[Edaily KIM SAE-MI Reporter] HanmiPharm has effectively shifted to a structure where it is once again developing “Tuspetinib” (HM43239), a new drug for acute myeloid leukemia (AML) that it had licensed to an overseas biotech company in 2021, in-house within the group. This shift comes after Hanmi Pharmaceutical fully acquired Aptose Biosciences—the company to which it had licensed the technology—following years of financial support as Aptose faced funding difficulties, and subsequently merged the related subsidiaries.

HanmiPharm(128940)announced in a corrective disclosure on the 26th that it is changing the counterparty to the HM43239 technology transfer agreement from Aptose Biosciences (U.S. and Canada) to Aptose Biosciences (Canada).

The new counterparty, Aptose, is a newly established entity formed on this day through the merger of HS North America—a wholly-owned subsidiary of HanmiPharm—and the original Aptose, in which HS North America held a 100% stake. Although the company name remains the same, changes to its legal entity and key corporate information mean that the technology transfer agreement signed in 2021 has been transferred to the new entity.

Consequently, the development structure for Tuspetinib—which had been licensed to an external biotech company—has effectively been brought back into the HanmiPharm Group. Since the licensee, Aptos, has become a wholly-owned subsidiary of HanmiPharm, the economic substance of the development and commercialization outcomes has changed significantly from what it was at the time of the 2021 contract.

496.1 Billion Technology Export Partner Relies on HanmiPharm Support Amid Financial Strains

The partnership between HanmiPharm and Aptose began in November 2021. HanmiPharm transferred the worldwide rights to HM43239 to Aptose in a technology transfer deal valued at a total of $420 million (approximately 496.1 billion won at the time). The non-refundable upfront payment was $12.5 million (approximately 14.8 billion won), consisting of $5 million in cash and Aptose stock valued at $7.5 million. Milestone payments tied to clinical trials, regulatory approvals, and commercialization totaled up to $407.5 million (approximately 481.3 billion won), with separate ongoing royalty payments based on net sales following commercialization.

However, as Aptose’s financial structure subsequently deteriorated, its relationship with HanmiPharm shifted to one of financial support. In August 2024, HanmiPharm lent Aptose $10 million (approximately 14 billion won) for the development of Tuspetinib. At the time, Aptose announced that it would use these funds to develop a three-drug combination therapy with Tuspetinib for patients newly diagnosed with AML.

In March of last year, $1.5 million (approximately 2.1 billion won) of this loan was converted into 409,063 shares of Aptose stock. In June of the same year, Aptose also signed an agreement to borrow an additional $8.5 million (approximately 11.9 billion won) from HanmiPharm to continue the tuspetinib clinical trials. At the time, Aptose invoked the “financial hardship” exception, which exempted it from certain procedures required for related-party transactions under Canadian securities laws.

The company also struggled to maintain its public listing. Aptose failed to meet Nasdaq’s minimum shareholder equity requirements by the end of March last year and was delisted from Nasdaq on April 2 of that year. Subsequently, it underwent a delisting review by the Toronto Stock Exchange (TSX) regarding its eligibility for continued listing; this review continued until June of this year, just before the acquisition by HanmiPharm.

Since the start of this year, its financial situation has become even tighter. As of the end of March, Aptose’s cash stood at just $4.1 million (approximately 5.7 billion won), while its working capital was negative $5.08 million (approximately 7.1 billion won) and shareholders’ equity was negative $34.67 million (approximately 48.5 billion won). Accumulated losses also reached $574.07 million (approximately 803.7 billion won). In its own earnings announcement, Aptose revealed that it did not have sufficient cash to cover operating expenses and was therefore relying on financial support from HanmiPharm.

Most Development Funds Ultimately Led to Acquisition… Technology Export Partner Becomes Subsidiary

Ultimately, HanmiPharm chose to directly acquire Aptose to ensure the continued development of Tuspetinib and secure a foothold in the North American market.

The two parties signed an acquisition agreement last November, and Aptose shareholders approved the deal in March of this year. HanmiPharm completed the acquisition on June 30 by acquiring all remaining shares of Aptose—which it had not previously held—through its subsidiary, HS North America. Existing Aptose shareholders received 2.41 Canadian dollars (approximately 2,500 won) per share.

HanmiPharm acquired the remaining 80.1% stake for C$4,925,363 (approximately 5.3 billion won). As a result, Aptos has become a wholly-owned subsidiary of HanmiPharm, and the entire existing board of directors has resigned. Subsequently, Aptos’ shares were delisted from the TSX, and the company became privately held.

Given Aptose’s financial situation, HanmiPharm’s acquisition is interpreted as a shift toward the original developer taking direct responsibility for the development of the candidate compound, as it had become difficult to continue development stably through an external technology export partner.

The Contract Remains, but the Economic Substance Has Changed

This amendment does not alter the terms of the 2021 technology transfer agreement itself. The total contract amount, milestone payments, and ongoing technology fees remain unchanged. However, since Aptose—which is responsible for future milestone and royalty payments—is now a wholly-owned subsidiary of HanmiPharm, the economic substance has changed from the perspective of consolidated financials compared to the time of the technology transfer.

Tuspetinib is an AML treatment candidate that works by inhibiting FLT3 mutations and spleen tyrosine kinase (SYK), among other targets. A clinical trial is currently underway to evaluate the potential of a three-drug regimen—combining tuspetinib with venetoclax and azacitidine—as a first-line treatment for newly diagnosed AML patients.

For HanmiPharm, this means that after transferring the development and commercialization rights for this new drug to an external partner in 2021, the company is once again managing it at the group level five years later. Since HanmiPharm continued to provide loans and equity investments to address Aptose’s financial difficulties following the technology export and eventually acquired the company itself, the financial burden of Tuspetinib’s future clinical development and the outcomes of that development are also expected to fall more directly on the HanmiPharm Group.

A HanmiPharm official stated, “We plan to disclose any future changes to the key terms of the agreement or any disclosure obligations without delay.”