Khartis Therapeutics Secures $95 Million to Advance Oral IGF-1R Inhibitor into Clinical Trials
$95 Million Raised to Fuel Development of a Novel Therapeutic
Khartis Therapeutics has secured $95 million in funding, including a $50 million Series B round led by Polaris Life Sciences Partners. The funding is in the form of equity investment and does not include upfront payments or milestone payments related to licensing agreements. Robert Hoffman, CEO, previously contributed to the chemical design of Lorbrena (lorlatinib) at Pfizer (PFE), and the management team has experience in successfully selling XinThera to Gilead Sciences (GILD) in 2023. The significant investment in this preclinical biotech company is driven by the team's proven track record in medicinal chemistry and their experience in building and scaling companies.
Targeting Patient Convenience with an Oral IGF-1R Inhibitor
The lead program is a selective, oral, small-molecule IGF-1R inhibitor for the treatment of Thyroid Eye Disease (TED), currently in the preclinical stage. The company plans to initiate a Phase 1 clinical trial in the first quarter of 2027, and the funding will support IND-enabling studies, manufacturing, and initial safety assessments. Blocking IGF-1R is a validated mechanism for inhibiting the abnormal activity of orbital fibroblasts and tissue remodeling in TED. Developing an oral formulation, as opposed to an injectable antibody, has the potential to improve patient convenience by reducing the need for hospital visits and injections. However, clinical trials will need to evaluate systemic exposure and potential adverse effects, such as hyperglycemia and hearing impairment.
Tepezza and Lumvoa Set a High Bar in the Market
Amgen's (AMGN) Tepezza (teprotumumab-trbw), an IGF-1R monoclonal antibody, received FDA approval on January 21, 2020, and has since been approved in Japan (September 24, 2024) and the European Union (June 19, 2025). The current standard of care involves intravenous infusions administered every three weeks, for a total of eight infusions. In 2025, Tepezza generated $1.93 billion in revenue, a 3% increase. Viridian Therapeutics' (VRDN) Lumvoa (veligrotug-vvze), also an IGF-1R-targeting antibody, has completed two Phase 3 clinical trials and is in the process of receiving FDA approval and launch. Therefore, Khartis' competitive advantage will depend on demonstrating clinical superiority in terms of oral administration, selectivity, safety, and patient compliance, rather than simply targeting the same mechanism.
Significant Market Opportunity, but Clinical Risk Remains
The global TED treatment market was valued at $3.42 billion in 2025 and is projected to grow at a CAGR of 7.3%. While Tepezza and Lumvoa have expanded treatment options beyond steroids and orbital decompression surgery, there is still room for improvement in terms of convenience and long-term disease management. Khartis aims to mitigate the risk associated with a single asset by using the $95 million in funding to advance its lead program into clinical trials and to develop additional small-molecule programs for other immune-mediated chronic diseases. The next key valuation event for the company will be the data from the Phase 1 clinical trial in 2027, which will provide insights into the drug's pharmacokinetics, target engagement, and safety profile.
Khartis' $95 million in funding demonstrates the early-stage investment appetite for oral IGF-1R inhibitors in the $3.42 billion TED market. Key near-term milestones include the IND submission and initiation of the Phase 1 clinical trial in the first quarter of 2027, as well as the demonstration of favorable pharmacokinetics and safety in humans. Hyperglycemia and hearing impairment will need to be carefully monitored and compared to existing IGF-1R therapies. In the long term, the company has the potential to differentiate itself from Tepezza and Lumvoa, which generated $1.93 billion in revenue in 2025, by offering an oral formulation. This program serves as a case study for researchers and industry professionals to evaluate whether a validated target can be effectively addressed with a small molecule, improving tissue penetration and patient compliance. A successful outcome could lead to strategic partnerships and acquisition opportunities. However, given the early stage of development, the company's ability to execute on its plans, meet the 2027 timeline, and demonstrate early clinical efficacy will be key drivers of its valuation.