Q4 2024 Aadi Bioscience Inc Earnings 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 factors section of our annual and quarterly filings with the.
Securities and Exchange Commission, which can be found at www dot SEC dot gov or on our website at white Hot TX Dot 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.
Okay.
On the call today is Dr. Dave Lennon, our president and CEO, Scott <unk>, our CFO and Dr. David Gordon our newly appointed CFO today, we will introduce Whitehorse therapeutics and provide an overview of Q4 and full year 2024 financial results.
Before turning the line open for questions I will now turn the call over to Dave.
Thanks, Audrey Hello, everyone. Good morning, Thank you for joining on deep learning, the president and CEO of the newly launched White Hot Therapeutics.
We are extremely excited about the transformation from Eddie Biosciences to White Hawk I look forward to walking you through our vision strategy and opportunity.
Ladies and gentlemen, thank you for standing by. Welcome to White Hawk, Therapeutics 4th Quarter in full year 2024 earnings call. At this time, all participants are in a listen and only mode.
And what we have.
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 Wuxi biologics the divestiture of <unk> to CAC in pharmaceuticals, and a $100 million pipe financing and were subsequently approved during a special meeting of stockholders last month.
As a next step in our evolution Eddie Biosciences is now divided into two organizations on the divestiture of Eddie subsidiary to Cat <unk> Jack.
<unk> will assume ownership of the <unk> name trademark and if the Aro business.
And today at the parent company Relaunches as whitewater quite hot 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 Whitehall carries several important to strength distinction.
As Adam we were focused on <unk> inhibition and rare cancer settings, and we're built on the foundation of a single commercial product.
Conversely, White Hawkins focus 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.
Speaker Change: Turning to slide six as White Hot 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.
Speaker Change: We are deliberate in identifying promising super targets that are both clinically validated and broadly over express.
Speaker Change: By leveraging clinical validation, we know we have droppable tumor targets and because these targets are broadly over express we can apply them to high potential cancer indications with significant patient populations and unmet needs.
Speaker Change: While first generation Edc's offered significant advances for patients we know that 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.
Speaker Change: <unk> predecessors.
Speaker Change: Lastly, we are hyper focused on speed and efficiency two major data inflections, we are rapidly advancing our portfolio to the clinic with <unk> for all three candidates anticipated in the next 15 months.
Speaker Change: So what are these candidates looking at slide seven our portfolio consists of three assets focused on validated tumor targets.
Speaker Change: <unk> hundred seven targets protein tyrant tyrosine kinase seven or PTK seven PTK seven as an alco fetal pseudo kinase that drives early embryonic development subsequently.
Speaker Change: As minimally expressed in adult tissues, but becomes highly over expressed in a broad range of tumors as they arise.
Speaker Change: There are no approved PTK 700, ADC. So it is becoming a popular target for research given us broad and deep over expression in multiple cancers.
Speaker Change: HOKA one six.
Speaker Change: The only known ADC that targets the membrane bound portion amongst <unk> glycoprotein with low level of expression in normal adult tissues, but often over expressed and even shed from tumors are female origin, including ovarian cervical and endometrial cancers, <unk> 16, better known as CA 125, as a biomarker for cancer screening.
Speaker Change: And disease monitoring, especially in ovarian cancer. So <unk> is a widely utilized and clinically validated target for ovarian cancer and was previously studied as an ADC target by Genentech.
Speaker Change: <unk> had two different adcs against <unk>.
Speaker Change: And we have talked to a <unk>, which is designed to address the neuronal target seizure protein six or <unk> six <unk> six is a CNS limited protein over expressed in tumors of neuroendocrine margin. Most prominent example includes small cell lung cancer small cell lung cancer as an aggressive high grade neuroendocrine carcinoma, which limited targeted there.
Speaker Change: Treatment options exist and class competition is limited to our knowledge abbvie the only.
Speaker Change: Has the only SEC six ADC currently in development.
Speaker Change: Underlying each of these programs as the advanced ADC technology platform developed by Hangzhou D AC known as CPT 113.
Speaker Change: This advanced ADC architecture is based on the novel took a one payload in a highly stable linker chemistry.
Speaker Change: So not part of this portfolio is important note that Hangzhou DSC is has two internally developed programs utilizing the exact same platform <unk> 100 too.
Speaker Change: <unk> had successful <unk> and are currently in dose escalating phase one clinical trials in China.
Speaker Change: Turning to slide eight as you can see we're working towards rapidly filing IND with a plan to submit all three <unk> and 15 months as I said to reiterate these assets are these assets are designed to target proteins that are broadly expressed across multiple tumor types with significant unmet needs.
Speaker Change: This slide highlights the cancer indications, where these targets are established clinical data from previous Adcs and also shows the numerous expansion opportunities showcasing the substantial market potential of the entire portfolio.
Speaker Change: Starting with <unk>. This candidate represents a different opportunity sorry differentiated opportunity potentially be among the first wave adcs in clinical development for high expressing PTK seven cancers.
Speaker Change: <unk> is currently being evaluated in R&D, enabling studies the phase one 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.
Speaker Change: One six targeting membrane bound <unk> is currently being evaluated in IND, enabling studies with phase one trials planned in ovarian cancer with the potential to expand an additional indications such as endometrial cervical and pancreatic cancers.
Speaker Change: <unk> hundred six targeting <unk> six is currently in candidate selection. The phase one trials plan in small cell lung cancer and are indifferent neoplasia, where there are limited treatment options today.
Speaker Change: Turning now to more detail on our platform.
Speaker Change: On slide nine.
Speaker Change: 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 Change: <unk> <unk> ADC platforms that are in development today, including the CPT one three platform, we utilized across our portfolio are improving on the limitations of first generation platforms by engineering three critical components.
One payload, we use a topos proprietary triple one inhibitor payload that minimizes off target effects and supports higher therapeutic index.
Speaker Change: Two linker design with a highly stable cleavable linker that supports low free payload release in circulation.
Speaker Change: 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.
Speaker Change: 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 increasing the potential dose intensity for which we can treat patients and improve efficacy.
Speaker Change: To further illustrate this point, let's turn to the next slide.
Speaker Change: On slide 10, you can see.
Speaker Change: That we are looking at examples of how our switch from first generation ADC platform deliver substantial FC gains in real World Examples and I won't go through all of these but as you can see it agnostic to target our indication switching from an older platform to advanced ADC technology platform generated notable objective response rate gains.
Speaker Change: <unk> from 16% to 45%.
Speaker Change: Our point improvement.
Speaker Change: On average we see a 30 point improvement in the typical switch.
Speaker Change: This along.
Speaker Change: Alongside coinciding with notable improvements in durability of response.
Speaker Change: 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.
Speaker Change: So now if we move to slide 11, we can apply this example to our own portfolio.
Speaker Change: Starting with PTK, seven and share why specifically, we're so excited about the potential of our assets.
Speaker Change: We want to start with the fact that PTK seven has precedented data from Pfizer's first generation <unk> based <unk>.
Speaker Change: ADC <unk> <unk> dot.
Speaker Change: Response rate seen in phase one trials were across a range of tumor types tested including ovarian lung which are shown here.
Speaker Change: Response rates were particularly robust and moderate and high expressing groups with or are up to 46%. Despite these encouraging signals Coca P was limited by the reduced dose intensity and narrow therapeutic index driven by toxicities consistent with class effects from the first generation payload and the.
Speaker Change: So what happens if we apply an advanced ADC platform to this validated tumor target.
Speaker Change: On slide 12, with these graphs represent his first placement of the phase <unk> data in the context of currently approved late stage ADC benchmarks for efficacy in lung and ovarian cancer.
Speaker Change: <unk> seven is a PTK seven switch to an advanced platform and therefore, if we extrapolate from prior examples we may expect to generate efficacy games, a 15% to 30%.
Speaker Change: Points more in objective.
Speaker Change: Sponsoring overcoat.
Speaker Change: This level of improvement will be disruptive to first generation ADC standard of care in lung and ovarian cancer.
Speaker Change: In both indications we believe we have the opportunity to significantly surpass the established ADC efficacy bar, representing meaningful clinical benefit to patients.
Speaker Change: And this is just the example for <unk> seven and PTK seven.
Speaker Change: We expect similar improvements with our other two programs.
Speaker Change: Which also take advantage of tumor targeting advances in addition to the advanced ADC platform switch likely show here.
We are enthusiastic about the potential of our portfolio and look forward to getting into the clinic on it quickly.
Speaker Change: With that I'll now turn it over to Scott for updates on our financial progress Scott.
Scott: Thanks, Dave.
Scott: Moving to slide 14.
Scott: We ended 2024 with $47 2 million in cash cash equivalents and short term investments.
Scott: Following the close of our recent strategic transactions.
Scott: We expect to have cash and cash equivalents in the range of $170 million to $180 million, including the payment of the upfront and early milestones under the ADC license agreement.
Scott: We anticipate that cash will fund operations into 2020 based on current plans.
Scott: <unk> net product sales were $7 2 million for the fourth quarter, representing 14% growth over the prior year quarter.
Scott: Full year by auto sales were $26 million.
Scott: An increase of 7% over 2023.
Scott: Research and development expenses for the quarter increased to $14 3 million compared to $12 8 million in the prior year quarter.
Scott: For the year R&D expense amounted to $51 million compared.
Scott: Compared to $48 9 million last year.
Scott: This increase was driven mainly by in process R&D expenses of $6 million related to the recently acquired ADC programs offset in part by reductions in clinical expenses personnel and other expenses.
Scott: Selling general and administrative expenses for the fourth quarter were $11 1 million <unk>.
Scott: Compared to $10 3 million in the same period in 2023.
Scott: This increase was due mainly to increased legal and consulting expenses offset in part by lower commercial expenses.
Scott: For the year SG&A expenses decreased to $36 7 million compared to $44 5 million in the prior year, driven primarily by reductions in commercial and personnel expenses.
Scott: Operating expenses for the year included $2 6 million of restructuring costs.
Scott: Net loss for the fourth quarter was $18 3 million compared to $16 3 million in the fourth quarter of 2023.
Scott: Net loss for the year was $63 $7 million.
Scott: Compared to $65 8 million in the prior year.
Dave: I'll now hand, the call back over to Dave for his closing comments Dave.
Dave: Thanks Scott.
Speaker Change: Slide 16.
Speaker Change: We're enormously excited about the potential it quite hard to make a transformative impact on patients with our portfolio. We are advancing three clinically validated tumor targets using next generation ADC technology with the goal of outperforming first generation predecessors.
Speaker Change: With a focus on high potential indications, we aim to file three <unk> within 15 months and we're well positioned to fund operations as Scott said into 2028 covering anticipated clinical inflections.
Speaker Change: Importantly, white Hawk is backed by an outstanding veteran team I'm also pleased to say this includes our recent addition of David Darmon, who joined US as Chief Scientific Officer.
Speaker Change: Many of you will know David as a former CFO 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 is a successful track record of shepherding drugs from discovery stage through the clinic for advanced modalities, including Adcs and conferencing numerous IND.
Speaker Change: NDA and BLA.
His experience at elevation is particularly relevant as he spearheaded the company's strategic pivot towards a portfolio of adcs.
David Darmon: We welcomed David and glad he is able to join us on the call today.
Speaker Change: With that I'll open the call for questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Tara Bancroft: And the first question will come from Tara Bancroft with.
Speaker Change: TD Securities Your line is open.
Speaker Change: Hi, Good morning. This is Greg wiesner on for Tara Bancroft.
Speaker Change: Considering that regeneron is developing a mucin <unk> targeted by spec 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 Change: Super Thanks, Craig for stepping in for Terra.
David Darmon: And thanks for the question I'll start a little bit and then turn it over to David.
David Darmon: For his comments S&P the expert in this target.
David Darmon: I mean, the first concept is obviously adcs and bi specific T. Caesar 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.
David Darmon: <unk>.
David Darmon: But obviously as a TCE.
David Darmon: That is targeting an immune modulating response, which can be very different from an EDC.
David Darmon: Chemo based response that we're developing here, we think both are complementary and important options for patient treatment.
David Darmon: Regardless of.
David Darmon: The tumor target, yes, so we don't necessarily have a direct comparison, we would highlight.
David Darmon: For this indication, but we do obviously because attention to that program.
David Darmon: But David do you want to say a little more about <unk>.
David Darmon: Yes, sure I think what is fair to say.
David Darmon: With respect to targeting positive the membrane portion that we're targeting <unk>.
Speaker Change: Certainly makes it help avoid the engine think as David mentioned, the presentation and with respect to the different modalities targeting I think you specifically asked about the CD three redirection approach I think it's fair to say like the CDG direction, sometimes they have challenges.
David Darmon: And there will be like syndrome.
David Darmon: With me is a cytotoxic ACC, we don't have the same problem.
David Darmon: And that bill, but obviously with our ADC setup fees okay.
David Darmon: Okay. So we have there.
David Darmon: Their OLED profiles, but the promise of our technology using our stable linker.
David Darmon: Technology really will mitigate that potential risk.
David Darmon: But that's how we feel that positioning wise.
David Darmon: This ADC will certainly be differentiated from our CDP redirected, but largely would have significant.
David Darmon: Gains in efficacy as Dave already mentioned.
Speaker Change: Thanks, David Operator next question.
Speaker Change: And our next question will come from Roger song with Jefferies. Your line is open.
Roger Song: Hey, good morning. Thanks.
Roger Song: Thanks for taking our questions. This is the launch of our Roger So first congrats on the new chapter.
Speaker Change: Next question is from US one is on the three.
Speaker Change: Three targets so understanding the prevalence there so maybe could you.
Speaker Change: How about the understanding about the distribution offering.
Speaker Change: High medium low expression levels.
Speaker Change: Each of those three deposits.
Speaker Change: The second question is about the financials. So understanding about 28, one way so does that cover the all of the three phase one studies. Thank you.
Speaker Change: Thanks again.
Speaker Change: Joining the call to hear from you again and.
Speaker Change: Thanks for the questions. So on the first question in terms of the prevalence obviously theres a lot of data to cover in context, what we would say is that first.
Speaker Change: First on PTK seven it is one of the most broadly over express tumor targets.
Speaker Change: In development today.
Speaker Change: So it impacts.
Large portion of patients who developed cancer overall.
Speaker Change: Hi, We express target.
Speaker Change: Across a broad range of people.
Speaker Change: But we really like about this target is that when it is expressed in patient it's often.
Speaker Change: Press in a moderate to high level. So we will generally find that the majority of patients who progressed PTK seven do some pilot.
Speaker Change: Across different again.
Speaker Change: Which we know correlates with potential for improved responses.
Speaker Change: As patients who have higher expression generally are responding better.
Speaker Change: And so we're really encouraged by both of those broad expression of PTK seven but also the relatively deep expression that we see in individual patients.
Speaker Change: The proportion of patients that potentially could respond very well to therapy.
Speaker Change: On March 16, a similar story, but I think in <unk> case, we really have an advantage that <unk> is a tumor target that to increase as the disease progresses.
Speaker Change: Higher expression of softness associated with worse disease in that.
Speaker Change: Is.
Speaker Change: Allows us to really target those patients who are in most of the care.
And secondly, with the circulating CA 125, we have a proxy for expression.
Speaker Change: Patients rather than looking at IHT based expression, we can also screen patient circulated.
Speaker Change: 100, <unk> hundred 25, biomarker and so we think.
Speaker Change: This case, we really have both this high level of compression, particularly across that logical cancers deep expression overall and ability to monitor that.
Speaker Change: Hi.
Speaker Change: And then in FCB sixth SEC <unk> is highly expressed across a broad range of.
Speaker Change: Across the full range of small cell lung cancer.
Speaker Change: And this has already been typified by Abbvie program, where they are actually not selecting patients extremely high response rate.
Speaker Change: For non small.
Speaker Change: Small cell lung cancer patient on that.
Speaker Change: Overall these are.
Speaker Change: Not only really interesting targets for the fact that they.
Speaker Change: A.
Speaker Change: Key roles in each of these indications, but they're highly and deeply expressed across all.
Speaker Change: The vast majority of patients.
Speaker Change: Yes.
Speaker Change: And as well as we mentioned before are not yet so competitive like drove two area are coordinating two or other areas.
Speaker Change: That we believe we can be first or second to market.
Speaker Change: Each of these targets.
Speaker Change: And then your second question on data availability, our goal is to get meaningful clinical phase one data for all three programs.
Speaker Change: Under the current funding that will obviously be slightly different amounts of data program just given that.
Speaker Change: They are staggered by a few months each but ultimately our goal in establishing white Hawk as we did in capital as well as it is was to ensure that we would generate that meaningful clinical data before our next one back to the market for additional funding.
Speaker Change: Thanks for the questions Operator next question.
Speaker Change: 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 Change: Thank you operator, and thanks to the team and everyone who joined us on the call today.
Speaker Change: We are really excited about the launch of Whitehorse therapeutics.
Speaker Change: New ADC company.
Speaker Change: Of the transformation, we've just performed with antibody science.
Speaker Change: We reiterate these three clinically validated broadly over express 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 and three <unk> in the next 15 months, including Hauck <unk> <unk>.
Speaker Change: In the second half of 2025 and <unk> <unk>.
Speaker Change: Fixed by the end of this year.
Speaker Change: With our experienced team and collaborative partners. We are singularly focused on executing to ensure these calls.
Speaker Change: 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.
Speaker Change: So thank you for joining us for this introduction of White Hot Therapeutics and have a great day.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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