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Tonix Pharmaceuticals (TNXP) - 2020 Q3 - Quarterly Report
2020-11-09 13:15
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 September 30, 2020 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) Securi ...
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2020-09-11 19:04
1 Investor Presentation NASDAQ:TNXP P H A R M A C E U T I C A L S September 2020 Version P0246 9-3-20 (Doc 0699) © 2020 Tonix Pharmaceuticals Holding Corp. 2 Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as ...
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2020-08-18 13:14
1 Investor Presentation NASDAQ:TNXP P H A R M A C E U T I C A L S August 2020 Version P0244 8-17-20 (Doc 0695) © 2020 Tonix Pharmaceuticals Holding Corp. 2 Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "a ...
Tonix Pharmaceuticals (TNXP) - 2020 Q2 - Quarterly Report
2020-08-10 13:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION TONIX PHARMACEUTICALS HOLDING CORP. 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 June 30, 2020 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 (Exact name of registrant as specified in its charter) (State or o ...
Tonix Pharmaceuticals (TNXP) - 2020 Q1 - Quarterly Report
2020-05-12 11:16
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, 2020 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- ...
Tonix Pharmaceuticals (TNXP) - 2019 Q4 - Annual Report
2020-03-24 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2019 Commission File Number 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 26-1434750 (IRS Employer Identification No.) 509 Madison Avenue, Suite 1608 New York, New York 10022 (Addre ...
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2020-02-11 17:15
TNX-102 SL for Fibromyalgia - TNX-102 SL is in Phase 3 clinical development for Fibromyalgia, a chronic pain condition [6] - Interim analysis results for the Phase 3 RELIEF study are expected in the 3rd Quarter of 2020, with topline data expected in the 1st Half of 2021 [6] - A retrospective analysis of the AFFIRM study showed statistically significant improvement in mean pain using both MMRM (p < 0001) and MMRM with MI (p < 001) [36] - The new Phase 3 RELIEF study is enrolling with approximately 470 participants across 40 US sites [38] Pipeline Expansion - Tonix is exploring TNX-102 SL for Agitation in Alzheimer's Disease (AAD), with a proposed Phase 2 study that could potentially support NDA approval [47, 48] - TNX-102 SL is also being considered for Alcohol Use Disorder (AUD), with plans to submit an IND application in 1Q 2020 for a Phase 2 Proof of Concept Study [50, 51] - TNX-601 CR (Tianeptine Oxalate Controlled Release) is a potential daytime treatment for depression and PTSD, with plans to initiate a Phase 2 study in depression, ex-US, in the second half of 2020 [65, 70, 84] Other Programs - TNX-1300 (cocaine esterase) is in Phase 2 development for cocaine intoxication and has received FDA Breakthrough Therapy designation [7, 81] A Phase 2 study showed that TNX-1300 rapidly reversed the physiologic effects of cocaine, with cocaine plasma exposures dropping by 90% within two minutes [54] - TNX-801 (live horsepox virus) is a potential smallpox and monkeypox preventing vaccine in the pre-clinical stage [74, 82] - An estimated 6-12 million adults in the US have fibromyalgia [17]
Tonix Pharmaceuticals Holding (TNXP) Presents At Biotech Showcase 2020 - Slideshow
2020-01-14 15:58
Investor Presentation Biotech Showcase 2020 Version P0217 1-13-20 (Doc 0584) © 2020 Tonix Pharmaceuticals Holding Corp. 1 Cautionary Note on Forward-Looking Statements 2 Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast ...
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2019-12-05 20:30
Investor Presentation December 2019 Version P0208 12-3-19 (Doc 0565) © 2019 Tonix Pharmaceuticals Holding Corp. 1 Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estima ...
Tonix Pharmaceuticals (TNXP) - 2019 Q3 - Quarterly Report
2019-11-08 21:32
Part I [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Tonix Pharmaceuticals reported a **$19.9 million net loss** and **$20.0 million cash used in operations** for the nine months ended September 30, 2019, with cash decreasing to **$10.0 million**, raising **going concern** doubts and necessitating financing Condensed Consolidated Balance Sheet Data (in thousands) | | Sep 30, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,024 | $25,034 | | Total current assets | $11,553 | $26,056 | | Total assets | $12,272 | $26,319 | | **Liabilities & Equity** | | | | Total current liabilities | $2,366 | $2,655 | | Total liabilities | $2,417 | $2,655 | | Total stockholders' equity | $9,855 | $23,664 | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended Sep 30 | Nine Months Ended Sep 30 | | :--- | :--- | :--- | | | **2019** | **2018** | **2019** | **2018** | | Research and development | $5,052 | $3,264 | $12,502 | $12,501 | | General and administrative | $2,839 | $2,277 | $7,592 | $6,171 | | **Operating Loss** | **($7,891)** | **($5,541)** | **($20,094)** | **($18,672)** | | **Net Loss** | **($7,838)** | **($5,479)** | **($19,911)** | **($18,501)** | | Net loss per share, basic | ($5.69) | ($54.99) | ($23.93) | ($195.51) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,969) | $(17,147) | | Net cash used by investing activities | $(12) | $(7) | | Net cash provided by financing activities | $4,974 | $6,352 | | **Net decrease in cash** | **$(15,010)** | **$(10,812)** | - The company has suffered recurring losses and negative cash flows, and its current resources are insufficient to meet operating requirements for the next year, raising substantial doubt about its ability to continue as a **going concern**[24](index=24&type=chunk) - In August 2019, the company acquired assets from TRImaran Pharma related to pyran-based compounds for an initial payment of **$100,000**, assumption of liabilities, and potential future milestone payments of approximately **$3.4 million**[58](index=58&type=chunk) - The company entered into two exclusive license agreements with Columbia University in 2019: one for TFF2 technology (gastric/pancreatic cancer) and another for a double-mutant cocaine esterase (cocaine intoxication), with combined potential milestone payments totaling **$6.1 million**[63](index=63&type=chunk)[67](index=67&type=chunk)[71](index=71&type=chunk) - In July 2019, the company raised approximately **$4.5 million** in net proceeds from an underwritten public offering of **900,000 shares** of common stock at **$6.00 per share**[75](index=75&type=chunk)[76](index=76&type=chunk) - As a subsequent event, the company effected a **1-for-10 reverse stock split** of its common stock, effective November 1, 2019. All share and per-share amounts in the financial statements have been retroactively restated[122](index=122&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage focus, led by TNX-102 SL for PTSD, noting increased net losses from higher R&D and G&A expenses, and reiterating a critical **going concern** risk due to insufficient liquidity [Business Overview](index=26&type=section&id=Business%20Overview) Tonix is a clinical-stage biopharmaceutical company developing treatments for psychiatric, pain, and addiction, with its lead product, TNX-102 SL, in Phase 3 development for PTSD, alongside a diverse pipeline - The company's lead product candidate is **TNX-102 SL**, a sublingual tablet of cyclobenzaprine, which is in **Phase 3 development for PTSD**[126](index=126&type=chunk) - The development pipeline includes **TNX-102 SL** for other indications (fibromyalgia, Alzheimer's), **TNX-1300** for cocaine intoxication, **TNX-601** for PTSD and neurocognitive dysfunction, **TNX-801** as a smallpox vaccine, **TNX-1500** for organ transplant rejection, and **TNX-1700** for cancers[126](index=126&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Net loss increased to **$7.8 million** in Q3 2019 due to a **55% rise in R&D**, and widened to **$19.9 million** for nine months due to **23% higher G&A** Comparison of Three Months Ended September 30 (in millions) | Expense Category | 2019 | 2018 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $5.1 | $3.3 | +$1.8 (55%) | Timing of PTSD RECOVERY study activities | | General & Administrative | $2.8 | $2.3 | +$0.5 (22%) | Increased legal and insurance fees | | **Net Loss** | **$7.8** | **$5.5** | **+$2.3** | | Comparison of Nine Months Ended September 30 (in millions) | Expense Category | 2019 | 2018 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $12.5 | $12.5 | $0 (0%) | Costs shifted from HONOR study (2018) to RECOVERY study (2019) | | General & Administrative | $7.6 | $6.2 | +$1.4 (23%) | Increased legal, IR, and insurance fees | | **Net Loss** | **$19.9** | **$18.5** | **+$1.4** | | [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2019, the company had **$9.2 million working capital** and **$10.0 million cash**, with **$20.0 million cash used in operations**, indicating insufficient resources and a critical need for additional financing - The company had working capital of **$9.2 million** and cash and cash equivalents of **$10.0 million** as of September 30, 2019[146](index=146&type=chunk) - A critical liquidity issue exists, as the company states it will not have enough resources to meet its operating requirements for the one-year period from the filing date of this report[167](index=167&type=chunk) - Net proceeds from financing activities for the nine months ended September 30, 2019, were approximately **$5.0 million**, primarily from the sale of common stock and warrant exercises[146](index=146&type=chunk) - The company will need to obtain additional capital to fund future R&D. Failure to do so may require delaying or reducing the scope of its development programs[169](index=169&type=chunk)[170](index=170&type=chunk) [Critical Accounting Policies and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies include Leases, Research and Development, and Stock-Based Compensation, all requiring significant management estimates and judgments for valuation and accruals - Key accounting policies requiring significant estimates include **Leases** (determining incremental borrowing rates), **Research and Development** (accruing clinical trial expenses based on progress), and **Stock-Based Compensation** (valuing awards)[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk)[190](index=190&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Disclosure under this item is not required as the company qualifies as a "smaller reporting company" under Regulation S-K - As a "smaller reporting company," the company is not required to provide disclosures about market risk[197](index=197&type=chunk) [Controls and Procedures](index=36&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2019, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2019, the company's disclosure controls and procedures were **effective at a reasonable assurance level**[198](index=198&type=chunk) - No changes occurred during the quarter ended September 30, 2019, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[199](index=199&type=chunk) Part II [Legal Proceedings](index=37&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings or claims - As of the filing date, the company is not involved in any **material legal proceedings**[202](index=202&type=chunk) [Risk Factors](index=37&type=section&id=ITEM%201A.%20Risk%20Factors) Disclosure under this item is not required as the company qualifies as a "smaller reporting company" under Regulation S-K - As a "smaller reporting company," the company is not required to provide disclosures for Risk Factors in a 10-Q[203](index=203&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On August 20, 2019, the company issued 35,529 shares of common stock to Lincoln Park Capital Fund, LLC as a commitment fee related to a Purchase Agreement dated the same day - On August 20, 2019, the company issued **35,529 commitment shares** to Lincoln Park Capital Fund, LLC as part of a purchase agreement[203](index=203&type=chunk) [Other Items](index=37&type=section&id=Other%20Items) The company reported no defaults upon senior securities, no mine safety disclosures, and no other information requiring disclosure under Item 5, with a list of exhibits filed including key asset purchase and license agreements - The company reports "None" for Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), and Item 5 (Other Information)[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) - Exhibits filed with the report include the **Asset Purchase Agreement with TRImaran Pharma** and two **Exclusive License Agreements with Columbia University**[207](index=207&type=chunk)