CorMedix Inc.

Note 1 -Organization, Business and Basis of Presentation

Organization and Business

CorMedix Inc. ( “CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. Prior to the acquisition of Melinta Therapeutics, LLC ("Melinta") in August 2025 (the "merger"), the Company had focused on commercialization of its product, DefenCath® (taurolidine and heparin) in the United States. CorMedix launched the product commercially in 2024 in both the hospital inpatient and outpatient hemodialysis settings of care.

The merger with Melinta expanded the Company’s team and commercial platform and increased the commercial portfolio with six marketed, hospital- and clinic-focused infectious disease products, comprised of REZZAYO® (rezafungin for injection), MINOCIN® (minocycline) for Injection, VABOMERE® (meropenem and vaborbactam), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin), BAXDELA® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL® (metoprolol succinate) (together, the “Melinta Portfolio”, and, together with DefenCath, “our Products”). REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults. On April 27, 2026, CorMedix announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation, and if approved by the U.S. Food and Drug Administration (the "FDA"), it is targeting commercialization of REZZAYO in this second indication beginning in 2027.

Given the closing of the merger during the third quarter of 2025, the financial results of Melinta are included in the Company’s unaudited condensed consolidated financial statements for the quarter ended March 31, 2026, but not for the quarter ended March 31, 2025.

Basis of Presentation

The preparation of these unaudited condensed consolidated financial statements and accompanying notes are in conformity with U.S. generally accepted accounting principles (“GAAP”) which requires the use of management estimates. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2026, or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 5, 2026. The accompanying condensed consolidated balance sheet as of December 31, 2025 has been derived from the audited financial statements included in such Annual Report on Form 10-K.

Reclassifications

Certain reclassifications were made to the prior year’s amounts to conform to the 2026 presentation.

Note 2 -Revenue and Accounts Receivable

Concentrations

The following table summarizes net revenue from each of the Company’s customers, who individually represent at least 10% of total revenue.

The following table summarizes accounts receivable concentrations for each of the Company’s customers, who individually represent at least 10% of gross total accounts receivable.

For DefenCath, the Company currently has one FDA-approved source (contract manufacturing organization, or “CMO”) for each of its two key active pharmaceutical ingredients (“APIs”), taurolidine and heparin sodium, respectively. With regards to taurolidine, the Company has a drug master file (“DMF”) filed with the FDA. There is a master commercial supply agreement between a third-party manufacturer that has been in place since August 2018. With respect to heparin sodium API, the Company has identified an alternate third-party supplier and may qualify such supplier under the DefenCath NDA over the next twelve months.

The Company received FDA approval of DefenCath with finished dosage production from its European based CMO, Rovi Pharma Industrial Services. The Company believes this CMO has adequate capacity to produce the volumes needed to meet near-term projected demand for DefenCath. In addition, the Company also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling up production at the facility.

Each of the products in the Melinta Portfolio has one FDA-approved CMO, primarily in Europe or in the United States. The Company has ongoing technology transfers intended to reduce costs of goods sold as well as to onshore the manufacture of several of its products, which it expects to complete over the next two to three years.

Accounts Receivable and Sales Allowances

Allowances recorded for credit losses as of March 31, 2026 and December 31, 2025 were approximately $0.6 million withno write-offs or recoveries during the three months ended March 31, 2026.

Variable consideration associated with net product sales, or "Sales Allowances," totaled $189.0 million and $19.3 million for the three months ended March 31, 2026, and March 31, 2025, respectively. As of March 31, 2026 and December 31, 2025, total accrued reserves and allowances to accounts receivable on the balance sheet were $98.2 million and $132.4 million, respectively.

A roll forward of the significant categories of Sales Allowances and the related accrual balances on the Condensed Consolidated Balance Sheet for the three months ended March 31, 2026 is as follows:

During the quarter ended March 31, 2026, the Company recorded a change in estimate related to variable consideration for Medicaid rebates and product returns. During the three months ended March 31, 2026, the Company obtained new information regarding Medicaid utilization and updated its assumptions based on substantially completed historical claims data. Such estimates are subject to uncertainty due to the timing and completeness of claims processing. In addition, the Company updated its estimate of product returns as initial rate of return history for DefenCath recently became available, which was lower than previously estimated. For the quarter ended March 31, 2026, the resulting changes in accounting estimates positively impacted net sales by $9.0 million and positively impacted income from continuing operations and net income by $6.2 million, net of taxes, and increased basic and diluted earnings per share by $0.08 and $0.07 per share, respectively.

Note 3 -Income Per Common Share

The following table shows the computation of basic and diluted earnings per share for the three months ended March 31, 2026 and 2025:

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be antidilutive:

Note 4 -Financial Instruments

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and accounts receivable. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which often exceed federally insured limits.

The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows:

The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. In addition, the Company holds marketable equity securities in Talphera, Inc., (“Talphera”) a publicly traded biotechnology company, and has elected the fair value option for accounting for this investment. The related unrealized loss pertaining to Talphera is recorded in Other Expense. During the fourth quarter of 2025, the Company’s CEO was appointed to the Board of Directors of Talphera, and as such, Talphera is considered a related party for any subsequent transactions. The Company has no related party transactions with Talphera to date.

As of March 31, 2026 and December 31, 2025, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at March 31, 2026 and December 31, 2025.

Fair Value Measurements

The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of March 31, 2026 and December 31, 2025:

Note 5 -Inventories

Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods. Inventories consist of the following:

Note 6 -Acquisition of Melinta:

On August 29, 2025 (the “Closing Date”), the Company completed the acquisition of Melinta for total consideration of $453.7 million (net of cash acquired), including contingent consideration of $95.9 million to which the former Melinta equity holders are eligible to receive pursuant to the terms of the underlying agreements. The merger is accounted for using the acquisition method of accounting for business combinations under FASB Accounting Standard Codification Topic No. 805, Business Combinations (“ASC 805”), with CorMedix representing the accounting acquirer under this guidance. The estimates relating to the allocation of the purchase price are preliminary through the conclusion of the measurement period, which will be no longer than one year from the Closing Date.

The preliminary allocation of the purchase price to acquired assets and liabilities assumed based on their estimated fair values as of Closing Date resulted in goodwill of $30.0 million and intangible assets associated with marketed product values and in-process research and development, the fair value of which was $248.1 million, and $143.0 million, respectively. The in-process research and development relates to the future cash flows associated with the REZZAYO Second Indication if and when approved by the FDA, the fair value of which was determined using probability-weighted, discounted cash flows.

The contingent consideration is comprised of milestone and net sales-based payments. Upon the issuance of the FDA marketing approval of REZZAYO (or any product that contains the active ingredient rezafungin), for the prevention or prophylaxis of invasive fungal infections in adult patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent (the “REZZAYO Second Indication”) on or prior to June 30, 2029, the Company shall pay, in cash or common shares, par value $0.001 per share, of the Company at the Company’s election, to the former Melinta equity holders the following payments (the “REZZAYO Milestone”):

(i)if the FDA-approved labeling includes candida, $20 million;

(ii)if the FDA-approved labeling includes aspergillus, $2.5 million; and

(iii)if the FDA-approved labeling includes pneumocystis, $2.5 million.

Further, the Company is obligated to pay to the former Melinta equity holders tiered royalties on REZZAYO U.S. net sales and low-single-digit royalties on MINOCIN U.S. net sales (each the “REZZAYO Royalties” and “MINOCIN Royalties”).

The fair value of the contingent payments of $95.9 million included the REZZAYO Milestone and the REZZAYO and MINOCIN Royalties (together, the “Royalties”). The Company estimated the fair value of the REZZAYO Milestone by probability-weighting each outcome and discounting the estimated payment back to the Closing Date. Key assumptions used in the valuation included probability of milestone achievement, the estimated timing of approval, an estimated weighted-average cost of capital, and the estimated timing of the REZZAYO Milestone payment occurring in 2027.

The Company estimated the fair value of the REZZAYO Royalties using a Monte Carlo simulation framework. Specifically, the Company simulated future net sales assuming a Geometric Brownian Motion framework, and these simulated metrics were used to determine the applicable percentage of REZZAYO Royalties. The fair value of the MINOCIN Royalties is linear with no thresholds, caps, tiers, or carry forwards, and was estimated using the Scenario-Based Method. For each method, the Royalties were calculated based on the contractual terms and then discounted from each payment date back to Closing Date. Key assumptions used in the valuation included projected net sales, the estimated duration of the related cash flows, and an estimated weighted-average cost of capital. Royalties payments are expected to occur until the expiration of patent or regulatory exclusivity in the late 2030s.

Fair value measurement of contingent consideration liability

Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded as Other income in the consolidated statements of operations on a quarterly basis. Changes in these estimates and assumptions could have a significant impact on the amounts recognized.

The following table summarizes the change in fair value, as determined by Level 3 inputs, for the contingent consideration liability using unobservable Level 3 inputs for the three months ended March 31, 2026:

During the three months ended March 31, 2026, a change in fair value of contingent consideration of approximately $4.2 million was recorded primarily due to a lower discount rate and accretion due to the passage of time as of March 31, 2026 compared to December 31, 2025. The following table summarizes key assumptions and inputs used in the fair value simulation as of the valuation dates:

The amount of revenue attributable to the Melinta business included in the unaudited condensed consolidated statements of operations for the three months ended March 31, 2026 is $29.9 million.

Unaudited Pro Forma Financial Information

The following unaudited pro forma financial information presents the combined results of operations of CorMedix and Melinta as if the merger occurred at the beginning of the year ended December 31, 2024. The unaudited pro forma financial information includes impact of certain adjustment related to changes from the purchase of TOPROL-XL product which was previously licensed to Melinta, amortization of intangibles, transaction related cost incurred, stock compensation expenses, interest expense on related borrowings, and related income tax effects. The unaudited pro forma financial information presented does not include any impact of transaction synergies. The unaudited pro forma financial information is presented for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place on the date indicated or of results that may occur in the future.

The unaudited pro forma financial information presented above includes the following adjustments:

Three Months Ended March 31, 2025:

•Elimination of $0.6 million of licensing fees and profit sharing costs associated with the TOPROL-XL brand

•Elimination of historical stock compensation expense of $0.1 million

•Inclusion of intangible asset amortization of $9.7 million

•Net impact of new convertible notes payable of $0.1 million

•$2.6 million tax benefit on proforma adjustments

Note 7 -Accrued Expenses and other current liabilities

Accrued expenses consist of the following:

Note 8 -Commitments and Contingencies:

Contingency Matters

In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.)

On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933.

On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded the original complaints in In re CorMedix Securities Litigation. On March 21, 2024, the Court denied Defendants’ motion to dismiss without prejudice and granted lead plaintiff leave to amend the complaint.

On April 22, 2024, the lead plaintiff filed a third amended consolidated complaint that superseded the second amended consolidated complaint. In the third amended complaint, the lead plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive. The third amended complaint names as defendants the Company and six (6) current and former officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a). In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier. The Company filed its motion to dismiss the third amended complaint on June 6, 2024. The motion to dismiss was fully briefed on August 21, 2024.

On August 19, 2025, the Court issued a revised opinion and order, denying the CorMedix Defendants’ motion to dismiss the third amended complaint. Since then, the case has proceeded to discovery.

On August 26, 2025, the parties proposed a revised Pretrial Scheduling Order, which the Court so-ordered on August 27, 2025.

The parties participated in a mediation before Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025, which did not result in a settlement.

On December 1, 2025, in response to, among other things, the death of an Officer Defendant, lead plaintiff filed an Unopposed Motion for Leave to Amend the complaint, which the Court granted on December 17, 2025. The CorMedix Defendants filed their answer to the Fourth Amended Consolidated Class Action Complaint on January 2, 2026.

On March 19, 2026, Plaintiffs filed a Notice of Motion and Motion Requesting International Judicial Assistance to the Appropriate Authority of the Ministry of Justice of Spain to obtain evidence under the Hague Convention of March 18, 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters from third parties Laboratorios Farmacéuticos ROVI, S.A. (“ROVI”) and Barragan BioConsulting, SL. The Court will decide the motion on the papers.

On April 30, 2026, the parties submitted a Joint Status Report updating the Court on the status of discovery and requesting an extension on the discovery deadlines set forth in the Scheduling Order entered on August 27, 2025. On May 4, 2026, the Court entered the Scheduling Order as proposed. As such, the Scheduling Order provides for the (i) completion of fact discovery by September 25, 2026; (ii) completion of affirmative expert reports by November 11, 2026; (iii) completion of responsive expert reports by January 15, 2027; and (iv) completion of expert depositions by March 29, 2027. The Court has set the next Status Conference for July 8, 2026.

In re CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.)

On or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty, abuse of control, and waste of corporate assets against the individual defendants, and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit was pending.

On or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al., Case No. 2:23-cv-00150-JXN-CLW. The complaint names as defendants Paulo F. Costa, Janet D. Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch, Robert Cook,

Matthew David, Phoebe Mounts, and John L. Armstrong, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty and unjust enrichment against the individual defendants.

On or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al., Case No. 2:23-cv-00406-ES-ESK. The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty.

On or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation, C.A. No. 2:21-cv-18493-JXN-LDW. The provisions of the Order to Stay that was previously entered in the Voter litigation on January 21, 2022 applied to the consolidated derivative action.

On August 19, 2025, the Court issued a revised opinion and order denying the CorMedix Defendants’ motion to dismiss the third amended complaint in the securities litigation. On November 10, 2025, the derivative plaintiffs filed a verified consolidated shareholder derivative complaint (the “Consolidated Complaint”), which alleges that during the relevant period (October 16, 2019 – August 8, 2022), the Individual Defendants, made or caused to be made materially false and misleading statements regarding CorMedix’s business and operations, specifically relating to purported manufacturing deficiencies during the Relevant Period that the Individual Defendants knew or should have known would impact the FDA approval of the developmental drug “DefenCath” prior to its ultimate approval by the FDA.

The Consolidated Complaint asserts claims for breach of fiduciary duty and unjust enrichment. On this basis, the Consolidated Complaint seeks unspecified damages and corporate governance reforms.

On November 18, 2025, the parties participated in a mediation before Michelle Yoshida, Esq. of Phillips ADR. On December 20, 2025, the parties signed a binding settlement term sheet. On January 19, 2026, the parties executed a binding stipulation of settlement, which, if approved, would resolve the case.

The plaintiffs in a new and separate action––the Jhoe action (discussed below)––filed a motion to intervene and stay this case on December 18, 2025. On January 6, 2026, the plaintiffs filed their opposition to the motion to intervene and stay. The Jhoe plaintiff filed his reply on January 13, 2026.

On January 19, 2026, the plaintiffs filed their Unopposed Motion for Preliminary Approval of Settlement (“Preliminary Approval Motion”). Following an exchange of letters, on February 3, 2026, the Jhoe plaintiff filed a purported opposition to the Preliminary Approval Motion raising, among other things, various objections to the proposed settlement. On February 10, 2026, the plaintiffs filed their reply in further support of preliminary approval of the proposed settlement, in which Defendants joined and advanced additional arguments in favor of preliminary approval.

On March 20, 2026, the Court denied the Motion to Intervene and Stay the Derivative Action. The Preliminary Approval Motion remains pending and will be decided on the papers.

Raval v. Baluch, Case No. UNN-L-003721-25 (N.J. Super Ct. Law Div.)

On or about September 26, 2025, a purported shareholder, derivatively and on behalf of CorMedix, filed a shareholder derivative complaint in the Law Division of the Union County Superior Court of New Jersey, in a case entitled, Raval v. Baluch, et al., Case No. UNN-L-003721-25 (N.J. Super Ct. Law Div.) (the “State Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along with CorMedix as Nominal Defendant. The complaint alleges breaches of fiduciary duty, waste of corporate assets, and abuse of control against the defendants and contains similar allegations to the previously-filed consolidated derivative complaint pending in federal court. The Raval complaint seeks unspecified money damages, governance reforms, and costs and expenses. On October 22, 2025, the parties filed a proposed Stipulation and Consent Order, which the Court entered on the same day. The Stipulation and Consent Order provided that Plaintiff would have until December 4, 2025 to file an amended complaint or designate the complaint as operative. On December 4, 2025, Plaintiff filed a notice with the Court designating its September 26, 2025 complaint as the operative complaint.

The parties attended a mediation before Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025. On December 20, 2025, the parties signed a binding settlement term sheet. On January 5, 2026, the parties filed a Stipulation and Consent Order Staying Action staying the case pending approval of the settlement in the federal derivative action, which the court entered on the same day. On January 19, 2026, the parties signed a stipulation of settlement. This action will be dismissed in the event that the proposed settlement is approved by the court in the federal derivative action.

Jhoe v. Todisco, et al., C.A. No. 2025-1367-PAF (Del. Ch.)

On November 24, 2025, an action was initiated under seal by Robert Jhoe, a purported shareholder of the Company, asserting claims derivatively and on behalf of CorMedix. A public version of the complaint was filed on December 1, 2025. The complaint names as defendants Khoso Baluch, Janet D. Dillione, Alan W. Dunton, Robert Cook, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco, along with the Company as Nominal Defendant.

The complaint asserts claims for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, and waste. Mr. Jhoe made a books-and-records demand on CorMedix pursuant to Section 220 of the Delaware General Corporation Law prior to initiating this action, and the complaint purports to quote and cite board-level materials in support of Mr. Jhoe’s claims. It seeks unspecified damages and costs along with certain governance reforms.

On December 29, 2025, the defendants moved to stay or dismiss this action, pending approval of the settlement in the federal derivative action. On January 15, 2026, the parties filed a Stipulation and Proposed Order Governing the Briefing Schedule for the Motion to Dismiss or Stay, which the court so-ordered the following day. Per the Stipulation, Defendants filed their Opening Brief on February 16, 2026. Further, Plaintiff’s Opposition Brief was due on March 18, 2026 and Defendants’ Reply was due on April 2, 2026.

On February 27, 2026, the parties filed a stipulation and proposed order to stay the case––including the Motion to Dismiss or Stay––pending decisions by the court in the New Jersey derivative case on two motions: (i) Mr. Jhoe’s Motion to Intervene and (ii) the plaintiffs’ Motion for Preliminary Approval of Settlement, which Mr. Jhoe opposes. The stipulation, which the court so-ordered on March 2, 2026, further provides that following the New Jersey court’s decisions on these motions, the parties in the Jhoe case will confer regarding appropriate next steps and update the court accordingly.

Melinta Legal Proceedings

Melinta markets MINOCIN, which is indicated for the treatment of certain bacterial infections. Melinta holds Orange Book listed patents for MINOCIN, including two formulation patents (patents 11,944,634 and 12,161,656) issued in 2024.

In 2020, Nexus Pharmaceuticals (“Nexus”) filed an Abbreviated New Drug Application (“ANDA”) with Paragraph IV (“PIV”) certification against the only Orange Book listed patents at the time, specifically patents ‘802 and ‘105 (“MINOCIN Treatment Patents”), on the alleged basis that the MINOCIN Treatment Patents were invalid and, in the alternative, that its ANDA did not infringe.

Melinta filed suit against Nexus in the US District Court for the Northern District of Illinois (the “Court”), asserting that the MINOCIN Treatment Patents were valid and accordingly, Nexus’s ANDA for its generic version of MINOCIN infringed these patents. In November 2024, the Court found that the MINOCIN Treatment Patents are valid and enforceable and issued a permanent injunction against the Nexus ANDA as part of that decision. Nexus subsequently filed an appeal with the U.S. Court of Appeals for the Federal Circuit. The appeal is ongoing.

Additionally, in February 2025, Melinta received a PIV certification for all four Orange Book listed patents from Gland Pharma (“Gland”) on the alleged basis that the patents were invalid, and in the alternative that its ANDA did not infringe these patents. Melinta filed a suit against Gland in the same Court in April 2025. The case is ongoing.

Commitments

Melinta is party to several license agreements, under which it will be required to make payments based on the achievement of agreed-upon milestones or circumstances. As of March 31, 2026, Melinta was not obligated to make any of the future payments discussed below.

Wakunaga Pharmaceutical Co., Ltd. ("Wakunaga") In May 2006, Wakunaga and Melinta executed a license agreement under which Melinta acquired rights to certain patents, patent applications, and other intellectual property related to BAXDELA. Melinta is obligated to pay royalties to Wakunaga on sales of BAXDELA. Under the license, Melinta has the right to grant sublicenses, although Wakunaga is entitled to a substantial portion of non-royalty income received from a sublicense of the Wakunaga technology. Wakunaga has certain termination rights, should Melinta fail to perform its obligations under the agreement, Melinta becomes subject to bankruptcy or similar events, or Melinta’s business is transferred or sold and the successor requires Melinta to terminate a substantial part of its development activities under the agreement. Melinta has the right to terminate the license for cause upon six months’ written notice to Wakunaga. Unless earlier terminated, the license agreement will continue in effect on a country-by-country and product-by-product basis until Melinta is no longer required to pay any royalties, which is the later of the date the manufacture, use or sale of a licensed product in a country is no longer covered by a valid patent claim, or a specified number of years following the first commercial sale in such country.

CyDex Pharmaceuticals, Inc. In November 2010, Melinta entered into a license and supply agreement with CyDex Pharmaceuticals, Inc. (now a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated, both hereafter referred to as Ligand) under which Melinta obtained an exclusive right, under certain patents and patent applications, to use Ligand’s beta sulfobutyl cyclodextrin, Captisol, in the development and commercialization of a BAXDELA product. In addition, under the terms of the license agreement, Melinta obtained a nonexclusive license to Ligand’s Captisol data package. Melinta is obligated to pay royalties to them based on its sales of BAXDELA. Melinta is obligated to certain diligence requirements and has the right to grant sublicenses to third parties. The license agreement provides for future payments to Ligand upon the achievement of a future commercial milestone, and obligations to make percentage royalty payments in the single digits based on net sales, if any, of the licensed product. Additionally, Melinta has agreed to purchase its requirements of Captisol from Ligand for use in a BAXDELA product, with pricing established pursuant to a tiered pricing schedule. Ligand has certain rights to terminate the agreement following a cure period, should Melinta fail to perform its obligations under the agreement. In addition, Ligand may terminate the agreement immediately if Melinta fails to pay milestones or royalties due under the agreement or if Melinta becomes subject to bankruptcy or similar events. Melinta has the right to terminate the license upon 90 days’ written notice to Ligand. Unless earlier terminated, the agreement will continue in effect until the expiration of our obligation to pay royalties. Such obligation expires, on a country-by-country basis, over a specified number of years following the expiration date of the last valid claim of a licensed product in the country of sale; if there has never been a valid claim of a licensed product in the country of sale, then such number of years after the first sale of the licensed product in such country.

AstraZeneca AB (“AZ”). In connection with the acquisition of TOPROL-XL, the seller assigned its rights, title, interests and obligations for the TOPROL-XL product in the U.S. under the supply and license agreements with AZ to Melinta, as a wholly-owned subsidiary of the Company. AZ is obligated to supply the TOPROL-XL product to Melinta in accordance with the supply agreement, and Melinta is obligated to pay royalties based on net sales of the TOPROL-XL product.

Mundipharma. In July 2022, Melinta entered into a license agreement with Cidara Therapeutics (“REZZAYO License Agreement”) (who in April 2024 sold all of its rights in REZZAYO to Napp Pharmaceutical Group Limited (“Napp”), a member of Mundipharma independent associated companies) to acquire an exclusive license to develop and sell REZZAYO in the U.S. Napp acquired all assets and rights related to rezafungin globally, including ongoing development and distribution, while commercialization rights to rezafungin in the United States remain licensed to Melinta.

As of the March 31, 2026, the commitments under the REZZAYO License Agreement include a regulatory milestone of between $30 million and $40 million upon receipt of the marketing approval for the prophylaxis indication, a number of commercial milestones upon exceeding certain net sales targets, and net sales-based royalties. The agreement additionally stipulates that upon the earlier of thirty-days following the receipt of the marketing approval for the prophylaxis indication or on June 30, 2028, Napp shall assign and transfer to Melinta all rights, title and interest in and to all product filings for the current product in the U.S. Following the first anniversary of the contract effective date, Melinta may terminate this agreement, in its sole discretion, upon 90 days prior written notice; otherwise, this agreement shall expire on the expiration of Melinta’s obligation to pay royalties to Napp when there is no valid claim of the licensed patent rights in the United States.

In connection with the purchase of the active pharmaceutical ingredient (API) for VABOMERE, Melinta has committed to API deliveries from the CMO in 2026 with a total cost of €5.9 million, subject to inflation adjustments.

Note 9 - Stockholders’ Equity

Common Stock

On February 2, 2026, the Company announced that the Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company's outstanding common stock. The repurchase program is authorized through December 31, 2027. Repurchases may be made at management’s discretion from time to time in privately negotiated transactions, through block trades, pursuant to open market purchases or pursuant to trading plans as permitted under applicable securities laws. In addition, any repurchases under the authorization will be subject to prevailing market conditions, liquidity and cash flow considerations, applicable securities laws and regulations, and other factors. The share repurchase program does not require the Company to acquire any amount of shares, and may be suspended or discontinued at any time. During the three months ended, March 31, 2026, the Company repurchased and retired 1.6 million shares of common stock for a total price of $11.1 million.

Preferred Stock

The Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following:

Restricted and Performance Stock Units

The Company has granted restricted stock units (“RSUs”) to certain employees and non-employee directors and performance stock units (“PSUs”) to certain executive employees as compensation for services. The grant date fair value of the RSUs is based upon the fair value of the Company’s common stock on the date of the grant for RSUs that vest upon service or performance conditions. For RSUs that vest upon market conditions, the grant date fair value of RSUs is based upon a Monte-Carlo simulation model.

During the three months ended March 31, 2026 and 2025, the Company granted 2,622,062 and 1,274,750 RSUs, to its employees and non-employee directors with service based vesting conditions and a weighted average grant date fair value of $7.26 and $10.21 per share, respectively.

In addition to the RSUs noted above, during the three months ended March 31, 2026 and 2025, the Company issued 464,554 and 487,500 PSUs to its executive officers with market performance and service based vesting conditions and, as such, the grant date fair value of $10.38 and $11.79 was calculated using a Monte-Carlo simulation model, respectively.

The following key assumptions were used to determine the fair value of the PSUs granted during the period:

As of March 31, 2026, the Company had 4,408,928 outstanding RSUs and PSUs. As of March 31, 2026, unrecognized compensation expense related to unvested RSUs and PSUs was $33.7 million, which will be recognized over a weighted average remaining period of 1.9 years as of March 31, 2026.

Stock Options

During the three months ended March 31, 2026 and 2025, no stock options were issued. As of March 31, 2026, there was approximately $1.7 million in total unrecognized compensation expense related to stock options granted, which will be recognized over an expected remaining weighted average period of 0.9 years.

Stock-Based Compensation

Total stock-based compensation expense recognized in the condensed consolidated statements of operations is as follows:

Note 10 -BARDA Agreement

In July 2023, Melinta entered into a partnership with BARDA to advance BAXDELA and VABOMERE for use in pediatrics and to partner on the development of BAXDELA against certain biothreat pathogens (BARDA-Supported Studies). Under this contract, BARDA reimburses Melinta certain percentages of costs incurred, as defined in the agreement, in connection with the BARDA-Supported Studies. BARDA has awarded a total of $47.5 million of funding with the potential of additional funding of $97.1 million, amounting to total funding up to $144.6 million, if all options are exercised. If all contract options are exercised, the contract is expected to continue through 2034. Through March 2026, Melinta has recognized BARDA reimbursement totaling $21.8 million.

There are two performance obligations under the BARDA contract, which are research and development services performed for (a) BAXDELA and VABOMERE pediatric studies and (b) BAXDELA biodefense studies. These research and development services were performance obligations because they are distinct within the context of the contract; that is, the services are separately identifiable from other obligations within the arrangement. In addition, the transaction prices included within the BARDA contract were equivalent to the standalone selling price of the research and development services and would be allocated. Therefore, research and development services are recognized as contract revenue over time, as the performance obligation is satisfied, in accordance with the BARDA agreement. The Company recognized $2.4 million of contract revenue under the BARDA agreement for the three-months ended March 31, 2026.

Note 11 - Segment Reporting

The Company has determined that it hastwo operating segments which are aggregated into a single reportable segment- Drug Product, located in a single geographic location – the United States.

The Company’s Chief Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM manages the Company’s business activities as a single reportable segment. The CODM uses consolidated profit and loss to evaluate and measure performance against progress in its commercialization efforts and clinical trials. The following table sets forth significant segment expenses.

The CODM also reviews DefenCath sales separately from sales from the Melinta Portfolio; the following table sets forth the breakdown of sales:

Note 12 - Income Taxes:

The following table summarizes the Company's effective tax rate for the periods indicated:

The effective income tax rates for the three months ended March 31, 2026 was 30.6% compared to 0% for the three months ended March 31, 2025. The tax expense for the current period reflects estimated federal and state income taxes. In contrast, no income tax expense was recorded for the three months ended March 31, 2025, as the Company maintained a full valuation allowance against its deferred tax assets during that period.

The effective tax differed from the U.S. Federal statutory rate of 21% principally due to the expected state tax profile for the period and certain discrete items.

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. During the three months ended March 31, 2026, management re-evaluated the realizability of its deferred tax assets and concluded that no release on the valuation allowance is needed.