Whitehawk Therapeutics Inc Q4 FY2024 earnings call

• Transition from Aadi Biosciences to Whitehawk Therapeutics, with the latter focusing on an ADC-focused portfolio.
• Framework for ADC development: building on established tumor biology, using advanced ADC platform technology, and focusing on speed to major data inflections.
• Portfolio consists of three assets: HWK-007 (targets PTK7), HWK-016 (targets MUC16), HWK-206 (targets SEZ6).
• Advanced ADC platform technology engineered for minimal off-target toxicity, greater stability, and higher therapeutic index.
• Anticipated INDs for all three candidates within the next 15 months.
• Addition of David Dornan as Chief Scientific Officer, bringing over 2 decades of oncology drug discovery and development experience, particularly in ADCs.

FYARRO net product sales were $7.2 million in the fourth quarter, representing 14% growth over the prior year quarter. Full year FYARRO sales were $26 million, an increase of 7% over 2023. Research and development expenses for the quarter increased to $14.3 million compared to $12.8 million in the prior year quarter. For the year, R&D expense amounted to $51 million compared to $48.9 million last year. Selling, general and administrative expenses for the fourth quarter were $11.1 million compared to $10.3 million in the same period in 2023. For the year, SG&A expenses decreased to $36.7 million compared to $44.5 million in the prior year. Net loss for the fourth quarter was $18.3 million compared to $16.3 million in the fourth quarter of 2023. Net loss for the year was $63.7 million compared to $65.8 million in the prior year.

• Plan to submit INDs for all three ADC candidates within the next 15 months.
• Aim to file three U.S. INDs within 15 months.
• Cash on hand is expected to fund operations into 2028, covering anticipated clinical inflections.

Statements made include forward-looking statements, and actual events or results could differ materially from those expressed due to various risks, uncertainties, and other factors set forth in the Risk Factors section of annual and quarterly filings with the SEC.

Q: Considering that Regeneron is developing a Mucin 16 targeted bispec antibody for ovarian, how do you anticipate that the clinical activity and safety profile of your ADC might compare to the bispecific approach within this indication?

A: Dave Lennon started the response, noting ADCs and bispecific TCEs are different modalities but both important for patient treatment. David Dornan added that ADCs using stable linker technology mitigate risks like cytokine release syndrome seen in some bispecifics.

Q: On the three targets, understanding the prevalence of high, medium, low expression levels; and about the 2028 runway covering the three Phase 1 studies.

A: Dave Lennon discussed the broad expression of PTK7, MUC16, and SEZ6, noting high and deep expression in many patients. Regarding the 2028 runway, it covers generating meaningful clinical Phase 1 data for all three programs with current funding.