Talphera Inc (TLPH)

We started all over again this week and we are now 2 days in a row over a buck.  Need 8 more consecutive days

Talphera Announces First Quarter 2026 Financial Results and Provides Corporate UpdateMay 13, 2026 4:05 PM
PR Newswire (US) NEPHRO CRRT clinical study expected to be completed this yearCash and investments of $21.1 million at March 31, 2026Conference call and webcast to be held on Wednesday, May 13, 2026 at 4:30 pm ETSAN MATEO, Calif., May 13, 2026 /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 2026 financial results and provided a corporate update."In early March, we announced the attainment of 50% enrollment in the NEPHRO CRRT study evaluating nafamostat. With continued steady enrollment, we have well exceeded this level, and continue to expect study completion later this year," stated Vince Angotti, CEO of Talphera.  "Our clinical study sites and principal investigators remain focused on enrollment and delivering a high quality study as they are eager for a potential alternative anticoagulant for Continuous Renal Replacement Therapy (CRRT). The investor and analyst event held in March also highlighted the need for an alternative, given the disadvantages of the currently used products, heparin and citrate.  If approved, we continue to believe nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT," continued Angotti.First Quarter 2026 and Recent HighlightsIn March 2026, announced reaching the 35-patient enrollment milestone, representing 50% enrollment in the NEPHRO CRRT study. Enrollment has continued to increase since this announcement, with study completion expected in 2026.In March 2026, held an investor and analyst event with two key opinion leaders (KOLs) focused on anticoagulants used during CRRT and the potential for nafamostat to address an unmet need.In March 2026, two posters were presented at the 31st Annual International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026), entitled: "A Randomized, Placebo-Controlled Multi-Center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy Who Cannot Tolerate Heparin or Are at a Higher Risk of Bleeding" and, "In Vivo Assessment of Nafamostat, A Novel Regional Anticoagulant in a Porcine Model AKI and CKRT".In March 2026, closed $4.1 million third tranche of the March 2025 private placement financing upon achieving the 35-patient enrollment milestone and other conditions.First Quarter 2026 Financial InformationThe cash and investments balance was $21.1 million as of March 31, 2026.Combined R&D and SG&A expenses for the first quarter of 2026 totaled $3.9 million compared to $2.9 million for the first quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the first quarter of 2026, compared to $2.7 million for the first quarter of 2025. The increase in combined R&D and SG&A expenses in the first quarter of 2026 was primarily due to higher Niyad® development expenses, reflecting increased enrollment, and an increase in certain G&A expenses.Net loss attributable to common shareholders for the first quarter of 2026 was $2.6 million, or $0.04 per basic and diluted share, compared to a net loss of $2.6 million, or $0.10 per basic and diluted share, for the first quarter of 2025.Conference Call and WebcastTalphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today 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 24180. 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 StudyThe NEPHRO CRRT Study 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 the NEPHRO CRRT clinical study will be completed later this year, and Talphera's belief that nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT.  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

2026
2025
Statement of Operations Data








Revenue$                   -
$               27





Operating costs and expenses:



Research and development (1)1,650
1,169
Selling, general and administrative (1)2,298
1,774
Total operating costs and expenses3,948
2,943
Loss from operations(3,948)
(2,916)





Other expense, net:



Interest income and other income, net 169
69
Gain on change in fair value of warrant liability1,223
181
Total other expense, net1,392
250
Net loss from continuing operations(2,556)
(2,666)
Net income from discontinued operations-
73
Net loss $          (2,556)
$        (2,593)





Net loss per share attributable to stockholders:








   Basic and diluted, continuing operations$            (0.04)
$          (0.10)





   Basic and diluted, discontinued operations$                   -
$            0.00





   Basic and diluted loss per share$            (0.04)
$          (0.10)
Shares used in computing net loss per share of common
stock, basic and diluted69,822
26,268





(1)   Includes the following non-cash stock-based
compensation expense:








            Research and development$                64
$               77
            Selling, general and administrative150
119
                   Total $              214
$             196
 Selected Balance Sheet Data(in thousands)




March 31, 2026
December 31, 2025(1)
(Unaudited)
(Unaudited)Cash, cash equivalents and investments$           21,108
$                     20,381Total assets30,155
29,719Total liabilities11,677
12,684Total stockholders' equity18,478
17,035
(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, 2025. Reconciliation of Non-GAAP Financial Measures
(Operating Expenses less stock-based compensation expense)






 Three Months Ended  

March 31

(in thousands)

(unaudited)

2026
2025





Operating expenses (GAAP):



Research and development $ 1,650
$ 1,169
Selling, general and administrative 2,298
1,774
Total operating expenses 3,948
2,943
Less stock-based compensation
expense 214
196
Operating expenses (non-GAAP) $ 3,734
$ 2,747
   View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-first-quarter-2026-financial-results-and-provides-corporate-update-302769923.htmlSOURCE Talphera, Inc. Original: Talphera Announces First Quarter 2026 Financial Results and Provides Corporate Update

Talphera to Host First Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, May 13, 2026May 7, 2026 4:05 PM
PR Newswire (US) SAN MATEO, Calif., May 7, 2026 /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 first quarter 2026 financial results after market close on Wednesday, May 13, 2026, then host a live webcast and conference call 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.Webcast InformationThe 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.Conference Call InformationInvestors 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 24180.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. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-to-host-first-quarter-financial-results-and-corporate-update-call-and-webcast-on-wednesday-may-13-2026-302764770.htmlSOURCE Talphera, Inc. Original: Talphera to Host First Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, May 13, 2026

Talphera to Host Virtual Investor & Analyst Event to Discuss Niyad® for Use in Continuous Renal Replacement Therapy (CRRT), on March 23, 2026March 18, 2026 4:05 PM
PR Newswire (US)

SAN MATEO, Calif., March 18, 2026 /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 host a virtual investor and analyst event on Monday, March 23, 2026 at 11:00 AM ET featuring Blaithin McMahon, PhD, MBBChr (Medical University of South Carolina) and Joao Teixeira, MD (University of New Mexico), principal investigators in Talphera's NEPHRO CRRT study evaluating Niyad for continuous renal replacement therapy (CRRT). To register, click here.The experts will discuss their experience with CRRT, the anticoagulants being used during CRRT today, and how they see Talphera's nafamostat filling a need. Nafamostat is a broad spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral properties with a variety of applications in medically supervised settings and has been the standard of care for CRRT anticoagulation in Japan and South Korea for over three decades. The Company's lead product candidate, Niyad, a lyophilized form of nafamostat, leverages the ultrashort half-life of nafamostat and its potent anticoagulant effects for potential use as a regional anticoagulant during CRRT in patients who cannot tolerate heparin or who have an increased risk of bleeding. Heparin is the only FDA approved anticoagulant for use in CRRT but it is not safe for patients with a high risk of bleeding or heparin intolerance. Citrate, the only other anticoagulant being used for CRRT, is used off-label, is complex to administer, cannot be used in liver impaired patients, and is principally only used by large academic institutions with the resources to monitor administration.A live question and answer session will follow the formal presentations.About Blaithin McMahon, PhD, MBBChr
Blaithin McMahon, PhD, MBBChr is an Associate Professor of Medicine at the Medical University of South Carolina. She did her medical residency and nephrology fellowship training at the Johns Hopkins Hospital, Baltimore, from 2011-2016. In July 2016, she joined the nephrology faculty at the Johns Hopkins Hospital prior to moving to MUSC in September 2018. Dr. McMahon's key research is in the field of Acute Kidney Injury (AKI). She has published over 50 papers in leading peer reviewed international nephrology medical journals and penned numerous editorials, commentaries, case reports, expert opinions, review papers, book chapters and has more than 1000 citations in this area of interest. She is the director of nephrology clinical trials at MUSC and is involved in several prospective national and international ICU studies ongoing in the area of Acute Kidney Injury and continuous kidney replacement therapy. Dr. McMahon is also the Director of CRRT at MUSC and is responsible for managing prescription protocols related to dialysis in the intensive care unit. She has been awarded multiple teaching awards at Johns Hopkins Hospital MUSC and University College Dublin.About Joao Teixeira, MD
Joao Teixeira, MD is an Associate Professor in Divisions of Nephrology and Pulmonary, Critical Care, and Sleep Medicine in the Department of Internal Medicine (DOIM) at the University of New Mexico (UNM). He staffs the inpatient nephrology consult service and medical intensive care unit (ICU) at UNM Hospital (UNMH), works as medical co-director of a local outpatient hemodialysis unit, and serves as the director of the acute dialysis and continuous kidney replacement therapy (CRRT) programs at UNMH. He was previously the Training Program Director of UNM's Nephrology Fellowship and has served as Core Faculty in the Critical Care Medicine Fellowship and the Internal Medicine Residency. As a critical care nephrologist, his scholarly interests lie in all areas of overlap between the two fields, centering on AKI. He developed a critical care research program focused on diagnostics and therapeutics for AKI, CRRT, septic shock, vasopressor therapy, extracorporeal membrane oxygenation (ECMO), hepatorenal syndrome (HRS), COVID-19, and acute respiratory distress syndrome (ARDS). As an investigator, he has enrolled approximately 300 critically ill or hospitalized patients into more than a dozen investigator-initiated or industry-sponsored clinical trials. He has coauthored over 100 peer-reviewed publications, book chapters, and conference abstracts; he is on the editorial boards of three journals and has served as an ad hoc reviewer for several dozen other journals. He has served as invited faculty at over a dozen national and international conferences, including the National Kidney Foundation Spring Clinical Meeting, American Society of Nephrology Kidney Week, and European Society of Intensive Care Medicine.About the NEPHRO CRRT StudyThe NEPHRO CRRT Study 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 of bleeding. The primary endpoint of the study is the mean post-filter activated clotting time on 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.About Niyad and NafamostatNafamostat 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 anti-viral treatment, amongst other potential targets.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.comForward-looking statementsThis 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: nafamostat's potential use as  regional anticoagulant for CRRT. 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.





View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-to-host-virtual-investor--analyst-event-to-discuss-niyad-for-use-in-continuous-renal-replacement-therapy-crrt-on-march-23-2026-302717591.htmlSOURCE Talphera, Inc.

Original: Talphera to Host Virtual Investor & Analyst Event to Discuss Niyad® for Use in Continuous Renal Replacement Therapy (CRRT), on March 23, 2026

Talphera Announces 50% Enrollment Milestone in Ongoing NEPHRO-CRRT Registrational TrialMarch 2, 2026 8:30 AM
PR Newswire (US)

Enrolled 35 of the 70 patients in the ongoing NEPHRO-CRRT registrational study, supported by new target profile sitesCompany to host a virtual investor and analyst event on March 23 at 11:00 am ET featuring nephrologists, Dr. Blaithin McMahon and Dr. Joao TeixeiraSAN MATEO, Calif., March 2, 2026 /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 50% patient enrollment of the NEPHRO-CRRT clinical trial."Over the course of 2025, with agreement from the FDA, we implemented significant changes to the NEPHRO CRRT clinical trial, including a nearly 60% reduction in the total number of patients to be enrolled and revising other enrollment criteria. In addition, we reviewed and updated our target profile for clinical sites to focus on medical ICUs and having nephrologists as our principal investigators. These changes have yielded positive results in enrollment rates, allowing us to achieve our 50% enrollment milestone with more than 90% of the patients from our new sites," said Vince Angotti, CEO of Talphera. "We're looking forward to completing the study, and anticipate filing our PMA this year to potentially have the only FDA approved regional anticoagulant for CRRT. We continue to receive feedback from physicians— that they desperately need a better CRRT anticoagulant. In just a few weeks, we are excited to have two key experts share their deep experience with CRRT at our planned virtual investor and analyst day," continued Angotti.Virtual Investor and Analyst Event Information and Biographies of Key ExpertsTalphera will hold a conference call and webcast for investors and analysts at 11:00 am Eastern Time on March 23, 2026 with two key experts and principal investigators in the NEPHRO CRRT study. The guest physicians will discuss their experience with CRRT and the anticoagulants currently being used during CRRT today, and how they see nafamostat filling a role. They will also take questions from investors and analysts.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.Dr. Blaithin McMahon (Medical University of South Carolina)Dr. McMahon is an Associate Professor of Medicine at the Medical University of South Carolina. She did her medical residency and nephrology fellowship training at the Johns Hopkins Hospital, Baltimore, from 2011-2016. In July 2016, she joined the nephrology faculty at the Johns Hopkins Hospital prior to moving to MUSC in September 2018.  Dr. McMahon's key research is in the field of Acute Injury Kidney. She has published over 50 papers in leading peer reviewed international nephrology medical journals and penned numerous editorials, commentaries, case reports, expert opinions, review papers, book chapters and has more than 1000 citations in this area of interest. She is the director of nephrology clinical trials at MUSC and is involved in several prospective national and international ICU studies ongoing in the area of Acute Kidney Injury and continuous kidney replacement therapy. Dr. McMahon is also the Director of CRRT at MUSC and is responsible for managing prescription protocols related to dialysis in the intensive care unit. She has been awarded multiple teaching awards at Johns Hopkins Hospital MUSC and University College Dublin.Dr. Joao Teixeira (University of New Mexico)Dr. Teixeira is an Associate Professor in Divisions of Nephrology and Pulmonary, Critical Care, and Sleep Medicine in the Department of Internal Medicine (DOIM) at the University of New Mexico (UNM). He staffs the inpatient nephrology consult service and medical intensive care unit (ICU) at UNM Hospital (UNMH), works as medical co-director of a local outpatient hemodialysis unit, and serves as the director of the acute dialysis and continuous kidney replacement therapy (CRRT) programs at UNMH. He was previously the Training Program Director of UNM's Nephrology Fellowship and has served as Core Faculty in the Critical Care Medicine Fellowship and the Internal Medicine Residency.As a critical care nephrologist, his scholarly interests lie in all areas of overlap between the two fields, centering on the realm of acute kidney injury (AKI). He developed a critical care research program focused on diagnostics and therapeutics for AKI, CRRT, septic shock, vasopressor therapy, extracorporeal membrane oxygenation (ECMO), hepatorenal syndrome (HRS), COVID-19, and acute respiratory distress syndrome (ARDS). As site principal investigator or an investigator, he has enrolled approximately 300 critically ill or hospitalized patients into more than a dozen investigator-initiated or industry-sponsored clinical trials. He has coauthored over 100 peer-reviewed publications, book chapters, and conference abstracts; he is on the editorial boards of three journals and has served as an ad hoc reviewer for several dozen other journals. He has served as invited faculty at over a dozen national and international conferences, including the National Kidney Foundation Spring Clinical Meeting, American Society of Nephrology Kidney Week, and European Society of Intensive Care Medicine.About the NEPHRO CRRT StudyThe NEPHRO CRRT Study 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 of bleeding. The primary endpoint of the study is the mean post-filter activated clotting time on 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.About Niyad and NafamostatNafamostat 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 anti-viral treatment, amongst other potential targets.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.comForward-looking statementsThis 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: looking forward to completing the NEHPRO CRRT study and the Company's target filing of the PMA this year to potentially have the only FDA approved regional anticoagulant for CRRT. 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.





View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-50-enrollment-milestone-in-ongoing-nephro-crrt-registrational-trial-302700601.htmlSOURCE Talphera, Inc.

Original: Talphera Announces 50% Enrollment Milestone in Ongoing NEPHRO-CRRT Registrational Trial

TLPH................................https://stockcharts.com/sc3/ui/?s=TLPH&p=w&b=5&g=0&id=p86431144783

Oh, one thing I forgot. How long will it take them to enroll the 66?  You posted almost 2 months ago that you would add once they signed up half.  So fairly slow right?

Kiwi had a little time this morning and going over the most recent posts here (not very recent I know), but I am finding a slight difference in tge discussion concerning the reduction in trial participants.  
In the post I am replying to, you used the terms: "FDA advised TLPH to reduce the size" of the trial.  A couple of posts below that you provided Grok's take on this and to me it sounded a bit different.  Yes, the FDA agreed to permit a reduction in trial size but the wording of Talphera reaching an agreement with the FDA to reduce the size sounds at least ever so different than the FDA advising them to do so.  Is there anything in my parsing of that or would the FDA not agree to such if it would doom the trial?  Obviously the FDA OKs many trials that ultimately fail. 

Your reasoning is sound, I always appreciate your insights. I'm in TLPH @ .933

Based on my understanding of clinical trial design , powering etc ...its a huge negative if you need to increase the numbers needed to enroll in a trial vs being told you can reduce them .
The FDA is advising TLPH that they believe they will get a statistically significant result with fewer patients enrolled . They believe the benefit will be strong based on the info they have seen .
ICU by contrast ...DSMC / FDA thinks based on the evidence so far , they think the benefit will be slight and want more patients treated longer to identify if and how much benefit there really is .
JMO
I sold my ICU as soon as I saw that notice from the DSMC and bt some TLPH today after seeing them mentioned by RMB ( small position just to track ...will add once 50% enrolled )
When a Co is told to increase the numbers its harder to recruit patients as hospitals less likely to dedicate resources .
Opposite when Co is told they can reduce numbers needed

Kiwi

ICU having to increase enrollment really put the brakes on it short term but like I said before, I don't mind being early since I never overload any positions so I never HAVE to sell to recover capital, that and I'm cheap that's what my wife and kids say all the time.

Wow ...lesson is ...maybe don't sell all .
Re TLPH
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.

I'll definitely get more interested in TLPH once they're past 50% enrolled .
There are risk with Heparin ...currently being used

Heparin remains safe and effective in most chronic hemodialysis patients when used judiciously, but the two most feared complications are:Major bleeding (especially in high-risk patients).
Heparin-induced thrombocytopenia (HIT) — always consider in any drop in platelets or new thrombosis after 5+ days of heparin exposure.

In patients with active bleeding, recent surgery, or known/suspected HIT, switch to citrate or heparin-free methods immediately.


TLPH's nafamostat (Niyad™) appears safer than heparin for its targeted use in CRRT, particularly in high-bleeding-risk patients, due to regional action, shorter half-life, and supportive international data/meta-analyses showing reduced complications.
If approved, it could fill a critical gap amid heparin shortages. However, definitive U.S. confirmation depends on the ongoing NEPHRO trial results expected in 2026.
For general CRRT, heparin remains viable with monitoring, but nafamostat offers a compelling alternative for ~20-30% of cases where heparin fails.

From Grok


Kiwi

Yeah but I messed up on CDTX, thought I was smart selling at $66.90 and look at it now.

We all have one good trade that just goes way beyond what was anticipated, at least for me

By the way ...big difference between ICU and TLPH ...FDA allowed TLPH to CUT their enrollment numbers by around 50% ...where as they required ( via DSMC ) that ICU INCREASE their enrollment number by about the same IIRC

Kiwi

Well congrats ...your strategy seems to be working ...at least for TLPH, RZLT , AMLX
Kiwi

Still in

Ernie ...U still in this ?

Kiwi

CRMD has an option to buy TLPH if their trial succeeds .
Some recent plus's for TLPH ...FDA agreed to allow them to cut their enrollment number down to 70 .
Some major hospitals have agreed to participate in...so waiting update by EOY .
This anticoagulant is already in use in Japan / Korea ...very clean 20 yr safety record
They'll provide an update once 50% enrolled . Achieving that will provide a tail wind to get fully enrolled .
I'll probably buy in on 50% enrollment ...may start a small position now so I dont forget about it
Kiwi

I used to have this one as well but ditched it a while back.  Now I have an interest in this thru my investment in CRMD.  An investment that has soured today. 

Back from the dead . The problem was getting this pivotal trial enrolled .
Definitely a need for the anti coagulant . Will do some more DD .
May buy back in
Kiwi

TLPH.....................................................https://stockcharts.com/sc3/ui/?s=TLPH&p=W&b=5&g=0&id=p86431144783

TLPH...........................................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

Thanks Ernie.  Appreciate it. 

December 1st looks like the drop dead date, voting Oct 23rd so I would expect it to take place pretty quickly after that, up to 30 to 1

On May 30, 2025, we transferred the listing of our securities to The Nasdaq Capital Market, and as a result, we were afforded the remainder of the 180-day
period, or until June 4, 2025, to regain compliance with the Nasdaq Minimum Bid Requirement. On June 5, 2025, Nasdaq notified us of our failure to regain
compliance with the Nasdaq Minimum Bid Requirement and that we were eligible for an additional 180 calendar day period, or until December 1, 2025, or the
Additional Grace Period, to regain compliance.

Ernie do we know by when this has to be over $1 before they then have to do a RS? Do they still have an option to request an extension or has that been used up already.

TLPH...........................................................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

Added more here today

This 'pump' has some meat: private placement financing of up to $29 million led by CorMedix Inc

Offering 25m shares at .55 cents awesome dilution campaign hasn't started yet 

$1.02 Up 83% in a few minutes second best pump of day special continues

It's saying hello again to Glenn

TLPH.........................................................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

Pump it some .57 + 30%

Yep, as a matter of fact I added at the beginning of the week

Re All these small bios have crapped out again

Are U still in RZLT ???. Small bio's have their own challenges ...basically getting results they need to advance.... before they run out of cash .
Many will flame out which is why I monitor closely and trim / sell when necessary . Limit loss's but when U find one like RZLT ...be willing to hold as it plays out .

I've been in RZLT since February...so since around $1 ....but sold half when it doubled
Kiwi

Less than a month ago enrollment looked like it was proceeding. All these small bios have crapped out again

Well unfortunately they are having trouble enrolling this trial ...and are burning thru their cash .
I sold most when they couldn't hold over $1 and will keep a small amount just to follow
Kiwi

Yep. fantastic . Their 2 immediate concerns where
1) Had they enrolled more in their trial
2) Was Nantahala going to extend their financing .

Looks like both are happening . Co was burning thru their cash and trial had been slow to enroll .
Almost 20X normal Vol ...maybe another fund adding big ...should see a filing in next day or so

If they keep the PPS over $1 for 10 consecutive days they have cured any Naz delisting issue

Kiwi

Obviously something good. Look at the price and volume.

Not very authoritative but saw comment posted on ST

Thx. where did U get that info . I wasn't able to access the fireside chat
Kiwi

Thx. where did U get that info . I wasn't able to access the fireside chat
Kiwi

5 active sites I see being reported but I unfortunately was not able to listen personally.

Bang ... 💲 THAT happened quickly ...

TLPH fireside chat tomorrow I think. Let's hope they announce some good trial recruiting numbers .
Kiwi

Thanks. Sailed around hurricane John a couple of days ago and now weather is great. Tomorrow canal.

Re TLPH ...my guess is market's concerned theres no update on trial enrollment so theres a risk Co will need to raise more $ .
Sold most of my position some time ago as noted in a previous post .
How's the weather where ever U are ?

Kiwi

Thx ...Yes probably no action till EOY .
I may copy and paste to the ARDX and UNCY boards
Safe travels
Kiwi

Saw this but it is a few days old:

“(Bloomberg Intelligence) - Ardelyx, Akebia Therapeutics and other makers of oral-only, end-stage renal disease (ESRD) drugs will likely see Congress pass legislation during the lame duck session
that blocks an administrative proposal to move the therapies out of the Medicare Part D program. Some lawmakers have expressed concerns with the regulatory decision, and a delay won't impact federal finances. Passing the bill would remove some near-term uncertainty around utilization and
pricing for newer drugs. (09/04/24)
1. Lawmakers Ramp Up Scrutiny of Regulatory Change Ramped-up congressional oversight of Medicare's implementation effort to incorporate oral-only drugs into the ESRD payment bundle should generate enough headline noise to keep the issue front-and-center for action during the lame-duck session. Lawmakers continue to raise concerns about the regulatory change, and have requested information from the Biden administration on the implementation process. But with only a handful of legislative weeks scheduled in September, major policy changes won't make it to the president's desk before Congress adjourns for election
campaigns. The policy change will likely be folded into a broad-based year-end omnibus bill with other member
priorities such as PBM regulation changes and legislation curtailing biotech research with China.
(09/04/24)”

Thanks Kiwi. I unfortunately have been running around today and just got home and am now going back out to cut the grass. Will listen if I can find a replay.

Going on a Panama Canal cruise in a couple days and of course the stuff always hits the fan when I leave.