季報
季度報告
10-Q
2026-08-10
Tonix製藥第二季產品收入增6倍 淨虧損擴大至4055萬美元
AI 繁中摘要
Tonix Pharmaceuticals Holding Corp.(納斯達克代號:TNXP)公佈截至2026年6月30日止第二季度(2026財年第二季)業績。作為一家綜合性生物製藥公司,Tonix專注中樞神經系統疾病、傳染病、免疫學及罕見病領域,目前擁有已上市產品及多元化研發管線。
📊 第二季度業績重點:
- 產品淨收入錄得1,354萬美元,較去年同期的200萬美元大幅增長約6倍,主要受惠於旗下纖維肌痛症藥物TONMYA®自2025年11月商業上市以來的銷售貢獻。
- 上半年產品淨收入為2,042萬美元,去年同期為443萬美元。
- 第二季度淨虧損為4,055萬美元(每股虧損2.44美元),去年同期淨虧損為2,827萬美元(每股虧損3.86美元)。上半年淨虧損為8,075萬美元(每股虧損5.32美元),去年同期為4,510萬美元(每股虧損6.80美元)。
- 研發開支第二季度為1,942萬美元,去年同期為1,082萬美元;銷售、一般及行政開支為3,596萬美元,去年同期為1,620萬美元,主要與TONMYA商業化推廣及新產品上市準備有關。
💰 財務狀況:
截至2026年6月30日,公司持有現金及現金等價物約1
展開英文正文
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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: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26-1434750 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 200 Connell Drive, Suite 3100 Berkeley Heights, New Jersey 07922 (Address of Principal Executive Offices) (Zip Code) (862) 799-8599 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock TNXP The NASDAQ Global Select Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ As of August 7, 2026, there were 17,151,024 shares of registrant’s common stock outstanding. TONIX PHARMACEUTICALS HOLDING CORP. INDEX PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements Condensed consolidated balance sheets as of June 30, 2026 (unaudited) and December 31, 2025 1 Condensed consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 (unaudited) 2 Condensed consolidated statements of comprehensive loss for the three and six months ended June 30, 2026 and 2025 (unaudited) 3 Condensed consolidated statements of stockholders’ equity for three and the six months ended June 30, 2026 and 2025 (unaudited) 4-5 Condensed consolidated statements of cash flows for the six months ended June 30, 2026 and 2025 (unaudited) 6 Notes to condensed consolidated financial statements (unaudited) 7-26 ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 27 ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 39 ITEM 4. Controls and Procedures 39 PART II. OTHER INFORMATION ITEM 1. Legal Proceedings 39 ITEM 1A. Risk Factors 39 ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 40 ITEM 3. Defaults Upon Senior Securities 40 ITEM 4. Mine Safety Disclosures 40 ITEM 5. Other Information 40 ITEM 6. Exhibits 40 SIGNATURES 43 PART I – FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED BALANCE SHEETS (In Thousands, Except Par Value and Share Amounts) (unaudited) June 30, December 31, 2026 2025 ASSETS Current assets: Cash and cash equivalents $176,232 $207,637 Accounts receivable, net 11,805 6,271 Inventory 4,678 6,013 Prepaid expenses and other current assets 10,717 8,955 Total current assets 203,432 228,876 Property and equipment, net 44,760 44,456 Operating lease right-of-use assets 1,346 1,544 Other non-current assets 4,550 2,295 Total assets $254,088 $277,171 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $9,051 $8,114 Accrued expenses and other current liabilities 21,484 22,598 Lease liability, short term 250 125 Total current liabilities 30,785 30,837 Lease liability, long term 1,022 1,184 Total liabilities 31,807 32,021 Commitments and contingencies (See Note 16) Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares issued and outstanding - as of both June 30, 2026 and December 31, 2025 — — Common stock, $0.001 par value; 1,000,000,000 shares authorized; 16,792,317 and 12,788,069 shares issued and outstanding as of June 30, 2026, and December 31, 2025, respectively and 5,883 shares to be issued as of December 31, 2025 17 13 Additional paid in capital 1,158,073 1,100,141 Accumulated deficit (935,461) (854,715) Accumulated other comprehensive loss (348) (289) Total stockholders’ equity 222,281 245,150 Total liabilities and stockholders’ equity $254,088 $277,171 See the accompanying notes to the condensed consolidated financial statements 1 TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Share and Per Share Amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 REVENUE: Product revenue, net $ 13,544 $ 1,998 $ 20,422 $ 4,427 COSTS AND EXPENSES: Cost of sales 703 3,272 2,281 4,215 Research and development 19,417 10,820 37,630 18,256 Selling, general and administrative 35,959 16,202 64,583 26,306 Total operating expenses 56,079 30,294 104,494 48,777 Operating loss (42,535 ) (28,296 ) (84,072 ) (44,350 ) Grant income 600 1,036 600 1,959 Loss on extinguishment of debt — — — (2,092) Interest income, net 1,432 943 2,778 1,571 Other expense, net (49) (1,955) (52) (2,189) Net loss available to common stockholders $ (40,552 ) $ (28,272 ) $ (80,746 ) $ (45,101 ) Net loss per common share, basic and diluted $ (2.44 ) $ (3.86 ) $ (5.32 ) $ (6.80 ) Weighted average common shares outstanding, basic and diluted 16,635,254 7,327,257 15,179,268 6,631,111 See the accompanying notes to the condensed consolidated financial statements 2 TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In Thousands) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net loss $(40,552) $(28,272) $(80,746) $(45,101) Other comprehensive loss: Foreign currency translation gain (loss) (65) (4) (59) (15) Comprehensive loss $(40,617) $(28,276) $(80,805) $(45,116) See the accompanying notes to the condensed consolidated financial statements 3 TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (In Thousands, Except Share and Per Share Amounts) (unaudited) Accumulated Additional Other Common stock Paid in Comprehensive Accumulated Shares Amount Capital Gain (loss) Deficit Total Balance, December 31, 2025 12,788,069 $13 $1,100,141 $(289) $(854,715) $245,150 Issuance of common stock under ATM program, net of transactional expenses of $676 1,411,449 1 20,125 — — 20,126 Employee stock purchase plan (ESPP) 5,883 — 79 — — 79 Stock-based compensation — — 1,970 — — 1,970 Foreign currency translation gain (loss) — — — 6 — 6 Net loss — — — — (40,194) (40,194) Balance, March 31, 2026 14,205,401 14 1,122,315 (283) (894,909) 227,137 Issuance of common stock under ATM program, net of transactional expenses of $1,049 2,585,400 3 33,486 — — 33,489 Issuance of common stock upon exercise of stock option 1,516 — 16 — — 16 Stock-based compensation — — 2,256 — — 2,256 Foreign currency translation gain (loss) — — — (65) — (65) Net loss — — — — (40,552) (40,552) Balance, June 30, 2026 16,792,317 $17 $1,158,073 $(348) $(935,461) $222,281 See the accompanying notes to the condensed consolidated financial statements 4 TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (In Thousands, Except Share and Per Share Amounts) (unaudited) Accumulated Additional Other Common stock Paid in Comprehensive Accumulated Shares Amount Capital Gain (loss) Deficit Total Balance, December 31, 2024 4,385,929 $4 $870,503 $(255) $(730,694) $139,558 Repurchase of common stock under share repurchase program (including transactional expenses of $8) (250,000) — (3,047) — — (3,047) Issuance of common stock under ATM program, net of transactional expenses of $2,182 2,741,887 3 59,840 — — 59,843 Stock-based compensation — — 882 — — 882 Foreign currency translation gain (loss) — — — (11) — (11) Net loss — — — — (16,829) (16,829) Balance, March 31, 2025 6,877,816 7 928,178 (266) (747,523) 180,396 Repurchase of common stock under share repurchase program (including transactional expenses of $5) (150,000) — (2,902) — — (2,902) Issuance of common stock under ATM program, net of transactional expenses of $487 769,752 1 15,522 — — 15,523 Issuance of common stock for 2025 Lincoln Park Transaction commitment shares 48,708 — 1,837 — — 1,837 Stock-based compensation — — 1,423 — — 1,423 Foreign currency translation gain (loss) — — — (4) — (4) Net loss — — — — (28,272) (28,272) Balance, June 30, 2025 7,546,276 $8 $944,058 $(270) $(775,795) $168,001 See the accompanying notes to the condensed consolidated financial statements 5 TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) (unaudited) Six Months Ended June 30, 2026 2025 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(80,746) $(45,101) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,174 976 Inventory write-off — 2,280 Amortization of debt discount — 65 Loss on extinguishment of debt — 2,092 Stock-based compensation 4,226 2,305 Issuance costs from derivative instruments — 1,837 Changes in operating assets and liabilities: Accounts receivable (5,534) 1,363 Inventory, current and non-current (534) 142 Prepaid expenses and other current assets (1,763) (483) Other non-current assets (2,169) — Accounts payable 937 2,711 Lease liabilities and right-of-use (ROU) asset, net 160 (12) Accrued expenses and other current liabilities (312) 413 Net cash used in operating activities (84,561) (31,412) CASH FLOWS FROM INVESTING ACTIVITIES: Issuance of note — (2,012) Purchase of property and equipment (2,279) (533) Net cash used in investing activities (2,279) (2,545) CASH FLOWS FROM FINANCING ACTIVITIES: Repurchase of common stock — (5,949) Proceeds from ESPP 79 — Proceeds from the exercise of options 16 — Payment of term loan — (9,650) Proceeds, net of $1,725 and $2,757 expenses, from sale of common stock 53,615 76,125 Net cash provided by financing activities 53,710 60,526 Effect of currency rate change on cash (58) (13) Net (decrease) increase in cash, cash equivalents and restricted cash (33,188) 26,556 Cash, cash equivalents and restricted cash beginning of the period 209,807 99,680 Cash, cash equivalents and restricted cash end of period $176,619 $126,236 Supplemental disclosures of cash flow information: Interest paid $— $117 Non-cash financing and investing activities: Issuance costs from derivative instruments $— 1,837 Net ATM proceeds received after quarter-end $— $1,629 Purchases of property and equipment included in accounts payable and accrued liabilities $63 $526 See the accompanying notes to the condensed consolidated financial statements 6 TONIX PHARMACEUTICALS HOLDING CORP. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) NOTE 1 – BUSINESS Tonix Pharmaceuticals (“Tonix” or the “Company”) is a fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system (“CNS”) disorders, infectious diseases, immunology, and rare diseases. Our portfolio consists of both commercial and development-stage programs. Tonix markets TONMYA® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults in the U.S., as well as Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for the treatment of acute migraine in adults in the U.S. Tonix received approval from the U.S. Food and Drug Administration (“FDA”) for TONMYA for the treatment of fibromyalgia in August 2025 and commercially launched TONMYA in November 2025. TONMYA is Tonix’s first internally developed product to become FDA approved and is the first new medicine for fibromyalgia in more than 15 years. TONMYA is a centrally acting, non-opioid analgesic designed for bedtime administration and long-term use, for which the Company holds worldwide commercialization rights. Tonix’s commercial platform includes sales, marketing, market access, distribution, and patient support capabilities. Tonix is advancing a diversified development pipeline generated through internal discovery, in-licensing, acquisitions, and collaborations with academic and non-profit institutions. The Company’s pipeline addresses conditions that span CNS, infectious disease, immunology, and rare disease, with multiple programs in clinical and preclinical development. TONMYA’s proprietary cyclobenzaprine HCl sublingual tablet formulation is referred to as “TNX-102 SL” outside of the fibromyalgia indication. Tonix is exploring the utility of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in Phase 2 clinical trials for major depressive disorder (MDD) and acute stress disorder (ASD)/acute stress reaction (ASR). A potentially pivotal Phase 2 study of TNX-102 SL as a first-line monotherapy in adults with MDD, the HORIZON study, commenced in June 2026. TNX-102 SL is being developed to treat ASD/ASR under an Investigator-Initiated investigational new drug application (“IND”) at the University of North Carolina in the ongoing OASIS study funded by a grant they received from the U.S. Department of Defense (“DoD”). Topline data from the OASIS study is expected to be reported mid-2027. Tonix’s clinical stage infectious disease portfolio includes monoclonal antibody TNX-4800 (anti Borrelia OspA human monoclonal antibody) for the prevention of Lyme disease in the U.S. which has no FDA-approved vaccines or prophylactics. The Company received positive, final minutes from the FDA following a Type C meeting in early third quarter of 2026. The minutes support the planned initiation of an adaptive Phase 2 field in the first quarter of 2027. TNX-4800 was licensed from UMass Chan Medical School. Tonix’s clinical-stage immunology development portfolio includes TNX-1500, which is a Phase 2 ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection, and for the treatment of autoimmune diseases. A Phase 2, open-label, investigator-initiated study in adult kidney transplant patients at Massachusetts General Hospital (MGH) is expected to initiate in the second half of 2026 pending FDA clearance of MGH’s IND application. Another CNS candidate in clinical development is TNX-1300 (double-mutant cocaine esterase), which is in Phase 2 for the treatment of cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation by the FDA and a Phase 2a study was completed. The Company intends to meet with the FDA in 2026 to help inform the clinical design of its next Phase 2 study. Finally, Tonix’s clinical-stage rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a Phase 2 study in the second half of 2027. Tonix’s pre-clinical, pre-IND infectious disease portfolio includes TNX-801 (horsepox, live virus vaccine), a potential vaccine for mpox and smallpox which is expected to enter a Phase 1 study in 2027 pending FDA clearance of an IND. Tonix owns a facility in Dartmouth, MA that was purpose-built to manufacture TNX-801 under Good Manufacturing Practices (GMP) to support clinical development and potential commercialization. The GMP suites were decommissioned in 2024 and may be reactivated the earlier of 2028 or in the case of a national or international emergency. Tonix’s pre-IND infectious disease portfolio also includes TNX-4200, which is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. The TNX-4200 program is supported by a $34 million contract over five years from the U.S. DoD’s Defense Threat Reduction Agency (DTRA). Tonix owns and operates a state-of-the art research facility in Frederick, Maryland that supports this research. Tonix’s pre-IND pre-clinical immunology portfolio includes TNX-1700, which is a fusion protein of TFF2 and albumin, is in preclinical development for the treatment of gastric and colorectal cancer in combination with PD-1 blockade in collaboration with Columbia University. Finally, Tonix’s pre-clinical, pre-IND CNS portfolio also includes TNX-4900, a highly selective small-molecule Sigma-1 receptor (“S1R”) antagonist for neuropathic pain licensed from Rutgers University. The condensed consolidated financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Pharmaceuticals, Inc., Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Jenner Institute LLC, Tonix R&D Center LLC and Tonix Pharma Limited (collectively, the “Company” or “Tonix”). All intercompany balances and transactions have been eliminated in consolidation. 7 TONIX PHARMACEUTICALS HOLDING CORP. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Going Concern The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from operations and negative cash flows from operating activities. At June 30, 2026, the Company had working capital of approximately $172.6 million. At June 30,