Macrocure Ltd., a clinical-stage biotech company developing treatments for chronic and hard-to-heal wounds, recently announced second quarter financial results. Highlights noted in the fiscal summary include:
- In June, a meeting with the Data Safety Monitoring Board (DSMB) resulted in an advisement to continue without modification a Phase III clinical trial for CureXcell for treating hard-to-heal diabetic foot ulcers (DFU).
- There continues to be strong enrollment rates for the DFU study.
- In May, patient enrollment was initiated for a venous leg ulcer (VLU) clinical trial.
- In August, an Initial Public Offering of 5.35 million ordinary shares was achieved, raising net $47.8 million after deducting underwriting discounts, commissions, and estimated offering expenses.
Nissim Mashiach, President and CEO of Macrocure, made the following statement:
Year-to-date, we made significant progress in executing our business strategy and advancing our clinical activities for CureXcell. We significantly advanced the DFU trial, a pivotal Phase III clinical trial for CureXcell. We continued to see high patient recruitment rates and remain on track to meet our previously disclosed milestone to complete patient enrollment in the second half of 2014. Additionally, we commenced a VLU trial, also a pivotal Phase III clinical trial, for the treatment of hard-to-heal VLUs, and randomized the first patient in May 2014.
With the proceeds of our Initial Public Offering, we are well-positioned to fund our clinical and regulatory activities in order to seek regulatory approvals for a broad indication for the treatment of DFU and VLU in all types of chronic wounds below the knee, and build our manufacturing operations. We look forward to reporting further progress this year and remain committed to enhancing shareholder value as a publicly-traded company.
A number of firms have since offered positive analyses of the company, ranging from “outperform” to “buy” in their recommendations. Several of these companies were actively involved in the management of Macrocure’s IPO. Credit Suisse Securities (USA) LLC and Jefferies LLC acted as joint book-running managers, while Nomura Securities International, Inc. and Oppenheimer & Co. Inc. acted as co-managers.
Credit Suisse began covering the company and set its initial recommendation with an “outperform” rating and a $15 price target on the company’s stock. The analysts wrote, “MCUR has two phase III trials for its CureXcell in diabetic foot ulcers (DFU) and venous leg ulcers (VLU), with data expected in 2015. CureXcell is a human-blood-derived product that uses activated macrophages to close hard-to-heal wounds. Currently, there are ~2M chronic DFUs & VLUs annually, which implies a $10B opportunity, given our assumed ~$5,000 per patient WW ASP for CureXcell. DFUs and VLUs are only modestly penetrated by existing AWC products due to a lack of clinical data, equivocal efficacy, product administration difficulties, and uneven reimbursement, which suggests a long runway for MCUR if its trials are successful.”
Jefferies Group initiated coverage with “buy” and a $14 price target.
Oppenheimer started coverage with a rating of “outperform” and a $20 price target on the company’s stock.
Nomura began coverage of the company with a rating of “buy” and a $19 price target. According to analyst M. Ian Somaiya, “We believe Macrocure’s lead product CureXcell could be the preferred advanced wound-care therapy in an estimated $5.5bn market opportunity in the US and EU based on robust clinical data, BLA approval, and favourable reimbursement. We view the risk related to CureXcell Phase III studies in diabetic foot ulcers (DFU) and venous leg ulcers (VLU) as significantly lowered, given 6,000 patients treated in 10 clinical trials and following approval in Israel. We expect Phase III trials to confirm market-leading wound closure rates despite inclusion of patients with larger wound sizes and infections at the wound site. We project CureXcell approval and launch in 2018 in the US and EU, with estimated peak sales of $1.2bn. Upside to our estimates and $19 TP is dependent on an earlier filing in the DFU indication alone. FY14E EPS at ($1.39); FY15E EPS at ($1.42).”
For more information, visit Macrocure’s website.