Aadi Bioscience Q4 2024 Earnings Call Transcript

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March 19, 2025

There are 6 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to WhiteHawk Therapeutics Fourth Quarter and Full Year twenty twenty four Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. And to ask a question during the session, you would need to press 11 on your telephone.

Operator

I would like now to turn the conference over to Audrey Gross, Head of Corporate Communications for WhiteHawk Therapeutics. Ms. Gross, please go ahead.

Speaker 1

Thank you. Good morning and welcome to the White Hawk Therapeutics conference call. We will be presenting slides as part of the live webcast of this call. Such slides will be posted on the Investor News page of the White Hawk Therapeutics website at whitehawktx.com following the conference call. A reminder that statements made on the call today will include forward looking statements.

Speaker 1

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 Factors 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, 03/19/2025, 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 Doctor. Dave Lennon, our President and CEO Scott Giacobello, our CFO and Doctor.

Speaker 1

David Dornan, our newly appointed CSO. Today, we will introduce White Hawk 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?

Speaker 2

Thanks, Audrey. Hello, everyone. Good morning. Thank you for joining. I'm Dave Lennon, the President and CEO of the newly launched WhiteHawk Therapeutics.

Speaker 2

We are extremely excited about the transformation from Addy Biosciences to WhiteHawk. I look forward to walking you through our vision, strategy and opportunity and what we the opportunity we have to deliver 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 Lucy Biologics, the divestiture of Fiaro to Catkin Pharmaceuticals and $100,000,000 pipe financing that were subsequently approved during a special meeting of stockholders last month. As a next step in our evolution, Addy Biosciences is now divided into two organizations. Upon the divestiture of ADDY's subsidiary to Kaken, Kaken will assume ownership of the ADDY name, trademark and the BRO business.

Speaker 2

And today, ADDY parent company relaunches as White Hawk Therapeutics, formalizing our transition into an ADC focused company. While we remain rooted on our legacy, that is to make bold choices in applying technology to deliver improved precision oncology therapies, White Hawk carries several important distinctions. As Addy, 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 therapies, all with the broad potential to make meaningful difference in a large number of different cancer populations. Turning to Slide six.

Speaker 2

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 over expressed. By leveraging clinical validation, we know we have druggable tumor targets. And because these targets are broadly over expressed, we can apply them to high potential cancer indications with significant patient populations and unmet needs.

Speaker 2

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 inflections. We are rapidly advancing our portfolio to the clinic with INDs for all three candidates anticipated in the next fifteen months. So what are these candidates?

Speaker 2

Looking at Slide seven, our portfolio consists of three assets focused on validated tumor targets. HAWK seven targets protein tyrosine kinase seven or PTK7. PTK7 is an onco fetal pseudokinase that drives early embryonic development. Subsequently is minimally expressed in adult tissues, but becomes highly over expressed 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 over expression in multiple cancers.

Speaker 2

HOP-sixteen 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 over expressed and even shed from tumors of female origin, including ovarian, cervical and endometrial cancers. SHEDMUC16, 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 MUC16. And we have HOK206, which is designed to address the neuronal target seizure protein six or SEZ6. SEZ6 is a CNS limited protein over expressed in tumors of neuroendocrine origin.

Speaker 2

The most prominent example includes small cell lung cancer. Small cell lung cancer is an aggressive high grade neuroendocrine carcinoma for its limited targeted therapies options exist and class competition is limited. To our knowledge, AbbVie has the only SEC6 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 TOPO-one payload and a highly stable linker chemistry.

Speaker 2

Though not part of this portfolio, it's important to note that Hamdao DXC 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 one clinical trials in China. Turning to Slide eight. As you can see, we're working toward rapidly filing INDs with a plan to submit all three INDs in fifteen 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.

Speaker 2

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 HAWK-seven, this candidate represents a different opportunity sorry, differentiated opportunity potentially be among the first wave ADCs in clinical development for high expressing PTK7 cancers. HAWK007 is currently being evaluated in IND enabling studies. The Phase one trial is planned for non small cell lung cancer and platinum resistant ovarian cancer with the potential to stand into novel indications, including the full range of gastrointestinal and gynecological cancers. HOK016 targeting membrane bound MUC16 is currently being evaluated in IND enabling studies.

Speaker 2

The Phase one trial is planned in ovarian cancer with the potential to expand in additional indications such as endometrial, cervical and pancreatic cancers. HOP206 targeting SEZ6 is currently in candidate selection. The Phase one trial is planned in small cell lung cancer in norepinephrine 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.

Speaker 2

Advanced ADC platforms that are in development today, including the CPT-one 13 we utilize across our portfolio are improving on the limitations of first generation platforms by engineering three critical components. One, payload. We use a TOPO 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.

Speaker 2

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 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.

Speaker 2

I won't go through all of these, but as you can see it, agnostic to target or indication, switching from an older platform to advanced ADC technology platform generated notable objective response rate gains ranging from 16 to 45 ORR point improvements. On average, we see a 30 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.

Speaker 2

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, cofetuzumab polydatin. Response rates seen in Phase one 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 forty six percent. Despite these encouraging signals, COPIKT was limited by the reduced dose intensity and narrow therapeutic index driven by toxicities consistent with class effects from the first generation payload, MAE.

Speaker 2

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 one CoVP data in the context of currently approved late stage ADC benchmarks for efficacy in lung and ovarian cancer. HAWK-seven is a PTK7 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 Coffe P. This level of improvement will be disrupted to first generation ADC standard of care in lung and ovarian cancer.

Speaker 2

In both indications, we believe we have an opportunity to significantly surpass the established ADC efficacy bar, representing a meaningful clinical benefit to patients. And this is just the example for HOP-seven 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 quickly. With that, I'll now turn it over to Scott for updates on our financial progress.

Speaker 2

Scott?

Speaker 3

Thanks, Dave. Moving to Slide 14. We ended 2024 with $47,200,000 in cash, cash equivalents and short term investments. Following the close of our recent strategic transactions, we expect to have cash and cash equivalents in the range of $170,000,000 to $180,000,000 including the payment of the upfront and early milestones under the ADC license agreement. We anticipate the cash will fund operations into 2028 based on current plans.

Speaker 3

Fiaro net product sales were $7,200,000 for the fourth quarter, representing 14% growth over the prior year quarter. Full year Fyarro sales were $26,000,000 an increase of 7% over 2023. Research and development expenses for the quarter increased to $14,300,000 compared to $12,800,000 in the prior year quarter. For the year, R and D expense amounted to $51,000,000 compared to $48,900,000 last year. This increase is driven mainly by in process R and D expenses of $6,000,000 related to the recently acquired AEC programs offset in part by reductions in clinical expenses, personnel and other expenses.

Speaker 3

Selling, general and administrative expenses for the fourth quarter were $11,100,000 compared to $10,300,000 in the same period in 2023. This increase was due mainly to increased legal and consulting expenses offset in part by lower commercial expenses. For the year, SG and A expenses decreased to $36,700,000 compared to $44,500,000 in the prior year, driven primarily by reductions in commercial and personnel expenses. Operating expenses for the year included $2,600,000 of restructuring costs. Net loss for the fourth quarter was $18,300,000 compared to $16,300,000 in the fourth quarter of twenty twenty three.

Speaker 3

Net loss for the year was $63,700,000 compared to $65,800,000 in the prior year. I'll now hand the call back over to Dave for his closing comments. Dave?

Speaker 2

Thanks, Scott. Looking at Slide 16, we are enormously excited about the potential of WhiteHawk to make a transformative impact to patients with our portfolio. We're advancing three clinically validated tumor targets using next generation ADC technology with the goal of outperforming first generation technology with the goal of outperforming first generation predecessors. With a focus on high potential indications, we aim to file three U. S.

Speaker 2

INDs within fifteen months and we're well positioned to fund operations, as Scott said, into 2028, covering anticipated clinical inflections. Importantly, White Hawk is backed by an outstanding veteran team. I'm also pleased to say this includes our recent addition of David Dornan, who joined us as Chief Scientific Officer. Many of you will know David as a former CSO of Elevation Oncology. David contributes more than two decades of experience in oncology drug discovery and development with deep expertise in ADCs and other targeted cancer therapies.

Speaker 2

He has a successful track record of shepherding drugs from discovery stage through the clinic for advanced modalities, including ADCs, encompassing numerous INDs, NDAs and BLAs. His experience at Elevation is particularly relevant as he spearheaded the company's strategic pivot towards a portfolio of ADCs. We welcome David and glad he is able to join us on the call today. With that, I'll open the call for questions.

Operator

Thank you. And the first question will come from Tara Bancroft with TD Securities.

Speaker 4

This is Greg Wiesner on for Tara Bancroft. So considering that Regeneron is developing a MUTIN-sixteen targeted bispecific 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? Thank you.

Speaker 2

Super. Thanks, Greg, for stepping in for Tara, and thanks for the question. I'll start a little bit and then turn it over to David for his comments since he is an expert in this target. You know, I mean, the first concept is obviously ADCs and bispecific TCs are very different modalities in terms of their mechanism. Certainly, there's commonality in the tumor targeting, and we're encouraged by the fact that Regeneron uses the same targeting approach to the membrane bound molecule on MOS 16.

Speaker 2

But obviously, as a TCE, that is targeting an immune modulating response, which will be very different from an EDC chemo based response that we're developing here. We think both are complementary and important options for patient treatment regardless of the tumor target here. So we don't necessarily have a direct comparison we would highlight for this indication, but we do obviously pay close attention to that program. But David, do you want to say a little more about MUC16?

Speaker 5

Yes, sure. I think this is what is fair to say with respect to targeting. Obviously, the membrane portion that we're targeting on MUC16 certainly makes it help avoid antigen sink as David mentioned in the presentation. And with respect to the different modalities of targeting, I think you specifically asked about the CD3 redirection approach. I think it's fair to say like the CD3 redirection approach, sometimes they have challenges with like cytokine release like syndrome.

Speaker 5

So obviously, it's a cytotoxic ADC. We don't have the same AE problems in that realm. But obviously, with our ADC cytotoxic ADCs, they certainly have their own AE profiles. But the promise of our technology using our stable linker technology really will mitigate that potential risk. And so that's how we feel that position wise that this ADC will certainly be differentiated from the C and C redirected, but largely would have significant gains and efficacy as Dave already mentioned.

Speaker 2

Thanks, David. Operator, next question.

Operator

And our next question will come from Roger Song with Jefferies. Your line is open.

Speaker 5

Hey, good morning. Thanks for taking our questions. This is Liang Chen on for Roger. So first congrats on the new chapter. So I guess question from us, one is on the three targets, so understanding the prevalence there.

Speaker 5

So maybe could you help us understanding about the distribution of the high, medium, low expression levels for each of those three targets? And the second question about the financials, so understanding about 2028 runway. So does that cover all the three Phase one studies? Thank you.

Speaker 2

Liang, thanks again. Thanks for joining the call. Good to hear from you again and thanks for the questions. So on the first question, in terms of the prevalence, obviously, there's a lot of data to cover in context. What we would say is that first on PTK7, it is one of the most broadly over expressed tumor targets in development today.

Speaker 2

And so it impacts a large portion of patients who develop cancer overall, very highly expressed target, lots of broad range of data. What we really liked about this target is that when it is expressed in patients, it's often expressed at a moderate to high level. So we'll generally find that the majority of patients who experience PTK7 do so in the high level across different cancer patients, which we know correlates with potential for improved responses, as patients who have higher expression generally respond to PC better. And so we're really encouraged by both of those, the broad expression of PTK7, but also the relatively deep expression that we see on individual patients, like a portion of patients then potentially could respond very well to therapy. On MUC16, it's a similar story, but I think in MUC16 case, we really have an advantage that MUC16 is a tumor target that tends to increase as the disease progresses.

Speaker 2

So higher expression is soft and associated with worse disease. And that is, you know, allows us to really target the patients who are in most care. And secondly, with the circulating CA125, we have a proxy for expression across patients. Rather than looking at IHC based expression, we can also screen patients using circulating one twenty one twenty five biomarker. And so we think in this case, we really have both this high level of depression, particularly across diatological cancers, deep expression overall and ability to monitor that from.

Speaker 2

And then at SCZ6, SCZ6 is highly expressed across a broad range of well, across the full range of small cell lung cancer. And this has already been typified by AbbVie's program where they're actually not selecting patients with extremely high response rates for non selected small cell lung cancer patient on that SE86. Overall, I think these are not only really interesting targets for the fact that they have key roles in each of these indications, but they're highly and deeply expressed across the vast majority of patients in each of these indications. And as well, as we mentioned before, are not yet so competitive like the TRO2 area or CLOD18.2 or other areas that we believe we'd be first or second to market on each of these targets. And then your second question on data availability, our goal is to get meaningful clinical Phase one data for all three programs under the current funding.

Speaker 2

That will obviously be slightly different amounts of data for each program just given that they are staggered by a few months each. But ultimately, our goal in establishing WhiteHawk as we did and capitalize as well as it is, was to ensure that we would generate that meaningful clinical data before our next go back to the market for additional financing. Thanks for the questions. Operator, next question.

Operator

I show no further questions at this time in the queue. I would like to turn the call back to Dave for closing remarks.

Speaker 2

Thank you, operator, and thanks to the team and everyone who joined us on the call today. We are really excited about the launch of White Hawk Therapeutics, a new ADC company, out of the transformation we've just performed with Addy Bioscience. We reiterate these three clinically validated broadly over expressed tumor targets are leveraging an advanced ADC linker payload architecture with key features that we believe will allow us to outperform first generation ADCs. We're moving quickly targeting filing of three U. S.

Speaker 2

INDs in the next fifteen months, including HOP-seven in the second half of twenty twenty five and by the end of this year. With our experienced team and collaborative partners, we are singularly focused on executing to ensure these goals are met. Lastly, upon closing, we expect to be well capitalized. And as I mentioned, we have cash to fund our operations into 2028 and with anticipated key clinical data. So thank you for joining us for this introduction of White Hawk Therapeutics and have a great day.

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Aadi Bioscience Q4 2024
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