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Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 25% mean reduction in LVMI by 12 months or sooner

Clinically meaningful improvements in majority of participants across cardiac biomarkers and functional measures

All SUNRISE-FA participants achieved meaningful increases in frataxin expression at 3-months post treatment; 115% average cardiac frataxin expression increase in high dose cohort, demonstrating dose response

Frataxin expression and LVMI improvement exceed co-primary target thresholds for planned registrational study

LX2006 generally well tolerated with no signs of complement activation or other immunogenicity to date

Company to host webcast today at 8:00 AM ET

NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced positive interim data across all dose cohorts of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. In both the Lexeo-sponsored SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (NCT05302271), treatment with LX2006 was associated with clinically significant improvements in cardiac biomarkers and functional measures, and increased frataxin protein expression was observed in all participants with cardiac biopsies.

“These data provide strong evidence that LX2006 is acting as a beneficial disease-modifying treatment candidate, supporting its continued development as a potential first- and best-in-class therapy for FA cardiomyopathy,” said Dr. Eric Adler, Chief Medical Officer and Head of Research at Lexeo Therapeutics. “Cardiac dysfunction is the leading cause of death for people with FA, and the clinical and functional improvements we’ve observed across these studies could be transformational to the standard of care. Participants have experienced clinically meaningful improvements across multiple measures, as well as increased frataxin expression in the heart, all of which underscore the potential of LX2006 to positively impact outcomes for people with FA cardiomyopathy.”

“We believe these data show LX2006 exceeding the thresholds aligned with the U.S. Food and Drug Administration (FDA) to support accelerated approval in the planned registrational study,” said Dr. Sandi See Tai, Chief Development Officer at Lexeo. “We are eager to advance this promising candidate as quickly as possible to support adults and children living with the devastating and fatal impacts of FA cardiomyopathy, and we expect to initiate a registrational study by early 2026. I would like to thank the participants, caregivers, and investigators who have helped to advance this important research.”

Lexeo has obtained alignment with the FDA on key parameters related to the LX2006 planned registrational study, including co-primary endpoints of LVMI, with a target threshold of >10% improvement at 12 months, and frataxin expression, with a target of any increase from baseline at three months.

Trial Design

SUNRISE-FA and the Weill Cornell Medicine investigator-initiated trial are 52-week, ascending dose, open-label trials evaluating the safety and preliminary efficacy of LX2006 in participants with FA cardiomyopathy. LX2006 is administered as a one-time intravenous infusion. While the two studies share similar designs, myocardial biopsies were conducted only in the SUNRISE-FA Phase 1/2 trial. Evidence of cardiomyopathy is required for study inclusion but participants vary in the severity of baseline hypertrophy as measured by LVMI. As of the data cutoff on March 25, 2025, a total of 16 participants have been dosed across the two studies, six of whom had cardiac hypertrophy with abnormal LVMI (at least two standard deviations above the mean in healthy volunteers). SUNRISE-FA enrollment was completed in Q4 2024.

Interim Clinical Update (n=12 participants with 

>

 6-months of follow-up)

Left ventricular mass index (LVMI):

• Among participants with abnormal baseline LVMI (a key inclusion criteria for planned registrational study; n=6):
  • 5 of 6 participants achieved >10% improvement by 12-month visit or sooner
  • 5 of 6 participants achieved LVMI measurements within the normal range as of latest visit
  • 27% mean improvement in LVMI as of latest visit
  • 25% mean improvement in LVMI by 12-month visit or sooner
  • Participants treated in Cohorts 2 and 3 (mid- and high-dose) demonstrate greater, dose-dependent improvement at earlier time points relative to Cohort 1 (low-dose)
• Among participants with normal baseline LVMI (n=6), the majority demonstrated LVMI improvement or stabilization over time

Secondary cardiac biomarkers, functional measures and patient-reported outcomes:

• 10 of 12 participants achieved reduction in lateral wall thickness (LWT) at latest visit
• 11 of 12 participants achieved >25% reduction in high-sensitivity troponin I at latest visit
• Majority of participants showed improvements across functional measures including the modified Friedreich Ataxia Rating Scale (mFARS) and Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

Cardiac frataxin expression (assessed in SUNRISE-FA trial only; n=8):

• All participants achieved increases in frataxin protein expression at 3 months
• Dose-dependent increases observed across cohorts on average, with 115% mean increase in Cohort 3 (n=4)

Interim Safety Update (n=16 participants)

• Treatment with LX2006 has been generally well tolerated with no Grade 3+ SAEs to date
• No signs of complement activation or other immunogenicity
• No signs of frataxin over-expression observed in cardiac tissue
• No participants discontinued from either study
• One previously disclosed, possibly treatment-related Grade 2 event of asymptomatic myocarditis observed one year after dosing

Registrational Study and Next Steps

• In Q2 2025, Lexeo expects to begin enrollment in a prospective natural history study serving as a concurrent external control arm for the registrational study
• Expect to initiate registrational study by early 2026 with a potential efficacy readout in 2027
• Registrational study will assess co-primary endpoints of frataxin protein expression and LVMI

Corporate Webcast Details

Lexeo Therapeutics will host a webcast at 8:00 AM ET today, April 7, 2025. Analysts and investors can participate by accessing the webcast live on the News & Events page in the Investors section of Lexeo’s website, www.lexeotx.com. The webcast will be archived on the company’s website following completion of the call.

About LX2006

LX2006 is an AAV-based gene therapy candidate for the treatment of FA cardiomyopathy, the leading cause of death in individuals with FA affecting approximately 5,000 people in the United States. LX2006 is designed to target the cardiac manifestations of FA by delivering a functional frataxin gene to promote the expression of the frataxin protein and restore mitochondrial function in myocardial cells. LX2006 has been granted Rare Pediatric Disease designation, Fast Track designation, Orphan Drug designation and Regenerative Medicine Advanced Therapy designation by the FDA for the treatment of FA cardiomyopathy, and orphan medicinal product designation by the European Commission.

About Lexeo Therapeutics

Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated. The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy, LX2020 for the treatment of plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Lexeo’s expectations and plans regarding its current product candidates and programs and the timing for receipt and announcement of data from its clinical trials, and the timing and likelihood of potential regulatory approval. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward-looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Annual Report on Form 10-K for the annual period ended December 31, 2024, filed with the SEC on March 24, 2025 and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Media Response:

[email protected] 

Investor Response:

Carlo Tanzi, Ph.D.
[email protected] 

DALLAS, April 07, 2025 (GLOBE NEWSWIRE) — Beneficient (NASDAQ: BENF) (“Ben” or the “Company”), a technology-enabled platform providing exit opportunities and primary capital solutions and related trust and custody services to holders of alternative assets through its proprietary online platform AltAccess, today announced it has closed on the financing of a $9.6 million primary capital commitment for Pulse Pioneer Fund, LP (“Fund”), a fund managed by Pulse Pioneer GP, LLC, an asset manager that manages venture capital funds that invest in scalable climate companies within its target interdependent investment verticals. The transaction represents Ben’s first GP Primary transaction of the fiscal year. In exchange for an interest in the Fund, the Fund received approximately $9.6 million in stated value of shares of the Company’s Resettable Convertible Preferred Stock (the “Preferred Stock”), which is convertible at the election of the holder into shares of the Company’s Class A common stock, subject to the terms and conditions of the transaction documents. As a result of the transaction, the collateral for Company’s ExAlt loan portfolio is expected to increase by approximately $9.6 million of interests in alternative assets.

“Successfully completing another GP primary capital transaction reinforces our ability to execute on our core liquidity and primary capital strategy by delivering innovative financing solutions for alternative asset holders and managers,” said Beneficient management. “We believe this financing reflects our ability to drive shareholder value while supporting impactful, vertically integrated investment strategies that enhance the value of the collateral backing our ExAlt loan portfolio. We’re excited to build on this momentum as we enter the new fiscal year and we continue to pursue additional opportunities that align with our strategic vision and growth objectives.”

Upon closing of the previously announced Public Stockholder Enhancement Transactions (the “Transactions”), the Company believes this transaction will result in the addition of approximately $1.28 million (and an aggregate of approximately $10.46 million) of tangible book value attributable to the Company’s stockholders.

Beneficient’s GP Primary Commitment Program is focused on providing primary capital solutions and financing anchor commitments to general partners during their fundraising efforts while immediately deploying capital into our equity. Through the program, Beneficient seeks to help satisfy the up to $330 billion of potential demand for primary commitments to meet fundraising needs.

Reconciliation of Non-GAAP Financial Measures
The following tables reconciles these non-GAAP financial measures to the most comparable GAAP financial measures as of December 31, 2024, on an actual basis and pro forma assuming the Transactions occurred on December 31, 2024.
(dollars in thousands)		Actual				Pro forma – Transactions (1)			Pro forma – Transactions and GP Primary ( 3 )
Tangible Book Value
Total equity (deficit)			14,260			14,260			23,680
Less: Goodwill and intangible assets			(13,014	)		(13,014	)		(13,014	)
Plus: Total temporary equity			90,526			90,526			90,526
Tangible book value			91, 772			91,772			101,372
		Actual				Pro forma – Transactions (1)			Pro forma – Transactions and GP Primary ( 3 )
Tangible book value attributable to Ben public company stockholders
Tangible book value			91,772			91,772			101,371
Less: Tangible book value attributable to Beneficient Holdings noncontrolling interest holders			(91,772	)		(82,595	)		(90,915	)
Tangible book value attributable to Ben’s public company stockholders			–			9,177(2)			10,457(4)
Market Capitalization of Ben’s Class A and Class B common stock as of April 4, 2025 (5)		$	2,728

(1)		Assumes the Transactions closed on December 31, 2024 including that the Beneficient Holdings limited partnership agreement was amended to provide that Ben, as the indirect holder of the Class A Units and certain Designated Class S Ordinary Units of Beneficient Holdings, would receive in the event of a liquidation of Beneficient Holdings 10% of the first $100 million of distributions of Beneficient Holdings following the satisfaction of the debts and liabilities of Beneficient Holdings on a consolidated basis.
(2)		Pro forma for the Transactions, represents 10% of the first $100 million of distributions of Beneficient Holdings in the event of the liquidation of Beneficient Holdings following the satisfaction of the debts and liabilities Beneficient Holdings on a consolidated basis.
(3)		Assumes the Transactions closed on December 31, 2024 including that the Beneficient Holdings limited partnership agreement was amended to provide that Ben, as the indirect holder of the Class A Units and certain Designated Class S Ordinary Units of Beneficient Holdings, would receive in the event of a liquidation of Beneficient Holdings (i) 10% of the first $100 million of distributions of Beneficient Holdings following the satisfaction of the debts and liabilities of Beneficient Holdings on a consolidated basis and (ii) 33.3333% of the net asset value of the added alternative assets of up to $5 billion in connection with ExAlt Plan liquidity and primary capital transactions entered after December 22, 2024.
(4)		Pro forma for the Transactions, represents (i) 10% of the first $100 million of distributions of Beneficient Holdings in the event of the liquidation of Beneficient Holdings following the satisfaction of the debts and liabilities Beneficient Holdings on a consolidated basis and (ii) 33.3333% of the net asset value of the added alternative assets of up to $5 billion in connection with ExAlt Plan liquidity and primary capital transactions entered after December 22, 2024.
(5)		Based upon the closing price of the Class A common stock as reported by Nasdaq as of market close on April 4, 2025.

About Beneficient 
Beneficient (Nasdaq: BENF) – Ben, for short – is on a mission to democratize the global alternative asset investment market by providing traditionally underserved investors − mid-to-high net worth individuals, small-to-midsized institutions and General Partners seeking exit options, anchor commitments and valued-added services for their funds− with solutions that could help them unlock the value in their alternative assets. Ben’s AltQuote® tool provides customers with a range of potential exit options within minutes, while customers can log on to the AltAccess® portal to explore opportunities and receive proposals in a secure online environment.
Its subsidiary, Beneficient Fiduciary Financial, L.L.C., received its charter under the State of Kansas’ Technology-Enabled Fiduciary Financial Institution (TEFFI) Act and is subject to regulatory oversight by the Office of the State Bank Commissioner. 

For more information, visit www.trustben.com or follow us on LinkedIn. 

Contacts

Matt Kreps: 214-597-8200, [email protected]
Michael Wetherington: 214-284-1199, [email protected]
Investor Relations: [email protected]

Important Information and Where You Can Find It

This press release may be deemed to be solicitation material in respect of a vote of stockholders to approve an amendment to approve the issuance of the Company’s Class A common stock upon conversion of the Series B-6 Preferred Stock pursuant to the transaction. In connection with the requisite stockholder approval, Ben will file with the Securities and Exchange Commission (the “SEC”) a preliminary proxy statement and a definitive proxy statement, which will be sent to the stockholders of Ben, seeking such approvals related to the transaction.

INVESTORS AND SECURITY HOLDERS OF BEN AND THEIR RESPECTIVE AFFILIATES ARE URGED TO READ, WHEN AVAILABLE, THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN CONNECTION WITH THE TRANSACTION, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT BEN AND THE TRANSACTION. Investors and security holders will be able to obtain a free copy of the proxy statement, as well as other relevant documents filed with the SEC containing information about Ben, without charge, at the SEC’s website (http://www.sec.gov). Copies of documents filed with the SEC by Ben can also be obtained, without charge, by directing a request to Investor Relations, Beneficient, 325 North St. Paul Street, Suite 4850, Dallas, Texas 75201, or email [email protected].

Participants in the Solicitation of Proxies in Connection with Transaction

Ben and certain of its directors, executive officers and employees may be deemed to be participants in the solicitation of proxies in respect of the requisite stockholder approvals under the rules of the SEC. Information regarding Ben’s directors and executive officers is available in its annual report on Form 10-K for the fiscal year ended March 31, 2024, which was filed with the SEC on July 9, 2024 and certain current reports on Form 8-K filed by Ben. Other information regarding the participants in the solicitation of proxies with respect to the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC. Free copies of these documents, when available, may be obtained as described in the preceding paragraph.

Not an Offer of Securities

The information in this communication is for informational purposes only and shall not constitute, or form a part of, an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities. The securities that are the subject of the transaction have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the Transactions, including receipt of required approvals and satisfaction of other customary closing conditions and excepted timing of closing of the Transactions, and expectations of future plans, strategies, and benefits of the Transactions. The words ”anticipate,” “believe,” ”continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” ”plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are based on our management’s beliefs, as well as assumptions made by, and information currently available to, them. Because such statements are based on expectations as to future financial and operating results and are not statements of fact, actual results may differ materially from those projected.

Important factors that could cause actual results to differ materially from those expressed in the forward-looking statements include, among others: the ultimate outcome of the transaction, including obtaining the requisite vote of securityholders; the Company’s ability to meet expectations regarding the timing and completion of the transaction; and the risks, uncertainties, and factors set forth under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and its subsequently filed Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable law.

Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.