Full Press Release Details
Biosciences Reports Second Quarter 2017 Financial Results and Provides Business Update
Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT -
| TEL AVIV, Israel, August 10, 2017 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX), a specialty clinical stage pharmaceutical Company specializing in the development of cannabinoid-based drugs, today reported financial results for the three and six months ended June 30, 2017. The Company will host a conference call and webcast today to discuss the financial results and to provide an update on current developments with respect to its clinical programs. |
| Financial Summary - Second Quarter 2017 vs. Second Quarter 2016 (Note: The functional currency of the Company is New Israeli Shekel; for presentation purposes, the financial data herein is presented in USD): |
| Net loss of $1.9 million, or $0.54 per ADS, for the three months ended June 30, 2017, compared to a net loss of $0.5 million, or $0.61 per ADS, for the three months ended June 30, 2016. This period's net loss included $0.44 million of exchange rate differences on balances of cash and cash equivalents, versus none incurred during the corresponding period in 2016. | ||
| Research and development ("R&D") expenses amounted to approximately $0.46 million for the three months ended June 30, 2017, compared to approximately $0.23 million for the three months ended June 30, 2016. The increase resulted primarily from a marked rise in expenses in connection with the clinical trials, as well as a R&D studies. | ||
| General and administrative expenses amounted to approximately $0.97 million for the three months ended June 30, 2017, compared to approximately $0.30 million for the three months ended June 30, 2016. The increase resulted primarily from a rise in investor relations and business development activities. | ||
| Cash totaled $11.8 million as of June 30, 2017, compared to $12.1 million at March 31, 2017. The decrease in cash primarily resulted from expenses incurred in our ongoing clinical trials, other R&D expenses, investor relations and business development activities and operational activities offset by additional net proceeds raised in the Company's Initial Public Offering through the complete exercise of the underwriter's overallotment option. The Company currently believes that its cash balance will be sufficient to maintain its current operations into the third quarter of 2018. |
update and developments in the Company's clinical R&D programs:
| In the Company's ongoing study Phase IIa clinical trial in Tourette's Syndrome at Yale University (n=18), 12 patients have been enrolled to date; patient #13 is scheduled to be screened this week. The last patient is currently projected to be enrolled by the end of September or early October, 2017, which is consistent with our previously disclosed estimate. To date, ten patients have completed the entire three-month treatment regimen. | ||
| In the Yale study, patients that have completed the initial 3-month treatment period have been given the option to extend their treatment for an additional 3 months based on a positive assessment of efficaciousness after the first 3 months. Of the 10 patients that have already completed the initial 3-month treatment period, 8 patients have opted to extend their treatment. |
| Regarding our Phase IIb, placebo-controlled 13-week clinical trial in Tourette's Syndrome, previously anticipated to be conducted at the Hannover Medical School in Germany, we are currently assessing the option to conduct a study in the United States as well. .We should be able to complete our decision within a few weeks. This will cause an immaterial delay in initiating the study. | ||
| Concerning our second clinical program for our Ultra-Low-Dose formulation of THC for the treatment of Mild Cognitive Impairment ("MCI"), the Company has completed the development of a formulation of sublingual administration of THC with expected enhanced bioavailability. Within the broader MCI indication, we are now focusing on the narrower Traumatic Brain Injury ("TBI") indication, and are now assessing the optimal regulatory pathway for this program. As a result, this will likely cause a delay in the initiation of the PK study. Nonetheless, we currently project this study will be initiated in the fourth quarter of 2017. The duration of this study is expected to be 1 month. From there, the Company intends to advance to a proof-of-concept trial. In addition to the sublingual administration, we are currently working on a nasal delivery formulation. | ||
| In the anticipated proof-of-concept study in MCI, the Company will be evaluating cognition in TBI patients who are generally symptomatic with significant cognitive dysfunction. The primary endpoint is expected to measure the cognitive functions post injury. The Company currently intends to initiate a similar pre-clinical study in small animals towards the end the third quarter, 2017, or early fourth quarter 2017, which is materially on track with our earlier disclosed estimate. |
August 10, 2017, 8:30 am Eastern Time / 5:30 am Pacific Time
| Toll-Free: | +1-877-870-4263 |
| Toll/International: | +1-412-317-0790 |
| Webcast: | https://www.webcaster4.com/Webcast/Page/1726/22002 |
available until Aug 17, 2017
| Toll-Free: | +1-877-344-7529 |
| Toll/International: | +1-412-317-0088 |
| Passcode: | 10110882 |
| USD in Thousands | ||||||||||||
| December 31, | March 31, | June 30, | ||||||||||
| 2016 | 2017 | 2017 | ||||||||||
| Audited | Unaudited | Unaudited | ||||||||||
| ASSETS | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash | $ | 676 | $ | 12,054 | $ | 11,784 | ||||||
| Restricted cash | 11 | 12 | 13 | |||||||||
| Accounts receivable | 117 | 133 | 242 | |||||||||
| Subtotal, current assets | 804 | 12,199 | 12,039 | |||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Prepaid public offering costs | 430 | - | - | |||||||||
| Property | 11 | 11 | 17 | |||||||||
| Subtotal, non-current assets | 441 | 11 | 17 | |||||||||
| TOTAL ASSETS | $ | 1,245 | $ | 12,210 | $ | 12,056 | ||||||
| LIABILITIES AND EQUITY | ||||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | $ | 590 | $ | 937 | $ | 520 | ||||||
| Other accounts payable | 82 | 177 | 128 | |||||||||
| Subtotal, current liabilities | 672 | 1,114 | 648 | |||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||||||
| Share capital | $ | 1,088 | $ | 3,375 | $ | 3,709 | ||||||
| Share premium | 26,612 | 35,105 | 36,447 | |||||||||
| Sharebased payment transactions | 4,443 | 4,507 | 4,578 | |||||||||
| Foreign currency translation reserve | 316 | 631 | 1,060 | |||||||||
| Transactions with noncontrolling interests | 261 | 261 | 261 | |||||||||
| Accumulated deficit | (32,147 | ) | (32,783 | ) | (34,647 | ) | ||||||
| Total equity | 573 | 11,096 | 11,408 | |||||||||
| TOTAL LIABILITIES AND EQUITY | $ | 1,245 | $ | 12,210 | $ | 12,056 |
| USD in Thousands | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development expenses, net | $ | 227 | $ | 455 | $ | 376 | $ | 695 | ||||||||
| General and administrative expenses | 299 | 971 | 635 | 1,376 | ||||||||||||
| Subtotal | 526 | 1,426 | 1,011 | 2,071 | ||||||||||||
| Other expenses | 26 | - | 26 | - | ||||||||||||
| Operating loss | 552 | 1,426 | 1,037 | 2,071 | ||||||||||||
| Finance income | (9 | ) | - | (1 | ) | - | ||||||||||
| Finance expenses | - | 438 | 5 | 429 | ||||||||||||
| Loss | $ | 543 | $ | 1,864 | $ | 1,041 | $ | 2,500 | ||||||||
| Attributable to: | ||||||||||||||||
| Equity holders of the Company | 533 | 1,864 | 1,027 | 2,500 | ||||||||||||
| Non-controlling interests | 10 | - | 14 | - | ||||||||||||
| $ | 543 | $ | 1,864 | $ | 1,041 | $ | 2,500 | |||||||||
| Basic and diluted loss per ADS attributable to equity holders of the Company | $ | 0.61 | $ | 0.54 | $ | 1.18 | $ | 1.08 |
3: Comprehensive Income:
| USD in Thousands | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Unaudited | ||||||||||||||||
| Net loss | $ | (543 | ) | $ | (1,864 | ) | $ | (1,041 | ) | $ | (2,500 | ) | ||||
| Other comprehensive income to be reclassified to profit or loss in subsequent periods | ||||||||||||||||
| Exchange differences on translation of foreign operations | (18 | ) | 429 | 8 | 744 | |||||||||||
| Total other comprehensive income (loss) | (18 | ) | 429 | 8 | 744 | |||||||||||
| Total comprehensive loss | (561 | ) | (1,435 | ) | (1,033 | ) | (1,756 | ) | ||||||||
| Attributable to: | ||||||||||||||||
| Equity holders of the Company | (555 | ) | (1,435 | ) | (1,017 | ) | (1,756 | ) | ||||||||
| Non-controlling interests | (6 | ) | - | (16 | ) | - | ||||||||||
| TOTAL | $ | (561 | ) | $ | (1,435 | ) | $ | (1,033 | ) | $ | (1,756 | ) |
| USD in Thousands | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Cash flows from operating activities: | ||||||||||||||||
| Net loss | $ | (543 | ) | $ | (1,864 | ) | $ | (1,042 | ) | $ | (2,500 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Depreciation and amortization | 2 | 1 | 3 | 2 | ||||||||||||
| Share-based payment expense | 132 | 71 | 208 | 135 | ||||||||||||
| Finance expenses, net | (5 | ) | 453 | (5 | ) | 446 | ||||||||||
| 129 | 525 | 206 | 583 | |||||||||||||
| Working capital adjustments: | ||||||||||||||||
| decrease (increase) in accounts receivable | (42 | ) | (102 | ) | (7 | ) | (110 | ) | ||||||||
| Increase (decrease) in trade payables | 2 | (441 | ) | 40 | (136 | ) | ||||||||||
| Increase (decrease) in other accounts payable | 24 | (54 | ) | 38 | 33 | |||||||||||
| (16 | ) | (597 | ) | 71 | (213 | ) | ||||||||||
| Net cash used in operating activities | (430 | ) | (1,936 | ) | (765 | ) | (2,130 | ) | ||||||||
| Cash flows from investing activities: | ||||||||||||||||
| Purchase of equipment | - | (7 | ) | (4 | ) | (7 | ) | |||||||||
| Net cash provided by (used in) investing activities | - | (7 | ) | (4 | ) | (7 | ) | |||||||||
| Cash flows from financing activities: | ||||||||||||||||
| Proceeds from issuance of share capital and share options (net of issuance expenses) | - | 1,676 | - | 12,900 | ||||||||||||
| Net cash provided by financing activities | - | 1,676 | - | 12,900 | ||||||||||||
| Exchange rate differences on balances of cash and cash equivalents | - | (453 | ) | - | (446 | ) | ||||||||||
| Translation differences on cash and cash equivalents | (25 | ) | 450 | 19 | 791 | |||||||||||
| Increase (decrease) in cash | (455 | ) | (270 | ) | (750 | ) | 11,108 | |||||||||
| Cash at the beginning of the period | 1,278 | 12,054 | 1,573 | 676 | ||||||||||||
| Cash at the end of the period | $ | 823 | $ | 11,784 | $ | 823 | $ | 11,784 |
5: Changes in Equity:
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Issued Capital | Share premium | Share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2017 | $ | 1,088 | $ | 26,612 | $ | 4,443 | $ | 316 | $ | 261 | $ | (32,147 | ) | $ | 573 | |||||||||||||
| Loss | (635 | ) | (635 | ) | ||||||||||||||||||||||||
| Total other comprehensive loss | - | - | - | 315 | - | - | 315 | |||||||||||||||||||||
| Total comprehensive loss | - | - | - | 315 | - | (635 | ) | (320 | ) | |||||||||||||||||||
| Issuance of shares | 2,287 | 8,493 | - | - | - | - | 10,780 | |||||||||||||||||||||
| Share-based payment | - | - | 64 | - | - | - | 64 | |||||||||||||||||||||
| Balance at March 31, 2017 | $ | 3,375 | $ | 35,105 | $ | 4,507 | $ | 631 | $ | 261 | $ | (32,782 | ) | $ | 11,097 | |||||||||||||
| Loss | (1,864 | ) | (1,864 | ) | ||||||||||||||||||||||||
| Total other comprehensive loss | - | - | - | 429 | - | - | 429 | |||||||||||||||||||||
| Total comprehensive loss | - | - | - | 429 | - | (1,864 | ) | (1,435 | ) | |||||||||||||||||||
| Issuance of shares | 334 | 1,342 | - | - | - | - | 1,676 | |||||||||||||||||||||
| Share-based payment | - | - | 71 | - | - | - | 71 | |||||||||||||||||||||
| Balance at June 30, 2017 | $ | 3,709 | $ | 36,447 | $ | 4,578 | $ | 1,060 | $ | 261 | $ | (34,646 | ) | $ | 11,409 |
6: R&D and G&A Detail:
| USD in Thousands | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Research and Development Expenses: | ||||||||||||||||
| Clinical studies | $ | 44 | $ | 163 | $ | 44 | $ | 257 | ||||||||
| R&D and preclinical studies | 37 | 120 | 80 | 158 | ||||||||||||
| General expenses | 8 | 97 | 15 | 108 | ||||||||||||
| Salaries and benefits | 53 | 56 | 92 | 139 | ||||||||||||
| Stock based compention | 43 | 11 | 63 | 23 | ||||||||||||
| Regulatory and other expenses | 10 | 8 | 21 | 10 | ||||||||||||
| Chemistry & formulation studies | 32 | - | 61 | - | ||||||||||||
| Subtotal, R&D expenses | 227 | 455 | 376 | 695 | ||||||||||||
| General and Administative Expenses: | ||||||||||||||||
| Investor relations and buisness development | $ | 85 | $ | 431 | $ | 117 | $ | 523 | ||||||||
| Professional & directors fees | 57 | 225 | 151 | 272 | ||||||||||||
| Salaries and benefits | 83 | 174 | 169 | 335 | ||||||||||||
| Rent and office maintenance | 11 | 80 | 79 | 135 | ||||||||||||
| Stock based compensation | 63 | 61 | 119 | 111 | ||||||||||||
| Subtotal, G&A expenses | 299 | 971 | 635 | 1,376 | ||||||||||||
| TOTAL | $ | 526 | $ | 1,426 | $ | 1,011 | $ | 2,071 |
Therapix Biosciences:
Biosciences Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists,
focused on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus,
the company is currently engaged in two internal drug development programs based on repurposing an FDA approved synthetic cannabinoid
(dronabinol): THX-TS01 targets to the treatment of Tourette's Syndrome; and THX-ULD01 targets the high-value and under-served
market of mild cognitive impairments. Please visit our website for more information at www.therapixbio.com
press release contains forward-looking statements about the Company's expectations, beliefs, and intentions. Forward-looking statements
can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan",
"may", "should", "could", "might", "seek", "target", "will",
"project", "forecast", "continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example,
forward-looking statements are used in this press release when we discuss our search for a U.S. based Chief Executive Officer.
These forward-looking statements involve certain risks and uncertainties, including, among others, risks that could cause the
Company's results to differ materially from those expected by Company management or otherwise described in or implied by the statements
in this press release. Any forward-looking statement in this press release speaks only as of the date of this press release. The
Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about
the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Therapix Biosciences
Ltd.'s annual report on Form 20-F dated May 1, 2017 filed with the SEC, which is available on the SEC's website, www.sec.gov.
further information: Investor Contact: Josh Blacher, CFO, Therapix Biosciences, josh@therapixbio.com
Therapix Biosciences Ltd
further information: +972-3-616-7055