Clearside Biomedical (CLSD) Stock Rockets On License Agreement

Clearside Biomedical CLSD Stock News

Clearside Biomedical Inc (NASDAQ: CLSD) is making a tremendous run for the top this morning, gaining more than 50% early on in the trading session. The gains come after the company announced that it had entered into an exclusive worldwide option and license agreement. Here’s what’s going on:

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CLSD Stock Gains Big On Agreement News

In a press release issued early this morning, Clearside Biomedical announced that it has entered into a new option and licensing agreement. The agreement is a global one signed with REGENXBIO Inc. (NASDAQ: RGNX).

The agreement surrounds exclusive worldwide rights to the company’s in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet AMD, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor treatment is currently the standard of care.

In the release, CLSD said that RGNX plans to evaluate RGX-314 using its SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space. This will assist in the advancement of its RGX-314 subretinal delivery program currently under development for wet AMD and DR.

In a statement, Kenneth T. Mills, President and CEO at RGNX, had the following to offer:

We are pleased to partner with Clearside in evaluating the use of the SCS Microinjector to deliver RGX-314 to the suprachoroidal space in the eye. We believe this approach can potentially allow for the treatment of an expanded population of patients with wet AMD and DR by providing access to gene therapy treatment in all settings of patient care. Delivery into the suprachoroidal space, which in clinical trials has demonstrated minimal associated procedural risks, may allow physicians to treat patients with diseases like DR earlier in the disease course with RGX-314. We will continue to advance the RGX-314 subretinal delivery clinical program, with a Phase IIb clinical trial in wet AMD and a Phase II clinical trial in DR expected to begin by the end of 2019, and we look forward to moving both delivery approaches through development as part of our deep commitment to patients.

The above statement was followed up by George Lasezkay, Pharm.D., J.D., CEO at CLSD. Here’s what he had to offer:

REGENXBIO is the ideal partner for us given its leadership, expertise and pioneering work in the development and manufacturing of AAV vectors for the delivery of anti-VEGF therapeutic antibodies in the ophthalmology space. We are excited by the recent positive interim data reported by REGENXBIO from the current RGX-314 Phase I/IIa trial in wet AMD. This is an exciting time for us to collaborate with REGENXBIO to evaluate the potential application of our proprietary in-office SCS Microinjector for AAV gene therapy.

Show Me The Money

The financial side of the agreement didn’t come until the end of the release. However, it’s great news for Clearside. As part of the agreement, Clearside has granted REGENXBIO an option to receive an exclusive, worldwide commercial license with rights to sublicense.

The rights surround the company’s SCS Microinjector for the delivery of AAV gene therapies for the treatment of wet AMD, DR, and other conditions.

Should RGNX choose to exercise this otpion, CLSD will receive an undisclosed upfront fee. The company will also be eligible to receive up to $34 million in total development milestones and up to $102 million in sales milestones. On top of milestone payments, the company will receive mid-single digit royalties on net sales of products using the SCS Microinjectors.

CLSD also announced that RGNX will be responsible for all development and commercial activities for these product candidates. This includes covering all costs of development.

So, should RGNX choose to exercise the option for the exclusive license, CLSD will have the potential to bring in hundreds of millions of dollars in upfront payments, milestone payments and royalties. That’s a huge win for a company with a market cap of under $35 million.

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