Core Viewpoint - Talphera, Inc. is advancing its NEPHRO CRRT clinical study with FDA's agreement on protocol changes aimed at accelerating patient enrollment and reducing the number of patients required for the study [1][2][3] Group 1: FDA Interactions and Protocol Changes - The FDA has agreed to review a Prior Approval Supplement (PAS) for a reduction in the number of patients in the NEPHRO CRRT study, which is expected to be submitted within the coming week [1] - Two additional protocol changes have been approved by the FDA to broaden inclusion criteria, allowing enrollment of patients on continuous renal replacement therapy (CRRT) beyond 48 hours and heparin-tolerant patients at certain institutions [2] - The PAS review by the FDA will take up to 30 days, and the company is optimistic about completing the study by the end of the year [3] Group 2: Product and Study Details - Talphera's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently under investigation as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation from the FDA [4][6] - The NEPHRO CRRT study aims to enroll 166 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding, with primary and secondary endpoints focused on clotting time and dialysis efficacy [7]

Financial Data and Key Metrics Changes - Cash operating expenses for Q3 2024 totaled $3.5 million, an increase from $3 million in the same period last year, attributed to the NEPHRO CRRT clinical study [20] - Year-to-date cash operating expenses reached $11.5 million, with full-year 2024 expenses expected to be in the range of $15 million to $17 million [21] - Cash and investments at the end of Q3 2024 amounted to $11.1 million, with an additional capital injection likely required before the completion of the NEPHRO study [21] Business Line Data and Key Metrics Changes - The NEPHRO CRRT study has onboarded five active clinical trial sites, with two additional sites expected to begin screening, totaling seven by the end of the year [7][8] - The primary endpoint of the NEPHRO trial is the mean activated clotting time measured over the first 24 hours, with patient participation lasting 72 hours [9] Market Data and Key Metrics Changes - The FDA has expanded the maximum number of trial sites from 10 to 14, indicating a proactive approach to enhance patient enrollment [15] - The company is focusing on high-volume CRRT sites with broader ICU populations to optimize patient recruitment [13] Company Strategy and Development Direction - The company is committed to improving enrollment rates at existing sites and onboarding new productive sites to expedite the NEPHRO trial [8][14] - There is a strong emphasis on leveraging breakthrough designation from the FDA to facilitate study enrollment and completion [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in nafamostat's potential clinical utility, citing a long track record of efficacy and safety in Japan and South Korea [17] - The company anticipates having more information on the clinical trial's progress early next year, indicating a positive outlook for future developments [16] Other Important Information - The company is consulting regulatory experts to implement potential changes to study design elements to facilitate enrollment [14] - Management highlighted the need for an alternative anticoagulant in CRRT, reinforcing the market opportunity for nafamostat [15] Q&A Session Summary Question: Can you walk through the optimization on the screening to drive enrollment? - Management discussed the need for improved site engagement and automated notifications to capture patients before CRRT begins, addressing previous enrollment challenges [26][27] Question: What percentage of patients are screened and successfully enrolled? - Management noted that screening percentages fluctuate by site, and feedback from physicians has been positive regarding patient experiences in the trial [40][41] Question: Will data from the NEPHRO study be available next year? - Management confirmed that the goal is to have data available next year, with a short timeline from study completion to PMA submission [44] Question: What measures are planned to accelerate enrollment? - Management mentioned ongoing evaluations of study design and the implementation of new site strategies to enhance patient identification and enrollment [46][47]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $117,000, compared to $370,000 for the same period in 2023, representing a decrease of approximately 68.4%[13] - The net loss for the three months ended September 30, 2024, was $3,353,000, compared to a net loss of $1,357,000 for the same period in 2023, indicating a worsening of 146.5%[13] - Basic and diluted loss per share for continuing operations was $(0.13) for the three months ended September 30, 2024, compared to $(0.08) for the same period in 2023[13] - As of September 30, 2023, the company reported a net loss of $1,357,000, with total equity amounting to $18,307,000[15] - For the nine months ended September 30, 2023, the net loss was $13,880,000, with cash used in operating activities totaling $10,429,000[16] - The company recognized a net loss from discontinued operations of $8.098 million for the nine months ended September 30, 2023, with total revenues of $501,000 during the same period[47] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2024, were $5,395,000, an increase of 42.8% from $3,777,000 for the same period in 2023[13] - Total operating costs and expenses for the three months ended September 30, 2024, were $3,749,000, compared to $3,426,000 for the same period in 2023, reflecting an increase of 9.4%[13] - The Company recorded total stock-based compensation expense of $234,000 for the three months ended September 30, 2024, compared to $378,000 for the same period in 2023[79] Equity and Liabilities - Total stockholders' equity decreased to $9,641,000 as of September 30, 2024, down from $14,105,000 as of December 31, 2023[10] - The accumulated deficit increased to $(455,360,000) as of September 30, 2024, compared to $(444,226,000) as of December 31, 2023[10] - The company reported total liabilities and stockholders' equity of $21,014,000 as of September 30, 2024, compared to $20,395,000 as of December 31, 2023[10] Cash and Financing Activities - The company had cash and cash equivalents of $11,117,000 at the end of the reporting period, down from $20,275,000 at the beginning of the period[16] - The company raised $8,924,000 from a private placement offering in July 2023, contributing to net cash provided by financing activities of $12,044,000 for the nine months ended September 30, 2023[16] - The Company entered into a private placement on January 17, 2024, resulting in aggregate gross proceeds of $6.0 million upfront, with an additional $10.0 million contingent upon positive clinical trial results for the NEPHRO CRRT study of Niyad[65] - The first tranche of the private placement closed on January 22, 2024, generating approximately $6.0 million for pre-funded warrants to purchase up to 7,792,208 shares of common stock[66] Product Development and Strategy - The company is focused on advancing the development of its lead product candidate, Niyad™, and aims to secure regulatory approval and commercialization[6] - The company is focused on developing Niyad™, a regional anticoagulant, and LTX-608, a nafamostat formulation, for various medical indications[18][21] - The company completed an asset acquisition agreement for the DSUVIA product on April 3, 2023, which included the transfer of certain assets and liabilities[20] Risks and Concerns - The company faces significant risks including market volatility, supply chain disruptions, and the ability to obtain necessary financing for ongoing operations[6] - The company has incurred recurring operating losses and negative cash flows since inception, raising concerns about its ability to continue as a going concern[23] - The Company may need to reduce its workforce or delay clinical trials if adequate funds are not available[25] Accounting and Financial Reporting - The Company is evaluating the impact of recently issued accounting standards but does not expect them to materially affect its consolidated financial statements[36] - Management's significant accounting estimates include fair value of warrants and impairment of long-lived assets, which could differ from actual results[28] - The effective interest rate for the liability related to the sale of future payments will be reassessed at each reporting date[33] Stock and Equity Compensation - The Company amended its 2020 Equity Incentive Plan to increase the number of authorized shares by 1,171,395, bringing the total to 3,161,395 shares[72] - The Company granted stock-based awards totaling 217,000 shares to a new employee as an inducement for employment in May 2024[73] - The Company amended its 2011 Employee Stock Purchase Plan to increase the number of authorized shares by 100,000, resulting in a total of 345,000 shares available for issuance[74] - As of September 30, 2024, the total stock options outstanding increased to 1,879,806, with a weighted average remaining contractual life of 7.7 years[81] Litigation - The Company believes ongoing litigation is without merit and intends to defend against it, but cannot estimate potential losses due to the uncertainty of litigation outcomes[64]

Financial Performance - Net loss from continuing operations for Q3 2024 was $3.4 million, compared to a net loss of $1.4 million in Q3 2023[7]. - Net loss attributable to common shareholders for Q3 2024 was $3.4 million, or $0.13 per share, compared to a net loss of $1.4 million, or $0.08 per share, in Q3 2023[8]. - Total operating costs and expenses for Q3 2024 were $3.7 million, compared to $3.4 million in Q3 2023[6]. - Total operating expenses for the three months ended September 2024 were $3,749,000, slightly up from $3,426,000, an increase of 9.4%[21]. - Non-GAAP operating expenses for the three months ended September 2024 were $3,515,000, compared to $3,048,000 for the same period in 2023, an increase of 15.3%[21]. - Total operating expenses for the nine months ended September 2024 were $12,256,000, slightly down from $12,976,000 for the same period in 2023, a decrease of 5.5%[21]. Cash and Investments - Cash and investments totaled $11.1 million as of September 30, 2024[5]. - Cash, cash equivalents, and investments increased to $11,117,000 from $9,381,000, representing a growth of 18.5%[20]. - Total assets rose to $21,014,000, up from $20,395,000, indicating an increase of 3.0%[20]. - Total liabilities increased significantly to $11,373,000 from $6,290,000, reflecting an increase of 80.5%[20]. - Total stockholders' equity decreased to $9,641,000 from $14,105,000, a decline of 31.7%[20]. Research and Development - Combined R&D and SG&A expenses for Q3 2024 were $3.7 million, up from $3.4 million in Q3 2023, primarily due to NEPHRO study costs[6]. - Research and development expenses for the three months ended September 2024 were $2,053,000, up 74.4% from $1,178,000 for the same period in 2023[21]. - The NEPHRO CRRT study aims to enroll 166 patients across up to 14 clinical sites in the U.S.[4]. - The first patient was enrolled in the NEPHRO CRRT study in August 2024[3]. - The study's primary endpoint is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours[4]. - Talphera anticipates completing the NEPHRO study by the end of 2025 with improved enrollment rates[2]. Operating Expenses - Selling, general, and administrative expenses decreased to $1,696,000 from $2,248,000, a reduction of 24.5%[21]. - Stock-based compensation expense for the three months ended September 2024 was $234,000, down from $378,000, a decrease of 38.3%[21]. Regulatory Status - The company has received Breakthrough Device Designation status from the FDA for its lead product candidate, Niyad™[11].

Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings [4] - The company's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently studied as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation from the FDA [4] - Talphera is also developing two pre-filled syringes in partnership with Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe [4] Financial Results Announcement - Talphera will release its third quarter 2024 financial results after market close on November 13, 2024 [1] - A live webcast and conference call will be held at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Standard Time to discuss the results and provide a business update [1] Webcast and Conference Call Details - The webcast can be accessed through the Investors section of Talphera's website, and a replay will be available for 90 days following the event [2] - Investors can participate in the conference call by dialing 1-800-836-8184 for North American callers or 1-646-357-8785 for international callers, with a conference ID of 89949 [3]

Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings [2] - The company's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently studied as an anticoagulant for the extracorporeal circuit [2] - Niyad™ has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) [2] Upcoming Events - Talphera management will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit, scheduled for October 15-17, 2024 [1] - The specific session for Talphera is set for October 16, 2024, at 3:00 PM ET / 12:00 Noon PT [2] - Registered investors will have the opportunity for 1x1 meetings with Talphera management during the summit [1]

Core Insights - Talphera, Inc. has initiated the NEPHRO CRRT registrational trial to assess the safety and effectiveness of nafamostat in 166 patients across up to 14 clinical sites in the U.S. [1][2] - The primary endpoint of the NEPHRO CRRT study is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours [2][7] - Nafamostat has been a standard of care in Japan and South Korea for over 30 years, and its approval in the U.S. could enhance anticoagulant options for patients requiring continuous renal replacement therapy (CRRT) [3][4] Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings [5] - The company's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently studied under an investigational device exemption (IDE) and has received Breakthrough Device Designation from the FDA [5][4] Study Details - The NEPHRO CRRT study is a prospective, double-blinded trial designed to enroll 166 adult patients who cannot tolerate heparin or are at risk for bleeding [7] - Key secondary endpoints of the study 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 [7]

Talphera, Inc. (NASDAQ:TLPH) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vince Angotti - Chief Executive Officer Pam Palmer - Founder and Chief Medical Officer Conference Call Participants Ed Arce - H.C. Wainwright Naz Rahman - Maxim Group James Molloy - Alliance Global Partners Operator Welcome to Talphera’s Second Quarter 2024 Financial Results Conference Call. This call is being webcasted live via the events page of the Invest ...

Exhibit 99.1 Talphera Announces Second Quarter 2024 Financial Results and Provides Corporate Update NEPHRO CRRT study patient screening has initiated at multiple clinical sites The safety and ef ectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational study in 166 patients at up to 14 clinical sites Cash and investments at June 30, 2024 of $14.0 million Conference call and webcast to be held Wednesday, August 14, 2024 at 4:30 pm ET SAN MATEO, Calif., August 14, 2024 – Talphera, Inc. (Nas ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 TALPHERA, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of incorporati ...