LadRx Issues 2024 Update to Shareholders

Rhea-AI Summary

LadRx Corporation (LADX) announces FDA acceptance of arimoclomol NDA triggering a $1 million payment from XOMA. Anticipated milestones for 2024 include first commercial sale of arimoclomol and entering first-in-human studies of LADR-7.

Insights

Financial Analyst

The FDA's acceptance of the New Drug Application for arimoclomol marks a significant milestone for LadRx Corporation, potentially catalyzing a series of financial transactions that could influence the company's cash flow and funding for ongoing projects. The immediate $1 million payment from XOMA Corporation enhances LadRx's liquidity, which is crucial for a biopharmaceutical company in the capital-intensive phase of drug development. Furthermore, the anticipated additional milestone payment upon the first commercial sale of arimoclomol, albeit netting $600,000 due to unspecified deductions, represents an additional influx of funds. The timing of these payments, contingent on regulatory approvals and market launch, introduces a degree of uncertainty that investors must consider when evaluating LadRx's financial trajectory.

From a broader financial perspective, the successful progression of LADR-7 through the manufacturing and toxicology phases, leading to an IND submission, could be a pivotal driver of long-term value creation. However, the inherent risks of clinical development suggest that investors should closely monitor the outcomes of the toxicology studies and subsequent FDA feedback. The company's ability to secure patent protection in multiple jurisdictions for its LADR-based molecules further underscores the strategic importance of intellectual property in sustaining competitive advantage and potential revenue streams.

Medical Research Analyst

The acceptance of arimoclomol's NDA by the FDA is a critical step forward in the drug's regulatory pathway, indicating that the application is sufficiently complete to permit a substantive review. The PDUFA date provides a regulatory timeline for approval, which is a key inflection point for the company's development efforts. The drug's progress towards potential commercialization is of particular interest, as it reflects the company's ability to transition from R&D to a market participant. The potential approval and market entry of arimoclomol will also have implications for the therapeutic landscape, especially if the drug demonstrates a differentiated profile in efficacy or safety.

Regarding LADR-7, the completion of GMP production and the initiation of GLP toxicology studies are foundational steps in the preclinical development process. These steps are prerequisites for IND filing, which is necessary before clinical trials can begin. The company's communication regarding the expected timeline for IND submission and potential first-patient dosing by the end of 2024 provides insight into their development strategy and operational targets. The mention of potential delays due to toxicology or regulatory hurdles underscores the uncertainties inherent in drug development, which can impact project timelines and investment considerations.

Patent Attorney

LadRx's success in securing patents for its auristatin-based and maytansinoid-based drugs across various jurisdictions is a significant achievement in protecting its intellectual property. Patents are a fundamental element in the biopharmaceutical industry, granting the holder exclusive rights to commercialize their inventions for a set period. The strategic importance of these patents cannot be overstated, as they can prevent competitors from entering the market with similar drugs, thereby potentially increasing the commercial viability and life cycle of LadRx's products. The patents also add to the company's asset portfolio, which could be factored into the company's valuation by investors.

The successful prosecution of patents and the existence of additional patents pending provide a layer of future security for the company's innovation pipeline. However, the actual value of these patents will ultimately depend on the commercial success of the drugs they protect, the company's ability to defend them against infringement and the legal robustness of the patent claims in each jurisdiction.

FDA Acceptance of Arimoclomol Triggers $1 Million Payment

LOS ANGELES--(BUSINESS WIRE)-- LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today issued the below letter to shareholders providing a corporate update and anticipated milestones for 2024 regarding arimoclomol and LADR-7.

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January 9, 2024

Dear LadRx Shareholders,

It was a busy close to 2023 and has already been an exciting start to 2024. We are pleased to provide the following updates on the subjects of arimoclomol and LADR-7.

Arimoclomol

In 2023, LadRx entered into an agreement with XOMA Corporation (NASDAQ: XOMA) (“XOMA”) in which LadRx transferred the economic rights from arimoclomol to XOMA in exchange for an upfront payment and subsequent payments upon the achievement of certain milestones. The first of those milestones is the notification of the sponsor, Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra”), by the U.S. Food and Drug Administration (“FDA”) that the New Drug Application (“NDA”) for arimoclomol has been accepted by the FDA. On January 8, 2024, Zevra announced the acceptance of the arimoclomol NDA by the FDA, with a Prescription Drug User Fee Act (“PDUFA”) date of June 21, 2024, triggering a $1 million payment obligation from XOMA to LadRx. The second milestone related to arimoclomol is the first commercial sale of arimoclomol by Zevra, which triggers an additional $1 million payment from XOMA to LadRx (which will net LadRx $600,000). Zevra has not released the expected timing of the first commercial sale, though LadRx management believes that the first commercial sale in 2024 is a reasonable expectation, should the FDA approve the NDA.

Development of LADR-7

As previously communicated, LadRx is working diligently towards entering the first-in-human studies of LADR-7, which is a targeted, controlled release form of the highly potent tubulin inhibitor auristatin-E. The Company is pleased to report that the production of approximately 100 grams of LADR-7 under Good Manufacturing Practices (“GMP”) has progressed smoothly, has been completed and the GMP LADR-7 currently in hand is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in humans.

The Company has also initiated the Good Laboratory Practices (“GLP”) toxicology program that is expected to form the foundation of the Investigational New Drug (“IND”) application for LADR-7 to the FDA. In the fourth quarter of 2023, the Company submitted a pre-IND to the FDA, outlining our proposed toxicology program. If the FDA agrees with our proposed toxicology program, management expects the toxicology studies to be completed and the IND for LADR-7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR-7 by the end of 2024 (the period for the FDA review of an IND is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND, the first-patient dosing could be substantially delayed.

With the $1 million milestone payment from XOMA, management projects the resulting cash on hand should be sufficient to reach at least the IND filing for LADR-7. In addition to receiving this additional cash influx, LadRx making an IND submission for LADR-7 by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024 is dependent on the toxicology program going smoothly, and on the FDA accepting LadRx’s proposed toxicology program.

In the second half of 2023, the Company made material progress on the patent protection of its LADR-based molecules. LadRx’s auristatin-based drugs were granted patents in Europe, Japan, Australia and South Africa, while the maytansinoid-based drugs received a patent in Israel. The broader LADR platform, which we employ in both auristatin- and maytansinoid-based drugs, received a patent in Brazil. The prosecution of patents covering the LADR drugs has been met with success, and there remain additional patents pending for both the LADR platform and its derivative drugs.

We look forward to continuing to build on our momentum at LadRx and a successful 2024.

Sincerely,
Stephen Snowdy, PhD
CEO of LadRx

***

Forward-Looking Statements

This press release may contain certain statements relating to future results which are forward-looking statements, including whether the company’s strategic review will be successful and whether the stock split will help the company be more successful in evaluating strategic alternatives. These statements are not historical facts, but instead represent only LadRx’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of LadRx’s control. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements; and other risks and uncertainties described in the most recent annual and quarterly reports filed by LadRx with the SEC, including disclosures under the heading “Risk Factors,” and current reports filed since the date of the LadRx’s most recent annual report. All forward-looking statements are based upon information available to LadRx on the date the statements are first published. LadRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

About LadRx

LadRx Corporation (OTCQB: LADX) is a biopharmaceutical company with expertise in discovering and developing new therapeutics principally to treat patients with cancer. LadRx transferred the royalty and milestone rights associated with its previously developed drugs, arimoclomol and aldoxorubicin, to XOMA Corporation (NASDAQ: XOMA) in exchange for $5 million in gross proceeds and up to an additional $6 million based on regulatory and commercial milestones related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and ImmunityBio, Inc. (net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin). LadRx Corporation’s website is www.ladrxcorp.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240109293094/en/

Longacre Square Partners

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ladrx@longacresquare.com

Source: LadRx Corporation

FAQ

What triggered the $1 million payment to LadRx?

The FDA acceptance of arimoclomol NDA triggered a $1 million payment from XOMA to LadRx.

What are the anticipated milestones for LadRx in 2024?

The anticipated milestones for LadRx in 2024 include the first commercial sale of arimoclomol and entering first-in-human studies of LADR-7.

What is the Prescription Drug User Fee Act (PDUFA) date for arimoclomol?

The PDUFA date for arimoclomol is June 21, 2024.

What is LADR-7 and what stage of development is it in?

LADR-7 is a targeted, controlled release form of the tubulin inhibitor auristatin-E. LadRx is working towards entering first-in-human studies of LADR-7.

What progress has LadRx made in the patent protection of its LADR-based molecules?

LadRx made material progress on the patent protection of its LADR-based molecules, with patents granted in various countries and additional patents pending.