Transplantation is also believed to be a model for treating autoimmunity In the oral presentation titled, "Extended Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression", Sanatkar, A. et al., data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig hearts.1,2 Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital "We remain encourage ...

Presentation to highlight statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for the management of fibromyalgia New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation at the Annual European Congr ...

Tonix Pharmaceuticals Holding Corp. - 8-K Exhibit 99.01 Tonix Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024 TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD) Commercial planning continues for U.S. launch of Tonmy ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26- ...

Exhibit 99.01 Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights Positive results from confirmatory Phase 3 RESILIENT study reported in December 2023 position Tonmya™ for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning underway, including go-to-market, supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, n ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 26 Main Street, Suite 101 Chatham, New Jersey 07928 (Address of principal executive office) (Zip Code) FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

PART I. FINANCIAL INFORMATION This section presents unaudited financial statements, management's discussion, market risk, and controls, highlighting a $89.3 million net loss and going concern doubt [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) This item provides the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20consolidated%20balance%20sheets%20as%20of%20September%2030%2C%202023%20(unaudited)%20and%20December%2031%2C%202022) This section presents the company's financial position as of September 30, 2023, and December 31, 2022 **Balance Sheet Highlights (in thousands):** | Metric | Sep 30, 2023 | Dec 31, 2022 | Change | | :-------------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $6,914 | $120,229 | $(113,315) | | Total current assets | $31,337 | $130,777 | $(99,440) | | Total assets | $139,282 | $225,690 | $(86,408) | | Total liabilities | $18,449 | $18,508 | $(59) | | Total stockholders' equity | $120,833 | $207,182 | $(86,349) | - Inventory increased from $0 at December 31, 2022, to **$13,317 thousand** at September 30, 2023, due to the acquisition of Zembrace® SymTouch® and Tosymra® products[8](index=8&type=chunk)[46](index=46&type=chunk) - Intangible assets, net, increased significantly from $120 thousand to **$9,982 thousand**, and goodwill of **$965 thousand** was recognized, both primarily due to the USL Acquisition[8](index=8&type=chunk)[50](index=50&type=chunk)[87](index=87&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20consolidated%20statements%20of%20operations%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202023%20and%202022%20(unaudited)) This section details the company's financial performance for the three and nine months ended September 30, 2023, and 2022 **Product Revenue (in thousands):** | Period | 2023 | 2022 | | :-------------------- | :----- | :----- | | Three Months Ended Sep 30 | $3,989 | $0 | | Nine Months Ended Sep 30 | $3,989 | $0 | **Net Loss (in thousands):** | Period | 2023 | 2022 | Change (YoY) | | :-------------------- | :------- | :------- | :----------- | | Three Months Ended Sep 30 | $(27,975) | $(28,981) | $(1,006) | | Nine Months Ended Sep 30 | $(89,336) | $(78,538) | $(10,798) | **Net Loss Per Common Share (Basic and Diluted):** | Period | 2023 | 2022 | | :-------------------- | :----- | :----- | | Three Months Ended Sep 30 | $(1.83) | $(4.24) | | Nine Months Ended Sep 30 | $(7.40) | $(18.58) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20consolidated%20statements%20of%20comprehensive%20loss%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202023%20and%202022%20(unaudited)) This section presents the company's comprehensive loss for the three and nine months ended September 30, 2023, and 2022 **Comprehensive Loss (in thousands):** | Period | 2023 | 2022 | | :-------------------- | :------- | :------- | | Three Months Ended Sep 30 | $(27,983) | $(28,998) | | Nine Months Ended Sep 30 | $(89,389) | $(78,606) | - Foreign currency translation loss contributed a minor amount to comprehensive loss, with **$(53) thousand** for the nine months ended September 30, 2023, compared to $(68) thousand in 2022[12](index=12&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20consolidated%20statements%20of%20stockholders'%20equity%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202023%20and%202022%20(unaudited)) This section outlines changes in stockholders' equity for the three and nine months ended September 30, 2023, and 2022 **Total Stockholders' Equity (in thousands):** | Date | Amount | | :-------------------- | :------- | | December 31, 2022 | $207,182 | | September 30, 2023 | $120,833 | - The company repurchased **2,672,044 shares** of common stock for **$13,965 thousand** during the nine months ended September 30, 2023[14](index=14&type=chunk) - A **1-for-6.25 reverse stock split** was effective May 10, 2023, retrospectively adjusting all common stock and per share data[28](index=28&type=chunk)[29](index=29&type=chunk)[91](index=91&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20consolidated%20statements%20of%20cash%20flows%20for%20the%20nine%20months%20ended%20September%2030%2C%202023%20and%202022%20(unaudited)) This section summarizes the company's cash flows from operating, investing, and financing activities for the nine months ended September 30, 2023, and 2022 **Net Cash Used in Operating Activities (in thousands):** | Period | 2023 | 2022 | Change (YoY) | | :-------------------- | :------- | :------- | :----------- | | Nine Months Ended Sep 30 | $(79,663) | $(75,752) | $(3,911) | **Net Cash Used in Investing Activities (in thousands):** | Period | 2023 | 2022 | Change (YoY) | | :-------------------- | :------- | :------- | :----------- | | Nine Months Ended Sep 30 | $(28,639) | $(43,476) | $14,837 | **Net Cash (Used in) Provided by Financing Activities (in thousands):** | Period | 2023 | 2022 | Change (YoY) | | :-------------------- | :------- | :------- | :----------- | | Nine Months Ended Sep 30 | $(4,197) | $80,615 | $(84,812) | **Cash, Cash Equivalents and Restricted Cash (in thousands):** | Date | Amount | | :-------------------- | :------- | | Beginning of Period (Jan 1, 2023) | $120,470 | | End of Period (Sep 30, 2023) | $7,916 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20condensed%20consolidated%20financial%20statements%20(unaudited)) This section provides detailed notes to the unaudited condensed consolidated financial statements, offering further context and breakdowns - The company faces substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows, requiring additional funding[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - On June 30, 2023, the company acquired Zembrace® SymTouch® and Tosymra® products from Upsher-Smith Laboratories LLC for approximately **$26.5 million**, marking its entry into commercial product sales[20](index=20&type=chunk)[111](index=111&type=chunk)[203](index=203&type=chunk) [NOTE 1 – BUSINESS](index=11&type=section&id=NOTE%201%20%E2%80%93%20BUSINESS) This note describes Tonix Pharmaceuticals Holding Corp.'s business operations and going concern considerations - Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics[20](index=20&type=chunk) - Acquired Zembrace® SymTouch® and Tosymra® for acute migraine treatment as of June 30, 2023[20](index=20&type=chunk)[111](index=111&type=chunk) - Recurring losses, negative cash flows, and insufficient cash resources raise substantial doubt about the company's ability to continue as a going concern, necessitating additional funding[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, including balance sheets, operations, equity, and cash flows, with detailed notes on business and accounting policies [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheets show decreased cash, cash equivalents, and total assets from December 2022 to June 2023, driven by cash used in operations, investing, and a business acquisition | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $25,617 | $120,229 | | Inventory | $13,700 | — | | Total current assets | $51,329 | $130,777 | | Total assets | $159,736 | $225,690 | | Total current liabilities | $18,442 | $18,180 | | Total liabilities | $19,273 | $18,508 | | Total stockholders' equity | $140,463 | $207,182 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported increased net losses for both the three and six months ended June 30, 2023, compared to the same periods in 2022, driven by higher research and development expenses | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $21,976 | $16,579 | $48,487 | $35,001 | | General and administrative | $7,026 | $6,757 | $14,417 | $14,771 | | Operating loss | $(29,002) | $(23,336) | $(62,904) | $(49,772) | | Net loss | $(28,356) | $(23,140) | $(61,361) | $(49,557) | | Net loss per common share, basic and diluted | $(2.68) | $(7.64) | $(5.88) | $(17.28) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The comprehensive loss for both the three and six months ended June 30, 2023, increased compared to the prior year, primarily reflecting the higher net loss and minor foreign currency translation losses | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss | $(28,356) | $(23,140) | $(61,361) | $(49,557) | | Foreign currency translation loss | $(1) | $(25) | $(45) | $(51) | | Comprehensive loss | $(28,357) | $(23,165) | $(61,406) | $(49,608) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased significantly from December 31, 2022, to June 30, 2023, primarily due to net losses and common stock repurchases, partially offset by stock issuances and stock-based compensation | Metric (in thousands) | Balance, December 31, 2022 | Balance, June 30, 2023 | | :------------------------------ | :------------------------- | :--------------------- | | Common stock shares outstanding | 12,368,620 | 10,762,341 | | Common stock amount | $12 | $11 | | Additional paid in capital | $677,375 | $686,025 | | Accumulated deficit | $(470,038) | $(545,361) | | Total stockholders' equity | $207,182 | $140,463 | | Repurchase of common stock | — | $(13,965) |\ | Issuance of common stock | — | $3,465 |\ | Stock-based compensation | — | $5,158 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash, cash equivalents, and restricted cash decreased substantially for the six months ended June 30, 2023, driven by operating, investing, and financing activities, reversing prior year's financing inflow | Metric (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(56,278) | $(52,217) | | Net cash used in investing activities | $(27,818) | $(34,656) | | Net cash (used in)/ provided by financing activities | $(10,471) | $85,240 | | Net decrease in cash, cash equivalents and restricted cash | $(94,610) | $(1,682) | | Cash, cash equivalents and restricted cash end of period | $25,860 | $177,218 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's business, significant accounting policies, and specific financial statement items, including acquisitions, equity transactions, and commitments [NOTE 1 – BUSINESS](index=11&type=section&id=NOTE%201%20%E2%80%93%20BUSINESS) Tonix Pharmaceuticals, a biopharmaceutical company, recently acquired acute migraine treatments and faces substantial doubt about its going concern ability due to recurring losses and limited cash into Q4 2023 - Tonix Pharmaceuticals acquired Zembrace® SymTouch® and Tosymra® for acute migraine treatment as of June 30, 2023[20](index=20&type=chunk) - The company has suffered recurring losses from operations and negative cash flows, raising substantial doubt about its ability to continue as a going concern[22](index=22&type=chunk)[24](index=24&type=chunk) | Metric (in thousands) | June 30, 2023 | | :-------------------- | :------------ | | Working capital | $32,900 | | Accumulated deficit | $(545,400) | | Cash and cash equivalents | $25,600 | [NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=NOTE%202%20%E2%80%93%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines key accounting principles, including a reverse stock split, business combinations, cash management, and expensing R&D costs, noting no material impact from new accounting standards - On May 10, 2023, the company effected a **1-for-6.25 reverse stock split**, retrospectively adjusting all common stock and per share data[29](index=29&type=chunk) - The company accounts for business combinations using the acquisition method, allocating consideration to acquired net assets at fair value, with any excess recorded as goodwill[32](index=32&type=chunk) - Research and development costs, including acquired intellectual property without alternative future uses, are expensed as incurred[43](index=43&type=chunk) - The adoption of ASU 2020-06 (convertible instruments) and ASU 2016-13 (credit losses) on January 1, 2023, did not impact the company's financial position, results of operations, or cash flows[57](index=57&type=chunk)[58](index=58&type=chunk) [NOTE 3 – PROPERTY AND EQUIPMENT, NET](index=17&type=section&id=NOTE%203%20%E2%80%93%20PROPERTY%20AND%20EQUIPMENT%2C%20NET) Net property and equipment increased to **$95.7 million** by June 30, 2023, from **$93.8 million** at December 31, 2022, reflecting investments in R&D facilities, with **$1.8 million** depreciation expense | Metric (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------- | :------------ | :---------------- | | Total property and equipment, net | $95,717 | $93,814 | | Accumulated depreciation and amortization | $(3,467) | $(1,653) | - Depreciation and amortization expense for the six months ended June 30, 2023, was **$1.8 million**, significantly higher than **$165 thousand** in the prior year[37](index=37&type=chunk) - The company has acquired and developed facilities in Frederick, MD, Dartmouth, MA (for vaccine development), and Hamilton, MT (for vaccine manufacturing), with the Montana site not yet ready for intended use[60](index=60&type=chunk)[61](index=61&type=chunk)[62](index=62&type=chunk) [NOTE 4 – GOODWILL AND INTANGIBLE ASSETS](index=17&type=section&id=NOTE%204%20%E2%80%93%20GOODWILL%20AND%20INTANGIBLE%20ASSETS) Goodwill of **$965 thousand** and developed technology intangible assets of **$10.1 million** were recognized from the USL Acquisition, with no amortization recorded in the first six months of 2023 | Metric (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------- | :------------ | :---------------- | | Goodwill | $965 | $— | | Developed technology | $10,100 | $— | | Internet domain rights | $120 | $120 | | Total intangible assets, net | $10,220 | $120 | - Goodwill and developed technology assets were acquired in connection with the USL Acquisition on June 30, 2023[40](index=40&type=chunk)[38](index=38&type=chunk) Amortization Schedule for Developed Technology | Year Ending December 31, | Amortization (in thousands) | | :----------------------- | :-------------------------- | | Remainder of 2023 | $428 | | 2024 | $856 | | 2025 | $856 | | 2026 | $856 | | 2027 and beyond | $7,104 | | Total | $10,100 | [NOTE 5 – FAIR VALUE MEASUREMENTS](index=18&type=section&id=NOTE%205%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENTS) The company values cash equivalents using Level 1 quoted prices, totaling **$19.2 million** as of June 30, 2023, and **$116.3 million** as of December 31, 2022, with no Level 2 or 3 assets/liabilities | Metric (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------- | :------------ | :---------------- | | Cash equivalents (Level 1) | $19,200 | $116,300 | [NOTE 6 – STOCKHOLDERS' EQUITY](index=19&type=section&id=NOTE%206%20%E2%80%93%20STOCKHOLDERS%27%20EQUITY) A 1-for-6.25 reverse stock split on May 10, 2023, reduced outstanding common stock from **64.6 million** to **10.3 million** shares and authorized shares from **1 billion** to **160 million**, regaining NASDAQ compliance - A **1-for-6.25 reverse stock split** was effective May 10, 2023, reducing outstanding common stock from **64,627,246** to **10,340,506** shares[71](index=71&type=chunk) - The number of authorized common stock shares was reduced from **1,000,000,000** to **160,000,000**[71](index=71&type=chunk) - The reverse stock split enabled the company to regain compliance with NASDAQ's minimum bid price requirement[71](index=71&type=chunk) [NOTE 7 – TEMPORARY EQUITY](index=19&type=section&id=NOTE%207%20%E2%80%93%20TEMPORARY%20EQUITY) Series A and B Convertible Redeemable Preferred Stock, issued in October and June 2022, were classified as temporary equity and subsequently redeemed for cash in December and August 2022, respectively - In October 2022, the company issued **1.4 million** Series A and **100,000** Series B Preferred Stock for gross proceeds of **$14.3 million**, with a conversion price of **$6.25** per share[72](index=72&type=chunk) - All outstanding preferred stock from the October 2022 offering was redeemed in December 2022 at **105%** of the stated value, totaling **$15.8 million**[77](index=77&type=chunk) - In June 2022, the company issued **2.5 million** Series A and **500,000** Series B Preferred Stock for gross proceeds of **$28.5 million**, with a conversion price of **$25.00** per share[78](index=78&type=chunk) - All outstanding preferred stock from the June 2022 offering was redeemed in August 2022 at **105%** of the stated value, totaling **$31.5 million**[83](index=83&type=chunk) [NOTE 8 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH](index=21&type=section&id=NOTE%208%20%E2%80%93%20ASSET%20PURCHASE%20AGREEMENT%20WITH%20UPSHER-SMITH) On June 30, 2023, Tonix acquired Zembrace® SymTouch® and Tosymra® from Upsher-Smith for approximately **$26.5 million**, including inventory, intangibles, and goodwill, with pro forma net product sales of **$7.6 million** - On June 30, 2023, Tonix acquired Zembrace® SymTouch® and Tosymra® products from Upsher-Smith Laboratories for an aggregate purchase price of approximately **$26.5 million**[84](index=84&type=chunk)[86](index=86&type=chunk) Acquired Assets | Acquired Assets (in thousands) | Amount | | :----------------------------- | :----- | | Inventory | $13,700 | | Prepaid expenses and other | $1,757 | | Intangible assets, net | $10,100 | | Goodwill | $965 | | Fair value of assets acquired | $26,522 | - A Transition Services Agreement was entered into, with USL providing services for base fees of **$100 thousand-$150 thousand** per month plus additional service fees[85](index=85&type=chunk) Pro Forma Net Product Sales | Pro Forma Metric (in thousands) | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :------------------------------ | :------------------------------- | :----------------------------- | | Net Product Sales | $3,544 | $7,621 | [NOTE 9 – ASSET PURCHASE AGREEMENT WITH HEALION](index=24&type=section&id=NOTE%209%20%E2%80%93%20ASSET%20PURCHASE%20AGREEMENT%20WITH%20HEALION) In February 2023, Tonix acquired preclinical infectious disease assets from Healion Bio Inc. for **$1.2 million**, expensed as R&D costs due to their preclinical stage and lack of alternative future use - Acquired preclinical infectious disease assets, including next-generation antiviral technology, from Healion Bio Inc. for **$1.2 million** in February 2023[97](index=97&type=chunk) - The **$1.2 million** cash consideration was expensed as research and development costs due to the preclinical stage and lack of alternative future use[97](index=97&type=chunk) [NOTE 10 – ASSET PURCHASE AGREEMENT WITH KATANA](index=24&type=section&id=NOTE%2010%20%E2%80%93%20ASSET%20PURCHASE%20AGREEMENT%20WITH%20KATANA) In December 2020, Tonix acquired Katana assets for insulin resistance and obesity for **$0.7 million**, expensed as R&D, including an exclusive license from the University of Geneva with development obligations - Acquired Katana assets related to insulin resistance and obesity for **$0.7 million** in December 2020, expensed as R&D costs[98](index=98&type=chunk) - Assumed an exclusive license agreement with the University of Geneva, obligating Tonix to diligently develop and market products and pay annual maintenance fees[99](index=99&type=chunk) [NOTE 11 – ASSET PURCHASE AGREEMENT WITH TRIGEMINA](index=24&type=section&id=NOTE%2011%20%E2%80%93%20ASSET%20PURCHASE%20AGREEMENT%20WITH%20TRIGEMINA) In June 2020, Tonix acquired Trigemina assets for migraine and pain treatment for **$2.4 million** (cash and stock), expensed as R&D, including an exclusive license from Stanford University - Acquired Trigemina assets for migraine and pain treatment technologies in June 2020 for **$824,759** cash, **10,000** shares of common stock, and **$250,241** to Stanford, totaling **$2.4 million**[100](index=100&type=chunk) - The acquisition costs were expensed as research and development due to the preclinical stage and lack of alternative future use[100](index=100&type=chunk) - Assumed an exclusive license agreement with Stanford University, obligating Tonix to diligently develop and market products and pay annual maintenance fees[101](index=101&type=chunk)[103](index=103&type=chunk) [NOTE 12 – ASSET PURCHASE AGREEMENT WITH TRIMARAN](index=25&type=section&id=NOTE%2012%20%E2%80%93%20ASSET%20PURCHASE%20AGREEMENT%20WITH%20TRIMARAN) In August 2019, Tonix acquired TRImaran's pyran-based CNS assets for **$168,500**, expensed as R&D, with potential **$3.4 million** milestone payments and an exclusive license from Wayne State University - Acquired TRImaran's assets related to pyran-based compounds for CNS disorders in August 2019 for **$168,500**, expensed as R&D costs[104](index=104&type=chunk) - Agreed to pay TRImaran and Selling Shareholders up to **$3.4 million** in restricted stock or cash upon achievement of specified development, regulatory, and sales milestones[104](index=104&type=chunk) - Entered into an exclusive license agreement with Wayne State University (WSU) for the technology, including single-digit royalties on net sales and additional milestone payments totaling approximately **$3.4 million**[105](index=105&type=chunk)[106](index=106&type=chunk) [NOTE 13 – LICENSE AGREEMENT WITH CURIA](index=25&type=section&id=NOTE%2013%20%E2%80%93%20LICENSE%20AGREEMENT%20WITH%20CURIA) In December 2022, Tonix licensed three humanized murine mAbs for SARS-CoV-2 from Curia, with an upfront fee of approximately **$0.4 million**, single-digit royalties, and contingent milestone payments - Entered into an exclusive license agreement with Curia in December 2022 for three humanized murine mAbs for SARS-CoV-2 infection[107](index=107&type=chunk) - Paid an upfront license fee of approximately **$0.4 million**, with future single-digit royalties and contingent milestone payments[107](index=107&type=chunk) [NOTE 14 – LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA](index=25&type=section&id=NOTE%2014%20%E2%80%93%20LICENSE%20AGREEMENT%20WITH%20UNIVERSITY%20OF%20ALBERTA) In May 2022, Tonix licensed broad-spectrum antiviral drugs from the University of Alberta, involving a low-five digit fee, single-digit royalties, and contingent milestone payments - Entered into an exclusive license agreement with the University of Alberta in May 2022 for broad-spectrum antiviral drugs[108](index=108&type=chunk) - Paid a low-five digit license fee, with future single-digit royalties and contingent milestone payments[108](index=108&type=chunk)[109](index=109&type=chunk) [NOTE 15 – LICENSE AGREEMENT WITH INSERM](index=27&type=section&id=NOTE%2015%20%E2%80%93%20LICENSE%20AGREEMENT%20WITH%20INSERM) In February 2021, Tonix licensed oxytocin-based therapeutics for Prader-Willi syndrome from Inserm, with annual fees, **$0.4 million** sales milestone payments, and royalties on net sales - Licensed oxytocin-based therapeutics for Prader-Willi syndrome and non-organic failure to thrive disease from Inserm in February 2021[111](index=111&type=chunk) - The agreement provides for annual fees, milestone payments totaling approximately **$0.4 million** upon sales milestones, and royalties on net sales[111](index=111&type=chunk) [NOTE 16 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY](index=27&type=section&id=NOTE%2016%20%E2%80%93%20LICENSE%20AGREEMENTS%20WITH%20COLUMBIA%20UNIVERSITY) Tonix holds multiple exclusive licenses from Columbia University for TFF2 Technology and cocaine esterase, with upfront fees, royalties, and milestone payments totaling **$4.1 million** and **$3 million**, respectively, plus SARS-CoV-2 mAbs - Exclusive license for TFF2 Technology (recombinant Trefoil Family Factor 2) from Columbia University, involving a five-digit license fee, single-digit royalties, and contingent milestone payments totaling **$4.1 million**[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) - Exclusive license for double-mutant cocaine esterase from Columbia University, involving a six-digit license fee, single-digit royalties, and contingent milestone payments totaling **$3 million**[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk)[121](index=121&type=chunk) - Exercised an option in February 2023 for an exclusive license from Columbia for a portfolio of fully human and murine mAbs for SARS-CoV-2 infection[122](index=122&type=chunk) [NOTE 17 – SALE AND PURCHASE OF COMMON STOCK](index=29&type=section&id=NOTE%2017%20%E2%80%93%20SALE%20AND%20PURCHASE%20OF%20COMMON%20STOCK) Common stock sales via Lincoln Park generated **$0.4 million** net proceeds, while ATM offerings yielded **$3.0 million** net proceeds for the six months ended June 30, 2023, a significant decrease from **$51.5 million** in 2022 - Under the 2022 Purchase Agreement with Lincoln Park, the company sold **0.1 million** shares of common stock for net proceeds of approximately **$0.4 million** during the six months ended June 30, 2023[125](index=125&type=chunk) - Through At-the-Market (ATM) offerings, the company sold approximately **1.0 million** shares for net proceeds of **$3.0 million** during the six months ended June 30, 2023, a decrease from **$51.5 million** in the same period of 2022[131](index=131&type=chunk) [NOTE 18 – STOCK-BASED COMPENSATION](index=31&type=section&id=NOTE%2018%20%E2%80%93%20STOCK%20BASED%20COMPENSATION) The Amended and Restated 2020 Stock Incentive Plan has **1,057,051** options available. Stock-based compensation expense was **$5.2 million** for the six months ended June 30, 2023, with **$10.3 million** unrecognized cost - As of June 30, 2023, **1,057,051** options were available for future grants under the Amended and Restated 2020 Stock Incentive Plan[138](index=138&type=chunk) Stock-Based Compensation Expense | Metric | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Stock-based compensation expense (total) | $2.4 million | $5.2 million | | - General and Administration | $1.6 million | $3.6 million | | - Research and Development | $0.8 million | $1.6 million | - As of June 30, 2023, the company had approximately **$10.3 million** of total unrecognized compensation cost related to non-vested awards, expected to be recognized over a weighted average period of **1.87 years**[145](index=145&type=chunk) [NOTE 19 – STOCK WARRANTS](index=33&type=section&id=NOTE%2019%20%E2%80%93%20STOCK%20WARRANTS) As of June 30, 2023, **3,196** outstanding warrants existed, with exercise prices from **$100.00** to **$7,000.00** and expirations between December 2023 and February 2025; no warrants were exercised in 2023 or 2022 Outstanding Warrants | Exercise Price | Number Outstanding | Expiration Date | | :------------- | :----------------- | :-------------- | | $100.00 | 125 | November 2024 | | $114.00 | 618 | February 2025 | | $7,000.00 | 2,453 | December 2023 | | Total | 3,196 | | - No warrants were exercised during the six months ended June 30, 2023, or 2022[150](index=150&type=chunk) [NOTE 20 – LEASES](index=33&type=section&id=NOTE%2020%20%E2%80%93%20LEASES) Operating lease agreements for office space resulted in right-of-use assets and total lease liabilities of **$1.2 million** each. Future minimum lease payments total **$1.267 million**, with **$0.3 million** operating lease expense Lease Liabilities and Right-of-Use Assets | Metric (in thousands) | June 30, 2023 | | :-------------------- | :------------ | | Right-of-use assets | $1,200 | | Total lease liability | $1,200 | | Current lease liability | $400 | | Long-term lease liability | $800 | Future Minimum Lease Payments | Year Ending December 31, | Future Minimum Lease Payments (in thousands) | | :----------------------- | :------------------------------------------- | | 2023 | $237 | | 2024 | $460 | | 2025 | $299 | | 2026 | $142 | | 2027 and beyond | $246 | | Total | $1,267 | - Operating lease expense was **$0.3 million** for both the six months ended June 30, 2023, and 2022[156](index=156&type=chunk) [NOTE 21 – COMMITMENTS](index=34&type=section&id=NOTE%2021%20%E2%80%93%20COMMITMENTS) The company has outstanding commitments of approximately **$62.8 million** for future research and development work. Additionally, it contributed **$0.5 million** to its 401(k) plan for the six months ended June 30, 2023 - Outstanding commitments for future research and development work aggregated approximately **$62.8 million** at June 30, 2023[158](index=158&type=chunk) 401(k) Contributions | Metric (in thousands) | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :-------------------- | :------------------------------- | :----------------------------- | | 401(k) contributions | $200 | $500 | [NOTE 22 – SUBSEQUENT EVENTS](index=34&type=section&id=NOTE%2022%20%E2%80%93%20SUBSEQUENT%20EVENTS) Subsequent to the quarter end, on August 1, 2023, the company closed an equity offering, selling common stock and warrants, which generated approximately **$6.2 million** in net proceeds - On July 27, 2023, the company entered into a securities purchase agreement to sell **2,530,000** shares of common stock, pre-funded warrants for up to **4,470,000** shares, and common warrants for up to **7,000,000** shares[160](index=160&type=chunk) - The offering closed on August 1, 2023, generating approximately **$6.2 million** in net proceeds after deducting offering expenses[161](index=161&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, liquidity, and capital resources, highlighting the business overview, detailed analysis of operating results, recent license and asset purchase agreements, and critical accounting policies. It emphasizes the company's ongoing need for additional financing due to recurring losses and significant R&D investments [Business Overview](index=35&type=section&id=Business%20Overview) Tonix Pharmaceuticals is a biopharmaceutical company focused on commercializing and developing therapeutics across CNS, rare disease, immunology, and infectious disease, with recent acquisitions for acute migraine and a pipeline of investigational drugs - Tonix is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics[165](index=165&type=chunk) - The company recently acquired and markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment[165](index=165&type=chunk) - Key development candidates include TNX-102 SL for fibromyalgia (mid-Phase 3) and fibromyalgia-type Long COVID (Phase 2), TNX-601 ER for MDD (Phase 2), TNX-1900 for chronic migraine (Phase 2), TNX-1300 for cocaine intoxication (Breakthrough Therapy designation, Phase 2 expected), TNX-2900 for Prader-Willi syndrome (Orphan Drug designation), TNX-1500 for organ transplant rejection (Phase 1 expected), and TNX-801 vaccine for smallpox/mpox[165](index=165&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) The company's operating results are expected to fluctuate due to product sales and R&D efforts. Net loss increased for both the three and six months ended June 30, 2023, primarily driven by higher research and development expenses - Operating results are anticipated to fluctuate due to sales of Zembrace® and Tosymra®, R&D progress, and regulatory outcomes[167](index=167&type=chunk) | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $21,976 | $16,579 | $48,487 | $35,001 | | General and administrative | $7,026 | $6,757 | $14,417 | $14,771 | | Net loss | $(28,356) | $(23,140) | $(61,361) | $(49,557) | [Three Months Ended June 30, 2023 Compared to Three Months Ended June 30, 2022](index=37&type=section&id=Three%20Months%20Ended%20June%2030%2C%202023%20Compared%20to%20Three%20Months%20Ended%20June%2030%2C%202022) R&D expenses increased **33%** to **$22.0 million** due to higher clinical, employee, lab, and building costs. G&A expenses rose **3%** to **$7.0 million**, mainly from legal expenses - Research and development expenses increased by **$5.4 million (33%)** to **$22.0 million**, driven by increased clinical expenses (**$1.4 million**), employee-related expenses (**$1.3 million**), lab supplies (**$0.6 million**), and building-related expenses (**$1.4 million**)[168](index=168&type=chunk) - General and administrative expenses increased by **$0.2 million (3%)** to **$7.0 million**, primarily due to a **$0.4 million** increase in legal expenses, partially offset by a **$0.2 million** decrease in employee-related expenses[171](index=171&type=chunk) - Net loss for the three months ended June 30, 2023, increased by **$5.3 million (23%)** to **$28.4 million**[172](index=172&type=chunk) [Six Months Ended June 30, 2023 Compared to Six Months Ended June 30, 2022](index=37&type=section&id=Six%20Months%20Ended%20June%2030%2C%202023%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202022) R&D expenses rose **39%** to **$48.5 million** due to increased clinical, non-clinical, employee, office, and lab costs, partially offset by lower manufacturing. G&A decreased **3%** to **$14.4 million** due to lower financial reporting - Research and development expenses increased by **$13.5 million (39%)** to **$48.5 million**, driven by increased clinical expenses (**$5.4 million**), non-clinical expenses (**$1.3 million**), employee-related expenses (**$3.2 million**), office-related expenses (**$2.9 million**), and lab supplies (**$2.5 million**), offset by a **$3.2 million** decrease in manufacturing expenses[173](index=173&type=chunk) - General and administrative expenses decreased by **$0.4 million (3%)** to **$14.4 million**, primarily due to a **$1.1 million** decrease in financial reporting expenses, partially offset by increases in legal and accounting fees[178](index=178&type=chunk) - Net loss for the six months ended June 30, 2023, increased by **$11.8 million (24%)** to **$61.4 million**[179](index=179&type=chunk) [License Agreements](index=39&type=section&id=License%20Agreements) The company holds several exclusive license agreements for therapeutic candidates, including SARS-CoV-2 mAbs, broad-spectrum antivirals, oxytocin-based therapeutics, TFF2 Technology, and cocaine esterase, involving upfront fees, royalties, and milestone payments - Exercised an option in February 2023 for an exclusive license from Columbia for a portfolio of fully human and murine mAbs for SARS-CoV-2 infection[180](index=180&type=chunk) - Entered into an exclusive license agreement with Curia in December 2022 for three humanized murine mAbs for SARS-CoV-2 infection, involving an upfront fee of approximately **$0.4 million**, single-digit royalties, and contingent milestone payments[181](index=181&type=chunk) - Holds exclusive licenses from Columbia University for TFF2 Technology and a double-mutant cocaine esterase, with contingent milestone payments totaling **$4.1 million** and **$3 million**, respectively, in addition to license fees and royalties[184](index=184&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk)[193](index=193&type=chunk) [Asset Purchase Agreements](index=41&type=section&id=Asset%20Purchase%20Agreements) The company completed several asset purchase agreements, notably acquiring Zembrace® SymTouch® and Tosymra® from Upsher-Smith for **$26.5 million**. Other acquisitions include preclinical infectious disease, insulin resistance, migraine/pain, and pyran-based compounds, with costs generally expensed as R&D - Acquired Zembrace® SymTouch® and Tosymra® products from Upsher-Smith Laboratories for approximately **$26.5 million** on June 30, 2023, including a **$22.2 million** upfront cash payment and a **$3.0 million** deferred payment[194](index=194&type=chunk)[196](index=196&type=chunk) - Acquired preclinical infectious disease assets from Healion Bio Inc. for **$1.2 million** in February 2023, expensed as R&D costs[197](index=197&type=chunk) - Acquired Katana assets (insulin resistance) for **$0.7 million** in December 2020, Trigemina assets (migraine/pain) for **$2.4 million** (cash and stock) in June 2020, and TRImaran assets (pyran-based compounds) for **$168,500** in August 2019; all were expensed as R&D costs due to their preclinical stage or lack of alternative future use[198](index=198&type=chunk)[202](index=202&type=chunk)[205](index=205&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had **$32.9 million** working capital and **$25.6 million** cash, but faces substantial doubt about its going concern ability, with resources projected only into Q4 2023, necessitating additional funding | Metric (in thousands) | June 30, 2023 | | :-------------------- | :------------ | | Working capital | $32,900 | | Cash and cash equivalents | $25,600 | | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(56,278) | $(52,217) | | Net cash used in investing activities | $(27,818) | $(34,656) | | Net cash (used) provided by financing activities | $(10,471) | $85,240 | - The company's cash resources at June 30, 2023, and subsequent equity offerings are expected to meet operating and capital expenditure requirements only into the fourth quarter of 2023, raising substantial doubt about its ability to continue as a going concern[211](index=211&type=chunk)[212](index=212&type=chunk) [Future Liquidity Requirements](index=44&type=section&id=Future%20Liquidity%20Requirements) The company anticipates continued losses and increasing R&D, requiring additional capital beyond Q4 2023. Future funding may involve equity, debt, or collaborations, with risks of dilution or delayed development if financing is not secured - The company expects to incur losses and increasing research and development expenses for the near future, requiring additional capital beyond Q4 2023[213](index=213&type=chunk) - Future capital requirements depend on R&D progress, regulatory approvals, intellectual property costs, competitive products, and financing availability[214](index=214&type=chunk) - Potential financing mechanisms include equity or debt securities, credit facilities, or collaborative arrangements, with risks of shareholder dilution or delays/reductions in R&D programs if funding is insufficient[216](index=216&type=chunk)[217](index=217&type=chunk) [Share Repurchase Program](index=45&type=section&id=Share%20Repurchase%20Program) In Q1 2023, the company repurchased **2,512,044** shares for **$12.5 million** under its 2022 program and **160,000** shares for **$1.1 million** under a new 2023 program, allowing open market or private transactions - Repurchased **2,512,044** shares under the 2022 share repurchase program for approximately **$12.5 million** in Q1 2023[218](index=218&type=chunk) - Approved a new 2023 share repurchase program in January 2023 for up to an additional **$12.5 million**, under which **160,000** shares were repurchased for **$1.1 million** in Q1 2023[219](index=219&type=chunk) [Convertible Redeemable Preferred stock](index=45&type=section&id=Convertible%20Redeemable%20Preferred%20stock) Series A and B Convertible Redeemable Preferred Stock were issued in October 2022 (**$14.3 million** gross) and June 2022 (**$28.5 million** gross), then fully redeemed for cash in December 2022 (**$15.8 million**) and August 2022 (**$31.5 million**) - Issued Series A and Series B Preferred Stock in October 2022 for gross proceeds of **$14.3 million**; all shares were redeemed in December 2022 for **$15.8 million**[220](index=220&type=chunk)[221](index=221&type=chunk) - Issued Series A and Series B Preferred Stock in June 2022 for gross proceeds of **$28.5 million**; all shares were redeemed in August 2022 for **$31.5 million**[222](index=222&type=chunk)[223](index=223&type=chunk) [July 2023 Financing](index=45&type=section&id=July%202023%20Financing) On August 1, 2023, the company completed an equity offering, selling common stock and warrants, which generated approximately **$6.2 million** in net proceeds - On July 27, 2023, the company entered into an agreement to sell **2,530,000** shares of common stock, pre-funded warrants for up to **4,470,000** shares, and common warrants for up to **7,000,000** shares[224](index=224&type=chunk) - The offering closed on August 1, 2023, yielding approximately **$6.2 million** in net proceeds after deducting offering expenses[225](index=225&type=chunk) [2022 Lincoln Park Transaction](index=46&type=section&id=2022%20Lincoln%20Park%20Transaction) In August 2022, the company entered a purchase agreement with Lincoln Park Capital Fund, LLC for up to **$50 million** of common stock, issuing **100,000** shares as consideration. **0.1 million** shares were sold for **$0.4 million** net proceeds in H1 2023 - Entered into a purchase agreement with Lincoln Park Capital Fund, LLC in August 2022 to sell up to **$50 million** of common stock[226](index=226&type=chunk) - Issued **100,000** shares of common stock to Lincoln Park as consideration for its commitment, valued at **$1.0 million**[227](index=227&type=chunk) - Sold **0.1 million** shares of common stock for net proceeds of approximately **$0.4 million** during the six months ended June 30, 2023[229](index=229&type=chunk) [Purchase Agreement with Lincoln Park](index=47&type=section&id=Purchase%20Agreement%20with%20Lincoln%20Park) In December 2021, the company entered a purchase agreement with Lincoln Park for up to **$80 million** of common stock, issuing **14,546** commitment shares. **$6.5 million** net proceeds were generated in H1 2022, but no 2023 sales occurred, requiring shareholder approval for future sales - Entered into a purchase agreement with Lincoln Park Capital Fund, LLC in December 2021 to sell up to **$80 million** of common stock[230](index=230&type=chunk) - Issued **14,546** shares of common stock to Lincoln Park as consideration, valued at **$1.6 million**[231](index=231&type=chunk) - Sold **0.2 million** shares for net proceeds of approximately **$6.5 million** during the six months ended June 30, 2022; no sales occurred in 2023. Further sales require shareholder approval due to NASDAQ rules[232](index=232&type=chunk)[233](index=233&type=chunk) [At-the-Market Offerings](index=47&type=section&id=At-the-Market%20Offerings) Through an ATM sales agreement with AGP, the company can sell up to **$320.0 million** in common stock. **1.0 million** shares were sold for **$3.0 million** net proceeds in H1 2023, a significant decrease from **$51.5 million** in H1 2022 - Has a sales agreement with AGP for at-the-market (ATM) offerings, allowing sales of common stock up to **$320.0 million**[234](index=234&type=chunk) - Sold approximately **1.0 million** shares for net proceeds of **$3.0 million** during the six months ended June 30, 2023[234](index=234&type=chunk) - In contrast, during the six months ended June 30, 2022, approximately **2.4 million** shares were sold for net proceeds of **$51.5 million**[234](index=234&type=chunk) [Stock Compensation](index=47&type=section&id=Stock%20Compensation) The Amended and Restated 2020 Stock Incentive Plan has **1,057,051** options available. Stock-based compensation expense was **$5.2 million** for H1 2023, with **$10.3 million** unrecognized compensation cost remaining - The Amended and Restated 2020 Stock Incentive Plan allows for various equity awards and includes an 'evergreen provision' for annual increases in available shares[237](index=237&type=chunk) - As of June 30, 2023, **1,057,051** shares were available for future grants under the Amended and Restated 2020 Plan[238](index=238&type=chunk) Stock-Based Compensation Expense | Metric | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Stock-based compensation expense (total) | $2.4 million | $5.2 million | | - General and Administration | $1.6 million | $3.6 million | | - Research and Development | $0.8 million | $1.6 million | - Approximately **$10.3 million** of total unrecognized compensation cost related to non-vested awards remains as of June 30, 2023, to be recognized over a weighted average period of **1.87 years**[244](index=244&type=chunk) [Employee Stock Purchase Plan](index=49&type=section&id=Employee%20Stock%20Purchase%20Plan) The 2022 ESPP allows eligible employees to purchase common stock at a discount. In January 2023, **14,999** shares were issued under the 2022 ESPP from payroll deductions, totaling approximately **$29,000** - The 2022 ESPP allows eligible employees to purchase up to **15,000** shares of common stock at **85%** of the fair market value[246](index=246&type=chunk) - In January 2023, **14,999** shares purchased under the 2022 ESPP were issued, with approximately **$29,000** of employee payroll deductions transferred to additional paid-in capital[247](index=247&type=chunk) [Commitments](index=49&type=section&id=Commitments) The company has outstanding contractual commitments of approximately **$62.8 million** for future research and development work. Additionally, future minimum operating lease payments total **$1.267 million** - Outstanding commitments for future research and development work aggregated approximately **$62.8 million** at June 30, 2023[249](index=249&type=chunk) Future Minimum Lease Payments | Year Ending December 31, | Future Minimum Lease Payments (in thousands) | | :----------------------- | :------------------------------------------- | | 2023 | $237 | | 2024 | $460 | | 2025 | $299 | | 2026 | $142 | | 2027 and beyond | $246 | | Total | $1,267 | [Critical Accounting Policies and Estimates](index=52&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section outlines critical accounting policies and estimates requiring significant management judgment, including business combinations, R&D costs, stock-based compensation, and redeemable preferred stock, noting no material impact from new pronouncements - Business combinations are accounted for using the acquisition method, requiring estimates of fair values for acquired assets and liabilities, with any excess recorded as goodwill[253](index=253&type=chunk) - Research and development costs, including acquired intellectual property without alternative future uses, are expensed as incurred, with accrual estimates based on trial progress and third-party reporting[254](index=254&type=chunk)[255](index=255&type=chunk) - Stock-based payments are measured at fair value on the grant date and recognized as compensation expense over the vesting period[256](index=256&type=chunk) - Conditionally redeemable preferred shares are classified as temporary equity until redemption conditions are removed or lapse[257](index=257&type=chunk) - The adoption of ASU 2020-06 (convertible instruments) and ASU 2016-13 (credit losses) on January 1, 2023, did not impact the company's financial position, results of operations, or cash flows[259](index=259&type=chunk)[260](index=260&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=54&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period - This item is not applicable to the company[261](index=261&type=chunk) [ITEM 4. Controls and Procedures](index=54&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2023. There were no material changes in internal control over financial reporting during the quarter - As of June 30, 2023, the company's disclosure controls and procedures were deemed effective at a reasonable assurance level[263](index=263&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2023, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[264](index=264&type=chunk) [PART II. OTHER INFORMATION](index=55&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [ITEM 1. Legal Proceedings](index=55&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or claims - The company is not currently a party to any material legal proceedings or claims[267](index=267&type=chunk) [ITEM 1A. Risk Factors](index=55&type=page&id=ITEM%201A.%20Risk%20Factors) There were no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - No material changes from the risk factors set forth in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022[268](index=268&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=55&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - None[269](index=269&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=55&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None[270](index=270&type=chunk) [ITEM 4. Mine Safety Disclosures](index=55&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[271](index=271&type=chunk) [ITEM 5. Other Information](index=55&type=section&id=ITEM%205.%20Other%20Information) There is no other information to report for the period - None[272](index=272&type=chunk) [ITEM 6. Exhibits](index=56&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including articles of incorporation, bylaws, asset purchase agreements, transition services agreements, and certifications - Includes various corporate documents such as Articles of Incorporation, Bylaws, and Certificates of Change[274](index=274&type=chunk) - Lists key agreements like the Asset Purchase Agreement with Upsher-Smith Laboratories and the Transition Services Agreement[274](index=274&type=chunk) - Contains certifications from the Chief Executive Officer and Chief Financial Officer as required by the Exchange Act and Sarbanes-Oxley Act[274](index=274&type=chunk) [SIGNATURES](index=58&type=section&id=SIGNATURES) The report is duly signed on behalf of Tonix Pharmaceuticals Holding Corp. by its Chief Executive Officer, Seth Lederman, and Chief Financial Officer, Bradley Saenger, as of August 10, 2023 - The report is signed by Seth Lederman, Chief Executive Officer, and Bradley Saenger, Chief Financial Officer, on August 10, 2023[279](index=279&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or 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 Ide ...

Financial Status - As of December 31, 2022, Tonix Pharmaceuticals had approximately $120 million in cash and cash equivalents and no debt[38] Pipeline Highlights - CNS Portfolio - TNX-102 SL for fibromyalgia is in Mid-Phase 3 with >50% enrollment in the confirmatory Phase 3 study (RESILIENT)[8, 11] - TNX-102 SL for fibromyalgia-type Long COVID is in Phase 2 with trial enrollment in process[10, 21] - TNX-601 ER for depression is in Phase 2 with the UPLIFT study currently enrolling[26] - TNX-1900 for prevention of chronic migraine is in Phase 2 with enrolling[59] Pipeline Highlights - Other Areas - TNX-1300 for cocaine intoxication has FDA Breakthrough Therapy Designation and is in Mid-Phase 2, with a targeted 2Q 2023 start for a new Phase 2 trial[7] - TNX-1500 for organ transplant rejection/autoimmune conditions is Phase 1 ready, targeted for 2Q 2023 start[59] - TNX-801 for smallpox and mpox vaccine is in Phase 1, targeted for 2H 2023 start[59] Key Upcoming Milestones - Interim analysis results for the Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia are expected in 2Q 2023[176] - Interim analysis results for the Phase 2 PREVENTION study of TNX-1900 for chronic migraine are expected in 4Q 2023[176] - Interim analysis results for the Phase 2 UPLIFT study of TNX-601 ER for major depressive disorder are expected in 4Q 2023[176] - Topline results of the Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia are expected in 4Q 2023[176]