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 March 31, 2025 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 incorporat ...

Exhibit 99.1 Talphera Announces First Quarter 2025 Financial Results and Provides Corporate Update Cash and investments at March 31, 2025, as adjusted to include the proceeds from the first tranche of the private placement financing which closed on April 2, 2025, were $9.8 million Three new clinical study sites activated and screening patients thus far in 2025, with five additional sites expected by mid-year, for a total of 13 Conference call and webcast to be held Wednesday, May 14, 2025 at 4:30 pm ET SAN ...

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 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 deterioration 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] - The company recognized a net loss from discontinued operations of $8,098 thousand for the nine months ended September 30, 2023, with total revenues from discontinued operations at $501 thousand[47] Expenses and Costs - Research and development expenses for the three months ended September 30, 2024, were $2,053,000, an increase of 74.4% from $1,178,000 in the same period of 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] - The total stock-based compensation expense for the nine months ended September 30, 2024, was $759,000, down from $1,418,000 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 Flow and Financing - The company experienced a net cash used in operating activities of $10,429,000 for the nine months ended September 30, 2023, compared to $13,543,000 for the same period in the previous year[16] - The company had cash and cash equivalents of $11,117,000 at the end of the reporting period, down from $13,389,000 at the beginning of the period[16] - The company raised $5,884,000 from the issuance of common stock related to the exercise of prefunded warrants during the reporting period[16] - Management plans to seek additional capital through various means, including public or private equity offerings and potential asset monetization[24] 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 innovative therapies, including Niyad™ and LTX-608, targeting conditions such as acute respiratory distress syndrome and disseminated intravascular coagulation[18] - The company has a product development pipeline that includes a license agreement for ephedrine and phenylephrine pre-filled syringes, pending FDA approval[22] Risks and Concerns - The company faces significant risks including market volatility, supply chain disruptions, and the ability to obtain necessary financing for 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 new accounting standards, including ASU 2023-07 and ASU 2023-09, but does not expect them to materially affect financial statements[34][35] - The Company has reclassified certain prior year amounts in its financial statements to conform to current year presentation[29] - The Company believes its most significant accounting estimates relate to revenue recognition and impairment of long-lived assets[28] Stock and Warrants - As of September 30, 2024, the Company had 29,474,257 warrants outstanding, with a weighted average exercise price of $0.96 per share[75] - 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 amended its 2011 Employee Stock Purchase Plan to increase the number of authorized shares by 100,000, totaling 345,000 shares[74] - The basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares outstanding for the period[83] - A total of 2,096,052 common stock equivalents were excluded from the computation of diluted net loss per share for the three months ended September 30, 2024, due to antidilutive effects[84]

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]. - Talphera's 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 30, 2024, were $3,749,000, slightly up from $3,426,000 in the same period last year[21]. - The company reported a total of $12,256,000 in operating expenses for the nine months ended September 30, 2024, compared to $12,976,000 for the same period in 2023[21]. 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 30, 2024, were $2,053,000, up from $1,178,000 for the same period in 2023, representing a 74% increase[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]. Financial Position - Cash and investments totaled $11.1 million as of September 30, 2024[5]. - Cash, cash equivalents, and investments increased to $11,117,000 as of September 30, 2024, up from $9,381,000 at December 31, 2023[20]. - Total assets rose to $21,014,000, compared to $20,395,000 at the end of 2023[20]. - Total liabilities increased significantly to $11,373,000 from $6,290,000[20]. - Total stockholders' equity decreased to $9,641,000, down from $14,105,000[20]. Operating Expenses - Selling, general, and administrative expenses decreased to $1,696,000 for the three months ended September 30, 2024, from $2,248,000 in the prior year[21]. - Non-GAAP operating expenses for the three months ended September 30, 2024, were $3,515,000, compared to $3,048,000 in the prior year[21]. - Stock-based compensation expense for the three months ended September 30, 2024, was $234,000, down from $378,000 in the same period last year[21]. Regulatory Status - The company has received Breakthrough Device Designation status from the FDA for its lead product candidate, Niyad™[11].

Financial Performance - The cash, cash equivalents, and investments balance was $14.0 million as of June 30, 2024, an increase from $9.4 million at the end of 2023[22]. - Combined R&D and SG&A expenses for Q2 2024 totaled $4.3 million, slightly up from $4.2 million in Q2 2023, primarily due to increased costs associated with Niyad development[7]. - The net loss from continuing operations for Q2 2024 was $3.8 million, an improvement from a net loss of $4.4 million in Q2 2023[8]. - Net loss attributable to common shareholders for Q2 2024 was $3.8 million, or $0.15 per share, compared to a net loss of $4.4 million, or $0.40 per share, in Q2 2023[9]. - The company recognized a change in fair value of the warrant liability, contributing to the net loss reduction in Q2 2024[8]. - Talphera's total assets increased to $24.9 million as of June 30, 2024, compared to $20.4 million at the end of 2023[22]. Clinical Development - Talphera initiated patient screening at multiple clinical sites for the NEPHRO CRRT registrational study, which will enroll 166 patients across up to 14 sites[5]. - Talphera received FDA approval to increase the maximum number of study sites for the NEPHRO study from 10 to 14, which is expected to expedite the study's completion[2]. - The primary endpoint of the NEPHRO study is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours[5]. - Talphera's lead product candidate, Niyad™, is being studied as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation from the FDA[11].

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 ...

Financial Performance - Total current assets increased to $19,953,000 as of March 31, 2024, compared to $11,576,000 as of December 31, 2023, representing a 72% increase[21]. - The net loss for Q1 2024 was $3,954,000, a decrease from a net loss of $8,152,000 in Q1 2023, reflecting a 51% improvement[24]. - Cash and cash equivalents rose to $12,122,000 at the end of Q1 2024, compared to $5,721,000 at the beginning of the period, marking a 112% increase[31]. - Total liabilities increased to $12,438,000 as of March 31, 2024, from $6,290,000 as of December 31, 2023, representing a 98% increase[21]. - The company’s accumulated deficit reached $448,180,000 as of March 31, 2024, compared to $444,226,000 at the end of 2023[21]. - The Company recorded approximately $6.1 million as a liability from the sale of future payments related to DSUVIA, with $1.2 million recognized as other income[52]. - Total other income (expense), net for Q1 2024 was $283,000, a decrease of 95% compared to $5.4 million in Q1 2023[132]. - Interest income and other income, net for Q1 2024 was $220,000, up 10% from $200,000 in Q1 2023[133]. - Cash used in operating activities for Q1 2024 was $2.9 million, reflecting a net loss of $4.0 million[146]. - Cash provided by financing activities for Q1 2024 was $12.0 million, primarily due to net proceeds from the XOMA Purchase Agreement and the January 2024 private placement[150]. Research and Development - Research and development expenses for Q1 2024 were $1,433,000, up from $1,047,000 in Q1 2023, indicating a 37% increase year-over-year[23]. - The company is focused on developing Niyad™, a regional anticoagulant for the dialysis circuit, and other product candidates for various medical indications[37]. - The company plans to begin enrollment in a registrational trial for Niyad in the second quarter of 2024, which has received FDA Breakthrough Device Designation[99][106]. - The NEPHRO CRRT study will evaluate 166 adult patients and aims to submit a Premarket Approval application to the FDA upon completion of the trial[106]. - The company is developing LTX-608 for various medical conditions and plans to submit an IND following toxicology evaluation[100][101]. - The company expects to submit Investigational New Drug applications for LTX-608, but unexpected findings in nonclinical studies could delay this process[207]. - The company has entered into a PFS Agreement with Aguettant for the development of ephedrine and phenylephrine pre-filled syringes, with expectations for FDA approval without additional changes[208]. Capital and Funding - Management expects to need additional capital to fund operations within the next twelve months due to ongoing losses and cash flow issues[43]. - The company plans to raise additional capital through various means, including public or private equity offerings and potential collaborations[44]. - The company raised approximately $6.0 million in gross proceeds from a private placement on January 22, 2024, with additional potential proceeds of $10.0 million and $2.0 million contingent on clinical trial results and stock price performance, respectively[79][80][81]. - The first tranche of the January 2024 private placement resulted in gross proceeds of approximately $6.0 million, with pre-funded warrants issued for up to 7,792,208 shares[139]. - The second tranche of the January 2024 private placement could provide additional gross proceeds of approximately $10.0 million, contingent on achieving specific clinical trial endpoints[140]. - The company expects to incur significant losses in 2024 and may require additional capital to fund operations within the next twelve months[136]. - The company has financed its operations primarily through equity securities issuance, borrowings, and payments from partners, including a recent agreement to monetize future payments related to DSUVIA sales[167]. Acquisitions and Agreements - On April 3, 2023, the Company completed the DSUVIA Agreement with Alora Pharmaceuticals, acquiring certain assets related to the sufentanil sublingual tablet product[39]. - The Company acquired Lowell Therapeutics, Inc. on January 7, 2022, gaining the Niyad™ product, which has received Breakthrough Device Designation from the FDA[40]. - Talphera entered into a Payment Interest Purchase Agreement with XOMA for $8 million related to certain receivables from the DSUVIA Agreement[38]. - The Company entered into an Asset Purchase Agreement with Alora for the acquisition of assets related to DSUVIA, with a total consideration of $1.1 million and potential sales-based milestones of up to $116.5 million[65]. - In January 2024, the Company sold certain receivables to XOMA for $8.0 million, with proceeds from the sale of future payments amounting to $6.133 million as of March 31, 2024[67]. Operational Challenges - 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[42]. - The company has ongoing litigation risks that may materially adversely affect its financial condition and results of operations[78]. - The company has identified risks related to potential delays in clinical trials and regulatory approvals, which could increase costs and jeopardize product development[163]. - The company may experience significant disruptions in financial markets, impacting its ability to obtain additional capital on favorable terms[174]. - The company may face difficulties in raising additional capital, which could force it to scale back or discontinue product development and commercialization efforts[173]. - The company has a material weakness in its internal control over financial reporting, which may result in errors in financial statements[164]. - Global supply chain disruptions may adversely impact the company's ability to develop and supply its product candidates[115]. Future Outlook - The company expects significant additional capital will be needed in the future to continue planned operations and capital requirements[176]. - The company may need to relinquish or license its rights to technologies or products under unfavorable terms if it cannot secure sufficient funding[173]. - The ability to generate future revenues from product sales depends heavily on successful clinical trials and regulatory approvals[188]. - The approval process for PMA or NDA is lengthy and may incur unexpected delays and costs, impacting the company's financial condition[203]. - The FDA's rejection of clinical data could adversely affect the company's ability to obtain marketing authorization for its product candidates[204]. - The company may need to conduct additional clinical development work to obtain FDA approval, which would increase expenses and delay revenue[205]. - The company may face unexpected liabilities from the acquisition of Lowell, which could adversely affect its financial condition[184].

Financial Position - Cash and investments totaled $18.6 million as of March 31, 2024[1] - Total assets as of March 31, 2024, were $28.8 million, with total liabilities of $12.4 million[19] - The company announced a total of $26 million in committed capital, including $8 million from DSUVIA royalties and $18 million in equity from existing investors[4] Expenses and Losses - Combined R&D and SG&A expenses for Q1 2024 were $4.2 million, down from $5.3 million in Q1 2023, primarily due to reduced headcount[6] - Net loss from continuing operations for Q1 2024 was $4.0 million, or $0.16 per share, compared to a net income of $0.1 million in Q1 2023[7] Product Development - Talphera's lead product candidate, Niyad, is currently under investigation as an anticoagulant and has received Breakthrough Device Designation from the FDA[9] - Talphera expects to enroll the first patients in the NEPHRO CRRT registrational study in Q2 2024, with the trial's primary endpoint measured at 24 hours[2] - The NEPHRO study will enroll 166 adult patients and evaluate the efficacy of Niyad compared to placebo[11] Leadership Changes - Dr. Shakil Aslam will join Talphera as Chief Development Officer on May 20, 2024, bringing over 20 years of nephrology expertise[5] Company Rebranding - The company underwent a rebranding from AcelRx Pharmaceuticals, Inc. to Talphera, Inc. in January 2024[3]

Acquisition and Product Development - The company acquired Lowell Therapeutics, Inc. for approximately $32.5 million, with up to $26.0 million in contingent consideration based on regulatory and sales milestones[17]. - Niyad™, a product candidate, has received FDA's Breakthrough Device Designation and is expected to begin patient enrollment in a registrational trial in Q1 2024, with a PMA application planned by the end of 2024[20][23]. - The NEPHRO CRRT Study will enroll 166 adult patients and aims to evaluate the efficacy of Niyad compared to placebo, with top-line data expected by Q3 2024[23]. - LTX-608, another product candidate, is being explored for indications such as antiviral treatment and acute respiratory distress syndrome, with initial studies showing potential benefits in COVID patients[30]. - The company plans to submit a PMA application for Niyad by the end of 2024 and expects to enroll the first patient in its registrational study in Q1 2024[38]. - The company is evaluating the second targeted indication for its nafamostat product development candidate, LTX-608, focusing on DIC and acute pancreatitis for initial development[50]. Financial Performance and Capital Needs - The company has not yet generated significant product revenue and anticipates continued losses in the future[9]. - The company has incurred significant losses since inception and may need to raise additional capital, which could dilute existing shareholders[9]. - The company will need to raise additional funds through equity sales, asset monetization, or debt issuance to sustain operations and development programs[338]. Regulatory and Approval Processes - The FDA approval process for product candidates is time-consuming and may involve unexpected delays and costs[9]. - Niyad is classified as a Class III medical device and is subject to the PMA application process, which is generally more costly and time-consuming than the 510(k) process[69]. - The FDA has 180 days to review a filed PMA application, although the review often takes significantly longer, and may request additional information during this period[72]. - The approval process for drug products requires substantial time and financial resources, and the company cannot be certain that approval will be granted on a timely basis[57]. - The Breakthrough Devices Program allows for expedited review of medical devices that address life-threatening conditions, with priority review for designated devices[76]. Market Potential and Sales Projections - The peak sales potential for Niyad, if approved for use in CRRT and IHD, may exceed $200 million annually in the United States, based on an estimated addressable population of 500,000 patients undergoing CRRT and 350,000 patients undergoing IHD[35]. - The company believes its two pre-filled syringe product candidates could have a peak sales potential of over $100 million, with a focus on eliminating the need for on-the-spot calculations and additional dilution steps[37]. - Nafamostat, if approved for regional anticoagulation in CRRT, may address safety concerns associated with current anticoagulants, as 29% of cases do not use any anticoagulant due to safety concerns[33]. - The incidence of bleeding during continuous hemofiltration with heparin was 66.7%, compared to only 4.3% with nafamostat, indicating a significant safety advantage[34]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers and suppliers for its product candidates, which poses risks to the supply chain[10]. - The company relies on contract manufacturers for the production of its Niyad product, with a single contract manufacturer currently producing the nafamostat API and a separate one for the finished product[52]. - The company is in discussions with a back-up manufacturer for Niyad to ensure there is not a single source of supply[52]. - Unforeseen delays in drug manufacturing and supply chains may arise from regulatory compliance issues, potentially impacting product availability[81]. Compliance and Regulatory Challenges - The company must comply with extensive cGMP requirements throughout the manufacturing process, which require considerable ongoing investment[66]. - Manufacturers must comply with stringent FDA regulations, including quality assurance procedures and medical device reporting regulations[77]. - The Drug Supply Chain Security Act mandates tracking and tracing obligations for pharmaceutical manufacturers, including reporting counterfeit products[80]. - The company faces significant penalties for violations of health regulatory laws, which could adversely affect operations and financial results[91]. Market and Legislative Environment - Sales of approved products depend on third-party payer coverage and reimbursement, which are increasingly scrutinized for cost-effectiveness[92]. - The company may need to conduct pharmacoeconomic studies to demonstrate the cost-effectiveness of products for reimbursement approval[92]. - The company anticipates ongoing legislative and regulatory changes in the healthcare system that may impact product commercialization and profitability[93]. - In the U.S., the Affordable Care Act and subsequent reforms aim to broaden insurance access and reduce healthcare spending, with potential implications for drug pricing and reimbursement rates[98]. - The Inflation Reduction Act of 2022 extends enhanced subsidies for health insurance coverage through 2025 and introduces measures to lower out-of-pocket costs for Medicare beneficiaries[98]. - The company faces competition from lower-priced products in foreign markets due to varying drug pricing regulations, particularly in the European Union[95]. - Legislative proposals are being made to increase transparency in drug pricing and reform reimbursement methodologies, which could affect the company's pricing strategies[102]. Workforce and Employment - As of December 31, 2023, the company employed 15 full-time employees, with a commitment to pay equity and competitive benefits[104]. - The company is not currently required to provide certain financial disclosures as a smaller reporting company under the Securities Exchange Act[339].

Core Viewpoint - AcelRx Pharmaceuticals, Inc. has rebranded to Talphera, Inc. to reflect its new mission of developing innovative therapies for medically supervised settings, moving beyond its original focus on acute pain [1][2]. Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, with its lead product candidate being Niyad, a formulation of nafamostat [6][7]. - The name "Talphera" is derived from "Talisman," symbolizing a strong leader and a new pharmaceutical era for the company [2]. Product Development - Talphera's lead product candidate, Niyad, has received FDA Breakthrough Designation and is being studied as an anticoagulant for the extracorporeal circuit [3][6]. - The company plans to initiate the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, which has received IRB approval and will evaluate 166 adult patients [4][5]. Regulatory and Market Strategy - A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024 [5]. - The first patient for the NEPHRO study is anticipated to be enrolled in the first quarter of 2024 [5].