GuruFocus -
- Cash, Cash Equivalents, and Short-term Investments: Ended 2024 with $47.2 million.
- Post-Transaction Cash Range: Expected to be $170 million to $180 million.
- FYARRO Net Product Sales (Q4): $7.2 million, 14% growth over prior year quarter.
- FYARRO Full Year Sales: $26 million, 7% increase over 2023.
- Research and Development Expenses (Q4): $14.3 million, up from $12.8 million in prior year quarter.
- Full Year R&D Expenses: $51 million, compared to $48.9 million last year.
- Selling, General and Administrative Expenses (Q4): $11.1 million, up from $10.3 million in 2023.
- Full Year SG&A Expenses: $36.7 million, down from $44.5 million in prior year.
- Net Loss (Q4): $18.3 million, compared to $16.3 million in Q4 2023.
- Full Year Net Loss: $63.7 million, compared to $65.8 million in prior year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aadi Bioscience Inc (NASDAQ:AADI) has successfully transitioned into Whitehawk Therapeutics, focusing on advanced ADC technology, which is expected to outperform first-generation ADCs.
- The company has secured $100 million in PIPE financing and expects to have cash and cash equivalents in the range of $170 million to $180 million, funding operations into 2028.
- Aadi Bioscience Inc (NASDAQ:AADI) has in-licensed three promising ADCs from Wuxi Biologics, targeting clinically validated tumor targets with significant unmet needs.
- The company plans to file three US INDs within the next 15 months, indicating a rapid advancement of their ADC portfolio to the clinic.
- Aadi Bioscience Inc (NASDAQ:AADI) has a strong leadership team, including the recent addition of David Dornan as Chief Scientific Officer, who brings extensive experience in oncology drug discovery and development.
- The company reported a net loss of $63.7 million for the year, slightly lower than the previous year’s loss of $65.8 million.
- Research and development expenses increased to $14.3 million for the quarter, driven by in-process R&D expenses related to the newly acquired ADC programs.
- Selling, general, and administrative expenses increased to $11.1 million for the fourth quarter, primarily due to increased legal and consulting expenses.
- The divestiture of FYARRO to Kaken Pharmaceuticals means Aadi Bioscience Inc (NASDAQ:AADI) will no longer benefit from its sales, which were $26 million for the full year.
- The transition to Whitehawk Therapeutics involves risks associated with strategic shifts and the need to establish a new brand identity in the competitive ADC market.
A: Dave Lennon, President and CEO, explained that ADCs and bispecific TCEs are different in their mechanisms. While both target the membrane-bound type MUC16, the ADC approach focuses on a chemo-based response, whereas the bispecific targets an immune-modulating response. David Dornan, Chief Scientific Officer, added that the ADC avoids antigen sink and does not have the cytokine release syndrome associated with CD3 redirection, offering a differentiated safety profile.
Q: Could you help us understand the distribution of high, medium, and low expression levels for each of the three targets?
A: Dave Lennon noted that PTK7 is broadly overexpressed in many cancers, often at moderate to high levels, which correlates with improved responses. MUC16 expression increases with disease progression, allowing targeting of patients most in need. SEZ6 is highly expressed across small cell lung cancer, with AbbVie (NYSE:ABBV)’s program showing high response rates without patient selection.
Q: Does the 2028 financial runway cover all three Phase I studies?
A: Dave Lennon confirmed that the current funding is intended to generate meaningful clinical Phase I data for all three programs. The programs are staggered by a few months, but the goal is to have significant data before seeking additional financing.
Q: What are the key features of the advanced ADC platform that differentiate it from first-generation ADCs?
A: Dave Lennon highlighted that the advanced ADC platform uses a proprietary TOPO1 inhibitor payload, a highly stable cleavable linker, and an enhanced pharmacokinetics profile. These features minimize off-target effects, support higher therapeutic index, and enable optimal dosing, potentially improving efficacy over first-generation ADCs.
Q: How does Whitehawk plan to leverage its advanced ADC technology in the market?
A: Dave Lennon stated that Whitehawk aims to rapidly advance its portfolio to the clinic, with INDs for all three candidates anticipated within 15 months. The focus is on high-potential cancer indications with significant unmet needs, leveraging clinically validated tumor targets and advanced ADC technology to outperform first-generation ADCs.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.