EXPERT INSIGHT: Meet the Leader: Lyn Baranowski, CEO of Avalyn Pharma

/ EXPERT INSIGHTS

Meet the Leader: Lyn Baranowski, CEO of Avalyn Pharma

Lyn Baranowski

CEO of Avalyn Pharma

(SEPTEMBER 2024)

In the specialized field of life sciences venture capital, the management team* is critical to a company’s success. In the early stages, when the focus is on developing the technology, the CEO will likely have a scientific or medical background. As the company progresses, the focus shifts toward business and clinical development expertise.

RiverVest portfolio company, Avalyn Pharma, reached such a leadership inflection point following the successful completion of a Phase 1b clinical study for its lead product, an inhaled therapy for pulmonary fibrosis.** It was time to bring in an experienced leader to drive the portfolio forward.

Avalyn Pharma CEO, Lyn Baranowski, was recruited not only for her experience across biotech, big pharma, and venture capital, especially in the respiratory therapeutics space, but also for her intellectual curiosity, genuine enthusiasm, and collaborative leadership style.

Since joining Avalyn as CEO in October 2022, Lyn has led the company through an oversubscribed $175 million Series C financing, expanded its executive team, and advanced two programs into their next phases of clinical trials.

For this Expert Insight, RiverVest spoke with Lyn about who she is, what brought her to Avalyn, and what fuels her passion for building great companies.

The interview has been edited for clarity and brevity. We invite you to view the short video clips below to hear directly from Lyn.

Tell us about Avalyn and the urgent unmet need the company is addressing.

Avalyn is a biopharmaceutical company focused on developing inhaled therapies for rare respiratory diseases, particularly pulmonary fibrosis (PF) and other interstitial lung diseases (ILD). PF significantly affects an individual’s ability to perform activities of daily living or exercise. Without a lung transplant, most patients only survive three to five years from diagnosis. That’s a more dire survival rate than many forms of cancer.

The good news is there are two FDA approved oral medications that have shown the ability to reduce the downward decline in lung function due to fibrotic tissue – pirfenidone and nintedanib. The bad news is fewer than 30 percent of patients with PF in the U.S. take either of them. Why is that? If only 30 percent of these patients are taking them, there must be something wrong with these medicines.

What’s wrong is that these medications are incredibly difficult to tolerate; they make patients feel like they have a terrible flu every day, on top of their inability to breathe. Often, doctors don’t even prescribe them in the first place because they’re so hard for patients to tolerate. Those who do start taking them are likely to cycle off therapy within the first few months because they’re vomiting, they’ve got terrible diarrhea, and they just feel awful.

We think that’s a problem Avalyn can do something about.

How does Avalyn propose to solve that problem?

At Avalyn, we’re taking these oral molecules, which we already know work in treating this debilitating lung disease and are delivering them through inhalation. Inhaled delivery makes intuitive sense. We’ve also learned from many other lung disease treatments that it’s effective.

First, inhaled therapies provide greater exposure in the lungs. We now have clinical data suggesting that the ability to increase exposure by targeting the right organ translates to better efficacy in patients. Second, delivering the drug directly to the lungs avoids the systemic exposure of the orals, translating into much better tolerability.

What we’re doing at Avalyn is bringing inhaled delivery to bear in pulmonary fibrosis, where we can make a big difference for patients, making these approved drugs more tolerable and effective.

Oral Pirfenidone and Nintedanib- The Tolerability Problem

Avalyn recently advanced two programs further into clinical trials. Could you elaborate on that progress?

Our lead program, inhaled pirfenidone, is called AP01. We’ve studied it now in over 150 patients with different forms of pulmonary fibrosis. Every one of those patients has been studied for at least one year, some on therapy for more than four yea rs now. The results have been encouraging, with better safety and efficacy compared to the historical data with the oral version. We’ve advanced this program into a Phase 2b study (MIST), which should yield important data that could drive the company forward.

We also recently initiated a Phase 1 study of our second program, inhaled nintedanib (AP02), evaluating its safety, tolerability, and pharmacokinetics in healthy adult volunteers.

And we are working on AP03, a fixed-dose combination of pirfenidone and nintedanib, which would offer two different mechanisms of action in a single inhaled solution. This combination could provide even better outcomes for patients than either drug alone.

Now, let’s talk about you and what brought you to Avalyn.

I fell in love with the respiratory disease space during my years with Novartis Pharmaceuticals in the early 2000s, right after grad school. It was an exciting time at Novartis because we were doing a lot of deals and building a business in the respiratory therapeutic area.

It really struck me at the time that interstitial lung diseases (ILDs), which includes pulmonary fibrosis (PF), have so much unmet need. There are more than 200 different types of ILDs, most of which lack any treatments. I saw this incredible opportunity to make a big difference for a lot of patients.

At the same time, I fell in love with the intellectual challenge of formulating and developing an inhalation. It’s a unique space where you can target the organ you’re trying to treat, which brings with it some important nuances that together allow us to build meaningful, durable products.

After Novartis, I joined a private investment firm, where I identified and evaluated investment opportunities. One of those investments was Pearl Therapeutics, a company developing meter-dose inhalers for treating asthma and chronic obstructive pulmonary disease (COPD). After we made the investment in Pearl, I realized how much I missed being on the operating side of an investment, so I joined Pearl’s executive team full-time, helping to build and grow the company and then sell it to AstraZeneca a few years later. That was a fun journey and a great exit, and it became clear to me how much I loved building a team and a portfolio.

I helped build two more companies, most recently as COO of Altavant Sciences, both before and after its acquisition by Sumitomo Dainippon. As I was thinking about next steps after we sold Altavant, I met Niall O’Donnell, RiverVest Managing Director and the chairman of the board of Avalyn, and several of Avalyn’s other investors. As we got to know each other, they asked if I’d be interested in a role at Avalyn. It felt like a unique opportunity for me to jump into a fantastic company with a brilliant idea that was already well-capitalized by some great investors and get to work on taking it to the next level. So, here I am!

A Career Driven by Unmet Need

The Importance of GRIT and TEAM BUILDING in Biotech Investing

You mentioned that you missed the operational role when you were an investor. What attracts you to operations?

It’s an intellectual challenge to make it work. I've done that now sequentially three times before Avalyn. And I’m passionate about bringing new medicines to patients that really need them, so I keep finding new opportunities to build great companies, build great teams of people, and hopefully make a big difference for patients.

“I love building a team. I love building a portfolio. When building a biotech company, if we’re being honest, you never know how it’s going to go. It’s a roller coaster. There are dark days. You have to have grit and resilience to find the path and figure it out. And I just love that.

Lyn Baranowski

How is the team coming together at Avalyn?

We completed an oversubscribed $175 million Series C financing last fall, which gave us the capital resources needed to advance our pipeline and hire a great team. If there’s one thing I’m most proud of here, it’s building a world-class team.

Howard Lazarus, our chief medical officer, and Craig Conoscenti, head of clinical development, worked on oral nintedanib at Boehringer Ingelheim, which is the innovator of the therapy. No two humans better understand this disease and how to do this the right way than Howard and Craig. Our chief operating officer, Melissa Rhodes, is a nonclinical pharmacologist and toxicologist, which is important for understanding and picking the right dose to work through the inhaler. Doug Carlson joined the team in May as chief financial officer and chief business officer. Doug has spent a lot of time doing IPOs and engaging with external markets, both in capital markets and financings, as well as business development and commercial work.

We have a really solid team and company culture now. I would describe us as a team of collaborative, smart, energetic people who enjoy working together.

Hiring a World-Class Team

Avalyn’s board chair, Niall O’Donnell, describes your leadership style as shrewd and strategic but also ego-free and enthusiastic. Those attributes have been very clear during our discussion. What’s it like working with Niall and the board?

When I say I’m proud of the team we’ve built at Avalyn, that includes our board of directors. They provide so much support. He always has ideas. I value the relationship we’ve built over time. I feel that the company would not be where it is without Niall.

“Niall is the most effective chairman I’ve ever worked with. He makes himself available whenever I need him as a sounding board and thought partner. I think the best investors are those who have operational experience, and Niall has a ton of it. He’s someone I can always count on to ask me tough questions – good questions, the right questions – which makes me better at my job.

Lyn Baranowski

The Value of a Board Chair as Thought Partner

In closing, what is most exciting to you about Avalyn’s future?

I’m most excited about the team we’ve built. I think great teams can take a good portfolio and make it amazing. And that’s the kind of team we have. Patients are at the center of our work, and we are all trying to make a difference for them. That’s genuine for us.

The focus for the next few years is to move these programs forward with patients top of mind, hopefully generating the data that we need to be able to then keep advancing and get these medicines to the market.

* Read about RiverVest’s approach to managing risks and maximizing investor returns in Eyes on the Exit, by Tom Melzer.

** Learn about pulmonary fibrosis and other interstitial lung diseases at the Pulmonary Fibrosis Foundation.

Lyn Baranowski is the chief executive officer of Avalyn Pharma, a clinical-stage biopharmaceutical company focused on developing targeted medicines for patients with rare lung diseases in need of better therapeutic options.

Lyn has more than two decades of experience leading a vast array of functions in biotech, big pharma, and venture capital firms with a focus in the respiratory therapeutic area. Prior to joining Avalyn, Lyn served as chief operating officer at Altavant Sciences, a biopharmaceutical company that successfully built and developed a portfolio of therapies for rare respiratory diseases prior to its 2019 acquisition by Sumitomo Dainippon. Earlier in her career, Lyn served in senior-level corporate development and commercial roles, including vice president of commercial development at Pearl Therapeutics, which successfully developed a portfolio of asthma & COPD medicines prior to its sale to AstraZeneca for $1.15 Billion in 2013; and vice president in a healthcare-focused venture capital firm based in New York. She had previously held roles in business development, marketing and public affairs with Novartis Pharmaceuticals in Switzerland and the U.S.

Lyn earned an MBA from Harvard Business School and a Bachelor of Arts from American University. In addition to her role at Avalyn, Lyn serves on the planning committee for the American Thoracic Society’s Respiratory Innovation Summit, an annual meeting that unites the innovators, investors, and clinicians who are leading the fight to create powerful new treatments for deadly and crippling diseases of the lungs and airways.

About Avalyn Pharma

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases, including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis.

About RiverVest

RiverVest Venture Partners is a leading venture capital firm building life science companies to address significant unmet needs of patients and deliver consistently strong returns to investors. With headquarters in St. Louis and offices in San Diego and Cleveland, RiverVest accesses forward-thinking research and clinical expertise at leading institutions across the country to found and fund biopharma and medical device companies.