Episode 3 | How to start your own biotech company – Part 1. Therapeutics

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Episode Guests

William Bozza, Ph.D.

William Bozza, Ph.D., serves as a Program Director, managing a portfolio of oncology startups (SBIR & STTR awardees) to facilitate small businesses in technology commercialization for cancer diagnosis and treatment.  Dr. Bozza is currently leading the Center’s efforts on the Small Business Concept Award for early-stage high-risk/high-reward technologies that target rare and pediatric cancers.  He is also taking the lead on the program’s Peer Learning and Networking Webinar Series to help SBIR companies learn from peers and facilitate collaboration.

Eric Broyles, J.D.

Eric Broyles, J.D., trained as a corporate attorney, has been a serial entrepreneur for over 15 years and has led breakthrough developments in pharma/healthcare. He is the Founder of ExpertConnect, which manages a global network of 150,000 subject matter experts including 60,000 healthcare/pharma experts who consult with many of the largest healthcare investors in the US. Broyles led the launch of a clinical trial and the first ever development of a transdermal patch with proven delivery of Vitamin D through the skin and Iron and Zinc through the skin with a top university in England who licensed one of Broyles' companies a proprietary formulation for this innovation.

Margaret Jackson, D.Phil.

Margaret Jackson, D.Phil., has worked in pharmaceutical and biotech R&D for more than 20 years, holding executive leadership roles at Pfizer, Napa Therapeutics, and Juvenescence. She specializes in identifying transformative drug discovery projects and translating them into high-value clinical drug development programs with an emphasis on translational efficacy, early safety de-risking, mechanistic biomarkers, target engagement biomarkers, and PK/PD modeling. Dr. Jackson has built and led multiple matrix preclinical and clinical development teams from hit identification to Phase 1/2 clinical studies. She has consistently delivered first-in-class and best-in-class programs, spanning small molecules and biologics for women’s health, diabetes, obesity, anorexia-cachexia, and fibrotic diseases.

Articles referenced in this episode

• Small Business Innovation Research Awards 
• The National Science Foundation 
• Department of Defense Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs 
• Small Business Association 
• ERA Commons
• System for Award Management (SAM) account registration 
• Grants.gov
• Eva Garland Consulting, LLC 

Visit our website, sbir.cancer.gov, for the latest funding opportunities and commercialization resources to support your journey from lab to market.

Episode Transcript

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BILLY: Hello and welcome to Innovation lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute Small Business Innovation Research, or SBIR Development Center.

BILLY: Our podcast host interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting-edge cancer solutions from lab to market. I'm Billy Bozza, a program director at NCI SBIR and today's host.

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In this episode, you will hear from two therapeutic companies funded by the NCI SBIR program about starting a business and how they kick started their journey going from lab to market. The first company, Nanocan will share their vision, licensing journey, and the various considerations that went into forming their cancer therapeutic startup.

Then we will hear from Biomass and how this company went about building a business team, established a corporate structure, and found resources for managing their business. Now, without any further ado, here's Eric Broyles, founder and CEO of Nanocan.

ERIC: Hello, my name is Eric Broyles, and I am the founder and CEO of Nanocan Therapeutics Corporation, which is a company that Harvard's Dana Farber Cancer Institute has spun out a patented technology that we believe will be revolutionary in cancer care.

Our company is at the preclinical stage, which means we have not done in human clinical trials yet, that is our next phase that we're going to move into over the next 6 to 9 months. We will use a proprietary nanoparticle drone delivery mechanism that actually can intratumorally deliver immunotherapy for certain solid cancers, cancer tumors. And then we have a formulation that works on brain and lung, that is a liquid formulation of this technology.

So I want to talk about why I started a company to undertake this endeavor. And one of the most important things to me is vision. What is the vision that you have? And I met a professor at Harvard Medical School who had invented this technology and just hearing his thoughts about how he developed the technology, what his hopes were for the technologies placed in the marketplace, really inspired me, and I was inspired by again his creativity, his genius, really with making this invention.

And so I really formulated my own vision for how I wanted to take -- where I wanted to take this product. And I was encouraged and inspired that that I would have an opportunity to lead and develop a commercialization of a technology that can save lives.

As an entrepreneur, you have the ability to be creative. You have the ability to make a positive impact on society, and you also have the ability to achieve financial rewards. I want to talk about the steps we took to secure the IP rights to the invention.

Initially I had to meet with Harvard University to share my vision and market approach for their intellectual property. And I'm trained as an attorney and so I understand intellectual property, but it's also very important in that step, after you share your vision and get buy in from them, you should engage good IP counsel, intellectual property counsel.

Following that, you will eventually get a term sheet for your technology, again, this assumes you have not invented the technology yourself. You'll get a term sheet. We got a term sheet and then you will get a draft license agreement. It's important for your license agreement, certain key terms, what's the scope of the license? What's the term? How long will you have the right? Is it exclusive or not? What's the geographical limitations? How much do you have to pay in royalties and are there other payments that you need? And then what are the milestones you have to achieve to maintain your rights to the IP?

Those are all key questions. Again, good IP counsel will be able to -- will know these things and be able to guide you through those topics. What are the right types of corporate structure that you should consider? Well, they're your usual suspects in which are going to be C corporations, limited liability corps, S corps. These all have their pros and cons. Most institutional investors of venture Capital fund or private equity fund, they're used to seeing a C corporation structure.

There's some investors that may want to see an LLC structure, an LLC provide you certain tax benefits. You could write off your losses, particularly during your pre-revenue stage, and you're just spending money. And then there's an S-Corp structure, you should seek good accounting advice and good legal advice to help you figure out which of these structures works best for your company.

And then you should also talk to other entrepreneurs about why they chose the structure that they did. It may depend on the industry, your timing of getting in and out of the business. Those are all important considerations that the right guidance will help you to figure out.

And then thinking about financial tools and funding sources, I would encourage you actually to be open to all types of funding source. Non-dilutive grant funding that like NIH provides or NCI is very important, it's a very good source of funding, but you should be aware that it does take a lot of time to prepare the applications. There may be a gap between when you submit the application and when you get notice of award funding. And it requires that you really pay attention to details and follow very specific instructions, and have very thoughtful responses because it's a competitive process, but it's definitely worthwhile, and I'd encourage you to consider it.

And then obviously there's raising private capital and the private capital, it could be venture capital, it could be a family office. Check your university and see if there's an angel network or check your local community to see if there's an angel investing group. There's several of these groups across the country that may be a good fit and you have what you call friends and family and you'll have to figure out which of these sources of capital works best for you.

And then there'll be key terms, again, you should get good legal counsel, they'll help you sort of work you through these issues. But you should also, again the importance of your vision is critical because you're going to get a lot of no’s and it can be discouraging to you at times, but keeping that vision in the why you decided to be an entrepreneur in front of you will help you to sort of work through those no’s and the challenges that you might encounter and will encounter.

How have I put my team together for Nanocan? So for me as the founder, the sort of two important considerations were number one, what am I doing? And then number two, who am I doing it with? I wanted to have a really a cohesive team and really pick people that I enjoyed working with. It doesn't mean we all have to be alike, in fact, you shouldn't all be alike, you need to be able to challenge each other.

But you should really share, have alignment on vision, which I think is important and share certain common values, particularly having visions about where the company is going and I was fortunate to be able to build a team that shares my vision and has -- And then look at the expertise that they bring in figuring out the gaps in your own expertise.

You should have a law firm prepare your employment agreements or consulting agreements. You'll have to figure out how you're going to compensate your team. If you have some seed funding, you may be able to pay them, but typically early stage companies, it's heavy on incentives and really light on cash compensation.

And then you also want to assemble a board of advisors who can help, you know, open doors, they have expertise, they have their networks, and that can just give you good guidance and direction, which would be very important. I have Dr. Nguyen who's actually a professor at Harvard and also, a researcher at Dana Farber and he's part-time with us but adds great value for our business.

We have another colleague who runs our clinical trial, we have another person on our team who's good at international projects, and that's important, that’s an important part of our vision, expanding our technology internationally. And then you need good financial advice and we actually have an in-house CFO with extensive experience, starting his career at Merrill Lynch and working on a number of high finance projects.

And then our advisory board, it actually includes the inventor, it includes oncologists from the top institutions in our country that were excited about our technology, and they make themselves available and you should really be respectful of their time, but really also leverage their expertise in the network. It can be very important and save you a lot of time and headache being a good steward of your relationship with your board of advisors.

So what were some of the key challenges we faced and how we overcame them? In any drug development project you're going to hit snags, so be prepared for that. Make sure you have access to the right expertise, which is why it's very important for you to have a good team and a good board of advisors. Our company had challenges securing a human grade immunotherapy for our inhuman trials, but through our network we were able to overcome that challenge.

We also had challenges finding the right CDMO partner and again leveraging our board of advisors, our team, we were able to find the right partner. I'd also encourage you to consider attending conferences like CPHI which has a broad range of players in the pharma and biotech industry who can be helpful to companies.

I thank you for your time. I wish you the best as you bring your technology to market and really appreciate this opportunity to share with you.

BILLY:  What a great journey. Up next we have Margaret Jackson, founder and CEO of Biomass.

MARGARET:  Welcome to NCI SBIR Peer Learning and Networking, first steps for starting small business. I am Dr. Margaret Jackson, founder and CEO of Biomass. We are a preclinical stage precision medicine company, focused on developing novel therapeutics for cancer anorexia-cachexia.

Biomass, as an early startup, was able to accelerate based on receiving both SBIR and federal contract phase one funding. So why did I decide to start a small business? I decided to start Biomass for three key reasons. First, passion, I'm incredibly passionate about finding a cure for cancer induced anorexia-cachexia.

I know the patient. My father passed away over 30 years ago with his debilitating disease, and yet fast forward 30 years, there is still no approved treatment. We can do so much more and we need to do it so much better. Second, expertise, I have over 20 years of drug discovery and drug development expertise in developing novel therapeutics and taking programs from early concept right through to early stage clinical trials. It's a wonderful thing when you can combine your passion and your career together to develop something truly important for patients.

And thirdly, culture. To develop a novel therapeutic, you can do it at large pharma or as a startup, both the pros and cons. At large pharma, there's fabulous resources, fabulous talent, but there's hierarchy, bureaucracy, slow decision-making. In a startup, you have a flatter structure, meaning being able to be more nimble, enable rapid decision making, build closer-knit teams, and faster execution of your programs.

At Biomass, we have developed our own culture. Scientific excellence, innovation, and people are at the core of our culture. We have a very high bar as we are developing drugs to survive and develop that first cure for cancer induced anorexia-cachexia. There is clear accountability to get things done with high integrity.

So guidance to anyone considering a startup. I would suggest don't be afraid to fail. Be afraid to not try. So how did we assemble our business team and what were some of the important considerations? As an early startup, it's really important to have the right people with the right talent at the right time to do the right job that helps you grow your business.

But as an early startup company, quite often you're cash constrained, often referred to as bootstrapping. And it's really important for you to consider how best to deploy your capital. Quite often for the business team, you do not need them in full time in the organization, but they are required at specific times for specific functions.

So the first question to ask is, do you need individuals as a full-time employee within the organization or can you use resources externally that can be more capital efficient? An example would be there isn't a need for chief finance officer for an early stage company, but it's essential to have an accountant, because you as a full-time employee can bring money into the organization, can receive the invoices, but you do need somebody externally who's able to pay those bills.

In addition, you need someone who's going to be able to do your monthly accounts and also your annual taxes, but that could be done as a monthly retainer or can be done at an hourly rate. Likewise, it's important to have business development expertise, but not required full-time. It's essential for thinking about in licensing or out licensing at certain periods of time, and also for setting up your templates for consultancy agreements, confidentiality agreements, and master service agreements.

Again, not required full time. IP is king for a company and therefore it's really essential to have an IP attorney which can be external to actually support your IP strategy, at times when needed. And finally, it's essential to have outside counsel. You don't need to have a chief legal officer internally in your organization, but you certainly do need an experienced life science outside counsel who can actually help you demystify term sheets from investors or any other additional contracts that may come from any other organization.

So the guidance at this stage of an early stage company when forming a business team is to consider resources outside your organization to support the organization, which can be done at a monthly rate or at an hourly rate.

What are the considerations for determining the right type of entity for starting your new company? There are essentially seven classes of business structures, and it can be overwhelming, but essentially the business structure you choose influences everything from day-to-day operations to taxes and how much of your personal assets are at risk.

In life sciences, limited liability companies, LLCS or corporations, C-Corp are the most common. LLCs can be a good choice for medium to high risk businesses, owners with significant personal assets they want to be protected, and owners who want to pay a lower tax rate than they would with a corporation.

Corporations offer the strongest protection to the owners from personal liability, but the cost to form a corporation is higher. Corporations also pay income tax on their profits and again when dividends are paid to shareholders on their personal tax returns. Corporations have a completely independent life separate from its shareholders, and if a shareholder leaves a company or sells his or her shares, the C-Corp can continue doing business relatively unstirred.

Corporations have an advantage when it comes to raising capital because they can raise funds through the sale of stock, which can also be a benefit and attract employees. Corporations can be a good choice for medium to high risk businesses, those who need to raise money, and businesses that plan to go public or eventually be sold. So guidance, really speak to outside counsel about what works best for your business vision.

Are there any technology specific considerations when starting a therapeutic small business? Yes, we live in a virtual world where technology is critical for communication, documentation, and archiving. It really is important to make sure that operations are in place. So for accounting, an example would be QuickBooks, which is great to be able to provide purchase orders to vendors for drug discovery, drug development work, helps you track your invoices against statements of work, helps you track expenses.

You're able to do a payroll and also provides reports such as your balance sheet and profit and loss. Payments can be also done both nationally and internationally using Bill.com. It is really important when working with external vendors or consultants or even with employees internally, that DISA and reporting is archived and easily accessible. Examples of being able to archive and share would be using Box or SharePoint.

In addition, it's important to have a dear room that's available for diligence with external investors. Examples would include dearrooms.com and also SharePoint. This means that you're able to give restricted access to individuals to confidential information that is clearly marked as confidential.

For data managed for high throughput screening data, regular screening data, biological data, chemical structures, antibodies, sequences, et cetera, it is important it's all in one central repository. And an example where this can be easily accessed, visualized, and interrogated is using software like CDD, Collaborative Drug Discovery, which also has the benefit of having access to an electronic lab notebook where your study protocols can also be uploaded.

And finally, as you're working with investors and trying to keep on top of the CAP table, it is important to make sure that you're able to access that and make sure there are no mistakes and a great software is Carta.

So the guidance for any startup company is to make sure that you have the proper operations software in place, do not store confidential important information fragmented and in people's inboxes. They need to be correctly archived and accessible and be able to visualize.

So what kind of financial tools and resources would I recommend to an early life science company? I cannot stress enough how important it is to go after non-dilutive funding. It is important for three reasons. One, it means that your research has been peer reviewed, it's scientifically validated, which is really important when talking to external investors.

Number two, it means you receive money, you get your company off the ground, you advance your research, and you create value in your company. And third, mid range you get money and not at the expense of taking equity of your company. There are multiple types of non-dilutive funding. There are the Small Business Innovation Research Awards, the National Science Foundation, Department of Defense, federal contracts, Bill and Melinda Gate Foundations, in addition to multiple grant opportunities that may be present on websites, all of areas that you're investing in.

There are multiple resources to help you apply for these grants, if this is your first time. There are books that are available online from Amazon which actually walk you through step-by-step how to apply and submit these grants. But most important to be aware of is you need to give yourself about eight weeks prior to submitting any grants to ensure that you actually have risk completed all your registrations.

You need an employer identification number. A Small Business Association registration, registration with ERA comments, SAM.gov, Grants.gov. And there are companies out there who have actually experienced writing grants and are now consultants to help the next generation apply for grants such as EGC and Free Mind.

The other opportunity to receive money is through dilute of funding. This is where you receive money from angel investors or from venture capitalists for seed funding or Series A investment. That'll be the first time you experience a term sheet which can be overwhelming, and there's a great resource called Venture Deals by Feld and Mendelson that you can purchase online, which actually take you through step by step the pros and the cons, all of each of the descriptions on the term sheet, of the economic terms, the controlling terms, the permissions, and the restrictions.

In addition, there are local networks to help you demystify term sheets. An example in Boston is the Capital Network. They also help you understand a cap table. There is also multiple incubators or accelerators that you could join that actually help you to understand how to get your first investment and how to meet investors. An example for women founders is Springboard Enterprises supporting life sciences and digital health.

And also really important to build your network of other CEOs or C-Suite executives who have lived and breathed this. So the guidance for applying for funding and the resources at your fingertips is to really build your network of individuals who have had the experience of doing this and have been successful in achieving funding.

What do I know now that I wish I had known first when setting up a small business? Well, setting up a startup company for the first time is a very steep learning curve, but a very rewarding experience. It is important to surround yourself with really great people, great talent that will help you as an individual grow, but also help the company grow.

It's very exciting to get your first non-dilutive funding and it's very exciting to get your first investor, but you should be very mindful of how the deals or the term sheets of an investor equity financing actually affects your eligibility to apply for an SBIR grant.

So if you have a single investor with over 50% of the company, you as a company are no longer eligible to apply for an SBIR grant until you have further investors who come to the table. So it's very important as part of the investor negotiations to ensure that you are still eligible to apply for non-diluted SBIR funding.

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BILLY: There you have it. Special thanks to Nanocan and Biomass for speaking with us today. As always, don't forget to check our website sbir.cancer.gov for the latest funding opportunities and commercialization resources to support your journey from lab to market.

This was Billy Bozza from NCIS SBIR. Please join us again for the next installment of NCI SBIR Innovation Lab and subscribe today wherever you listen.

If you have questions about cancer or comments about this podcast, email us at NCIinfo@nih.gov or call us at 800-422-6237. And please be sure to mention Innovation Lab in your query. We are a production of the U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.

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