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LadRx and ImmunityBio Mutually Agree to Terminate Aldoxorubicin License

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LadRx (OTCQB: LADX) and ImmunityBio have agreed to mutually terminate the aldoxorubicin license, returning control of the drug to LadRx. This move follows LadRx's 2023 transfer of royalty and milestone rights of aldoxorubicin to XOMA for $5 million upfront, potentially up to $7 million more in milestones. XOMA has consented to the termination and will receive a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage from future out-license agreements. Aldoxorubicin, part of LadRx's LADR-based drug program, has shown promise in clinical trials with lower cardiotoxicity compared to doxorubicin. LadRx plans to review aldoxorubicin's data for further clinical development and expects to file an IND for another drug, LADR-7, by late 2024.

Positive
  • LadRx regains control of aldoxorubicin, a drug with promising clinical trial results.
  • LadRx received $5 million from XOMA for transferring royalty and milestone rights of aldoxorubicin.
  • Potential for up to $7 million in additional milestone payments from XOMA.
  • XOMA consented to the termination of the license agreement, facilitating the return of aldoxorubicin.
  • Aldoxorubicin showed lower cardiotoxicity and promise of efficacy in Phase II trials.
  • LadRx is on track for filing an IND application for LADR-7 by late 2024.
Negative
  • Termination of the aldoxorubicin license could indicate challenges in its commercial viability.
  • Ongoing financial reliance on milestone payments and royalties from XOMA.
  • Future revenues from aldoxorubicin will be reduced by the royalties owed to XOMA.

Insights

The termination of the aldoxorubicin license agreement between LadRx and NantCell marks a significant shift in LadRx's control over its cancer therapeutic assets. By regaining control of aldoxorubicin, LadRx can now directly manage the development and potential commercialization of this drug, which could have important financial implications. The amended agreement with XOMA, where XOMA receives a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage from future out-licenses, suggests a strategic financial maneuver to maintain collaboration while maximizing internal control. Investors should note that these financial structures could impact future revenue streams and present both opportunities and risks depending on the success of the drug’s further development. In the short term, this move might not create immediate financial benefits, but in the long term, successful commercialization could result in significant revenue boosts for LadRx.

From a medical research perspective, the return of aldoxorubicin to LadRx is noteworthy due to the drug’s previous clinical trial performance. Aldoxorubicin, which is a derivative of doxorubicin, has demonstrated lower cardiotoxicity and promising efficacy in Phase II trials for advanced soft tissue sarcoma. This could be particularly compelling as it suggests a potentially safer chemotherapeutic option with effective results. Understanding that LADR-based drugs can allow for higher dosing of chemotherapy with reduced side effects could be a game-changer in oncology treatments. However, the path to further clinical development may be lengthy and require substantial investment and time, which can be a potential drawback.

Aldoxorubicin Returns to LadRx

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, is pleased to announce that the Company and NantCell, Inc. (“NantCell”), together with NantCell’s parent company ImmunityBio, Inc. (“ImmunityBio”), have agreed to a mutual termination of the license of aldoxorubicin entered into in 2017.

With the termination of the license agreement between LadRx and NantCell, LadRx regains control of aldoxorubicin. In 2023, LadRx transferred the royalty and milestone rights of arimoclomol and aldoxorubicin to XOMA Corporation (NASDAQ: XOMA) (“XOMA”) in exchange for $5 million in upfront gross proceeds, up to an additional $2 million for milestones related to arimoclomol and $5 million for milestones related to aldoxorubicin. XOMA consented to the mutual termination of the LadRx-NantCell agreement in order to facilitate the return of the program to LadRx. In parallel, LadRx and XOMA have amended their 2023 Royalty Purchase Agreement to provide XOMA with a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage of any economics derived by LadRx from future out-license agreements related to aldoxorubicin. The agreement between LadRx and XOMA regarding future royalties and milestones associated with arimoclomol is not affected by the termination of the aldoxorubicin license between LadRx and NantCell.

Stephen Snowdy, PhD, CEO of LadRx commented, “We are excited to have aldoxorubicin back in-house. Aldoxorubicin is the first LADR-based drug to reach the clinic and was shown in multiple clinical studies to have lower cardiotoxicity compared to doxorubicin while showing promise of efficacy in a Phase II trial in advanced soft tissue sarcoma. Aldoxorubicin also proved the premise of LADR-based drugs that targeting chemotoxins via the LADR backbone allows for several-fold higher dosing of chemotherapeutic drugs.”

Dr. Snowdy continued, “We congratulate ImmunityBio on their recent successes with their immunity-based products and certainly understand their going-forward focus on those modalities. Over the coming months, we will be reviewing the pre-clinical and clinical data for aldoxorubicin and plotting a path forward for its continued clinical development. Meanwhile, we continue to march LADR-7 towards the clinic and remain on track for filing an IND application for LADR-7 in the third or fourth quarter of 2024.”

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 developing new therapeutics to treat patients with cancer. LadRx Corporation’s website is www.ladrxcorp.com.

Longacre Square Partners

Greg Marose / Charlotte Kiaie

ladrx@longacresquare.com

Source: LadRx Corporation

FAQ

What is the significance of the mutual termination of the aldoxorubicin license for LadRx?

LadRx regains control of aldoxorubicin, enabling it to direct its future clinical development.

How much did LadRx receive from XOMA for the royalty and milestone rights of aldoxorubicin?

LadRx received $5 million upfront, with the potential for an additional $7 million in milestone payments.

What is the impact of the termination of the aldoxorubicin license on future royalties?

XOMA will receive a low-single-digit synthetic royalty and a mid-single-digit percentage from future out-license agreements of aldoxorubicin.

How did aldoxorubicin perform in clinical trials?

Aldoxorubicin showed lower cardiotoxicity compared to doxorubicin and promise of efficacy in Phase II trials for advanced soft tissue sarcoma.

What are LadRx's future plans for aldoxorubicin?

LadRx plans to review pre-clinical and clinical data for aldoxorubicin to plot a path forward for its continued clinical development.

When does LadRx plan to file an IND application for LADR-7?

LadRx expects to file an IND application for LADR-7 in the third or fourth quarter of 2024.

LADRX CORPORATION

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