Intec Pharma Reports Third Quarter 2019 Financial Results and Provides Business Update
Highlights of the third quarter 2019 and recent weeks include:
- Presented two posters highlighting data from the Company's Phase 3 clinical development program for the Accordion Pill® Carbidopa/Levodopa (AP-CD/LD) at the International Congress of Parkinson's and Movement Disorder Society (MDS 2019);
- Completed the qualification studies for the commercial scale manufacture of AP-CD/LD with our partner, LTS LohmanTherapie-Systeme (LTS);
- Announced topline results from the Company's pivotal Phase 3 trial (ACCORDANCE) evaluating the safety and efficacy of the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease (PD), reporting that AP-CD/LD provided treatment for Parkinson's disease symptoms but did not demonstrate statistical superiority to IR-CD/LD in terms of reduction in OFF time from baseline under the conditions established in the protocol; and
- Completed the pharmacokinetic (PK) study of the custom-designed AP developed for a proprietary compound under the previously announced feasibility and option agreement with
Novartis Pharmaceuticals .
Management Commentary
"We gained important information and knowledge from the ACCORDANCE study that we believe makes AP-CD/LD an attractive partnership opportunity for late-stage development and commercialization. First, the ACCORDANCE results validate the AP platform and provide very important long-term safety data. The responder analysis and subset analyses provide key insights for future study design and dosing that should be invaluable to a potential partner. We have qualified the commercial scale manufacturing process with LTS, which can also be used to provide clinical supply for the next Phase 3 study. This is a key advantage as Chemistry, Manufacturing and Controls (CMC) is a critical component in drug development and one that often trips up small companies. Importantly, there continues to be a large unmet need for a better baseline LD, which we believe provides a significant market opportunity of between
"We were delighted to present two posters highlighting AP-CD/LD at MDS 2019 in late September. We were particularly pleased to have our Phase 3 ACCORDANCE clinical trial poster chosen for the conference's Guided Tour, a distinction that drives attendees to view the approximately ten percent of posters selected for inclusion. Consequently, there was considerable interest in our program's results. We believe the data underscored the potential of AP-CD/LD as a better baseline levodopa therapy in PD while highlighting its long-term safety data. In tandem, we are in the process of seeking to partner AP-CD/LD in PD and found it most beneficial to have these data delivered at this important medical meeting. The continued understanding of the full dataset from ACCORDANCE will be important as we seek to partner AP-CD/LD for late-stage clinical development and commercialization in PD patients.
"Moving forward, we continue to glean important learnings from the ongoing data analysis. As we present these to potential partners, we continue to advance the buildout of our commercial manufacturing process with LTS. As noted, having these state-of-the art commercial scale production facilities in place is expected to be of great value to any potential partner. We will also be completing the required regulatory submissions and reports that are necessary for clinical and CMC filings, which we expect to further enhance partnership opportunities.
"In
"We continued to invest in building out the Company's next phase of growth through the AP platform's innovation engine as it can provide multiple opportunities for pipeline expansion. Toward that end, we were delighted to partner with
"The development of our AP containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis, completed an initial PK study earlier this year. The results showed that the delivery of THC did not meet our full expectations for this program. Our R&D team is in the process of refining the AP-THC in order to fully meet our specifications for the oral delivery of THC and CBD. We are seeking to launch a PK study with the optimized AP-THC next year.
"In addition to our current development pipeline, our team continues to advance discussions with other potential pharmaceutical partners for the development of new custom-designed APs. We believe the data from our ACCORDANCE trial enhances those discussions as it validates the AP platform and provides long-term safety data. Our goal remains to add one or two new programs per year. We believe this is the most efficient strategy for building our pipeline and for creating value from our platform.
"Our mission remains steadfast; to build value by leveraging the potential of our AP platform to enhance the characteristics of a number of proprietary compounds and to develop innovative approaches to the treatment of diseases. Our growth strategy continues to focus on advancing a mix of internally-led programs with partnered programs believing that having a variety of 'shots on goal' will provide Intec with a growing pipeline and long-term royalty stream with the potential to create significant value over time," concluded Mr. Meckler.
Financial Highlights for the Three and Nine Months Ended
Research and development expenses, net, for the three-month period ended
General and administrative expenses for the three-month period ended
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three and nine months ended
Net loss for the three-month period ended
Loss per ordinary share for the three-month period ended
As of
Net cash used in operating activities during the nine-month period ended
The Company had negative cash flow from investing activities of approximately
Net cash provided by financing activities during the nine-month period ended
About
Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company's Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage development for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with
For more information, visit www.intecpharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward looking statements about our 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. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our ability to continue as a going concern, our ability to obtain additional financing, our ability to successfully operate our business or execute our business plan, our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, manufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influence of extensive and costly government regulation and our ability to remain listed on the
-Tables to Follow-
INTEC PHARMA LTD. |
|||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||
September 30, 2019 |
December 31, 2018 |
||
U.S. dollars in thousands |
|||
Assets |
|||
CURRENT ASSETS: |
|||
Cash and cash equivalents |
$ 14,966 |
$ 39,246 |
|
Investment in marketable securities |
767 |
1,333 |
|
Prepaid expenses and other receivables |
2,453 |
2,986 |
|
TOTAL CURRENT ASSETS |
18,186 |
43,565 |
|
NON-CURRENT ASSETS: |
|||
Other assets |
4,204 |
5,431 |
|
Property and equipment, net |
6,200 |
12,233 |
|
Operating lease right-of-use assets |
1,687 |
- |
|
Deferred tax assets |
504 |
281 |
|
TOTAL NON-CURRENT ASSETS |
12,595 |
17,945 |
|
TOTAL ASSETS |
$ 30,781 |
$ 61,510 |
|
Liabilities and shareholders' equity |
|||
CURRENT LIABILITIES - |
|||
Accounts payable and accruals: |
|||
Trade |
$ 4,834 |
$ 2,849 |
|
Other |
6,774 |
4,807 |
|
TOTAL CURRENT LIABILITIES |
11,608 |
7,656 |
|
LONG-TERM LIABILITIES - |
|||
Non-current operating lease liabilities |
1,132 |
- |
|
Other liabilities |
554 |
309 |
|
TOTAL LONG-TERM LIABILITIES |
1,686 |
309 |
|
TOTAL LIABILITIES |
13,294 |
7,965 |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
|||
SHAREHOLDERS' EQUITY: |
|||
Ordinary shares, with no par value - authorized: 100,000,000 Ordinary Shares as of |
727 |
727 |
|
Additional paid-in capital |
199,627 |
194,642 |
|
Accumulated deficit |
(182,867) |
(141,824) |
|
TOTAL SHAREHOLDERS' EQUITY |
17,487 |
53,545 |
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ 30,781 |
$ 1,510 |
INTEC PHARMA LTD. |
|||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
Three months ended |
Nine months ended |
||||||
2019 |
2018 |
2019 |
2018 |
||||
U.S. dollars in thousands |
U.S. dollars in thousands |
||||||
OPERATING EXPENSES: |
|||||||
RESEARCH AND DEVELOPMENT EXPENSES, net |
(8,448) |
(7,809) |
(24,850) |
(25,089) |
|||
GENERAL AND ADMINISTRATIVE EXPENSES |
(2,157) |
(1,696) |
(6,491) |
(5,800) |
|||
IMPAIRMENT OF LONG-LIVED ASSETS |
(9,759) |
(9,759) |
|||||
OPERATING LOSS |
(20,364) |
(9,505) |
(41,100) |
(30,889) |
|||
FINANCIAL INCOME (EXPENSES), net |
14 |
163 |
157 |
(5) |
|||
LOSS BEFORE INCOME TAX |
(20,350) |
(9,342) |
(40,943) |
(30,894) |
|||
TAX BENEFIT (INCOME TAX) |
(28) |
164 |
(100) |
(46) |
|||
NET LOSS |
(20,378) |
(9,178) |
(41,043) |
(30,940) |
|||
U.S. dollars |
|||||||
LOSS PER SHARE BASIC AND DILUTED |
(0.61) |
(0.28) |
(1.23) |
(1.01) |
|||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN |
33,516 |
33,226 |
33,356 |
30,505 |
(Continued) - 1 |
|||||||||||
INTEC PHARMA LTD. |
|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY |
|||||||||||
Ordinary Shares |
Additional |
Accumulated Deficit |
Total |
||||||||
Number of shares |
Amounts |
Amounts |
|||||||||
U.S. dollars in thousands |
|||||||||||
BALANCE AT JANUARY 1, 2018 |
|||||||||||
CHANGES IN THE NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2018: |
26,075,770 |
$ 727 |
$ 156,356 |
$ (98,281) |
$ 58,802 |
||||||
Issuance of ordinary shares, net of issuance costs |
7,150,000 |
- |
35,029 |
- |
35,029 |
||||||
Exercise of options |
218 |
- |
1 |
- |
1 |
||||||
Share-based compensation |
- |
- |
2,452 |
- |
2,452 |
||||||
Net loss |
- |
- |
- |
(30,940) |
(30,940) |
||||||
BALANCE AT SEPTEMBER 30, 2018 |
33,225,988 |
$ 727 |
$ 193,838 |
$ (129,221) |
$ 65,344 |
||||||
BALANCE AT JANUARY 1, 2019 |
|||||||||||
CHANGES IN THE NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2019: |
33,232,988 |
$ 727 |
$ 194,642 |
$ (141,824) |
$ 53,545 |
||||||
Issuance of ordinary shares, net of issuance costs |
1,716,679 |
- |
1,969 |
- |
1,969 |
||||||
Exercise of options |
69,812 |
- |
268 |
- |
268 |
||||||
Share-based compensation |
- |
- |
2,748 |
- |
2,748 |
||||||
Net loss |
- |
- |
- |
(41,043) |
(41,043) |
||||||
BALANCE AT SEPTEMBER 30, 2019 |
35,019,479 |
$ 727 |
$ 199,627 |
$ (182,867) |
$ 17,487 |
(Continued) - 2 |
|||||||||||
INTEC PHARMA LTD. |
|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY |
|||||||||||
Ordinary Shares |
Additional |
Accumulated |
Total |
||||||||
Number of shares |
Amounts |
Amounts |
|||||||||
U.S. dollars in thousands |
|||||||||||
BALANCE AT JULY 1, 2018 |
33,225,988 |
$ 727 |
$ 192,987 |
$ (120,043) |
$ 73,671 |
||||||
CHANGES IN THE THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2018: |
|||||||||||
Share-based compensation |
- |
- |
851 |
- |
851 |
||||||
Net loss |
- |
- |
- |
(9,178) |
(9,178) |
||||||
BALANCE AT SEPTEMBER 30, 2018 |
33,225,988 |
$ 727 |
$ 193,838 |
$ (129,221) |
$ 65,344 |
||||||
BALANCE AT JULY 1, 2019 |
33,302,800 |
$ 727 |
$ 196,871 |
$ (162,489) |
$ 35,109 |
||||||
CHANGES IN THE THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2019: |
|||||||||||
Issuance of ordinary shares, net of issuance costs |
1,716,679 |
- |
1,969 |
- |
1,969 |
||||||
Share-based compensation |
- |
- |
787 |
- |
787 |
||||||
Net loss |
- |
- |
- |
(20,378) |
(20,378) |
||||||
BALANCE AT SEPTEMBER 30, 2019 |
35,019,479 |
$ 727 |
$ 199,627 |
$ (182,867) |
$ 17,487 |
INTEC PHARMA LTD. |
|||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
|||
Nine months ended September 30 |
|||
2019 |
2018 |
||
U.S. dollars in thousands |
|||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|||
Net loss |
(41,043) |
(30,940) |
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|||
Depreciation |
643 |
639 |
|
Impairment of long-lived asset |
9,759 |
||
Exchange differences on cash and cash equivalents |
69 |
(528) |
|
Right of use asset |
523 |
- |
|
Lease liability |
(380) |
- |
|
Losses (gains) on marketable securities |
(10) |
141 |
|
Share-based compensation |
2,748 |
2,452 |
|
Changes in operating assets and liabilities: |
|||
Decrease in prepaid expenses and other receivables |
483 |
(979) |
|
Increase in deferred tax assets |
(223) |
- |
|
Increase in accounts payable and accruals |
3,268 |
(1,734) |
|
Increase in other liabilities |
245 |
- |
|
Net cash used in operating activities |
(23,918) |
(30,949) |
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|||
Purchase of property and equipment |
(791) |
(2,632) |
|
Investment in other assets |
(2,315) |
(2,450) |
|
Proceeds from disposal (purchase) of marketable securities, net |
576 |
(38) |
|
Net cash used in investing activities |
(2,530) |
(5,120) |
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|||
Proceeds from issuance of ordinary shares, net of issuance costs |
1,969 |
35,029 |
|
Proceeds from exercise of options |
268 |
1 |
|
Net cash provided by financing activities |
2,237 |
35,030 |
|
DECREASE IN CASH AND CASH EQUIVALENTS |
(24,211) |
(1,039) |
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD |
39,246 |
53,393 |
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
(69) |
528 |
|
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD |
14,966 |
52,882 |
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING ACTIVITIES: |
|||
Liability with respect to property and equipment |
123 |
1,898 |
|
Liability with respect to other assets |
549 |
244 |
|
SUPPLEMENTARY DISCLOSURE OF CASH FLOW INFORMATION - |
|||
Taxes paid |
50 |
31 |
|
Interest received |
315 |
522 |
Intec Pharma Investor Contact:
Anne Marie Fields
646-200-8808
amf@intec-us.com
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