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10 stories mentioning ASX:DXBUpdated 15d ago

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Asia

Dimerix Secures US Patent Regarding Kidney Injury Drug Candidate, Shares Jump 4%

Dimerix (ASX:DXB) said the United States Patent and Trademark Office granted a patent providing composition-of-matter-type claims covering the firm's drug candidate, DMX-652, until April 11, 2043, according to a Thursday Australian bourse filing.The candidate is a selective inhibitor of USP30, a mitochondrial enzyme, designed to prevent kidney injury and promote mitophagy where damage has occurred. A divisional application has also been filed to pursue additional claims covering DMX-652, the filing added.Its shares rose 4% in recent trading on Thursday.

ASX:DXB
Asia

Dimerix Hits 'Major Milestone' With AU$10 Million Financing Package, Euroz Hartleys Says

Dimerix's (ASX:DXB) AU$10 million financing package represents a "major milestone" as the company is now fully funded through the completion of its phase 3 focal segmental glomerulosclerosis study for the first time, Euroz Hartleys said in a Friday note."While not without cost, we view borrowing against the up to AU$1.9 billion in potential milestones and royalties secured across five licensing deals as substantially cheaper than diluting at the current share price," the investment firm said.Dimerix is also in late-stage discussions for an additional AU$40 million in financing on similar terms to fund a newly acquired second asset. Securing the additional amount would take the company's pro-forma cash to around AU$83.6 million, Euroz Hartleys said.Meanwhile, the company's acquisition of the DMX-652 therapeutic asset from UK-based Mission Therapeutics provides a consistent stream of catalysts over the next two years and transitions Dimerix from a single-asset play into a diversified biotech company, the equity research firm said."We view DMX-652 as a low-cost strategic option that provides a clear pathway into a complementary kidney indication," Euroz Hartleys said, adding that the deal's $5 million upfront consideration "is modest for a phase 2-ready asset targeting a multi-billion-dollar end market."The investment firm maintained a speculative buy recommendation on Dimerix with an under-review price target of AU$2.05.Dimerix shares gained 2% in recent Friday trade.

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Asia

Dimerix Acquires Therapeutic Asset from UK-Based Firm; Shares Up 8%

Dimerix (ASX:DXB) acquired therapeutic asset DMX-652 for all indications from UK-based Mission Therapeutics for an upfront payment of $5 million, expanding the company's pipeline in rare kidney disease, according to a Friday filing with the Australian bourse.The company will also pay up to $47 million in deferred acquisition fee payable upon success of pre-defined clinical development milestones, $40 million on product marketing approval, $25 million on approval in a second indication, and up to $175 million on specific sales milestones, the filing said.The acquisition includes assignment of the composition-of-matter patent, an open Investigational New Drug application in the US with a phase two clinical trial protocol, a pharmaceutical-grade drug product for the trial, and all manufacturing methodology, per the filing.Dimerix shares rose 8% in morning trade on Friday.

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Asia

Dimerix Secures AU$10 Million Loan Facility From Substantial Shareholder Associate; Shares Up 9%

Dimerix (ASX:DXB) entered into a loan facility agreement with Skiptan, an associate of substantial shareholder Peter Meurs, under which the lender has agreed to advance AU$10 million to the company at its discretion, according to a Friday Australian bourse filing.The company said the facility will support commercial manufacturing of DMX-200 ahead of potential marketing approval submissions and preparation for commercial launch, expanded access programs for eligible patients, and initiation of a phase 2 program for DMX-652, its newly acquired pipeline asset for acute kidney injury.Negotiations are progressing to access up to a further AU$40 million in non-dilutive funding on substantially similar terms, which would further extend the cash runway beyond the Action3 Phase 3 clinical trial in DMX-200 and the Phase 2 trial in DMX-652, the filing added.The company's shares rose nearly 9% in recent Friday trade.

ASX:DXB
Asia

Dimerix Expands Post-Trial Access to Kidney Disorder Drug for Eligible Patients

Dimerix (ASX:DXB) said eligible patients with focal segmental glomerular sclerosis who complete treatment in its phase three clinical trial and open-label extension study will be able to continue receiving investigational therapy DMX-200 through post-trial access programs in key territories, according to a Thursday Australian bourse filing.The company said access will be provided to patients whose treating physicians determine that ongoing therapy is appropriate and that no suitable alternative is available through expanded access, compassionate use, special access, or other applicable regulatory pathways, subject to local regulations, per the filing.The company's commercial partners will handle market access and supply costs for DMX-200 in their territories, while it will assume these responsibilities in territories where no commercialization partner has been appointed, the filing added.The company's shares rose past 2% in recent Thursday trade.

ASX:DXB
Asia

Dimerix's Everest Deal Adds Value, Eases Funding Concerns, Euroz Hartleys Says

Dimerix (ASX:DXB) has added incremental value through its licensing deal with Everest Medicines while strengthening its funding position and validating DMX-200's commercial potential, Euroz Hartleys said in a note on Tuesday.The company has entered into an exclusive licensing agreement with Everest Medicines to commercialize DMX-200 for focal segmental glomerulosclerosis (FSGS) across Greater China, South Korea and Southeast Asia.The company will receive AU$14.1 million upfront, up to AU$467 million in development and sales milestone payments, and tiered royalties of 10% to 15% on net sales, while Everest Medicines will fund regulatory, sales and marketing activities in the region.Euroz Hartleys said the agreement creates significant value from a region that was not factored into its forecasts, representing entirely incremental upside.The firm added that the deal further validates DMX-200, with the company now securing five partners committing up to AU$1.9 billion in upfront and milestone payments, including more than AU$80 million in non-refundable cash.The firm estimates the total addressable market for DMX-200 in FSGS in China at AU$3 billion, bringing the combined opportunity across all licensed territories to around AU$9.5 billion.The firm noted that the company would have pro-forma cash of AU$40.7 million post-upfront, with talks for up to $50 million in non-dilutive funding potentially lifting total available capital to over AU$110 million to fund its phase three program.The investment firm retained its speculative buy rating on Dimerix and raised its price target to AU$2.05 from AU$1.35.Dimerix's shares were down almost 3% in recent Wednesday trade.

ASX:DXB
Asia

Dimerix Signs Exclusive License Agreement for DMX-200 in Greater China, South Korea, Southeast Asia, Shares Surge 18%

Dimerix (ASX:DXB) entered into an exclusive license agreement with Everest Medicines for the commercialization of its phase 3 drug candidate DMX-200 in Greater China, South Korea, and certain Southeast Asian countries, according to a Tuesday Australian bourse filing.The company said it is eligible to receive upfront and potential success-based milestone payments of up to about AU$481 million, comprising an upfront payment of about AU$14.1 million, up to about AU$467 million in potential milestone payments, and tiered royalties on net sales.DMX-200 is being developed for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disease, with the agreement covering the Chinese mainland, Hong Kong, Macao, and Taiwan, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines, the filing added.Across five transactions in total, Dimerix said it may be eligible to receive up to about AU$1.9 billion in aggregate upfront and potential milestone payments plus additional royalties on net sales, it added.The company's shares surged 18% in recent Tuesday trade

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Asia

Dimerix's Potential Non-Dilutive Funding May Lead to Ongoing Phase Three Trial Being Fully Funded, Euroz Hartleys Says

Dimerix's (ASX:DXB) potential access to $50 million in non-dilutive funding could lead to it having up to AU$96.6 million in combined cash and non-dilutive funding available, which would be sufficient to fully fund the ongoing phase three trial and dispel any near-term capital raising risk, Euroz Hartleys said in a note on Thursday.It indicated this would not be traditional debt funding, but is rather repayable from future milestone payments and/or royalties.The commercial opportunity remains significant and unchanged, Euroz Hartleys added.The investment firm maintained its speculative buy rating on Dimerix with a price target of AU$1.35 per share.

ASX:DXB
Asia

Dimerix Says Phase 3 Clinical Trial Data Review Shows Over 90% Statistical Power to Detect Proteinuria Treatment Effect; Shares Reach Two-Year Low

Dimerix (ASX:DXB) said an external statistical blinded review of the data from the ACTION3 phase 3 clinical trial, evaluating its DMX-200 drug candidate in patients with focal segmental glomerulosclerosis, confirmed that the study had an over 90% statistical power to detect the treatment effect for the proteinuria primary endpoint, according to a Tuesday Australian bourse filing.The US Food and Drug Administration (FDA) previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo could support traditional approval of its DMX-200 drug candidate via the 505(b)(1) pathway, should the findings of the study be positive.Its shares fell 35% in recent trading on Tuesday, reaching a two-year low.

ASX:DXB
Asia

Dimerix Poised to Benefit From US FDA's Approval of Travere Therapeutics' Kidney Disorder Drug, Euroz Hartleys Says

Dimerix (ASX:DXB) is poised to benefit from the US Food and Drug Administration's recent approval of Travere Therapeutics' sparsentan drug to treat focal segmental glomerulosclerosis, a rare kidney disorder Dimerix is also working on, Euroz Hartleys said in a Tuesday note."This outcome has positive implications for [Dimerix] and its lead asset, DMX-200, across both the regulatory pathway and potential future commercialization," the equity research firm said.It noted that sparsentan marks the first full FDA approval for the kidney disease based on a reduction in proteinuria, or the levels of protein in urine, creating a clear precedent for its use as a surrogate endpoint. The development meaningfully de-risks the FDA's acceptance of proteinuria for traditional and accelerated approvals for DMX-200 and highlights the US regulator's flexibility in focal segmental glomerulosclerosis, Euroz Hartleys said."Commercially, Travere is likely to help establish the [focal segmental glomerulosclerosis] market, driving awareness, diagnosis, and reimbursement, which should support a faster uptake of DMX-200," the equity research firm said.It added that sparsentan and DMX-200 are complementary, not competitive, and are expected to be used simultaneously in clinical practice based on the progressive nature of the disease and feedback from clinicians.Euroz Hartleys maintained its speculative buy recommendation and AU$1.65 price target on Dimerix.The company's shares advanced 11% in recent Tuesday trading.

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