Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing:
Leigh Hsu is a biotechnology executive with 25 years’ experience in the biopharma industry. Leigh is the Co-founder and Chief Executive Officer of Atticus Pharma, a therapeutics company developing drugs for immunodermatology and associated diseases utilizing their proprietary topical delivery system. Their two initial programs are for the treatment of cutaneous lupus lesions and androgenic alopecia. Previously he served as SVP of Business Development with CARsgen for seven years, and prior to that, he was with Lpath for six years as VP of Corporate Development & Strategy. Dr. Hsu received his PhD in molecular pathology from UC San Diego and an MBA from UC Irvine.
What was the original insight or gap in the market that led you to co-found Atticus Pharma, particularly within immunodermatology?
What really drove our initial excitement was the power of the novel delivery technology. The ability to essentially create a drug depot in the skin—where the drug is administered once and then released steadily over hours to days—opens up a wide range of potential applications.
This approach offers several key advantages: it avoids first-pass metabolism, minimizes systemic side effects, and reduces the peaks and troughs typically associated with drug levels with systemic or oral drugs.
These benefits are particularly compelling in immunodermatology. The technology enables targeted delivery to the epidermal layer of the skin, which is where many of these diseases originate. Conditions like psoriasis and atopic dermatitis—both of which affect large patient populations with significant unmet need—are often driven by disruptions in the epidermis.
Being able to deliver therapeutic agents directly to this layer in a sustained, controlled manner is a meaningful advantage. That combination of precision, durability, and broad applicability is what makes the platform so exciting, particularly within immunoderm.
Can you walk us through how Z-pod® technology fundamentally changes drug delivery compared to traditional topical formulations?
Z-Pods offer several important advantages. At a high level, there are many molecules that could be effective for immunodermatology indications, but the challenge has always been delivery. Some compounds pass straight through the skin, while others don’t penetrate at all.
What we’ve found is that by combining these molecules with Z-Pods, we can at least give them a viable path to work. Not every molecule will be a perfect fit—there’s still an empirical element—but the platform meaningfully expands what’s possible. And benefits like minimizing systemic exposure and reducing side effects are significant.
The system itself is relatively straightforward. The API is encapsulated within the Z-Pod and then formulated into a serum or cream that’s applied topically. Once applied, the Z-Pods deposit into the stratum corneum—the outermost layer of the skin—and also into hair follicles, which is particularly important for our alopecia program. From there, the drug is released in a controlled manner over hours to days.
In many ways, this functions as a “quasi-topical” approach. After application, the formulation dries within seconds, and even if the surface is rinsed, the drug depot remains embedded in the skin and continues releasing the therapeutic. Over time, the Z-Pods are naturally shed through normal skin turnover.
While silica-based delivery approaches have been explored before, to our knowledge, this is the first demonstration of sustained, localized drug delivery to the epidermis in this way. That differentiation is what sets it apart from traditional topical therapies.
ATC-001 leverages the endocannabinoid system for cutaneous lupus—what excites you most about this mechanism, and how could it change the treatment paradigm?
Lupus is an extremely complex—and frankly devastating—disease, and we’re still working to fully understand its underlying biology. What excites us is our approach using anandamide, a naturally occurring, highly potent anti-inflammatory endocannabinoid.
As you noted, anandamide is something the body already produces. Similar to other endogenous molecules—like EPO or insulin—there are circumstances where supplementing or delivering them therapeutically can have meaningful clinical impact. Anandamide represents a similar opportunity.
There’s also strong scientific rationale behind targeting this pathway in lupus. For example, patients with systemic lupus have been shown to exhibit elevated levels of an enzyme that degrades anandamide, suggesting that dysregulation of this pathway may play a role in disease biology. Big pharma has been interested in this pathway for lupus for a long time. Collectively, these data point to anandamide as a compelling therapeutic target.
The challenge, however, has always been delivery. Anandamide’s bioavailability is tightly regulated—if administered systemically, the body rapidly increases expression of the enzyme that breaks it down. It’s also difficult to deliver effectively through the skin using conventional approaches.
This is where the Z-Pod technology becomes particularly impactful. By encapsulating anandamide within Z-Pods and applying it topically, we’ve been able to demonstrate meaningful efficacy in preclinical models. In transgenic lupus mouse models, this approach led to resolution of skin lesions and improvements in skin score, histology score and markers of inflammation.
We’re especially encouraged because this is a molecule the body already recognizes, which may translate to a more favorable safety profile. The preclinical data show strong activity, and we’re optimistic about both the therapeutic potential and tolerability as we move forward.
Your recent data for ATC-002 showed statistically significant improvements in hair density—what do you believe most differentiates this approach from existing treatments?
We’re very excited about this program. We recently completed a six-month clinical study in 98 women and demonstrated statistically significant hair growth within a defined one–square centimeter measurement area. Based on these results, we’re optimistic that continued use beyond six months could drive even greater growth.
What makes this particularly compelling is how differentiated our approach is relative to existing therapies. As you may know, there hasn’t been a truly new approved treatment for androgenic alopecia in roughly 30 years. The current standards—minoxidil (Rogaine) and finasteride (Propecia)—have limited efficacy and, importantly, side effects that can restrict their use. Minoxidil is associated with cardiovascular-related concerns, while finasteride, as a hormone modulator, carries its own set of tolerability issues.
Our approach is fundamentally different. We’re delivering a mitochondrial-activating molecule, which we believe works at the level of the hair follicle—potentially even the follicular stem cells—to strengthen and support the follicle itself. This may not only promote new hair growth but also help retain existing hair.
Equally important, we’ve observed no treatment-related adverse events in our study to date. That safety profile is critical, particularly for a therapy that patients would use daily over an extended period.
There’s also a significant opportunity in addressing an underserved population. Approximately 80 million Americans experience androgenic alopecia, including around 30 million women. Many existing therapies are not well-suited for women—high-dose minoxidil and finasteride, for example, are often contraindicated—leaving a large gap in effective treatment options.
While we don’t expect our therapy to be limited to women, our initial clinical study focused on this population, where we were able to demonstrate meaningful hair growth. Taken together, the efficacy, safety profile, and broad applicability make this a very exciting program for us.
As a first-time CEO and co-founder, what have you learned about the day-to-day realities of building and operating a company compared to what you expected going in?
What I’ve learned is that you really have to rely on your team. There are so many competing priorities as a CEO, and I’ve been fortunate to work with a group at Atticus that is both highly experienced and incredibly capable. You depend on their expertise and judgment every day.
That’s probably the biggest realization—if you don’t have the right team in place, it’s very difficult to succeed.
The other aspect that has been somewhat unexpected is the broader macro environment, particularly around fundraising. Since we started in mid-2024, it’s been a challenging climate to raise capital. That said, I’m optimistic things are beginning to improve—we’ve had some very encouraging conversations recently.
We still have work to do on the financing side, but we believe we have a strong story: a differentiated platform, a great team, and a focus on therapeutic areas with significant unmet need. While the market remains tough, we’re confident in our ability to move things forward.
What advice would you give to founders building platform biotech companies in today’s more capital-constrained environment?
We have a somewhat unique position in that we’re both a therapeutics company and a platform company. Our platform allows us to generate additional pipeline assets—either internally or in collaboration with partners—which gives us a different strategic lens than a traditional single-asset, clinical-stage company.
In a one-product model, the strategy is often to advance that asset as far as possible and rely heavily on a single inflection point—if the data are positive, you win; if not, it can be existential. In contrast, our platform provides multiple paths to value creation.
One of the key advantages is that we maintain a clear line of sight to product development. As we engage with potential partners—particularly those working in immunodermatology—they may have assets that underperformed systemically due to challenges in reaching the site of action. Since these are skin-based diseases, targeted delivery becomes critical.
That’s where our platform can add value. We can take an existing molecule, incorporate it into our Z-Pod delivery system, and evaluate whether localized, sustained delivery improves efficacy. This creates meaningful partnership opportunities.
Ultimately, while the platform itself is a powerful asset, the primary value driver will always be the underlying products. That said, in the interim, platform-enabled partnerships can be highly strategic—allowing us to support partner programs, generate non-dilutive funding, and continue advancing our own pipeline without relying solely on external fundraising.