Mesoblast Completes Private Placement

Rhea-AI Summary

Mesoblast Limited (NASDAQ:MESO; ASX:MSB) has successfully completed a global private placement, raising approximately US$40 million at A$0.85 per share, primarily from existing major shareholders in the US, UK, and Australia. The funds will support the commercialization of remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD), pending FDA approval, with a PDUFA goal date set for August 2, 2023. Additionally, proceeds will aid in the ongoing manufacturing of this product and the initiation of a Phase 3 clinical trial for rexlemestrocel-L aimed at chronic low back pain. CEO Dr. Silviu Itescu emphasized the company's commitment to bringing innovative treatments to market and acknowledged the strong support from major shareholders.

Positive

• Raised approximately US$40 million to support commercialization efforts.
• Funding will facilitate the launch of remestemcel-L for SR-aGVHD upon FDA approval.
• Initiation of Phase 3 clinical trial for rexlemestrocel-L targeting chronic low back pain.

Negative

• FDA approval for remestemcel-L is still pending, introducing regulatory risk.

NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has completed a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs, at A$0.85 per share.

Proceeds will be used to fund:

• Launch and commercialization of the company’s lead product, remestemcel-L, in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) subject to approval by the US Food & Drug Administration (FDA) of Mesoblast’s resubmitted Biologics License Application (BLA) which has a PDUFA goal date of August 2, 2023.
• Ongoing manufacturing of commercial remestemcel-L product at the Lonza Biosciences facility in Singapore, where the upcoming scheduled pre-licensure inspection (PLI) will be performed by FDA.
• Initiation of patient enrolment in the confirmatory Phase 3 clinical trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease.

Chief Executive Dr Silviu Itescu said “We appreciate the strong support from our major shareholders as we look forward to commercializing our platform technology and bringing the first FDA approved treatment to children with life-threatening SR-aGVHD.”

About Mesoblast
Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors	Media
Paul Hughes	BlueDot Media
T: +61 3 9639 6036	Steve Dabkowski
E: investors@mesoblast.com	T: +61 419 880 486
	E: steve@bluedot.net.au
	Rubenstein
	Tali Mackay
	E: tmackay@rubenstein.com

Not an offer in the United States
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction. Any securities described in this announcement have not been registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws.

FAQ

What is the significance of Mesoblast's recent US$40 million private placement?

The private placement will fund the commercialization of remestemcel-L for treating SR-aGVHD, pending FDA approval, and support manufacturing and clinical trials.

When is the FDA's decision on Mesoblast's remestemcel-L application expected?

The FDA's decision on the resubmitted Biologics License Application for remestemcel-L has a PDUFA goal date of August 2, 2023.

What will the proceeds from the private placement be used for?

Proceeds will be used for launching remestemcel-L, ongoing manufacturing, and initiating a Phase 3 clinical trial for rexlemestrocel-L.

Who are Mesoblast's major shareholders?

The private placement primarily involved Mesoblast’s existing major shareholders from the US, UK, and Australia.

What are the potential risks associated with Mesoblast's recent funding announcement?

A key risk is the pending FDA approval for remestemcel-L, which could impact commercialization plans.