Market Newsdesk

MIDLAND, Texas, Jan. 30, 2025 (GLOBE NEWSWIRE) — Viper Energy, Inc. (NASDAQ: VNOM) (“Viper”) announced today the pricing of an underwritten public offering of 24,640,000 shares of its Class A common stock at a price to the public of $44.50 per share (the “Primary Offering”). Viper’s offering of 24,640,000 shares of Class A common stock represents a 2,640,000 share upsize to the originally proposed 22,000,000 share offering. The underwriters have a 30-day option to purchase up to an additional 3,696,000 shares of Class A common stock from Viper at the public offering price (less the underwriting discount).

Net proceeds to Viper from the sale of the 24,640,000 shares of its Class A common stock, after the underwriting discount and estimated offering expenses, will be approximately $1.1 billion (or $1.2 billion, if the underwriters exercise their option in full).

Viper intends to use the net proceeds from the Primary Offering to fund the cash consideration for its previously announced pending acquisition of all of the equity interests of certain mineral and royalty-interest owning subsidiaries of Viper’s parent, Diamondback Energy, Inc. (the “Pending Drop Down”), if it closes. If the Pending Drop Down does not close, Viper will use the net proceeds from the Primary Offering for general corporate purposes.

The Primary Offering is expected to close on February 3, 2025, subject to customary closing conditions.

J.P. Morgan, Citigroup, Mizuho and Morgan Stanley are acting as joint book-running managers for the Primary Offering. Copies of the written base prospectus and prospectus supplement for the Primary Offering may be obtained on the website of the Securities and Exchange Commission, www.sec.gov or, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146; Mizuho Securities USA LLC, Attn: Equity Capital Markets, 1271 Avenue of the Americas, New York, New York 10020, by telephone at 1-212-205-7600 or by email at [email protected]; or Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

The Class A common stock will be issued and sold pursuant to an effective automatic shelf registration statement on Form S-3ASR previously filed with the Securities and Exchange Commission (the “Registration Statement”).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. The Primary Offering may only be made by means of a prospectus supplement and related base prospectus.

About Viper Energy, Inc.

Viper is a publicly traded Delaware corporation that owns and acquires mineral and royalty interests in oil and natural gas properties primarily in the Permian Basin.

Cautionary Note Regarding Forward-Looking Statements

The information in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact included in this press release, regarding the completion of the Primary Offering, Viper’s strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this press release, the words “could,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” “goal,” “plan,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Be cautioned that these forward-looking statements are subject to all of the risk and uncertainties, most of which are difficult to predict and many of which are beyond Viper’s control, incident to the development, production, gathering and sale of oil and natural gas. These risks include, but are not limited to, commodity price volatility, inflation, lack of availability of drilling and production equipment and services, risks relating to the Pending Drop Down, including its consummation or the realization of the anticipated benefits and synergies therefrom. Actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth in Viper’s filings with the SEC, including the base prospectus and prospectus supplement relating to the Primary Offering, the Registration Statement, its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, under the caption “Risk Factors,” as may be updated from time to time in Viper’s periodic filings with the SEC. Any forward-looking statement in this press release speaks only as of the date of this release. Viper undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Investor Contacts:
Adam Lawlis
+1 432.221.7467
[email protected]

Austen Gilfillian
+1 432.221.7420
[email protected]

Source: Viper Energy, Inc.

SAN DIEGO, Jan. 30, 2025 (GLOBE NEWSWIRE) — A class action lawsuit has been filed on behalf of sellers of Arconic Corporation (NYSE: ARNC) (“Arconic” or the “Company”) securities between April 19, 2022 through May 3, 2023 (the “Class Period”), charging the Company and certain senior executives and directors with violations of the federal securities laws (collectively, “Defendants”).  

Arconic investors have until March 31, 2025 to seek appointment as lead plaintiff of the Arconic class action lawsuit.

If you



sold



Arconic securities between April 19, 2022 through May 3, 2023, and suffered substantial losses
, and you wish to obtain additional information or serve as lead plaintiff in this lawsuit, you may submit your information and contact us here: https://dicellolevitt.com/securities/arconic/.

You can also contact DiCello Levitt attorneys Brian O’Mara or Hani Farah by calling (888) 287-9005 or emailing [email protected].   Those who inquire by email are encouraged to include their mailing address, telephone number, and the number of shares purchased.

No Class Has Been Certified.   Until a class is certified, you are not represented by counsel unless you retain one.   You may select counsel of your choice.

Case Allegations

Arconic is a provider of aluminum sheets, plates, and extrusions, as well as architectural products to the ground transportation, aerospace, building and construction, industrial and packaging end markets.

The Arconic lawsuit alleges that Defendants failed to disclose offers to purchase all of the outstanding shares of Arconic common stock at a material premium far above the Company’s then-current stock price, while at the same time repurchasing millions of shares of Arconic common stock through stock buyback programs at prices below the offer price. These omissions of material non-public information artificially deflated the price of Arconic common stock. Arconic had an obligation to either disclose that it had received a formal acquisition offer from Apollo Global Management, Inc. (“Apollo”) or abstain from trading in its own securities.

In April 2022, Arconic received an unsolicited non-public offer from Apollo to purchase all of the outstanding shares of Arconic at a price between $34 and $36 per share. Arconic rejected Apollo’s offer, but Apollo continued to demonstrate interest in an acquisition of Arconic. Apollo partnered with Irenic Capital Management LP (“Irenic”) concerning the potential acquisition of Arconic starting in May 2022. From May 2022 through November 2022, Apollo, Irenic, and Arconic had discussions concerning a potential acquisition of Arconic, but these contacts did not result in the submission of any new proposals for an acquisition of Arconic.   During the period June 1, 2022 through August 31, 2022, Arconic repurchased 4,357,690 shares of its common stock on public markets for a total cost of $122,943,904 and at an average price of $28.21 per share, significantly below Apollo’s offer of $34 to $36 per share.

On November 28, 2022, Apollo informed Arconic that it was considering submitting a new proposal for an acquisition of Arconic at a meaningful premium to Arconic’s stock price. On December 12, 2022, Apollo submitted a revised proposal to acquire Arconic in an all-cash transaction at a price of $30.00 per share, a meaningful premium to the price of Arconic’s common stock, which closed on December 12, 2022 at $22.57 per share. Arconic thereafter negotiated and engaged with Apollo. However, Arconic continued repurchase its own stock at prices materially below Apollo’s $30 per share offer. From November 2022 to January 2023, Arconic repurchased over 2 million shares of Arconic common stock at an average price of $22.32 per share.

On February 28, 2023, at approximately 2:00 p.m. Eastern Time, The Wall Street Journal reported that Apollo had submitted a bid at an unspecific price to acquire Arconic and that Arconic’s advisors had reached out to other potential acquirors. In response, the price of Arconic common stock increased $4.68 per share, or 21.5%, from its price immediately before the WSJ report of $21.76 per share to a closing price on February 28, 2023 of $26.44 per share.

On May 4, 2023, during pre-market hours, Arconic announced that it had entered into an agreement to be acquired by Apollo in an all-cash transaction at $30.00 per share. In response, the price of Arconic common stock increased $6.38 per share, or 28.3%, from a closing price on May 3, 2023 of $22.55 per share to a closing price on May 4, 2023 of $28.93 per share.

The merger eventually closed on August 18, 2023, with Apollo acquiring Arconic for $30 per share.

About DiCello Levitt

At DiCello Levitt, we are dedicated to achieving justice for our clients through class action, business-to-business, public client, whistleblower, personal injury, civil and human rights, and mass tort litigation. Our lawyers are highly respected for their ability to litigate and win cases – whether by trial, settlement, or otherwise – for people who have suffered harm, global corporations that have sustained significant economic losses, and public clients seeking to protect their citizens’ rights and interests. Every day, we put our reputations – and our capital – on the line for our clients.

DiCello Levitt has achieved top recognition as Plaintiffs Firm of the Year and Trial Innovation Firm of the Year by the National Law Journal, in addition to its top-tier Chambers and Benchmark ratings. The New York Law Journal also recently recognized DiCello Levitt as a Distinguished Leader in trial innovation. For more information about the Firm, including recent trial victories and case resolutions, please visit www.dicellolevitt.com.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Media Contact

Amy Coker
4747 Executive Drive, Suite 240
San Diego, CA 92121
619-963-2426
[email protected]

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, today announced the pricing of its upsized initial public offering of 8,750,000 shares of its common stock at a public offering price of $16.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $140.0 million. All shares of common stock to be sold in the offering will be sold by Maze Therapeutics. In addition, Maze Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,312,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the Nasdaq Global Market on January 31, 2025, under the symbol “MAZE.” The offering is expected to close on February 3, 2025, subject to the satisfaction of customary closing conditions.

J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities are acting as the joint bookrunning managers for the offering. The offering is being made only by means of a prospectus.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on January 30, 2025. The offering is being made only by means of a prospectus. A copy of the final prospectus may be obtained, when available, from J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or email: [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-(800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, with a focus on renal, cardiovascular and related metabolic, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.

For further information, please contact:

Investors:

Jillian Connell, Maze Therapeutics
[email protected]
(650) 850-5080

Media:

Dan Budwick, 1AB
[email protected]

GREENWICH, Conn., Jan. 30, 2025 (GLOBE NEWSWIRE) — Belpointe PREP, LLC (NYSE American: OZ) (“Belpointe OZ,” “we,” “us,” “our” or the “Company”) the first and only Qualified Opportunity Fund listed on a national securities exchange, today announced that we have received notice from NYSE American LLC (“NYSE American”) that we have regained compliance with the continued listing standards following the successful completion of our 2024 Annual Meeting of Unitholders on January 28, 2025.

The Company was originally notified by NYSE American of non-compliance with the continued listing standards as a result of rescheduling our 2024 Annual Meeting in 2025. With the meeting now complete, Belpointe OZ has fulfilled its obligations, and we have been formally notified that we have regained compliance with all applicable listing requirements.

“We appreciate the patience and support of our unitholders as we worked to resolve this matter,” said Brandon Lacoff, Chief Executive Officer of Belpointe OZ. “With compliance restored, we remain focused on executing our investment strategy and creating long-term value for our unitholders through high-quality real estate investments in Opportunity Zones across the country.”

Belpointe OZ continues to leverage its publicly traded structure, providing investors with liquidity, transparency, and access to Opportunity Zone investments without the typical constraints of private funds. The Company has actively invested in prime residential and mixed-use developments in high-growth markets, reinforcing its position as a leader in the Opportunity Zone space.

About Belpointe OZ

Belpointe OZ is a publicly traded qualified opportunity fund, listed on NYSE American under the symbol “OZ.” To date, Belpointe OZ has over 2,500 units in its development pipeline throughout four cities, representing an approximate total project cost of over $1.3 billion.

Belpointe OZ has filed two registration statements (including a combined prospectus) with the U.S. Securities and Exchange Commission (“SEC”) for the offer and sale of up to an aggregate of $1,500,000,000 of Class A units representing limited liability interests in Belpointe OZ (the “Class A units”). Before you invest, you should read Belpointe OZ’s most recent prospectus and the other documents that it has filed with the SEC for more complete information about Belpointe OZ and the offering. Investing in Belpointe OZ’s Class A units involves a high degree of risk, including a complete loss of investment. Prior to making an investment decision, you should carefully consider Belpointe OZ’s investment objectives and strategy, risk factors, fees and expenses and any tax consequences that may results from an investment in Belpointe OZ’s Class A units. To view Belpointe OZ’s most recent prospectus containing this and other important information visit sec.gov or investors.belpointeoz.com. Alternatively, you may request Belpointe OZ send you the prospectus by calling (203) 883-1944 or emailing [email protected]. Read the prospectus in its entirety before making an investment decision.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may be considered forward-looking, such as statements containing estimates, projections, and other forward-looking information. Forward-looking statements are typically identified by words and phrases such as “anticipate,” “estimate,” “believe,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “seek,” “should,” “will,” “would,” “expect,” “objective,” “projection,” “forecast,” “goal,” “guidance,” “outlook,” “effort,” “target” or the negative of such words and other comparable terminology. However, the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and involve risks, uncertainties, and other factors beyond our control. Therefore, we caution you against relying on any of these forward-looking statements. Actual outcomes and results may differ materially from what is expressed in any forward-looking statement. Except as required by applicable law, including federal securities laws, we do not intend to update any of the forward-looking statements to conform them to actual results or revised expectations.

Investor Relations and Media Contact:

Cody H. Laidlaw
Belpointe PREP, LLC
255 Glenville Road
Greenwich, Connecticut 06831
[email protected]
203-883-1944

NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the progress of the U.S. commercial launch of Ryoncil^® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older and key upcoming milestones for its late-stage pipeline.

”We are committed to making our FDA approved product Ryoncil^® available as quickly as possible to the many children with SR-aGVHD in need of life-saving therapy,” said Dr. Silviu Itescu, Chief Executive of Mesoblast. “The team has been working relentlessly on finalizing product availability, including logistics, regulatory documentation, and contractual arrangements to ensure a successful launch of Ryoncil^® this quarter.”

“The successful financing of US$160 million (A$260 million) this month, which provides the Company with proforma cash on hand of approximately US$200 million (A$322 million), puts us in a strong position to execute the U.S. commercial launch activities of Ryoncil^®, to expand the clinical indications of the product, and ensure that commercial manufacturing will meet projected product uptake and demand.”

“I look forward to providing an update at half year results on February 27^th 9.00am AEDT (February 26^th 5.00pm EST).”

INVESTMENT HIGHLIGHTS

Mission

Mesoblast is committed to bring to market innovative off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses.

Market Opportunity

• Steroid-refractory acute GvHD >$1 billion annual market potential.
• Heart failure with reduced ejection fraction (HFrEF) >$10 billion addressable market potential.
• Chronic low back pain (CLBP) >$10 billion addressable market potential.
• Additional potential multi-billion-dollar opportunities from existing and future product pipeline based on existing technology platforms.

Product Portfolio

• Ryoncil^® the only FDA-approved MSC therapy for any indication; lifesaving for pediatric SR-aGvHD.
• Revascor^® has potential for FDA accelerated approval in end-stage HFrEF.
• Rexlemestrocel-L in Phase 3 trial for potential approval in CLBP.
• Additional pipeline therapies targeting unmet medical needs.

Competitive Advantage

• Proven scientific approach, with deep understanding of mechanism of action (MOA).
• Robust and extensive intellectual property.
• Extensive positive clinical trial results across multiple indications.
• Demonstrated ability to meet regulatory requirements of FDA.
• Scalability of manufacturing processes and proprietary next generation technology.

Financials and Projections

• Strong balance sheet to support Ryoncil^® launch and product portfolio.
• Current revenue streams anticipated to expand based on Ryoncil^® performance.
• Continued prudent cash management strategy.
• Long-term revenue potential from the existing and future pipeline.

Upcoming Milestones

• Ryoncil^® commercial launch planned this quarter.
• Revascor^® FDA meeting and subsequent BLA submission.
• Rexlemestrocel-L CLBP Phase 3 completion and BLA submission.
• Expansion into new indications and markets.

PORTFOLIO UPDATE

Ryoncil

^®

(remestemcel-L) U.S. Launch for Steroid-Refractory Acute Graft Versus Host Disease

• On December 18, 2024, Ryoncil^® (remestemcel-L) became the first mesenchymal stromal cell (MSC) therapy approved by U.S. FDA for any indication.
• FDA approved Ryoncil^® as the first and only therapy for pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.
• Ryoncil^® planned for launch this quarter once Company receives National Drug Codes (NDC) from FDA, enabling subsequent publication of product pricing in the U.S. Price Compendia.
• The U.S. launch of Ryoncil^® will be led by Mesoblast’s commercial leadership team comprising
  • Marcelo Santoro, Chief Commercial Officer, a seasoned pharmaceutical executive with over three decades of experience successfully leading high-performing teams at Pfizer, Otsuka, and AstraZeneca, with a proven track record of launching innovative therapies, including the creation of multi-billion-dollar brands and the execution of global product launches.
  • Peter McSweeney, MB ChB FRACP, Head of Medical Affairs, is a hematologist and bone-marrow transplant specialist with over 30 years’ experience. He has worked at the Fred Hutchinson Cancer Research Center, has been Clinical Director at the University of Colorado’s Blood & Marrow Transplant Program, and more recently Director of Cellular Therapy at Colorado Blood Cancer Institute. He has extensive experience in the clinical application and research of allogeneic and autologous transplantation, CAR-T cell therapy, and has many publications in these areas.
  • Commercial and medical affairs functions will be supported by a team of key account managers (KAMs) and medical science liaisons (MSLs), respectively, to provide critical infrastructure for the commercial function and engagement and servicing of treatment centers.
• Commercial launch strategy will initially target those centers with greatest experience using the Ryoncil^® product and highest volume, followed by a broader staged rollout. Half of all pediatric transplants are performed at just 15 centers across the U.S. Our commercial team will be heavily engaged in these centers of excellence along with another 30 sites, which together account for almost 80% of pediatric transplants.
• Commercial inventory has been manufactured and a distribution network has been established using Cencora, a leader in specialty pharmaceutical services and distribution. Cencora will leverage its cryogenic logistics capabilities and state-of-the art cryogenic storage infrastructure, to enable the efficient and secure delivery of cryopreserved product to U.S. treatment centers.
• Our patient access hub, MyMesoblast™, has been established and will be managed by Cencora to facilitate patient enrollment, shipment & logistics, and will provide support for patients in the inpatient and outpatient setting.
• Mesoblast will have a significant presence, including scientific presentations and exhibitor booth, at the industry’s most important meeting, the 2025 Transplantation & Cellular Therapy Meetings (Tandem Meetings) of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), taking place February 12-15 in Honolulu, HI.

Ryoncil

^®

Label Extension in Pediatric & Adult Inflammatory Diseases

• Mesoblast is developing a comprehensive clinical, regulatory and commercial strategy to build a pediatric inflammatory disease franchise using Ryoncil^® to target diseases of high unmet need given the extensive safety profile of the product in children, the unique mechanism of action of Ryoncil^®, and the limited options available for these inflammatory conditions.
• For adult patients, Mesoblast is collaborating with Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in the United States, a body that is funded by the National Institutes of Health (NIH) and is responsible for approximately 80% of all US allogeneic BMTs, to conduct a pivotal trial in adults with SR-aGVHD.
• Survival in adults with SR-aGVHD who have failed at least one additional agent, such as ruxolitinib, remains as low as 20-30% by 100 days.^1,2 In contrast, 100-day survival was 73% after Ryoncil^® treatment was used under expanded access in 25 adults with SR-aGVHD who failed to respond to at least one additional agent, such as ruxolitinib.

Revascor

^®

(rexlemestrocel-L) for Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation

• In 2024 FDA informed Mesoblast that it supports an accelerated approval pathway for REVASCOR, Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy, in patients with end-stage ischemic HFrEF kept alive with a left ventricular assist device (LVAD).
• Accelerated approval to market REVASCOR, if received, will require Mesoblast to commit to a post-approval confirmatory study in NYHA Class II/III HFrEF patients which could result in full approval in the broader HFrEF population.
• In November 2024 a publication in the prestigious peer-reviewed European Journal of Heart Failure (EJHF) reported that a single intramyocardial injection of REVASCOR results in improved survival in high-risk NYHA Class II/III patients with ischemic heart failure and inflammation.³ This identifies the HFrEF population that is responsive to REVASCOR and will be the target of a confirmatory trial after accelerated approval, if received.
• Under its Regenerative Medicine Advanced Therapy (RMAT) designation Mesoblast intends to meet with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in these patients.

Revascor

^®

for Pediatric Congenital Heart Disease – Hypoplastic Left Heart Syndrome

• U.S. FDA granted REVASCOR a RMAT designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition.
• Earlier in 2024, FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for treatment of children with HLHS.
• RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for the disease or condition. An RMAT designation for rexlemestrocel-L provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License Application (BLA).
• On FDA approval of a BLA for REVASCOR for the treatment of HLHS, if received, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.

Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative Disc Disease – Phase 3 Program

• The confirmatory Phase 3 trial of Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product candidate rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration has commenced enrollment and treatment at multiple sites across the U.S.
• The capital raise concluded this month will facilitate expansion of sites enrolling in the trial and acceleration of patient accrual.
• FDA has previously agreed on the design of this 300-patient randomized, placebo-controlled confirmatory Phase 3 trial, and the 12-month primary endpoint of pain reduction as an approvable indication.
• This endpoint was successfully met in Mesoblast’s first Phase 3 trial. Key secondary measures include improvement in quality of life and function.
• A particular focus is on treatment of patients on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the US. Significant pain reduction and opioid cessation were observed in Mesoblast’s first Phase 3 trial.
• FDA has designated rexlemestrocel-L a RMAT for the treatment of chronic low back pain.

About Mesoblast

Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform 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’s RYONCIL^® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.

About Mesoblast manufacturing: 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 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

References / Footnotes

1. Jagasia M et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20): 1739–1749
2. Abedin S, et al. Ruxolitinib resistance or intolerance in steroid-refractory acute graft versus-host disease — a real-world outcomes analysis. British Journal of Haematology, 2021;195:429–43.
3. Perin EC. Et al. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail 2024. https://doi.org/10.1002/ejhf.3522

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 RYONCIL for pediatric SR-aGVHD and any other 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 – Global
Paul Hughes	Allison Worldwide
T: +61 3 9639 6036	Emma Neal
E: [email protected]	T: +1 603 545 4843
	E: [email protected]
	Media – Australia
	BlueDot Media
	Steve Dabkowski
	T: +61 419 880 486
	E: [email protected]