Tonix Pharmaceuticals (TNXP)

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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)
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2019-10-29 10:51
TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) - TNX-102 SL is in Phase 3 development for Bedtime Treatment for PTSD (Tonmya®) and Fibromyalgia, and Phase 2 ready for Bedtime Treatment for Agitation in Alzheimer's [7] - TNX-102 SL is also in Pre-IND stage for Bedtime Treatment for Alcohol Use Disorder (AUD) [7] - TNX-102 SL's intellectual property is expected to have U S protection until 2035 [18] - A Phase 2 study showed that 21.10% of patients in the TNX-102 SL 5.6 mg group achieved remission at Weeks 8 & 12, compared to 5.20% in the placebo group [34] - AEs in P201/AtEase and P301/HONOR Studies showed that 38.7% and 37.3% of patients in the TNX 5.6 mg group experienced Hypoaesthesia oral, respectively [41] - A new Phase 3 P302/RECOVERY Study for TNX-102 SL in PTSD was initiated in 1Q 2019 [43] Other Pipeline Products - TNX-1300 (Cocaine esterase) is in Mid-Phase 2 development for Cocaine intoxication [101] - TNX-601 (Tianeptine oxalate oral formulation) is in Phase 1 formulation development for Daytime Treatment for PTSD [7, 101] - TNX-801 (Live horsepox virus (HPXV) vaccine from cell culture) is in Pre-clinical development for Smallpox-preventing vaccine [14, 101] - An estimated 16 million people in the U S have AUD [55] - Approximately 21% of all emergency department (ED) visits involve cocaine [71]
Tonix Pharmaceuticals (TNXP) Investor Presentation - Slideshow
2019-09-17 20:01
Investor Presentation September 2019 Version P0195 9-13-19 (Doc 0531) © 2019 Tonix Pharmaceuticals Holding Corp. 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," "estimat ...
Tonix Pharmaceuticals (TNXP) - 2019 Q2 - Quarterly Report
2019-08-12 11:51
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 June 30, 2019 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 26-1 ...
Tonix Pharmaceuticals (TNXP) - 2019 Q1 - Quarterly Report
2019-05-13 11:51
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, reporting a $6.2 million net loss and highlighting a 'going concern' issue due to limited cash [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20consolidated%20balance%20sheets) Total assets decreased to $20.0 million, driven by a reduction in cash to $16.4 million, while stockholders' equity declined to $17.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2019 (unaudited) | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $16,448 | $25,034 | | Total current assets | $19,182 | $26,056 | | Total assets | $20,022 | $26,319 | | **Liabilities & Equity** | | | | Total current liabilities | $2,011 | $2,655 | | Total liabilities | $2,211 | $2,655 | | Total stockholders' equity | $17,811 | $23,664 | | Total liabilities and stockholders' equity | $20,022 | $26,319 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20consolidated%20statements%20of%20operations) Net loss decreased to $6.2 million, or $1.29 per share, primarily due to lower research and development expenses Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--- | :--- | :--- | | Research and development | $3,896 | $5,170 | | General and administrative | $2,401 | $1,818 | | Operating loss | $(6,297) | $(6,988) | | Net loss | $(6,233) | $(6,935) | | Net loss per common share, basic and diluted | $(1.29) | $(8.80) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20consolidated%20statements%20of%20cash%20flows) Net cash used in operating activities increased to $8.6 million, resulting in a $8.6 million decrease in cash and equivalents, ending at $16.5 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,639) | $(6,771) | | Net cash used by investing activities | $(7) | $(2) | | Net cash provided by financing activities | $70 | $532 | | Net decrease in cash, cash equivalents and restricted cash | $(8,586) | $(6,243) | | Cash, cash equivalents and restricted cash end of period | $16,548 | $19,342 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20condensed%20consolidated%20financial%20statements) Details the company's biopharmaceutical business, discloses a 'going concern' uncertainty, and outlines key accounting policies and contractual commitments - The company is a clinical-stage biopharmaceutical firm focused on psychiatric, pain, and biodefense products, with all candidates currently in development[19](index=19&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, with **$16.4 million** cash sufficient only through the end of 2019[21](index=21&type=chunk) - The company adopted the new lease accounting standard, ASC Topic 842, on January 1, 2019, recognizing right-of-use assets and lease liabilities[28](index=28&type=chunk)[30](index=30&type=chunk) - As of March 31, 2019, the company had outstanding commitments of approximately **$8.7 million** for future work with contract research organizations[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the development of Tonmya, analyzes Q1 2019 results showing decreased R&D and increased G&A, and reiterates the 'going concern' issue requiring additional financing - The company's lead product candidate, Tonmya (TNX-102 SL), is in Phase 3 development for PTSD, with other programs targeting fibromyalgia and Alzheimer's agitation[111](index=111&type=chunk)[113](index=113&type=chunk) - The company lacks sufficient resources to meet operating requirements for the next year and requires additional capital for future research and development[145](index=145&type=chunk)[147](index=147&type=chunk) Comparison of Expenses (in millions) | Expense Category | Q1 2019 | Q1 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $3.9 | $5.2 | -25% | | General & Administrative | $2.4 | $1.8 | +33% | | **Net Loss** | **$6.2** | **$6.9** | **-10%** | [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Research and development expenses decreased by **$1.3 million** (25%) to **$3.9 million**, while general and administrative expenses increased by **$0.6 million** (33%) to **$2.4 million**, leading to a 10% lower net loss - R&D expenses decreased by **25%** year-over-year, primarily due to the non-recurrence of a pharmacokinetic bridging study conducted in Q1 2018[120](index=120&type=chunk) - G&A expenses increased by **33%** year-over-year, driven by higher investor relations and insurance premiums[121](index=121&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Working capital was **$17.2 million** with **$16.4 million** in cash, but resources are insufficient for the next year, necessitating additional funding and detailing past financing efforts - The company had working capital of **$17.2 million** and cash and cash equivalents of **$16.4 million** as of March 31, 2019[123](index=123&type=chunk) - Cash used in operating activities increased to **$8.6 million** in Q1 2019 from **$6.8 million** in Q1 2018, primarily due to non-recurring clinical study costs and higher insurance premiums[123](index=123&type=chunk) - The December 2018 financing provided net proceeds of approximately **$13.6 million** through the sale of Class A and Class B units[127](index=127&type=chunk) - No shares were sold under the 2018 Purchase Agreement with Lincoln Park or the At-the-Market (ATM) offering with Cowen during the quarter ended March 31, 2019[130](index=130&type=chunk)[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=33&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Disclosure is not required as the company qualifies as a 'smaller reporting company' - Disclosure is not required as the company qualifies as a 'smaller reporting company'[175](index=175&type=chunk) [Controls and Procedures](index=33&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of March 31, 2019, the company's disclosure controls and procedures were effective[176](index=176&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended March 31, 2019[177](index=177&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=34&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[180](index=180&type=chunk) [Risk Factors](index=34&type=section&id=ITEM%201A.%20Risk%20Factors) Disclosure is not required as the company qualifies as a 'smaller reporting company' - Disclosure is not required as the company qualifies as a 'smaller reporting company'[181](index=181&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported for the period[181](index=181&type=chunk) [Exhibits](index=34&type=section&id=ITEM%206.%20Exhibits) Lists exhibits filed with Form 10-Q, including CEO and CFO certifications and XBRL data files - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906[187](index=187&type=chunk)
Tonix Pharmaceuticals (TNXP) Investor Presentation - Slideshow
2019-03-29 21:03
Investor Presentation March 2019 Version P0167 3-18-19 (Doc 0451) © 2019 Tonix Pharmaceuticals Holding Corp. 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," "estimate" a ...
Tonix Pharmaceuticals (TNXP) - 2018 Q4 - Annual Report
2019-03-18 11:50
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Exact name of registrant as specified in its charter) Nevada 26-1434750 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 509 Madison Avenue, Suite 1608 New York, New York 10022 (212) 980-9155 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2018 Commission File Number 001-36019 TONIX PHARMACEUTICALS HOLDI ...
Tonix Pharmaceuticals Holding (TNXP) Investor Presentation - Slideshow
2019-02-11 18:23
Investor Presentation February 2019 Version P0158 2-5-19 (Doc 0435) © 2019 Tonix Pharmaceuticals Holding Corp. 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," "estimat ...