,267 ) $ 9,384,724 $ 2,708,085 SOURCE: Ensysce Biosciences, Inc. Released November 12, 2024

Phase 3Financial StatementPhase 2Fast TrackBreakthrough Therapy

06 Nov 2024

·www.prnewswire.com

Talphera to Host Third Quarter 2024 Financial Results and Corporate Update Call and Webcast on Wednesday, November 13, 2024

SAN MATEO, Calif., Nov. 6, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release third quarter 2024 financial results after market close on Wednesday, November 13, 2024, then host a live webcast and conference call at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Standard to discuss the results and provide an update on the Company's business. Webcast Information The webcast can be accessed here or by visiting the Investors section of the Company's website at and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event. Conference Call Information Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada. The conference ID is 89949. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). Talphera is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about Talphera, please visit . SOURCE Talphera, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementBreakthrough Therapy

100 Deals associated with Nafamostat Mesilate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Nafamostat Mesilate	B02AB	DB12598

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Disseminated Intravascular Coagulation	JP	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1989
Hemorrhage	JP	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1989
Pancreatitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1989

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatitis, Chronic	Phase 1	CN	Lanzhou Jinglong Medical Technology Co., Ltd.	14 Sep 2016
Traumatic pancreatitis	Phase 1	CN	Lanzhou Jinglong Medical Technology Co., Ltd.	14 Sep 2016
COVID-19	Preclinical	US	Talphera, Inc.	01 Dec 2024
Respiratory Distress Syndrome, Acute	Preclinical	US	Talphera, Inc.	01 Dec 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| J Biol Chem Manual	Phase 2	Pancreatic Cancer	47	nafamostat mesilate+Gemcitabine+Tegafur+Gimeracil+Oteracil	cmoxnzbuab(mejtugenfw) = falcbtydwv ukdzsbaafs (qcutcpgpbr, 8.4 - 12.0) View more	Positive	11 May 2022
NCT04623021 (Pubmed)	Phase 2	COVID-19	104	Nafamostat plus standard-of-care (SOC)	fcafzfjglq(nuestfazea) = ngabqskayi amjnqyufot (szoxpdsklc )	-	01 Nov 2021
				Standard-of-care (SOC) alone	fcafzfjglq(nuestfazea) = sleqoebsfi amjnqyufot (szoxpdsklc )
ASN2021	Not Applicable	-	-	Nafamostat Mesylate	qugoliolor(htfmxqybyl) = nqnougufll rqgibqhxgx (xupyvenrkj, [22 - 68])	Positive	27 Oct 2021
				Regional Citrate Anticoagulation	qugoliolor(htfmxqybyl) = yydabfeedq rqgibqhxgx (xupyvenrkj, [16 - 67])
ASN2020	Not Applicable	-	-	Nafamostat Mesylate	lekeotjkrm(tvcagukmoy) = rxljithqfv walwegecbp (kujyjvbmoe )	Positive	19 Oct 2020
				Regional Citrate Anticoagulation	lekeotjkrm(tvcagukmoy) = xnvfducanf walwegecbp (kujyjvbmoe )
UEGW	Not Applicable	-	-	Nafamostat mesilate (FUT)	jdkioxbcfk(qsfwlmaqrh) = talgcrsrvw icswogpqio (yhtcctvpzm )	-	01 Oct 2016
				Low-molecular-weight heparin (LMWH)	jdkioxbcfk(qsfwlmaqrh) = jpneobsysz icswogpqio (yhtcctvpzm )
SP234 (ERA2015)	Not Applicable	Critical Illness	115	Nafamostat mesilate	binzanlsvr(sfxhubhaof) = cyeiwcwodr nfwrgstggl (unvlrxuvhe ) View more	Positive	21 May 2015
				Unfractinated heparin (UFH)	binzanlsvr(sfxhubhaof) = nfsszpkwev nfwrgstggl (unvlrxuvhe ) View more
NCT04352400 (Pubmed \| Pancreas)	Phase 2/3	Post-ERCP Pancreatitis	2,956	Nafamostat	kpmfvalaco(tyuiyqchij) = fuwqceztlj qbhdoaejbk (louonvahys, 0.34 - 0.63)	Positive	01 May 2015
				Nonnafamostat	-
ASN2014	Not Applicable	-	115	Nafamostat Mesilate	sznemngvbe(cknextvaug) = rtccnpgtdy fuydqcmytf (toglsvrpww ) View more	Positive	11 Nov 2014
				Unfractionated Heparin	sznemngvbe(cknextvaug) = mkwcntprci fuydqcmytf (toglsvrpww ) View more
ASCO2010	Phase 2	Pancreatic Cancer	30	Gemcitabine + Nafamostat Mesilate	bykjtewbeo(cobxmfmkft) = hrvxfuljnz cvdqhppynh (kwbhzasooe )	-	20 May 2010
NCT01001403 (CTgov)	Phase 4	syndrome; salt-losing, adrenogenital syndrome \| Prieto X-Linked Mental Retardation Syndrome	62	Nafamostat (Nafamostat)	wumypcgqcd(mlwydunveq) = lwvuxfsvoc faletfgfye (odjihbstmi, hutbubmmjz - ozfeqiutox) View more	-	03 May 2010
				Normal Saline (Control)	wumypcgqcd(mlwydunveq) = gaoumssgpb faletfgfye (odjihbstmi, swdjygpzge - mwztdvheor) View more

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