Whitehawk Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to White Hawk Therapeutics fourth quarter and full year 2024 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you would need to press star 11 on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Audrey Gross, head of corporate communications for White Hawk Therapeutics. Ms. Gross, please go ahead.

Thank you. Good morning and welcome to the White Hawk Therapeutics conference call. We will be presenting slides as part of a live webcast of this call. Set slides will be posted on the investor news page of the WhiteHawk Therapeutics website at whitehawkpx.com following the conference call. A reminder that statements made on the call today will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factor section of our annual and quarterly filings with the Securities and Exchange Commission, which can be found at www.sec.gov or on our website at whitehawktx.com. In addition, any forward-looking statements made on this call represent our views only as of today, March 19th, 2025, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. On the call today is Dr. Dave Lennon, our president and CEO, Scott Giacobbello, our CFO, and Dr. David Dornan, our newly appointed CSO. Today we will introduce WhiteHawk Therapeutics and provide an overview of Q4 and full year 2024 financial results before turning the line open for questions. I'll now turn the call over to Dave. Dave?

Thanks, Audrey. Hello, everyone. Good morning. Thank you for joining. I'm Dave Lennon, the president and CEO of the newly launched WhiteHawk Therapeutics. We are extremely excited about the transformation from Addi Biosciences to Whitehawk. I look forward to walking you through our vision, strategy, and opportunity, and the opportunity we have to deliver a meaningful impact for patients with our advanced ADC portfolio. As a reminder, in December, we announced a series of strategic transactions, including the in-licensing of three ADCs from Wuxi Biologics, the divestiture of Fiaro to Kaken Pharmaceuticals, and $100 million pipe financing that were subsequently approved during a special meeting of stockholders last month. As a next step in our evolution, Addi Biosciences is now divided into two organizations. Upon the divestiture of Addi's subsidiary to Kaken, Kaken will assume ownership of the Addi name, trademark, and the Fiaro business. And today, Addi parent company relaunches as White Hawk Therapeutics, formalizing our transition into an ADC-focused company. While we remain rooted in our legacy, that is to make bold choices in applying technology to deliver improved precision oncology therapies, Whitehawk carries several important distinctions. As ADDIE, we were focused on mTOR inhibition in rare cancer settings and were built on the foundation of a single commercial product. Conversely, Whitehawk is focused on rapidly progressing a multi-asset portfolio of advanced ADC therapy all with the broad potential to make meaningful difference in a large number of different cancer populations. Turning to slide six, as WhiteHawk, we developed a framework that establishes a clear value proposition and investment thesis as an ADC company. Firstly, we are building on the foundation of established tumor biology. We are deliberate in identifying promising tumor targets that are both clinically validated and broadly overexpressed. By leveraging clinical validation, we know we have drug-able tumor targets. And because these targets are broadly overexpressed, we can apply them to high potential cancer indications with significant patient populations and unmet needs. While first-generation ADCs offered significant advances for patients, we know they were hindered by limitations largely driven by lack of therapeutic index. To overcome these challenges, we are applying an advanced ADC platform technology that is engineered for minimal off-target toxicity, greater stability, and higher therapeutic index compared to first-generation predecessors. Lastly, we are hyper-focused on speed and efficiency to major data inflection. We are rapidly advancing our portfolio to the clinic with INDs for all three candidates anticipated in the next 15 months. So what are these candidates? Looking at slide seven, our portfolio consists of three assets focused on validated tumor targets. HOX007 targets protein tyrosine kinase 7, or PTK7. PTK7 is an oncofetal pseudokinase that drives early embryonic development. Subsequently, it is minimally expressed in adult tissues, but becomes highly overexpressed in a broad range of tumors as they arise. There are no approved PTK7 ADCs, though it is becoming a popular target for research, given this broad and deep overexpression in multiple cancers. HOC016 is the only known ADC that targets the membrane-bound portion of MUC16, a glycoprotein with low level of expression in normal adult tissues, but often overexpressed and even shed from tumors of female origin, including ovarian, cervical, and endometrial cancers. Shed MUC16, better known as CA125, is a biomarker for cancer screening and disease monitoring, especially in ovarian cancer. So MUC16 is a widely utilized and clinically validated target for ovarian cancer, and was previously studied as an ADC target by Genentech, who had two different ADCs against SMOX16. And we have HOC206, which is designed to address the neuronal target seizure protein 6, or SEZ6. SEZ6 is a CNS-limited protein overexpressed in tumors of neuroendocrine origin. The most prominent example includes small cell lung cancer. Small cell lung cancer is an aggressive high-grade neuroendocrine carcinoma, for which limited targeted therapy treatments options exist and class competition is limited. To our knowledge, ABBYY has the only SEZ6 ADC currently in development. Underlying each of these programs is the advanced ADC technology platform developed by Hangzhou DAC, known as CPT113. This advanced ADC architecture is based on the novel TOPA1 payload and a highly stable linker chemistry. Though not part of this portfolio, it's important to note that Hangzhou DAC has two internally developed programs utilizing the exact same platform. DXC006 and DXC1002. These have had successful INDs and are currently in dose-escalating phase 1 clinical trials in China. Turning to slide 8, as you can see, we're working toward rapidly filing INDs with a plan to submit all three INDs in 15 months, as I said. To reiterate, these assets are designed to target proteins that are broadly expressed across multiple tumor types with significant unmet needs. This slide highlights the cancer indications where these targets have established clinical data from previous ADCs and also shows the numerous expansion opportunities showcasing the substantial market potential of the entire portfolio. Starting with HAWC-07, this candidate represents a differentiated opportunity potentially be among the first wave ADCs in clinical development for high-expressing PTK7 cancers. HAWC007 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned for non-small cell lung cancer and platinum-resistant ovarian cancer with the potential to expand into novel indications, including the full range of gastrointestinal and gynecological cancers. HAWC016, targeting membrane-bound MUX16, is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer with the potential to expand in additional indications, such as endometrial, cervical, and pancreatic cancer. HAWC 206 targeting SEZ6 is currently in candidate selection. The phase one trials plan in small cell lung cancer and neuroendocrine neoplasias where there are limited treatment options today. Turning now to more detail on the platform on slide nine. First generation ADCs were challenged by the high free payload release in circulation, limiting their therapeutic window as high free payload can generate significant off-target side effects. Advanced ADC platforms that are in development today, including the CPT113 platform we utilize across our portfolio, are improving on the limitations of first-generation platforms by engineering three critical components. One, payload. We use a proprietary topo1 inhibitor payload that minimizes off-target effects and supports higher therapeutic index. Two, linker design. We use a highly stable cleavable linker that supports low free payload release in circulation. And three, pharmacokinetics profile, the ability to support higher DAR with an enhanced PK profile enables optimal dosing. The right-hand side of this slide highlights the generalized concept of therapeutic index improvements that you can expect by implementing an advanced ADC platform as compared to first-generation ADCs. With advanced ADC platforms, we're expanding the lower bound of the minimally effective dose with more potent targeting and increasing the upper bound of the maximally tolerated dose with optimized payloads. We thereby are increasing the potential dose intensity for which we can treat patients and improve efficacy. To further illustrate this point, let's turn to the next slide. On slide 10, you can see that we are looking at examples of how a switch from first-generation ADC platform delivers substantial efficacy gains in real-world examples. I won't go through all of these, but as you can see, agnostic to target or indication, Switching from an older platform to an advanced ADC technology platform generated notable objective response rate gains, ranging from 16 to 45 ORR-point improvements. On average, we see a 30-point improvement in the typical switch. This is alongside coinciding with notable improvements in durability of response. Thereby, advanced ADC platforms have the potential to disrupt the standard of care for treatment options today and have demonstrated the ability to help many more patients by increasing response rates and time on therapy. So now if we move to slide 11, we can apply this example to our own portfolio, starting with PTK7 and share why specifically we're so excited about the potential of our assets. We want to start with the fact that PTK7 has precedented data from Pfizer's first-generation MME-based ADC, cofituzumab-polidotin. Response rates seen in Phase I trials were across a range of tumor types tested, including ovarian lung, which are shown here. Response rates were particularly robust in moderate and high-expressing groups, with ORR up to 46%. Despite these encouraging signals, CoVP was limited by the reduced dose intensity and narrow therapeutic index driven by toxicities consistent with class effects from the first-generation payload MMAE. So what happens if we apply an advanced ADC platform to this validated tumor target? On slide 12, what these graphs represent is, first, placement of the Phase I CoVP data in the context of currently approved late-stage ADC benchmarks for efficacy in lung and ovarian cancer. HAWC-007 is a PTK-7 switch to an advanced platform. And therefore, if we extrapolate from prior examples, we may expect to generate efficacy gains of 15% to 30% points more in objective response rate over CoVP. This level of improvement would be disruptive to first-generation ADC standards of care in lung and ovarian cancer. In both indications, we believe they have the opportunity to significantly surpass the established ADC efficacy bar, representing a meaningful clinical benefit to patients. And this is just the example for HOC007 and PTK7. We expect similar improvements with our other two programs, which also take advantage of tumor targeting advances in addition to the advanced ADC platform switch, like we show here. We are enthusiastic about the potential of our portfolio and look forward to getting into the clinic clinic quickly. With that, I'll now turn it over to Scott for updates on our financial progress. Scott?