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 Date24 Nov 2024

Sponsor / Collaborator

Ensysce Biosciences, Inc.

[+1]

NCT06676085

/ RecruitingNot ApplicableIIT

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

100 Clinical Results associated with Nafamostat Mesilate

100 Translational Medicine associated with Nafamostat Mesilate

100 Patents (Medical) associated with Nafamostat Mesilate

1,258

Literatures (Medical) associated with Nafamostat Mesilate

31 Dec 2025·RENAL FAILURE

Nafamostat mesylate versus regional citrate anticoagulation for chronic hemodialysis in patients at high risk of bleeding: a single-center, retrospective study

Article

Author: Chen, Yue ; Zhou, Ying ; Wang, Lirui ; Lu, Yuqiu ; Li, Jiangtao

INTRODUCTION:

For hemodialysis patients at high risk of bleeding, a regional anticoagulant can be used, such as citrate or nafamostat mesylate (NM). The objective of this study was to evaluate NM as an alternative to citrate for anticoagulation in hemodialysis patients at high risk of bleeding.

METHODS:

This retrospective single-center study included consecutive patients in our dialysis center treated with either citrate or NM anticoagulation for hemodialysis from January 2022 to December 2023.The primary outcome was major clotting, defined as premature dialysis due to extracorporeal circuit clotting. The secondary outcome was the incidence of a major bleeding episode during or after hemodialysis.

RESULTS:

In total, 651hemodialysis sessions were performed in 196 patients and were compared (289 citrate and 362 NM anticoagulation). A lower number of premature dialysis due to clotting occurred in the NM sessions compared to citrate sessions (0.84% vs.5.19%, p = 0.001). NM was associated with a lower risk of major clotting compared with citrate during treatment (OR:0.063; CI: 0.008-0.475; p = 0.007). Regarding second outcome, no more major bleeding events related to NM occurred compared to citrate.

CONCLUSION:

Among hemodialysis patients with high risk of bleeding, anticoagulation with NM, compared with citrate anticoagulation, provided relatively better efficacy, with no bleeding increment. NM is a valid alternative to citrate for hemodialysis patients at high risk of bleeding.

01 Aug 2025·CANCER LETTERS

Corrigendum to “Inhibition of the NF-κB pathway by nafamostat mesilate suppresses colorectal cancer growth and metastasis” [Cancer Lett. 380 (2016) 87–97]

Author: Wang, Feng ; Lu, Yun-Xin ; Mo, Hai-Yu ; Wu, Qi-Nian ; Xu, Rui-Hua ; Sheng, Hui ; Zeng, Zhao-Lei ; Kang, Tie-Bang ; Yun, Jing-Ping ; Chen, Gong ; Pan, Zhi-Zhong ; Chen, Le-Zong ; Ju, Huai-Qiang ; Xie, Dan

01 May 2025·ANTIVIRAL RESEARCH

Assessment of repurposed compounds against coronaviruses highlights the antiviral broad-spectrum activity of host-targeting iminosugars and confirms the activity of potent directly acting antivirals

Article

Author: Hill, Michelle L ; Gileadi, Carina ; Brun, Juliane ; Kiappes, J L ; Witt, Karolina D ; Dwek, Raymond A ; von Delft, Annette ; Arman, Benediktus Yohan ; Rangel, Victor ; Makower, Laetitia L ; Zitzmann, Nicole ; Alonzi, Dominic S

The COVID-19 pandemic highlights the need for novel antiviral drug discovery approaches that could dramatically shorten timelines from compound discovery to clinical development. At the beginning of the pandemic, repurposing approaches were at the forefront of early research efforts to screen for antiviral activity against SARS-CoV-2 in over 2500 compounds. Here, we report cellular screening results of 100 FDA-approved and experimental compounds against SARS-CoV-2 in the human Calu-3 cell line. We observed 13 compounds showing antiviral activity against SARS-CoV-2, including seven FDA-approved compounds (remdesivir, boceprevir, amiloride, nafamostat, cisplatin, silmitasertib, and miglustat), and six compounds in pre-clinical and clinical development (tarloxotinib, lucerastat (NB-DGJ), MON-DNJ, NAP-DNJ, NN-DGJ and NN-DNJ). Further, we observed that our screening hits include several host-targeting antivirals, namely iminosugars, that are largely non-toxic and offer a large therapeutic window. The most-developed iminosugar MON-DNJ (UV-4B), which has been evaluated in a Phase 1 clinical trial, shows antiviral activity against SARS-CoV-2 wild type as well as alpha, beta, gamma, delta, and Omicron variants. Its activity also extended to another betacoronavirus HCoV OC43, but not alphacoronavirus HCoV 229E. Our cellular screening results add to the body of knowledge on antivirals against coronaviruses and confirm the antiviral efficacy of iminosugars in cellular assays using the human lung-cell line Calu-3.

News (Medical) associated with Nafamostat Mesilate

14 May 2025

·ir.talphera.com

Talphera Announces First Quarter 2025 Financial Results and Provides Corporate Update

Cash and investments at March 31, 2025 , as adjusted to include the proceeds from the first tranche of the private placement financing which closed on April 2, 2025 , were $9.8 million Three new clinical study sites activated and screening patients thus far in 2025, with five additional sites expected by mid-year, for a total of 13 Conference call and webcast to be held Wednesday, May 14, 2025 at 4:30 pm ET SAN MATEO, Calif. , May 14, 2025 /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 first quarter 2025 financial results and provided a corporate update. "We remain on track with new study site activation, including three institutions already activated and beginning to screen patients in 2025, and five new potentially high-enrolling sites by mid-year. The new target profile of our clinical study sites has proven beneficial as engagement with the principal investigators and activity at the sites is much higher than with the legacy sites with which we first initiated the study," stated Vince Angotti , CEO of Talphera. "We believe that the increased engagement from the new sites, including those expected to come on board in the coming months, will allow us to complete the 70-patient study by the end of the year. We expect our next enrollment update to occur when we enroll 17 patients, which is the milestone for closing the second tranche of our recent financing. Our confidence in the need for this product candidate continues to grow as we introduce more physicians to the Niyad clinical profile and NEPHRO study," continued Angotti. First Quarter 2025 and Recent Highlights In March 2025 , the Company announced it received approval from the U.S. Food and Drug Administration (FDA), on its Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study from 166 in the original study protocol to 70. With 70 patients, the primary endpoint is powered at 90%. In January 2025 , the agency also agreed to two other changes to broaden the clinical study inclusion criteria which allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours, as well as heparin-tolerant patients at certain institutions. In March 2025 , Talphera announced the agreement for a financing of up to $14.8 million , including two committed tranches upon achievement of 25% and 50% enrollment and Talphera's stock price trades at a price at or above $0.7325 for five consecutive days following the announcement of achieving the enrollment milestones. The financing was led by existing investors, Nantahala Capital and Rosalind Advisors , and includes a member of management. The first tranche of this financing amounting to $4.4 million in net proceeds closed on April 2, 2025 . First Quarter 2025 Financial Information The cash and cash equivalents balance was $5.4 million as of March 31, 2025 . Combined R&D and SG&A expenses for the first quarter of 2025 totaled $2.9 million compared to $4.2 million for the first quarter of 2024. Excluding non-cash stock-based compensation expense, these amounts were $2.7 million for the first quarter of 2025, compared to $3.9 million for the first quarter of 2024. The decrease in combined R&D and SG&A expenses in the first quarter of 2025 was primarily due to reductions in personnel expense and other general and administrative expenses. For the first quarter of 2025, the Company recognized net loss from continuing operations of $2.7 million , as compared to net loss of $4.0 million for the first quarter of 2024, largely due to reductions in personnel expense in 2025 and the change in fair value of the Company's warrant liability, partially offset by the gain on sale of future payments in 2024. The divestment of DSUVIA represents a discontinued operation; accordingly, all historical operating results for the business are reflected within discontinued operations. Net income from discontinued operations was $0.1 million in the first quarter of 2025. Net loss attributable to common shareholders for the first quarter of 2025 was $2.6 million , or $0.10 per basic and diluted share, compared to a net loss of $4.0 million , or $0.16 per basic and diluted share, for the first quarter of 2024. 2025 Expense Guidance Cash operating expenses, or selling, general and administrative, and research and development expenses, excluding stock-based compensation, is expected to be in the range of $17 million to $19 million in 2025, which includes the expenses related to executing and completing the NEPHRO CRRT registration trial before the end of the year. Conference Call and Webcast Information Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific 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 58894.The webcast can be accessed here or by visiting the Investors section of the Company's website at www.talphera.com 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 www.talphera.com. 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 CRRT 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 70 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 the mean post-filter activated clotting time over 72 hours, 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 there will be five new potentially high-enrolling sites activated by mid-year, that the NEPHRO study enrollment rates will increase, and additional study sites will be activated allowing the study to be completed by the end of 2025; the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and potential FDA approval of the nafamostat product candidate; Talphera's expectation that the committed capital from the private placement financing, upon completion of certain milestones and meeting certain closing conditions, should provide sufficient capital to fund the completion of the NEPHRO study, expected by the end of 2025; Talphera's expected cash operating expenses will be in the $17 million to $19 million range for 2025; and Talphera's ability to successfully meet the enrollment goals and minimum stock price to satisfy the requirements of the two additional committed private placement financing tranches. 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 www.talphera.com 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. Selected Financial Data (in thousands, except per share data) (unaudited) Three Months Ended March 31 2025 2024 Statement of Operations Data Revenue $ 27 $ - Operating costs and expenses: Research and development (1) 1,169 1,433 Selling, general and administrative (1) 1,774 2,804 Total operating costs and expenses 2,943 4,237 Loss from operations (2,916) (4,237) Other income, net: Interest income and other income, net 69 220 Gain on sale of future payments - 1,246 Gain (loss) on change in fair value of warrant liability 181 (1,002) Non-cash interest expense on liability related to sale of future payments - (181) Total other income, net 250 283 Net loss from continuing operations (2,666) (3,954) Net income from discontinued operations 73 - Net loss $ (2,593) $ (3,954) Net loss per share attributable to stockholders: Basic and diluted, continuing operations $ (0.10) $ (0.16) Basic and diluted, discontinued operations $ 0.00 $ - Basic and diluted loss per share $ (0.10) $ (0.16) Shares used in computing net loss per share of common stock, basic and diluted 26,268 24,722 (1) Includes the following non-cash stock-based compensation expense: Research and development $ 77 $ 107 Selling, general and administrative 119 195 Total $ 196 $ 302 Selected Balance Sheet Data (in thousands) March 31, 2025 December 31, 2024 (1) (Unaudited) (Unaudited) Cash, cash equivalents and investments $ 5,388 $ 8,863 Total assets 14,995 18,236 Total liabilities 9,396 10,235 Total stockholders' equity 5,599 8,001 (1) Derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 . Reconciliation of Non-GAAP Financial Measures (Operating Expenses less stock-based compensation expense) Three Months Ended March 31 (unaudited) 2025 2024 Operating expenses (GAAP): Research and development $ 1,169 $ 1,433 Selling, general and administrative 1,774 2,804 Total operating expenses 2,943 4,237 Less stock-based compensation expense 196 302 Operating expenses (non-GAAP) $ 2,747 $ 3,935 View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-first-quarter-2025-financial-results-and-provides-corporate-update-302455637.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com

Financial StatementPhase 3Breakthrough Therapy

15 Apr 2025

·ir.ensysce.com

Ensysce Biosciences Announces Positive Data from Opioid Overdose Protection Study

~ Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study ~ SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / 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 announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection. PF614-MPAR-102 demonstrated that the combined Ensysce TAAPTM and MPAR® technologies can deliver strong relief for severe pain yet protect from the risk of excessive doses when consumed accidentally or deliberately. Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed. Subjects were studied as their own control and received up to five 100 mg doses of the overdose-protected PF614-MPAR versus the unprotected PF614. The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time (Cmax) was reduced compared to that released following the consumption of same amount of PF614 alone, evidence of overdose protection. When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. We believe this data, combined with that from a previous study, PF614-MPAR-101, demonstrates overdose protection across the full dosage range of PF614-MPAR planned for commercialization. This complete analysis will be discussed with the FDA in an upcoming meeting focusing on the full development plans for PF614-MPAR. The trial will now continue to enroll Part 2 to examine potential food effect and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR. The aggregate data will allow the Company to focus on perfecting a final drug product to move into commercialization. Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "These clinical data demonstrate that MPAR® is a vital tool to limit overdoses from prescription medications. Our initial study demonstrated the unique overdose protection built into PF614-MPAR, which is the only opioid product to have been granted FDA's Breakthrough Therapy designation. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is now closer to the finish line." Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "Each phase of our MPAR related clinical studies thus far have provided highly encouraging data supporting the safety features of PF614 and PF614-MPAR that other opioids don't have. We are continuing to quickly execute the final stages of this study with Quotient Sciences and their Translational Pharmaceutics® platform, and we are working with a commercial manufacturing partner to prepare this unique product for the market. We look forward to productive discussions with the FDA to establish our path to registration for the first overdose-protected opioid." PF614-MPAR 102 Clinical Study Description Clinical study PF614-MPAR-102, ‘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 of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. About Ensysce Biosciences Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) 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. For more information, please visit www.ensysce.com. 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, 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-K 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 Devine MZ North America Main: 203-741-8811 ENSC@mzgroup.us SOURCE: Ensysce Biosciences Released April 15, 2025

Breakthrough TherapyClinical ResultClinical Study

31 Mar 2025

·ir.talphera.com

Talphera Announces Agreement with the FDA to Reduce the NEPHRO CRRT Study Size to 70 Patients From 166 and a Private Placement Financing Priced At-the Market of up to $14.8 Million

The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 patients, of which 6 patients are already enrolled Talphera believes the NEPHRO CRRT study should be completed by the end of 2025 Existing investors, Nantahala Capital and Rosalind Advisors led the capital commitment priced at-the-market as defined by Nasdaq rules $4.925 million in gross proceeds at first closing with the potential to receive an additional $9.85 million across two $4.925 million tranches upon achieving certain patient enrollment milestones Cash and investments at December 31, 2024 of $8.9 million, together with the expected proceeds from the financing of up to $14.8 million should provide capital through targeted completion of the NEPHRO CRRT study by the end of 2025 SAN MATEO, Calif., March 31, 2025 /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 its agreement with the FDA to reduce the size of the NEPHRO CRRT study to 70 patients from the 166 previously included in the study protocol. The Company also announced it has entered into securities purchase agreements with certain institutional investors and a member of management for the sale and issuance of shares of common stock and pre-funded warrants in lieu of shares to purchase common stock in a three-tranche private placement for potential gross proceeds of up to $14.8 million. "We are pleased that the FDA agreed with our assessment to reduce the study size to 70 patients, which still keeps the study's primary endpoint powered at 90%," stated Vince Angotti, Talphera CEO. "This change, along with the other protocol changes to the study inclusion criteria and the addition of new sites with higher enrollment potential will support a timely completion of the study, which we are targeting by the end of the year. We are also thankful for the continued support from our existing investors, Nantahala and Rosalind, which led the private placement financing. The additional capital should support our objective of completing the study by the end of the year as we look forward to submitting our PMA early next year and a potential approval in the second half of 2026." The Private Placement The private placement is led by Nantahala Capital and Rosalind Advisors, and includes a member of management, and has the potential to raise gross proceeds of up to $14.8 million, which amount includes (i) $4.925 million in the first closing (which is expected to occur on April 2, 2025), (ii) $4.925 million in a second closing upon the enrollment of at least 17 patients in the Company's NEPHRO CCRT study (the "Second Milestone"), and a minimum stock price of at least $0.7325 per share for five consecutive days following a public announcement of the achievement of the Second Milestone, and (iii) $4.925 million in a third closing upon the enrollment of at least 35 patients (the "Third Milestone"), and a minimum stock price of at least $0.7325 per share for five consecutive days following a public announcement of the achievement of the Third Milestone. In the first closing, Talphera will issue 3,405,118 shares of common stock and 4,999,316 pre-funded warrants, at a price of $0.586 per share and $0.585 per pre-funded warrant, respectively. The pre-funded warrants will have an exercise price of $0.001 per share. In each of the second and third closings upon achievement of the respective milestones and if closing conditions are met, Talphera expects to issue an additional 3,405,118 shares of common stock and 4,999,316 pre-funded warrants, at a price of $0.586 per share and $0.585 per pre-funded warrant, respectively. The offer and sale of the securities described above are being offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder, and have not been registered under the Act, or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement under the Act with the Securities and Exchange Commission (the "SEC"), covering the resale of the shares of common stock to be issued in the private placement and the shares of common stock underlying the pre-funded warrants no later than 45 days following the closing date, and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the closing date in the event of a "full review" by the SEC. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. 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 www.talphera.com. About 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 CRRT 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 70 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 the mean post-filter activated clotting time over 72 hours, 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. 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 "potential," "potentially," "believe," "expect," "anticipate," "may," "will," "if," "enable," "should," "seek," "approximately," "intends," "intended," "plans," "planned," "planning," "targeted," "estimates," "sufficient," "benefits," or the negative of these words or other comparable terminology, and include Talphera's statements regarding and include Talphera's statements regarding a potential completion of the NEPHRO CRRT study by the end of 2025; Talphera's expectation that the committed capital from the financing, upon completion of certain milestones and meeting certain closing conditions, should provide sufficient capital to fund the completion of the study expected by the end of 2025, with an expected PMA application submitted in early 2026 and a potential approval in the second half of 2026; and Talphera's ability to successfully meet the enrollment goals and minimum stock price to achieve the Second Milestone and Third Milestone. The discussion of strategy, plans or intentions may 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 and ongoing commercial business operations; (ii) risks related to the ability of Talphera and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for Talphera 's commercial and developmental products and technologies; (iv) risks related to Talphera 's liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; (v) Talphera 's ability to retain its listing on the Nasdaq exchange; and (vi) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates. 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 www.talphera.com 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-agreement-with-the-fda-to-reduce-the-nephro-crrt-study-size-to-70-patients-from-166-and-a-private-placement-financing-priced-at-the-market-of-up-to-14-8-million-302415309.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com

Phase 3

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.

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

Developing

10 top R&D records.

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

Clinical Result

Indication

Phase

Evaluation

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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	xclndcjsuw(fngwbjksjl) = ozikkbopud jbuejepkrn (xcvtwbbdqw, 8.4 - 12.0) View more	Positive	11 May 2022
NCT04623021 (Pubmed)	Phase 2	COVID-19	104	Nafamostat plus standard-of-care (SOC)	fftcqnizhk(xssrmrbxjn) = fdorjrffry vzjpiyuacf (tjbewtnolz )	-	01 Nov 2021
				Standard-of-care (SOC) alone	fftcqnizhk(xssrmrbxjn) = xllzonjzqq vzjpiyuacf (tjbewtnolz )
ASN2021	Not Applicable	-	-	Nafamostat Mesylate	gcqsbrzajo(oxsbchbeps) = xuitpmyszs kbnscwppic (wbgtrimvoi, [22 - 68])	Positive	27 Oct 2021
				Regional Citrate Anticoagulation	gcqsbrzajo(oxsbchbeps) = dxvgdooumt kbnscwppic (wbgtrimvoi, [16 - 67])
ASN2020	Not Applicable	-	-	Nafamostat Mesylate	ejxzxvaker(ptcolazyuf) = qwholtagqp vljjdszdgy (tqymvflmvj )	Positive	19 Oct 2020
				Regional Citrate Anticoagulation	ejxzxvaker(ptcolazyuf) = euldqlmyec vljjdszdgy (tqymvflmvj )
UEGW2016	Not Applicable	-	-	Nafamostat mesilate (FUT)	bqqzlivjvr(tncqcdfhdl) = ysukewrmdj mefwgmcgvc (gzmempyias )	-	01 Oct 2016
				Low-molecular-weight heparin (LMWH)	bqqzlivjvr(tncqcdfhdl) = pyhijyjfwc mefwgmcgvc (gzmempyias )
SP234 (ERA2015)	Not Applicable	Critical Illness	115	Nafamostat mesilate	edfpvazhsc(vljgkgtnhi) = otpfawbgvx bagfsodurd (bdpsywpswu ) View more	Positive	21 May 2015
				Unfractinated heparin (UFH)	edfpvazhsc(vljgkgtnhi) = zpjzeoqljz bagfsodurd (bdpsywpswu ) View more
NCT04352400 (Pubmed \| Pancreas)	Phase 2/3	Post-ERCP Pancreatitis	2,956	Nafamostat	smxkzswxxb(vmhhiwjgaj) = agbotprpaf njnxsqlpfc (dptugktlyd, 0.34 - 0.63)	Positive	01 May 2015
				Nonnafamostat	-
ASN2014	Not Applicable	-	115	Nafamostat Mesilate	qzmqixocvn(tcusqibezx) = aerhcbqtws wzgrwfqolt (gffcqfnypb ) View more	Positive	11 Nov 2014
				Unfractionated Heparin	qzmqixocvn(tcusqibezx) = ksvlrlwpws wzgrwfqolt (gffcqfnypb ) View more
ASCO2010	Phase 2	Pancreatic Cancer	30	Gemcitabine + Nafamostat Mesilate	duaqrxpwpd(zpgfxguwjr) = xqrlmidfew oryxaqfscx (xmjxzgvjld )	-	20 May 2010
NCT01001403 (CTgov)	Phase 4	syndrome; salt-losing, adrenogenital syndrome \| Prieto X-Linked Mental Retardation Syndrome	62	Nafamostat (Nafamostat)	chuqnngwzz = qlpnumcqzv tpnqklndpb (drsitsosnd, pozioaptke - tmmuffygit) View more	-	03 May 2010
				Normal Saline (Control)	chuqnngwzz = klptqljbca tpnqklndpb (drsitsosnd, akvwpkfxew - wurnjeppxz) View more

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