0001144204-15-064294.txt : 20151112 0001144204-15-064294.hdr.sgml : 20151112 20151112060233 ACCESSION NUMBER: 0001144204-15-064294 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20151111 FILED AS OF DATE: 20151112 DATE AS OF CHANGE: 20151112 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NeuroDerm Ltd. CENTRAL INDEX KEY: 0001598696 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36737 FILM NUMBER: 151221013 BUSINESS ADDRESS: STREET 1: RUHRBERG SCIENCE BUILDING STREET 2: 3 PEKERIS ST. CITY: REHOVOT STATE: L3 ZIP: 7670203 BUSINESS PHONE: 97289462729 MAIL ADDRESS: STREET 1: RUHRBERG SCIENCE BUILDING STREET 2: 3 PEKERIS ST. CITY: REHOVOT STATE: L3 ZIP: 7670203 FORMER COMPANY: FORMER CONFORMED NAME: NeuroDerm, Ltd. DATE OF NAME CHANGE: 20140130 6-K 1 v424361_6k.htm FORM 6-K

 



SECURITIES AND EXCHANGE COMMISSION

 

Washington, D.C.  20549

______________________

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

 

Pursuant to Rule 13a-16 or 15d-16 of the

 

Securities Exchange Act of 1934

 

For the month of November 2015

 

Commission File Number: 001-36737

 

NeuroDerm Ltd.

 

(Translation of registrant’s name into English)

 

NeuroDerm Ltd.

Ruhrberg Science Building

3 Pekeris St.

Rehovot 7670212, Israel

+972 (8) 946-2729l

 (Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 


 

 

  

EXPLANATORY NOTE

 

On November 11, 2015, NeuroDerm Ltd. issued a press release announcing its third quarter 2015 financial results. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.

 

On November 11, 2015, NeuroDerm Ltd. issued a press release announcing a streamlined U.S. developed plan following feedback received from the U.S. Federal Drug Administration regarding ND0612H and ND0612L. A copy of this press release is attached to this Form 6-K as Exhibit 99.2.

 

The press releases attached as Exhibit 99.1 and Exhibit 99.2 to this Report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statement on Form S-8, File No. 333-200331.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NeuroDerm Ltd.
     
     
Date: November 11, 2015 By: /s/Roy Golan
   

Name: Roy Golan 

Title: Chief Financial Officer 

   

 

 

 

Exhibit Index

 

Exhibit   Description
     
99.1   Press release dated November 11, 2015, announcing its third quarter 2015 financial results.
     
99.2   Press release dated November 11, 2015, announcing a streamlined U.S. developed plan following feedback received from the U.S. Federal Drug Administration regarding ND0612H and ND0612L.

 

 

EX-99.1 2 v424361_ex99-1.htm EXHIBIT 99.1

 

 

Exhibit 99.1

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NeuroDerm Announces Third Quarter 2015 Financial Results

 

- Company to host conference call and webcast today at 8:30 a.m. ET -

 

REHOVOT, Israel – November 11, 2015 – NeuroDerm Ltd. (Nasdaq: NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced financial results for the third quarter ended September 30, 2015.

 

“We made solid progress in the third quarter developing our next-generation treatments for Parkinson’s disease through subcutaneous administration of the first ever liquid formulation of levodopa/carbidopa to provide a better quality of life for patients suffering from this debilitating disease,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We look forward to executing on our streamlined clinical development program and initiating our planned clinical trials in the coming months.”

 

Financial Results for the Quarter Ended September 30, 2015

 

Research and development expenses, net were $3.7 million in the three months ended September 30, 2015 compared to $1.3 million in the same period in 2014. The increase was primarily due to production costs related to our product candidates for use in our planned clinical trials and an increase in share-based payments.

 

General and administrative expenses were $1.2 million in the three months ended September 30, 2015 compared to $0.8 million in the same period in 2014. The increase was primarily due to an increase in share-based payments.

 

The Company reported a net loss of $1.5 million in the three months ended September 30, 2015 compared to $3.9 million for the same period in 2014. The decrease in net loss was primarily due to the positive impact of changes in exchange rates on our cash balances in the three months ended September 30, 2015, partially offset by an increase in research and development expenses, net. In addition, in the three months ended September 30, 2014 the Company had non-cash financial expenses related to the fair value of our convertible loans, embedded derivatives and financial instruments which were converted into ordinary shares prior to the Company’s initial public offering in the fourth quarter of 2014.

 

As of September 30, 2015, the Company had cash and cash equivalents and short-term bank deposits totaling $104.6 million.

 

 

 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

The Company is a clinical-stage pharmaceutical company with a limited operating history, has not yet generated revenue from its operations and continues to incur significant research and development and other expenses related to its ongoing operations. The Company is still in the early stages of development of its product candidates. Accordingly, there is no assurance that the Company’s business will generate positive cash flow. As of September 30, 2015, the Company had an accumulated deficit of $141.5 million and its activities have been funded through public and private offerings of the Company's securities and issuance of convertible loans and warrants.

 

Conference Call Details

 

NeuroDerm will host a conference call at 8:30 a.m. ET today to discuss the Company’s 2015 third quarter financial results. Individuals can access the webcast in the Events and Presentations section of the Company’s website, by clicking here, or by dialing 888-389-5988 (U.S.) or 719-325-2428 (outside of the U.S.). The passcode is 5664132. A webcast will be archived on the website.

 

About NeuroDerm

NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson’s disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson’s disease patients, respectively, and ND0680 for a subset of severe Parkinson’s disease patients whose symptoms have advanced to a highly advanced stage, requiring even higher doses of LD/CD. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.

 

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2014 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

2 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NEURODERM LTD.

CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(Unaudited)

(U.S. dollars in thousands)

 

   December 31,   September 30, 
Assets:  2014   2015 
         
Current assets:          
Cash and cash equivalents  $43,238   $89,482 
Short-term bank deposits   -    15,072 
Prepaid expenses and receivables   506    636 
    43,744    105,190 
Non-current assets:          
Restricted bank deposits   50    50 
Long-term prepaid expenses   -    146 
Property, plant and equipment   120    144 
    170    340 
Total  assets  $43,914   $105,530 

 

3 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NEURODERM LTD.

CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(Unaudited)

(U.S. dollars in thousands)

 

    December 31,     September 30,  
Liabilities and Shareholders’ deficit:   2014     2015  
Liabilities:                
Current liabilities:                
Accounts payable:                
Trade   $ 54     $ 966  
Other     3,354       2,425  
      3,408       3,391  
Shareholders payable     1,037       44  
Total  Liabilities   $ 4,445     $ 3,435  
Shareholders’ deficit:                
Share capital:                
Ordinary Shares, NIS 0.01 par value –
authorized – 160,000,000 shares at December 31, 2014 and September 30, 2015, issued and outstanding – 16,996,960 shares and 21,536,938 shares at December 31, 2014 and September 30, 2015, respectively.
    25       37  
Additional paid-in capital     167,281       239,246  
Share-based compensation capital reserve     5,091       6,929  
Accumulated deficit     (132,629 )     (141,508 )
Foreign currency translation differences     (299 )     (2,609 )
Total shareholders’ deficit     39,469       102,095  
Total  liabilities and shareholders’ deficit   $ 43,914     $ 105,530  

 

4 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NEURODERM LTD.

CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(U.S. dollars in thousands, except per share data)

    Nine months ended   Three months ended 
   September 30,   September 30,   September 30,   September 30, 
   2014   2015   2014   2015 
Operating expenses:                    
Research and development  $5,485   $9,405   $1,812   $3,896 
Participation in research and development   (843)   (725)   (504)   (242)
Research and development, net   4,642    8,680    1,308    3,654 
General and administrative   2,552    3,125    849    1,235 
Operating loss:   7,194    11,805    2,157    4,889 
Financial income   291    2,937    359    3,412 
Financial expenses   2,662    11    2,128    3 
Financial expenses (income), net   2,371    (2,926)   1,769    (3,409)
Net loss   9,565    8,879    3,926    1,480 
Other comprehensive loss -                    
Items that will not be reclassified                    
to profit or loss -                    
Foreign currency translation differences   (560)   2,310    (624)   3,396 
Total comprehensive loss  $9,005   $11,189   $3,302   $4,876 
Basic and diluted loss per ordinary share  $24.38   $0.49   $10.01   $0.07 

 

5 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NEURODERM LTD.

CONDENSED INTERIM STATEMENTS OF CASH FLOWS

(Unaudited)

(U.S. dollars in thousands)

 

   Nine months ended   Three months ended 
   September 30,   September 30,   September 30,   September 30, 
   2014   2015   2014   2015 
Cash flows from operating activities:                    
Net loss  $(9,565)  $(8,879)  $(3,926)  $(1,480)
Adjustments in respect of:                    
Depreciation   27    32    9    12 
Capital loss   12    -    -    - 
Interest and exchange differences of convertible loans   *    -    -    - 
Changes in fair value of embedded derivatives and financial
instruments at fair value through profit or loss
   1,747    -    1,223    - 
Changes in fair value of warrants   (115)   -    (154)   - 
Share-based compensation to employees and service providers   46    1,867    12    815 
Interest and exchange differences on Short- term deposits and restricted deposits   -    247    -    (860)
Exchange differences in respect of cash and cash equivalents   (176)   (2,807)   (207)   (2,510)
    (8,024)   (9,540)   (3,043)   (4,023)
Changes in asset and liability items:                    
Decrease (increase) in prepaid expenses and receivables   106    (144)   (230)   27 
Decrease (increase) in long-term prepaid expenses   -    (136)   -    7 
Increase (decrease) in accounts payable:                    
Trade   188    919    44    659 
Other   2,336    (907)   660    (649)
Decrease in shareholders payable   -    (993)   -    - 
    2,630    (1,261)   474    44 
Net cash used in operating activities   (5,394)   (10,801)   (2,569)   (3,979)
                     
Cash flows from investing activities:                    
Purchase of property, plant and equipment   (120)   (55)   -    (7)
Sale of property, plant and equipment   3    -    (9)   - 
Proceeds from Short-term bank deposits   -    8,545    -    8,545 
Investment in short-term bank deposits   -    (23,510)   -    - 
Restricted bank deposits, net   (53)   -    4    - 
Net cash provided by (used in) investing activities   (170)   (15,020)   (5)   8,538 
Cash flows from financing activities -                    
Proceeds from exercise of options by employees to ordinary shares   -    46    -    46 
Issuance of ordinary shares, net of issuance costs   -    71,902    -    71,902 
Convertible loans and warrants issued   7,819    -    5,641    - 
Net cash provided by financing activities   7,819    71,948    5,641    71,948 
Increase in cash and cash equivalents   2,255    46,127    3,067    76,507 
Balance of cash and cash equivalents at beginning of the period   2,435    43,238    1,632    13,011 
Foreign currency translation differences                    
in respect of cash and cash equivalents   (358)   (2,690)   (398)   (2,546)
Exchange differences in respect of cash and                    
cash equivalents   176    2,807    207    2,510 
Balance of cash and cash equivalents at end of period  $4,508   $89,482   $4,508   $89,482 
Supplementary information on interest received from cash and cash equivalents   *    99    *    78 

 

* Represents amount less than $1 thousand.

 

# # #

 

6 

 

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NeuroDerm Contact:

Oded S. Lieberman, PhD MBA, CEO

oded@neuroderm.com

Tel.: +972-8-946 2729

Cell: +1-617-517 6077

 

U.S. Investor Contact:

David Carey

Lazar Partners Ltd.

dcarey@lazarpartners.com

+212-867-1762

 

7 

EX-99.2 3 v424361_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

3 Pekeris St., Rabin Science Park, Rehovot 7670212, ISRAEL. Tel: 972-8-9462729, Fax: 972-8-9461729

 

 

NeuroDerm Announces Streamlined U.S. Development Plan Following FDA Feedback on ND0612H and ND0612L for the Treatment of Parkinson’s Disease

 

– Based on FDA input, NeuroDerm is not required to conduct its largest Phase III pivotal trial of 360 patients –

 

– Company to host conference call today at 8:30 a.m. ET –

 

REHOVOT, Israel – November 11, 2015 NeuroDerm Ltd. (Nasdaq: NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that it has modified its U.S. development plan for ND0612H and ND0612L, the company’s continuous, subcutaneously delivered levodopa/carbidopa product candidates for the treatment of Parkinson’s disease. The updated and abbreviated plan incorporates written feedback that the company recently received from the U.S. Food and Drug Administration (FDA) within the framework of an ongoing Type C meeting communication that was initiated by the company. NeuroDerm asked the agency to provide strategic and operational guidance related to the U.S. clinical and regulatory development of ND0612H and ND0612L.

 

NeuroDerm’s new development plan for ND0612H and ND0612L consists of the following:

 

ND0612H:

Clinical development of ND0612H for the U.S. will proceed as planned with one Phase II trial and one Phase III trial of essentially the same design, treatment duration and patient numbers as originally planned. The Phase II trial will include centers in Israel and the EU in addition to U.S. centers, however essentially preserving the original design, number of centers, number of patients and treatment duration.

 

ND0612L:

Clinical development of ND0612L for the U.S. and the EU will be based on only one and not two pivotal efficacy trials of essentially the same design, treatment duration and patient numbers (200-240) as originally planned. The second pivotal efficacy trial of 360 patients that was originally planned for this product candidate is not required by the FDA.

 

ND0612 Safety Follow-up:

A safety follow up study for both ND0612H and ND0612L will include at least 100 patients treated for one year of whom at least half will receive the maximum dose. The safety follow-up studies that were originally planned included 50-150 patients treated for 6-12 months for each of the product candidates.

 

Timelines:

The supplier of the delivery devices used in the clinical trials of both ND0612L and ND0612H has been requested by the FDA to provide additional documentation pertaining to good manufacturing practices of the Quality System regulation. Until documentation is provided to the satisfaction of the FDA, this supplier may not import devices into the U.S. This does not preclude the sale or use of devices currently in the US nor the importation of devices for investigational purposes if approved as part of an investigational study. Nevertheless, NeuroDerm has decided to request additional documentation from the device manufacturer before proceeding with enrollment at U.S. investigator sites. Patient enrollment in its upcoming clinical trials will thus begin at non-U.S. investigator sites. NeuroDerm expects that the requested documents will be provided by the supplier in the first quarter of 2016 enabling the company to start enrolling U.S. patients in the second quarter of 2016.

 

 

 

 

In the EU, the pharmacokinetic pilot dose finding study of ND0612H is ongoing and topline results are now expected in the second quarter of 2016. NeuroDerm does not foresee any changes to previously disclosed timelines related to anticipated EU submission.

 

The currently anticipated timelines for the ongoing and upcoming clinical trials are as follows:

 

ND0612H

·Pharmacokinetic (PK) pilot dose finding study (EU trial): ongoing; topline results expected in the second quarter of 2016
·Initiation of Phase II efficacy trial and long-term safety follow-up (Israel-EU-U.S.): end of 2015 – beginning of 2016

 

ND0612L

·Initiation of Phase III efficacy trial and long-term safety follow-up (Israel-EU-U.S.): first half of 2016

 

“We are pleased that based on feedback from the FDA the largest clinical trial in our development program will not be required, resulting in a streamlined clinical development plan,” said Oded S. Lieberman, PhD, NeuroDerm’s CEO. “We believe our product candidates have the potential to revolutionize the treatment of Parkinson’s disease and we are committed to provide a new treatment option to both advanced and moderate Parkinson’s patients.”

 

Conference Call Details

NeuroDerm will host a conference call at 8:30 a.m. ET today to discuss the Company’s updated development strategy and review third quarter 2015 financial results. Individuals can access the webcast in the Events and Presentations section of the Company’s website, by clicking here, or by dialing 888-389-5988 (U.S.) or 719-325-2428 (outside of the U.S.). The passcode is 5664132. A webcast will be archived on the website.

 

ND0612H and ND0612L

ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson’s disease patients through continuous, subcutaneous delivery of LD/CD. Previously completed Phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including “off time” reductions when added to optimized oral standard of care. ND0612H, intended for severe Parkinson’s disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.

 

About Parkinson’s disease

Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as "off" time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia. The "off" time and dyskinesia affect the majority of Parkinson's disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson's disease patients, however, a convenient route of continuous administration has not been introduced to date.

 

 

 

 

About NeuroDerm

NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson’s disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson’s disease patients, respectively. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.

 

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2014 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

NeuroDerm Contact:

Oded S. Lieberman, PhD, MBA, CEO

oded@neuroderm.com

Tel.: +972-8-946 2729

Cell: +1-617-517 6077

 

U.S. Investor and Media Contact:

David Carey

Lazar Partners Ltd.

dcarey@lazarpartners.com

+212-867-1762

 

 

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