[Edaily Reporter KIM SAE-MI ] “We’ve set a company goal of closing at least one deal next year, and all employees are working toward that goal.”

, Inc.

Lee Seung-ju, CEO of #Orum Therapeutics, Inc., made these remarks at an investor briefing held after the conclusion of an extraordinary general meeting of shareholders on the 23rd. About a month after Bristol-Myers Squibb (BMS) halted clinical development of a new drug candidate it had licensed, Orum Therapeutics, Inc.’s stock price plummeted 69.7%, falling to about one-third of its previous value. Investor attention is now focused on the potential for a technology transfer of the follow-up blood cancer candidate “ORM-1153” and whether CEO Lee will be able to achieve the deal target he set for next year.

It drew attention with a 1.6 trillion “big deal,” but… it’s “stumbling” amid a series of clinical setbacks

CEO Lee is the founder who established Orum Therapeutics, Inc. in 2016. Based on antibody-drug conjugate (DAC) technology—which combines an antibody with a target protein degrader (TPD)—he secured a series of major contracts with global pharmaceutical companies. DAC is a technology designed to use antibodies to deliver a drug to target cells and then degrade disease-related proteins. It differs from conventional antibody-drug conjugates (ADCs), which primarily deliver cytotoxic drugs, in that it induces the degradation of specific proteins.

In October 2023, the company signed an asset transfer agreement with BMS for the blood cancer candidate “ORM-6151,” totaling $180 million (approximately 252 billion won). The deal attracted significant attention in the biotech industry, with the upfront payment alone amounting to $100 million (approximately 140 billion won). In July of the following year, the company signed a technology transfer and option agreement with Vertex Pharmaceuticals worth up to $945 million (approximately 1.323 trillion won). The combined value of the two agreements amounts to a maximum of $1.125 billion (approximately 1.575 trillion won).

Building on the success of these successive global agreements, Orum Therapeutics, Inc. made its debut on the KOSDAQ market in February of last year. However, following the IPO, a series of setbacks occurred during the new drug development process. In April of last year, the company halted the Phase 1 clinical trial for “ORM-5029,” a breast cancer candidate it had been developing in-house, and in September, BMS decided to discontinue development of ORM-6151.

While the company is not obligated to return the $100 million upfront payment received at the time of the agreement with BMS, the possibility of receiving up to $80 million (approximately 112 billion won) in additional milestone payments has vanished due to the suspension of clinical development.

As of the end of June this year, Orum Therapeutics, Inc.’s cash and cash equivalents (including short-term financial instruments) totaled 254.5 billion won, so the company is not currently facing an immediate liquidity crisis. However, aside from its cash reserves, the company still faces the challenge of demonstrating the clinical success of its subsequent pipeline. Given that BMS’s decision to halt development has heightened investors’ doubts about the company’s technological capabilities, it has become crucial to secure new contracts to restore market confidence.

Reason for BMS’s Development Halt Undisclosed… A New Attempt with ORM-1153

The point that most intrigued investors was the reason BMS halted development of ORM-6151. At an investor briefing on the 23rd, one shareholder repeatedly asked whether the development halt was due to toxicity issues. This stems from concerns that, since ORM-1153 is also being developed based on DAC technology, the cause of the suspension of the previous candidate could affect subsequent candidates as well.

CEO Lee replied, “We have received all the information available from BMS,” adding, “ORM-6151 never experienced a clinical hold.” However, he did not disclose the specific reasons BMS halted development or the clinical results.

The key driver of future growth highlighted by CEO Lee is the blood cancer candidate ORM-1153. ORM-1153 is a CD123-targeted DAC candidate, similar to the existing ORM-6151, but differs in antibody and drug design. The company’s strategy is to overcome the limitations of the existing candidate by improving intracellular delivery efficiency and the drug’s mechanism of action.

ORM-1153 completed the first patient dosing in a U.S. Phase 1 clinical trial on the 14th. The company plans to conduct the trial with 42 participants and secure initial data sometime next year.

CEO Lee explained, “We received a $100 million upfront payment for ORM-6151 without any clinical data,” adding, “Since securing clinical data for ORM-1153 could further increase the total contract size and value, we are preparing to conduct the clinical trial and then proceed with the technology transfer.” In other words, rather than rushing into a deal in the early clinical stages, the company intends to secure human data first to strengthen its negotiating position.

Some shareholders asked about the possibility of BMS re-acquiring the follow-on candidate, ORM-1153. In response, CEO Lee said, “It’s not entirely out of the question, as BMS’s investor relations materials indicate they remain highly interested in blood cancers, proteolytic inhibitors, and DAC technology,” but added, “We intend to carefully select the partner best suited to commercialize ORM-1153.”

The joint research with Vertex is another factor that will determine future business development outcomes. Unlike the agreement with BMS, the contract with Vertex remains in effect, though specific details on the progress of the research have not been disclosed. CEO Lee maintained that he could not reveal specific details due to contractual confidentiality obligations.

Pursuing External Technology Acquisition and New Payload Development in Parallel

Investors are eagerly awaiting Orum Therapeutics, Inc.’s next major contract. However, CEO Lee has repeatedly stated that it is difficult to guarantee when a deal will be finalized. “I’ve seen deals fall through right before the pen was put to paper,” he noted, adding, “There are cases where contracts fall through even while press releases are being exchanged.”

Another strategy highlighted by CEO Lee is expanding the pipeline through the introduction of external technologies and the development of new payloads. Since last year, Orum Therapeutics, Inc. has announced plans to diversify its drug candidates by introducing external antibody and payload technologies. The company’s vision is to secure new candidates and increase opportunities for technology transfer by combining its in-house technologies with external assets.

Meanwhile, CEO Lee recently increased his stake by personally purchasing company shares. On the 21st, he bought 10,000 shares of Orum Therapeutics, Inc. on the open market. This move is noteworthy because it marks the first time the largest shareholder has personally purchased shares following a sharp drop in the stock price. An Orum Therapeutics, Inc. official emphasized, “The CEO’s recent stock purchase demonstrates his confidence in the company’s pipeline.”

◇ Profile of Lee Seung-ju, CEO of Orum Therapeutics, Inc.
△Born December 8, 1974
△B.S. in Biochemistry, Yonsei University
△ Ph.D. in Biophysics, University of California, Berkeley
△ 2003–2005: Postdoctoral Researcher, Department of Chemistry, Stanford University, USA
△2005–2010: Researcher, R&D Division, LG Corp. Life Sciences
△2010–2013: Director of R&D, Sanofi Korea
△2013–2016: Director, Sanofi Asia-Pacific Research Institute
△2016: Founded Orum Therapeutics, Inc.; CEO