Financial Data and Key Metrics Changes - The cash balance as of September 30, 2025, was $21.3 million, which is expected to be sufficient for operations through the anticipated Nifamostat PMA approval next year [17] - Cash operating expenses for Q3 2025 totaled $3.4 million, a decrease from $3.7 million in Q3 2024, primarily due to reductions in personnel and other SG&A expenses [17][18] - The revised expected cash operating expense guidance for 2025 is now in the range of $14-$15 million, down from the previous range of $16-$17 million [18] Business Line Data and Key Metrics Changes - The nephrostudy enrollment rate has shown improvement, with a focus on medical ICUs and nephrologists as principal investigators, leading to a robust enrollment from existing sites [5][10] - The study size was reduced from 166 to 70 patients to accelerate completion, with the goal of achieving 35 patients or 50% enrollment [5][10] Market Data and Key Metrics Changes - The company is positioned to become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy (CRRT) if Nifamostat is approved [8][14] - There is a clear market need for an FDA-approved regional anticoagulant due to the disadvantages of currently used products like heparin and citrate [15] Company Strategy and Development Direction - The company is focused on completing the nephrostudy and preparing for the launch of Nifamostat, with a potential FDA approval expected in late 2026 [3][31] - Recent investments have validated the Nifamostat opportunity, and the company is restructuring its clinical study approach to enhance enrollment rates [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risks associated with the Nifamostat program, citing its established use in Japan and South Korea [14][15] - The anticipated completion of the nephrostudy has been pushed to the first half of 2026 due to delays in activating new clinical sites, but management remains optimistic about the quality and enrollment potential of these sites [12][18] Other Important Information - The company completed a $17 million financing round, which included a strategic investment from CorMedix, providing them with a 60-day exclusive negotiation period for a potential acquisition [3][4] - The company is also advancing a compassionate use IDE for specific patients with contraindications to currently available anticoagulants [13] Q&A Session Summary Question: Are the new target sites enrolling patients faster? - Management indicated that the new target sites are enrolling at a similar rate as before, and additional sites are needed to achieve accelerated enrollment [20][23] Question: Has federal government volatility affected clinical studies? - Management has not received feedback indicating that federal government issues have impacted the sites, although one site experienced delays due to personnel cuts [24][26] Question: What is the expected timeline for the Veterans Affairs Medical Center site? - The Veterans Affairs Medical Center site is expected to begin enrollment before the end of the year, despite earlier delays [27]

Financial Performance - Total assets increased to $30,742,000 as of September 30, 2025, compared to $18,236,000 as of December 31, 2024, representing a growth of 68.5%[15] - Revenue for the three months ended September 30, 2025, was $1,000, compared to $0 for the same period in 2024, indicating a significant increase[19] - Net loss for the three months ended September 30, 2025, was $4,436,000, compared to a net loss of $3,353,000 for the same period in 2024, reflecting a 32.3% increase in losses[19] - Basic and diluted loss per share for continuing operations was $0.11 for the three months ended September 30, 2025, compared to $0.13 for the same period in 2024[19] - For the nine months ended September 30, 2025, the net loss was $10,518 thousand, an improvement from a net loss of $11,134 thousand in the same period of 2024[25] - The net loss for the three months ended September 30, 2025, was $4.4 million, compared to $3.4 million for the same period in 2024, representing a 29.4% increase in net loss[99] - For the nine months ended September 30, 2025, the net loss was $10.5 million, compared to $11.1 million for the same period in 2024, indicating a 5.4% decrease in net loss[99] Equity and Liabilities - Total stockholders' equity increased to $19,177,000 as of September 30, 2025, from $8,001,000 as of December 31, 2024, marking a 139.5% increase[15] - Total liabilities increased to $11,565,000 as of September 30, 2025, compared to $10,235,000 as of December 31, 2024, an increase of 13.0%[15] - The company has incurred recurring operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern[31] Cash Flow and Investments - Cash and cash equivalents decreased to $3,457,000 as of September 30, 2025, from $8,863,000 as of December 31, 2024, a decline of 61.0%[15] - Net cash used in operating activities for the nine months ended September 30, 2025, was $8,928 thousand, compared to $10,429 thousand in the prior year, indicating a reduction in cash outflow[25] - The company reported a significant increase in cash and cash equivalents, ending the period with $3,457 thousand, down from $11,117 thousand at the end of the previous year[25] - The company incurred $17,815 thousand in cash used for investing activities, a substantial increase from $4,979 thousand in the prior year[25] - The net cash provided by financing activities was $21,337 thousand for the nine months ended September 30, 2025, compared to $12,044 thousand in the same period of 2024[25] Research and Development - Research and development expenses for the nine months ended September 30, 2025, totaled $4,472,000, down 16.9% from $5,395,000 for the same period in 2024[19] - Research and development expenses for the three months ended September 30, 2025, decreased by $0.3 million (12%) compared to the same period in 2024, primarily due to a reduction in employee compensation and related expenses[108] - For the nine months ended September 30, 2025, research and development expenses decreased by $0.9 million (17%) compared to the same period in 2024, mainly due to a reduction in headcount and related costs[108] Capital Raising and Financing - The company plans to seek additional capital through various means, including public or private equity offerings and potential collaborations[32] - In September 2025, the company raised approximately $17.0 million from a private placement of common stock and pre-funded warrants[122] - The first closing of the April 2025 Private Placement raised approximately $4.9 million by issuing 3,405,118 shares at $0.586 per share and pre-funded warrants at $0.585 per warrant[68] - The company may seek additional capital through public or private equity offerings, debt securities, or strategic partnerships[118] - The company expects to need additional capital to fund planned operations for at least the next twelve months[143] Legal and Regulatory Matters - The company has faced multiple lawsuits related to alleged misstatements, with the Ninth Circuit affirming the dismissal of a securities class action on August 20, 2025[55][56] - The FDA and other regulatory agencies strictly regulate promotional claims, and improper promotion of off-label uses could lead to significant liabilities[200] Market and Competitive Environment - The company anticipates intense competition in the biotechnology and pharmaceutical industries, which may affect its market position[192] - Future sales of DSUVIA to the Department of Defense (DoD) are unpredictable and may not meet expectations due to various government-related factors[168] Operational Challenges - The company may experience delays in clinical trials, which could increase costs and jeopardize regulatory approval and commercialization of its product candidates[171] - The process for obtaining FDA approval is time-consuming and may involve unexpected delays and costs, impacting the company's financial condition[186] - The company has limited financial and managerial resources, which may lead to missed opportunities for more profitable product candidates[184] Future Outlook - The company expects to incur significant losses in 2025 and may require additional capital to fund operations before the twelve-month anniversary of the filing date of the Quarterly Report[117] - The company has not yet generated significant product revenue and does not anticipate significant near-term revenues from its product candidates, which may impact its ability to achieve profitability[164]

Financing and Cash Position - Talphera closed a $17 million first tranche financing led by CorMedix, with a total financing goal of up to $29 million[6]. - Cash and investments as of September 30, 2025, were $21.3 million, expected to be sufficient through a potential PMA approval of Niyad in late 2026[1]. - As of September 30, 2025, cash, cash equivalents, and investments increased to $21,289,000 from $8,863,000 as of December 31, 2024, representing a growth of 140.4%[17]. Clinical Studies and Product Development - Five of the nine target clinical study sites for the NEPHRO study are activated, with completion expected in H1 2026[1]. - The NEPHRO CRRT study aims to enroll 70 adult patients and has received central IRB approval[12]. - Talphera's lead product candidate, Niyad, is being studied as an anticoagulant and has received Breakthrough Device Designation from the FDA[9]. Financial Performance - The net loss from continuing operations for Q3 2025 was $4.4 million, compared to a net loss of $3.4 million in Q3 2024[6]. - The company recognized revenue of $1,000 for Q3 2025, compared to $0 for Q3 2024[15]. - Net loss attributable to common shareholders for Q3 2025 was $4.4 million, or $0.11 per share, compared to a net loss of $3.4 million, or $0.13 per share, in Q3 2024[6]. Operating Expenses - Combined R&D and SG&A expenses for Q3 2025 totaled $3.4 million, a decrease from $3.7 million in Q3 2024[6]. - For the three months ended September 30, 2025, total operating expenses were $3,423,000, a decrease of 8.7% from $3,749,000 in the same period of 2024[18]. - Research and development expenses for the three months ended September 30, 2025, were $1,803,000, down from $2,053,000 in 2024, representing a decline of 12.1%[18]. - Selling, general and administrative expenses decreased to $1,620,000 in the three months ended September 30, 2025, from $1,696,000 in 2024, a reduction of 4.5%[18]. - Non-GAAP operating expenses for the nine months ended September 30, 2025, were $9,545,000, down from $11,497,000 in 2024, indicating a decrease of 16.9%[18]. - Stock-based compensation expense for the three months ended September 30, 2025, was $152,000, compared to $234,000 in 2024, a decrease of 35.0%[18]. - The company reported a total operating expenses (non-GAAP) of $3,271,000 for the three months ended September 30, 2025, down from $3,515,000 in 2024, a decline of 6.9%[18]. Balance Sheet Highlights - Total assets rose to $30,742,000 in September 2025, up from $18,236,000 in December 2024, indicating a 68.5% increase[17]. - Total liabilities increased to $11,565,000 in September 2025, compared to $10,235,000 in December 2024, reflecting a rise of 13.0%[17]. - Total stockholders' equity surged to $19,177,000 in September 2025, up from $8,001,000 in December 2024, marking an increase of 139.5%[17].

Core Insights - Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, which is expected to provide sufficient capital through a potential PMA approval of Niyad anticipated in late 2026 [1][2] - The NEPHRO study, which is crucial for the development of Niyad, is progressing with 5 of the 9 target clinical sites activated, and completion is expected in the first half of 2026 [1][2][12] Financial Highlights - As of September 30, 2025, Talphera reported cash and investments totaling $21.3 million [1][6] - The combined R&D and SG&A expenses for Q3 2025 were $3.4 million, a decrease from $3.7 million in Q3 2024, primarily due to reductions in personnel and other expenses [6][15] - The net loss from continuing operations for Q3 2025 was $4.4 million, compared to a net loss of $3.4 million in Q3 2024 [6][15] Clinical Development - The NEPHRO CRRT study is designed to evaluate Niyad as an anticoagulant for patients undergoing renal replacement therapy, with a primary endpoint focused on mean post-filter activated clotting time [12][11] - Positive feedback from principal investigators indicates a strong preference for nafamostat as an alternative to current CRRT anticoagulants, contributing to ongoing enrollment momentum in the NEPHRO study [2][12] Strategic Partnerships - CorMedix's investment includes the right to nominate a board member and an exclusive negotiation period for a potential acquisition following the Phase 3 study results for Niyad [6][2] - The financing round also included support from existing investors and new institutional investors, highlighting the market opportunity for Niyad [2][6]

Core Insights - Talphera, Inc. has achieved a significant milestone in its NEPHRO CRRT clinical trial by enrolling 17 out of the planned 70 patients, which is approximately 25% of the total enrollment target [1][2] - The company is on track to complete the study by the end of 2025, supported by an accelerated recruitment rate from new clinical sites [1][2] Enrollment Progress - The NEPHRO CRRT trial has seen an increase in enrollment, with 17 patients now participating, up from 15 just a week prior [2] - Over 90% of the enrolled patients are coming from newly targeted clinical sites, indicating a successful re-launch of the study [2] Study Design and Objectives - The NEPHRO CRRT Study is a prospective, double-blinded trial conducted in up to 14 U.S. hospital intensive care units, focusing on 70 adult patients who cannot tolerate heparin or are at risk for bleeding [3] - The primary endpoint is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan and dialysis efficacy [3] Product Information - Niyad is a lyophilized formulation of nafamostat, a synthetic serine protease inhibitor with anticoagulant and anti-inflammatory properties, currently under investigation as an anticoagulant for extracorporeal circuits [4][5] - The product has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications [5] Company Overview - Talphera, Inc. specializes in developing and commercializing innovative therapies for medically supervised settings, with a focus on products like Niyad [5]

Financial Data and Key Metrics Changes - The company reduced its expected cash operating expense guidance for 2025 to a range of $16 million to $17 million, down from the previous range of $17 million to $19 million [20] - Cash operating expenses for 2025 totaled $3.7 million compared to $4.3 million for 2024, indicating a decrease primarily due to reductions in personnel and general administrative expenses [20][21] - The cash balance as of June 30, 2025, was $6.8 million, which includes proceeds from the first tranche of financing [21] Business Line Data and Key Metrics Changes - The enrollment rate for the Nephros study has more than doubled since May, with a strong acceleration observed in the last six weeks [5][12] - The company has shifted its focus to new clinical study sites, specifically targeting nephrologists as principal investigators, which has led to improved enrollment rates [7][12] Market Data and Key Metrics Changes - There is a growing interest from healthcare providers in Nafamostat due to ongoing shortages of heparin and citrate, which are commonly used anticoagulants [9][39] - The company is advancing a compassionate use IDE for Nafamostat, indicating a strong market potential for the product if approved [9][15] Company Strategy and Development Direction - The company is focused on completing the nephro CRRT registrational trial by the end of 2025, with a clear regulatory path and breakthrough designation from the FDA [17][19] - The strategy includes adding new clinical study sites with a focus on nephrology to enhance patient enrollment and engagement [12][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risks associated with the Nafamostat program, citing its established track record in Japan and South Korea [17] - The management team is optimistic about the potential for Nafamostat to become the only FDA-approved regional anticoagulant for CRRT if approved [10][19] Other Important Information - The company is in discussions with multiple institutions regarding the compassionate use of Nafamostat for specific patient populations that do not respond well to existing anticoagulants [9][15] - The company has made significant changes to its clinical study design, including reducing the study size and adjusting the target profile of clinical sites [4][6] Q&A Session Summary Question: What is the expected enrollment acceleration to reach the 70 patient target by year-end? - Management indicated that the enrollment rates are significantly increasing with new sites, and they are confident in reaching the target based on current trends [25][26] Question: Is there an opportunity to leverage data from compassionate use for future publications? - Management confirmed that data collected from compassionate use patients will contribute to a larger safety dataset, which could be beneficial for future publications and commercial uptake [30][33] Question: What is the status of heparin and citrate shortages? - Management noted that heparin shortages are episodic and ongoing, while citrate shortages are also being reported, affecting supply predictability [38][39] Question: What are the main components driving down operating expenses? - Management expects operating expenses to increase in the second half of the year due to rising enrollment rates [43] Question: What gives confidence in the new site initiations? - Management highlighted improved vetting processes and historical data on site performance, indicating high confidence in having new sites operational by the end of the third quarter [50][56]

PART I. FINANCIAL INFORMATION Talphera's unaudited financial statements, management's analysis, market risk, and internal controls are presented [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Talphera's unaudited condensed consolidated financial statements and notes detail financial position, operations, cash flows, and equity, highlighting liquidity and going concern [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, as of specific reporting dates Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :------------------ | | Cash and cash equivalents | $6,791 | $8,863 | | Total current assets | $7,696 | $9,417 | | Total assets | $16,515 | $18,236 | | Total current liabilities | $2,630 | $2,647 | | Total liabilities | $9,888 | $10,235 | | Total stockholders' equity | $6,627 | $8,001 | - Common stock outstanding increased to **20,522,655 shares** as of June 30, 2025, from **17,029,469 shares** as of December 31, 2024[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $— | $— | $27 | $— | | Research and development | $1,500 | $1,909 | $2,669 | $3,342 | | Selling, general and administrative | $2,193 | $2,361 | $3,967 | $5,165 | | Total operating costs and expenses | $3,693 | $4,270 | $6,636 | $8,507 | | Loss from operations | $(3,693) | $(4,270) | $(6,609) | $(8,507) | | Total other income, net | $204 | $443 | $454 | $726 | | Net loss | $(3,489) | $(3,827) | $(6,082) | $(7,781) | | Basic and diluted loss per share | $(0.10) | $(0.15) | $(0.20) | $(0.31) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%20Equity) This section outlines changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Changes in Stockholders' Equity (in thousands) | Metric | Balance as of January 1, 2025 | Balance as of June 30, 2025 | | :----------------------------------- | :---------------------------- | :-------------------------- | | Common Stock (Shares) | 17,029,469 | 20,522,655 | | Common Stock (Amount) | $17 | $20 | | Additional Paid-in Capital | $465,214 | $469,919 | | Accumulated Deficit | $(457,230) | $(463,312) | | Total Stockholders' Equity | $8,001 | $6,627 | - Net proceeds from the issuance of common stock and pre-funded warrants in connection with equity financing for the six months ended June 30, 2025, amounted to **$4,354 thousand**[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(6,418) | $(7,493) | | Net cash provided by investing activities | $— | $3,181 | | Net cash provided by financing activities | $4,346 | $12,014 | | Net change in cash and cash equivalents | $(2,072) | $7,702 | | Cash and cash equivalents—End of period | $6,791 | $13,423 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures on the company's organization, significant accounting policies, financial instrument valuations, discontinued operations, sale of future payments, legal commitments, equity transactions, stock-based compensation, net loss per share, and segment reporting [1. Organization and Summary of Significant Accounting Policies](index=10&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes the company's business, product pipeline, and critical accounting policies, including its going concern status - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings[26](index=26&type=chunk)[78](index=78&type=chunk) - The company's product development portfolio includes Niyad™ (a regional anticoagulant for dialysis) and LTX-608 (a nafamostat formulation for direct IV infusion for indications like DIC, ARDS, acute pancreatitis, or as an anti-viral treatment)[26](index=26&type=chunk)[27](index=27&type=chunk)[78](index=78&type=chunk) - The company has incurred recurring operating losses and negative cash flows, raising **substantial doubt** about its ability to continue as a **going concern**, and expects to need **additional capital** within the next twelve months[28](index=28&type=chunk)[103](index=103&type=chunk) [2. Investments and Fair Value Measurement](index=12&type=section&id=2.%20Investments%20and%20Fair%20Value%20Measurement) This note details the company's cash, cash equivalents, and fair value measurements of financial instruments, particularly warrant liabilities Cash and Cash Equivalents (in thousands) as of June 30, 2025 | Category | Fair Value | | :-------------------------- | :--------- | | Cash | $615 | | Money market funds | $404 | | U.S. government agency securities | $5,772 | | **Total** | **$6,791** | - The warrant liability, a Level III measurement, was valued at **$759 thousand** as of June 30, 2025, reflecting a **gain** on change in fair value of **$302 thousand** for the six months ended June 30, 2025, compared to a **loss** of **$547 thousand** for the same period in 2024[42](index=42&type=chunk)[100](index=100&type=chunk) [3. Discontinued Operations](index=14&type=section&id=3.%20Discontinued%20Operations) This note provides financial information related to the company's discontinued operations and associated accrued liabilities Net Income from Discontinued Operations (in thousands) | Period | Net Income | | :----------------------------- | :--------- | | Six months ended June 30, 2025 | $73 | | Six months ended June 30, 2024 | $— | - Accrued liabilities for discontinued operations were **$650 thousand** as of June 30, 2025, down from **$723 thousand** as of December 31, 2024[46](index=46&type=chunk) [4. Sale of Future Payments](index=14&type=section&id=4.%20Sale%20of%20Future%20Payments) This note explains the accounting for the sale of future DSUVIA payments and its impact on other income - In January 2024, the company recognized **$1.2 million** in other income from the sale of future commercial DSUVIA payments to XOMA (US) LLC[48](index=48&type=chunk)[99](index=99&type=chunk) - Alora Pharmaceuticals, LLC discontinued DSUVIA sales efforts to non-DoD customers in October 2024, leading the company to estimate future payments under the Purchase Agreement will be less than proceeds, resulting in a **0% estimated effective interest rate** for the six months ended June 30, 2025[50](index=50&type=chunk) [5. Commitments and Contingencies](index=16&type=section&id=5.%20Commitments%20and%20Contingencies) This note discloses the company's legal proceedings, including securities class action and shareholder derivative complaints - A securities class action complaint, dismissed with prejudice on May 7, 2024, is currently under appeal by plaintiffs in the Ninth Circuit Court of Appeals[52](index=52&type=chunk)

[Company Overview and Recent Developments](index=1&type=section&id=Company%20Overview%20and%20Recent%20Developments) [Second Quarter 2025 Highlights & Corporate Update](index=1&type=section&id=Second%20Quarter%202025%20Highlights%20%26%20Corporate%20Update) Talphera announced its second quarter 2025 financial results and provided a corporate update, highlighting significant progress in the NEPHRO clinical study with accelerated patient enrollment and a strategic financing round to support ongoing operations - **15 patients** have been enrolled in the NEPHRO clinical study, which remains on track for completion by the end of **2025**, with a planned PMA submission in the **first quarter of 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - Enrollment momentum has accelerated in the last six weeks due to new target profile clinical sites and study protocol changes, with new sites enrolling **90% of patients** to date[2](index=2&type=chunk) - Talphera announced the closing of the first tranche of **$4.9 million** of a three-tranche financing for up to **$14.8 million**, led by existing investors Nantahala Capital and Rosalind Advisors[3](index=3&type=chunk) [About Talphera, Inc.](index=3&type=section&id=About%20Talphera%2C%20Inc.) Talphera is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings, with Niyad® (nafamostat) as its lead product candidate - Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings[9](index=9&type=chunk) - Talphera's lead product candidate, **Niyad®**, is a lyophilized formulation of nafamostat, currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit[9](index=9&type=chunk) - **Niyad®** has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA)[9](index=9&type=chunk) [Clinical Development](index=1&type=section&id=Clinical%20Development) [NEPHRO CRRT Study Progress](index=1&type=section&id=NEPHRO%20CRRT%20Study%20Progress) The NEPHRO clinical study is progressing well, with accelerated patient enrollment and strategic expansion of clinical sites, supporting the projected completion by year-end 2025 and a subsequent PMA submission in Q1 2026 - **15 patients** have been enrolled in the NEPHRO clinical study, supporting the expected completion timeline by the end of **2025**[1](index=1&type=chunk)[3](index=3&type=chunk) - Enrollment momentum has increased, with new target profile clinical sites enrolling **90% of patients** to date[2](index=2&type=chunk) - Talphera expects to add **six new clinical sites** by the end of the **third quarter**, bringing the total number of sites up to **13**, including **nine** with the target profile[2](index=2&type=chunk)[3](index=3&type=chunk) - A planned PMA submission is anticipated in the **first quarter of 2026**, assuming enrollment and site activation trends continue[3](index=3&type=chunk) [About Niyad and Nafamostat](index=3&type=section&id=About%20Niyad%20and%20Nafamostat) Nafamostat is a broad-spectrum synthetic serine protease inhibitor with anticoagulant, anti-inflammatory, and potential anti-viral activities. Niyad® is its lyophilized formulation, currently undergoing a registrational study (NEPHRO CRRT) as an anticoagulant for extracorporeal circuits, and has received Breakthrough Device Designation - **Nafamostat** is a broad-spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities[11](index=11&type=chunk) - **Niyad®** is a lyophilized formulation of nafamostat, currently being studied under an IDE as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA[11](index=11&type=chunk) - The registrational study of **Niyad®** is named the **NEPHRO CRRT** (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study[11](index=11&type=chunk) - An ICD-10 procedural code, **XY0YX37**, has been issued for the extracorporeal introduction of nafamostat, and **LTX-608** is a proprietary nafamostat formulation for direct IV infusion with other potential therapeutic targets[11](index=11&type=chunk) [About the NEPHRO CRRT Study Design](index=3&type=section&id=About%20the%20NEPHRO%20CRRT%20Study%20Design) The NEPHRO CRRT Study is a prospective, double-blinded trial designed to enroll 70 adult patients undergoing renal replacement therapy who are at risk for bleeding or cannot tolerate heparin, evaluating Niyad®'s efficacy as an anticoagulant - The **NEPHRO CRRT Study** is designed as a prospective, double-blinded trial to be conducted at up to **14 U.S. hospital intensive care units**[12](index=12&type=chunk) - The study will enroll and evaluate **70 adult patients** undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding[12](index=12&type=chunk) - The primary endpoint of the study is mean post-filter activated clotting time using **Niyad** versus placebo over the **first 24 hours**[12](index=12&type=chunk) - Key secondary endpoints include 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 over the **first 24 hours**[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Second Quarter 2025 Financial Information Overview](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Information%20Overview) Talphera reported a reduced net loss for Q2 2025 compared to Q2 2024, primarily due to lower personnel and general administrative expenses, and provided updated, reduced guidance for 2025 cash operating expenses - Cash and cash equivalents balance was **$6.8 million** as of **June 30, 2025**[7](index=7&type=chunk) - Net loss from continuing operations for the **second quarter of 2025** was **$3.5 million**, compared to **$3.8 million** for the **second quarter of 2024**, largely due to reductions in personnel expense and change in fair value of warrant liability[7](index=7&type=chunk) - Net loss attributable to common shareholders for **Q2 2025** was **$3.5 million**, or **$0.10 per basic and diluted share**, compared to **$3.8 million**, or **$0.15 per basic and diluted share**, for **Q2 2024**[7](index=7&type=chunk) [2025 Expense Guidance](index=2&type=section&id=2025%20Expense%20Guidance) - Cash operating expenses (selling, general and administrative, and research and development expenses, excluding stock-based compensation) are expected to be in the range of **$16 million to $17 million** in **2025**[5](index=5&type=chunk) - This **2025** guidance is a reduction from the previously provided range of **$17 million to $19 million**[5](index=5&type=chunk) [Key Financial Results (Q2 2025 vs Q2 2024)](index=2&type=section&id=Key%20Financial%20Results%20(Q2%202025%20vs%20Q2%202024)) Combined R&D and SG&A Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :----------------------------------- | :--------------------- | :--------------------- | :----------- | | Combined R&D and SG&A expenses | $3,700 | $4,300 | -$600 | | Excluding non-cash stock-based compensation | $3,500 | $4,000 | -$500 | | Net loss from continuing operations | $3,489 | $3,827 | -$338 | | Net loss attributable to common shareholders | $3,489 | $3,827 | -$338 | | Basic and diluted loss per share | $0.10 | $0.15 | -$0.05 | - The decrease in combined R&D and SG&A expenses in **Q2 2025** was primarily due to reductions in personnel expense and other general and administrative expenses[7](index=7&type=chunk) - The divestment of DSUVIA represents a discontinued operation; all historical operating results for the business are reflected within discontinued operations, with no DSUVIA related expenses in **Q2 2025** or **Q2 2024**[7](index=7&type=chunk) [Selected Financial Data Tables](index=5&type=section&id=Selected%20Financial%20Data%20Tables) The selected financial data tables provide a detailed breakdown of the company's statement of operations for the three and six months ended June 30, 2025 and 2024, balance sheet data as of June 30, 2025 and December 31, 2024, and a reconciliation of non-GAAP operating expenses [Statement of Operations Data](index=5&type=section&id=Statement%20of%20Operations%20Data) Statement of Operations Data (in thousands, except per share data) | Statement of Operations Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $ - | $ - | $ 27 | $ - | | Research and development | 1,500 | 1,909 | 2,669 | 3,342 | | Selling, general and administrative | 2,193 | 2,361 | 3,967 | 5,165 | | Total operating costs and expenses | 3,693 | 4,270 | 6,636 | 8,507 | | Loss from operations | (3,693) | (4,270) | (6,609) | (8,507) | | Interest income and other income, net | 83 | 201 | 152 | 421 | | Gain on sale of future payments | - | - | - | 1,246 | | Gain (loss) on change in fair value of warrant liability | 121 | 455 | 302 | (547) | | Non-cash interest expense on liability related to sale of future payments | - | (213) | - | (394) | | Total other income, net | 204 | 443 | 454 | 726 | | Net loss from continuing operations | (3,489) | (3,827) | (6,155) | (7,781) | | Net income from discontinued operations | - | - | 73 | - | | Net loss | $ (3,489) | $ (3,827) | $ (6,082) | $ (7,781) | | Basic and diluted loss per share, continuing operations | $ (0.10) | $ (0.15) | $ (0.20) | $ (0.31) | | Basic and diluted loss per share, discontinued operations | $ - | $ - | $ 0.00 | $ - | | Basic and diluted loss per share | $ (0.10) | $ (0.15) | $ (0.20) | $ (0.31) | | Shares used in computing net loss per share, basic and diluted | 34,530 | 26,202 | 30,422 | 25,462 | Non-Cash Stock-Based Compensation Expense (in thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $ 55 | $ 85 | $ 132 | $ 192 | | Selling, general and administrative | 111 | 138 | 230 | 333 | | Total | $ 166 | $ 223 | $ 362 | $ 525 | [Selected Balance Sheet Data](index=6&type=section&id=Selected%20Balance%20Sheet%20Data) Selected Balance Sheet Data (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Unaudited) | | :----------------------------------- | :-------------------------- | :---------------------------- | | Cash, cash equivalents and investments | $ 6,791 | $ 8,863 | | Total assets | 16,515 | 18,236 | | Total liabilities | 9,888 | 10,235 | | Total stockholders' equity | 6,627 | 8,001 | [Reconciliation of Non-GAAP Financial Measures](index=6&type=section&id=Reconciliation%20of%20Non-GAAP%20Financial%20Measures) Reconciliation of Non-GAAP Operating Expenses (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating expenses (GAAP): | | | | | | Research and development | $ 1,500 | $ 1,909 | $ 2,669 | $ 3,342 | | Selling, general and administrative | 2,193 | 2,361 | 3,967 | 5,165 | | Total operating expenses | 3,693 | 4,270 | 6,636 | 8,507 | | Less stock-based compensation expense | 166 | 223 | 362 | 525 | | Operating expenses (non-GAAP) | $ 3,527 | $ 4,047 | $ 6,274 | $ 7,982 | [Additional Information](index=2&type=section&id=Additional%20Information) [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) Talphera will host a conference call and webcast on August 14, 2025, to discuss the financial results and provide a business update, with details provided for participation and replay access - Talphera will hold a conference call and webcast on **Thursday, August 14, 2025**, at **4:30 p.m. Eastern Time/1:30 p.m. Pacific Time**[1](index=1&type=chunk)[6](index=6&type=chunk) - Investors can participate by dialing **1-800-836-8184** (North America) or **1-646-357-8785** (international), using conference ID **32530**[8](index=8&type=chunk) - A webcast, including a slide presentation, will be accessible via **www.talphera.com** and a replay will be available on the Talphera website for **90 days** following the event[8](index=8&type=chunk) [Forward-looking Statements](index=4&type=section&id=Forward-looking%20Statements) This press release contains forward-looking statements based on current expectations and assumptions, subject to risks and uncertainties that could cause actual results to differ materially, as detailed in the company's SEC filings - The press release contains forward-looking statements based upon Talphera's current expectations and assumptions, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of **1995**[13](index=13&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied, including risks related to product development, regulatory approvals, commercialization, and liquidity[13](index=13&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of their original date, and are advised to consult Talphera's SEC reports for full details on risks[13](index=13&type=chunk) [Investor Contacts](index=4&type=section&id=Investor%20Contacts) Contact information for Talphera's Chief Financial Officer and LifeSci Advisors is provided for investor inquiries - Talphera Investor Contact: Raffi Asadorian, CFO, **650-216-3500**, investors@talphera.com[14](index=14&type=chunk) - LifeSci Advisors Contact: Kevin Gardner, **617-283-2856**, kgardner@lifesciadvisors.com[14](index=14&type=chunk)

Core Viewpoint - Talphera, Inc. is set to release its second quarter 2025 financial results on August 14, 2025, followed by a live webcast and conference call to discuss the results and provide a business update [1]. Group 1: Financial Results Announcement - The financial results for the second quarter of 2025 will be released after market close on August 14, 2025 [1]. - A live webcast and conference call will take place at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time on the same day [1]. Group 2: 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 post-event [2]. - Investors can participate in the conference call by dialing specific numbers for North American and international callers, with a conference ID provided [3]. Group 3: Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing 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 and has received Breakthrough Device Designation from the FDA [4].

Financial Data and Key Metrics Changes - The cash operating expenses for Q1 2025 totaled $2.9 million, a decrease from $4.2 million in Q1 2024. Excluding non-cash stock-based compensation, the amounts were $2.7 million for Q1 2025 compared to $3.9 million for Q1 2024 [15][16] - The company reduced the lower end of its 2025 expected cash operating expense guidance to a range of $17 million to $19 million [15] Business Line Data and Key Metrics Changes - The nephro CRRT trial has seen a reduction in study size from 166 patients to 70 patients, which is expected to shorten the time to complete the study [4][5] - The company has added three new clinical study sites that are actively screening patients, with five more expected by mid-year [6][9] Market Data and Key Metrics Changes - There are ongoing shortages of citrate supply and potential supply chain issues with heparin, leading healthcare providers to inquire about the availability of Nefamostat [7] Company Strategy and Development Direction - The company is focused on completing the nephro study by the end of the year and has made significant progress in engaging new clinical study sites [5][10] - The company believes that NIAID, if approved, would fill a significant unmet medical need during renal replacement therapy, as it would be the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy [8][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risk elements for the nephro program due to the established track record of nafamostat and the clear regulatory path provided by the FDA [13][14] - The company anticipates that the changes made to the nephro CRRT study and the new sites will accelerate enrollment rates [16] Other Important Information - The company completed a PIPE financing structured in three equal tranches, with the first tranche received at the initial closing [16] - The cash balance as of March 31, 2025, was $5.4 million, or $9.8 million on a pro forma basis after the financing [16] Q&A Session Summary Question: Has the broader enrollment criteria started to translate into increased enrollment? - Management noted that while there has been increased activity at the sites due to broader criteria, it has not yet translated into new patients from legacy sites [18][19] Question: What are the challenges with legacy sites? - The legacy sites are still dependent on patient populations that may not align with the new broader criteria, which has limited their enrollment despite the changes [24][25]