Heparin Calcium

‒ Q1 2025 Unaudited Net Revenue of $39.0 million ‒ ‒ Expected Q1 Adjusted EBITDA above $22.5 million ‒ ‒ Q1 2025 Cash and Cash Equivalents of Approximately $77.5 million ‒ Berkeley Heights, NJ – April 8, 2025 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited first quarter results and provides an update on its business. These include the following key updates: CorMedix announces preliminary, unaudited net revenue of $39.0 million for 1Q 2025, and expects 1Q 2025 adjusted EBITDA(1) to exceed $22.5 million once final numbers are reported. Since providing initial guidance, the Company received larger than expected orders during the final week of March, and has also obtained additional visibility into inventory levels on hand at some of our current purchasing customers. Based on this new information, CorMedix is increasing its H1 2025 guidance for Net Sales to existing purchasing customers to a revised range of $62 million to $70 million. While the Company is currently forecasting net sales from existing purchasing customers in 2Q 2025 to be lower than 1Q 2025, this is due to the timing of shipments to those customers between quarters, and does not suggest an anticipated decrease in patient utilization in the second quarter or the second half of 2025. CorMedix currently forecasts patient utilization with existing purchasing customers to continue to grow throughout 2025 as implementation expands to new patients, and currently anticipates unit shipments in H2 2025 to exceed shipments in H1 2025. CorMedix expects patient enrollment for our Phase 3 study of DefenCath in patients receiving Total Parenteral Nutrition, or TPN, to begin in late April. The Company believes DefenCath, if approved for this indication, can achieve peak annual sales in this patient population of $150 million to $200 million, with a total addressable market opportunity of $500 million to $750 million. Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to approximately $77.5 million. The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of the quarterly review procedures of CorMedix’s first quarter 2025 financial statements. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in Total Parenteral Nutrition and Pediatric patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties, including expectations regarding CorMedix’s first quarter 2025 unaudited net revenue, adjusted EBITDA, cash and short-term investments as of March 31, 2025 and increased net sales guidance for the first half of fiscal year 2025, and expectations regarding patient utilization and enrollment. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 patients, of which 6 patients are already enrolled Talphera believes the NEPHRO CRRT study should be completed by the end of 2025 Existing investors, Nantahala Capital and Rosalind Advisors led the capital commitment priced at-the-market as defined by Nasdaq rules $4.925 million in gross proceeds at first closing with the potential to receive an additional $9.85 million across two $4.925 million tranches upon achieving certain patient enrollment milestones Cash and investments at December 31, 2024 of $8.9 million, together with the expected proceeds from the financing of up to $14.8 million should provide capital through targeted completion of the NEPHRO CRRT study by the end of 2025 SAN MATEO, Calif., March 31, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), (Talphera), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced its agreement with the FDA to reduce the size of the NEPHRO CRRT study to 70 patients from the 166 previously included in the study protocol. The Company also announced it has entered into securities purchase agreements with certain institutional investors and a member of management for the sale and issuance of shares of common stock and pre-funded warrants in lieu of shares to purchase common stock in a three-tranche private placement for potential gross proceeds of up to $14.8 million. "We are pleased that the FDA agreed with our assessment to reduce the study size to 70 patients, which still keeps the study's primary endpoint powered at 90%," stated Vince Angotti, Talphera CEO. "This change, along with the other protocol changes to the study inclusion criteria and the addition of new sites with higher enrollment potential will support a timely completion of the study, which we are targeting by the end of the year. We are also thankful for the continued support from our existing investors, Nantahala and Rosalind, which led the private placement financing. The additional capital should support our objective of completing the study by the end of the year as we look forward to submitting our PMA early next year and a potential approval in the second half of 2026." The Private Placement The private placement is led by Nantahala Capital and Rosalind Advisors, and includes a member of management, and has the potential to raise gross proceeds of up to $14.8 million, which amount includes (i) $4.925 million in the first closing (which is expected to occur on April 2, 2025), (ii) $4.925 million in a second closing upon the enrollment of at least 17 patients in the Company's NEPHRO CCRT study (the "Second Milestone"), and a minimum stock price of at least $0.7325 per share for five consecutive days following a public announcement of the achievement of the Second Milestone, and (iii) $4.925 million in a third closing upon the enrollment of at least 35 patients (the "Third Milestone"), and a minimum stock price of at least $0.7325 per share for five consecutive days following a public announcement of the achievement of the Third Milestone. In the first closing, Talphera will issue 3,405,118 shares of common stock and 4,999,316 pre-funded warrants, at a price of $0.586 per share and $0.585 per pre-funded warrant, respectively. The pre-funded warrants will have an exercise price of $0.001 per share. In each of the second and third closings upon achievement of the respective milestones and if closing conditions are met, Talphera expects to issue an additional 3,405,118 shares of common stock and 4,999,316 pre-funded warrants, at a price of $0.586 per share and $0.585 per pre-funded warrant, respectively. The offer and sale of the securities described above are being offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder, and have not been registered under the Act, or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement under the Act with the Securities and Exchange Commission (the "SEC"), covering the resale of the shares of common stock to be issued in the private placement and the shares of common stock underlying the pre-funded warrants no later than 45 days following the closing date, and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the closing date in the event of a "full review" by the SEC. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera' s lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO CRRT Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking Statements This press release contains forward-looking statements based upon Talphera's current expectations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "potential," "potentially," "believe," "expect," "anticipate," "may," "will," "if," "enable," "should," "seek," "approximately," "intends," "intended," "plans," "planned," "planning," "targeted," "estimates," "sufficient," "benefits," or the negative of these words or other comparable terminology, and include Talphera's statements regarding and include Talphera's statements regarding a potential completion of the NEPHRO CRRT study by the end of 2025; Talphera's expectation that the committed capital from the financing, upon completion of certain milestones and meeting certain closing conditions, should provide sufficient capital to fund the completion of the study expected by the end of 2025, with an expected PMA application submitted in early 2026 and a potential approval in the second half of 2026; and Talphera's ability to successfully meet the enrollment goals and minimum stock price to achieve the Second Milestone and Third Milestone. The discussion of strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities and ongoing commercial business operations; (ii) risks related to the ability of Talphera and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for Talphera 's commercial and developmental products and technologies; (iv) risks related to Talphera 's liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; (v) Talphera 's ability to retain its listing on the Nasdaq exchange; and (vi) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera 's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-agreement-with-the-fda-to-reduce-the-nephro-crrt-study-size-to-70-patients-from-166-and-a-private-placement-financing-priced-at-the-market-of-up-to-14-8-million-302415309.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com