Completed patient enrollment in Pivotal, Phase III Diabetic Foot Ulcer clinical trial
Pivotal, Phase III Venous Leg Ulcerclinical trial is showing strong recruitment rates
PETACH TIKVA, Israel, Nov. 3, 2014 (GLOBE NEWSWIRE) -- Macrocure Ltd. (Macrocure or the Company) (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced financial and operating results for the three and nine months ended September 30, 2014.
Recent Highlights:
- The Company's ongoing Diabetic Foot Ulcer (DFU), pivotal, Phase III, randomized, double-blind, and placebo controlled clinical trial completed patient enrollment in early September 2014, meeting its previously disclosed milestone.
- The Company's ongoing Venous Leg Ulcer (VLU), pivotal, Phase III, randomized, double-blind, and placebo controlled clinical trial, commenced patient enrollment in May 2014 and is showing strong recruitment rates. As of October 1st, 25+ sites in the United States are fully operational.
- The Company's Mechanism of Action (MOA) study is ongoing and is on track to be completed by Q4 2014.
- The Company reached an agreement with the U.S. Food & Drug Administration (FDA) in September 2014 whereby the Company is able to remove a blood matching requirement, which was previously necessary when administering CureXcell, Macrocure's lead product candidate for the treatment of chronic and hard-to-heal wounds.
Management Commentary
"We had a strong third quarter in terms of progressing our clinical trials and attaining key corporate milestones. We are pleased with the progress we continue to make with CureXcell's clinical development and path towards commercialization," stated Nissim Mashiach, President and Chief Executive Officer of Macrocure.
"Next year is an important year for Macrocure given our full roster of clinical milestones, including our MOA study results, the completion of our DFU trial and announcement of clinical results, and the interim analysis of our VLU trial. We look to the future with a lot of optimism as we endeavor to transform the advanced wound care space with CureXcell, our novel – once-monthly, injectable therapy of human, living cells for the treatment of chronic and hard-to-heal wounds," concluded Mr. Mashiach.
Financial Results for Third Quarter / Three Months Ended September 30, 2014
Research and development expenses for the third quarter of 2014 were $3.9 million, compared with $2.4 million for the third quarter of 2013. This increase was primarily due to costs associated with opening and operating new clinical sites in support of the VLU trial for CureXcell.
General and administrative expenses for the third quarter of 2014 were $1.7 million, compared with $2.9 million for the third quarter of 2013. The third quarters of 2014 and 2013 include a one-time, non-cash expense of $0.5 million and $2.5 million, respectively, which are related to a previous option grant.
Finance expenses, net for the third quarter of 2014 were $4.4 million, compared with $4.8 million for the third quarter of 2013. These expenses are one-time non-cash expenses associated with a convertible credit line, made available to the Company.
For the third quarter of 2014, the Company posted a net loss of $10.1 million, or $0.70 per share compared with a net loss of $10.2 million, or $1.37 per share, in the third quarter of 2013.
Financial Results for Nine Months Ended September 30, 2014
Research and development expenses for the nine months ended September 30, 2014 were $9.9 million, compared with $6.3 million for the comparable period in 2013. This increase was primarily due to costs associated with opening and operating new clinical sites in support of the VLU trial for CureXcell.
General and administrative expenses for the nine months ended September 30, 2014 were $3.5 million, compared with $3.7 million for the comparable period in 2013. The nine month periods ended September 30, 2014 and 2013 include a one-time, non-cash expense of $0.5 million and $2.5 million, respectively, which are related to a previous option grant.
Finance expenses, net for the nine months ended September 30, 2014 were $4.4 million, compared with $4.4 million for the comparable period in 2013. These are one-time non-cash expenses associated with a convertible credit line, made available to the Company.
For the nine months ended September 30, 2014, the Company posted a net loss of $17.9 million, or $1.84 per share, compared with a net loss of $14.5 million, or $1.94 per share, for the comparable period in 2013.
Balance Sheet Highlights
As of September 30, 2014, cash and cash equivalents, including short term deposits were $53.3 million, compared with $19.0 million as of December 31, 2013. This increase was due to the Company's Initial Public Offering on August 5, 2014, which resulted in the Company's receipt of approximately $46.7 million in net proceeds.
Expected Corporate Milestones
- Q4 2014: Mechanism of Action (MOA) study completion
- 1H 2015: MOA study results & Analyst Day
- 2H 2015: Phase 3 results for DFU
- 2H 2015: Phase 3 study interim data for VLU
- 2H 2016: Phase 3 study completion for VLU
- 2H 2016: Submit BLA to the FDA
Financial Results Conference Call and Webcast
Macrocure's management will host a conference call to discuss the financial results and provide a business update on Tuesday, November 4, 2014 at 9:00 am EST; 6:00 am PST; 4:00 pm Israel time. Shareholders and other interested parties may participate in the call by dialing (877) 303-6496 (domestic/U.S.) or (315) 625-3080 (international) and provide Conference ID: 18086398. Alternatively, to access a live audio webcast of the call please visit the Investor Relations section of the Company's website at http://investor.macrocure.com. The audio webcast will continue to be available for 30 days.
About Macrocure Ltd.
Macrocure Ltd. is a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, such as diabetic foot ulcers and venous leg ulcers. The Company's novel approach is to treat and close chronic and other hard-to-heal wounds by injecting the human body's own wound healing and regenerative components directly into the wound itself.
Macrocure's lead product candidate, CureXcell, is a unique combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure. CureXcell addresses each phase of healing in the impaired wound, including the production of growth factors and other biochemical factors involved in fibroblast activation, cell migration and extracellular matrix production, stimulating the body's natural healing process. CureXcell is currently in two pivotal Phase III, double-blind clinical trials targeting a broad indication for the treatment of all types of wounds below the knee. For more information, please visit: www.macrocure.com.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecasts, commercial results, clinical trials and regulatory authorizations. Forward-looking statements are based on Macrocure's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in regulatory approval process or additional competition in the market, including those risks discussed under the heading "Risk Factors" in Macrocure's Registration Statement on Form F-1 filed with the Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this announcement and Macrocure undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
| Unaudited Condensed Interim Consolidated Statements of Financial Position as of | ||
| U.S. dollars in thousands | As of Sep-30 | As of Dec-31 |
| 2014 | 2013 | |
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | 45,785 | 18,995 |
| Short term deposits | 7,500 | -- |
| Accounts receivable | 1,175 | 569 |
| Total current assets | 54,460 | 19,564 |
| Non-current assets | ||
| Property and equipment, net | 473 | 330 |
| Intangible assets, net | 413 | 827 |
| Deposits | 10 | 17 |
| Total non-current assets | 896 | 1,174 |
| Total assets | 55,356 | 20,738 |
| Liabilities and Shareholders' Equity | ||
| Current liabilities | ||
| Trade and other payables | 1,971 | 1,971 |
| Total liabilities | 1,971 | 1,971 |
| Shareholders' equity | ||
| Ordinary shares of NIS 0.01 par value | 46 | 20 |
| Series A preferred shares of NIS 0.01 par value | * | |
| Share premium | 99,978 | 48,158 |
| Capital reserve | 5,752 | 5,117 |
| Warrants held by shareholders | 8,219 | 8,219 |
| Accumulated deficit | (60,610) | (42,747) |
| Total shareholders' equity | 53,385 | 18,767 |
| Total liabilities and shareholders' equity | 55,356 | 20,738 |
| * Represents an amount lower than $1. | ||
| Unaudited Condensed Interim Consolidated Statements of Loss | ||||
|
Nine months ended |
Three months ended |
|||
| U.S. dollars in thousands | September 30, | Sep 30, | ||
| 2014 | 2013 | 2014 | 2013 | |
| Research and development expenses, net | 9,863 | 6,283 | 3,946 | 2,446 |
| General and administrative expenses | 3,512 | 3,732 | 1,689 | 2,933 |
| Operating Loss | (13,375) | (10,015) | (5,635) | (5,379) |
| Finance expenses, net | (4,410) | (4,355) | (4,421) | (4,778) |
| Loss before income tax | (17,785) | (14,370) | (10,056) | (10,157) |
| Taxes on income | (78) | (99) | -- | (49) |
| Loss for the period | (17,863) | (14,469) | (10,056) | (10,206) |
| Loss per share - basic and diluted (in U.S. dollars) (*) | (1.84) | (1.94) | (0.70) | (1.37) |
| Unaudited Condensed Interim Consolidated Statements of Cash Flows | ||||
| U.S. dollars in thousands | ||||
| Nine months ended | Three months ended | |||
| September 30, | Sep 30, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Cash flows from operating activities: | ||||
| Loss for the period | (17,863) | (14,469) | (10,056) | (10,206) |
| Adjustments: | ||||
| Depreciation | 82 | 64 | 25 | 22 |
| Amortization | 414 | 413 | 138 | 137 |
| Financing expenses, net | 4,410 | 4,355 | 4,421 | 4,778 |
| Taxes on income | 78 | 99 | -- | 49 |
| Share based compensation | 1,222 | 2,432 | 655 | 2,419 |
| 6,206 | 7,363 | 5,239 | 7,405 | |
| Changes in operating assets and liability items: | ||||
| Decrease (increase) in accounts receivable | (606) | (6) | 1,297 | (172) |
| Increase (decrease) in trade and other payables | 33 | 911 | (1,156) | 1,021 |
| (573) | 905 | 141 | 849 | |
| Income tax paid | (152) | -- | -- | |
| Interest received | 14 | 58 | 6 | 13 |
| Net cash used in operating activities | (12,368) | (6,143) | (4,670) | (1,939) |
| Cash flows from investing activities: | ||||
| Purchase of property and equipment | (226) | (70) | (120) | (8) |
| Decrease in long terms deposits | 7 | 1 | 1 | -- |
| Investment in short term deposits | (7,500) | -- | (7,500) | -- |
| Net cash used in investing activities | (7,719) | (69) | (7,619) | (8) |
| Cash flows from financing activities: | ||||
| Proceeds from issuance of ordinary shares, net of issuance costs | 46,689 | 13,750 | 46,689 | 13,750 |
| Exercise of options | 200 | -- | 200 | -- |
| Net cash provided by financing activities | 46,889 | 13,750 | 46,889 | 13,750 |
| Net increase (decrease) in cash and cash equivalents | 26,802 | 7,538 | 34,600 | 11,803 |
| Effect of exchange rate changes on cash and cash equivalents | (12) | (11) | (6) | 3 |
| Cash and cash equivalents at beginning of the period | 18,995 | 15,322 | 11,191 | 11,043 |
| Cash and cash equivalents at end of the period | 45,785 | 22,849 | 45,785 | 22,849 |