Reg A+ Investor Resources

Information for InSitu Biologics Current & Prospective Shareholders

A Letter from InSitu Biologics:

Hello,

Thank you for your interest in investing in our company. We are proud of where we’ve been and excited about where we’re going. This page along with Updates Page should serve as a good resource for you as a prospective or current investor. And as always please feel free to send us an email: info@insitubiologics.com

-InSitu Biologics

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Regulation A+ and Company Q&A

Find below the answers from our most frequently asked questions, as well as questions pertaining to our Reg A+ Offering:

Question:
What happened to CEO James  Segermark? I’ve invested, and now there appears to be a new CEO. I would like to know what is going on and where my  investment stands.

Answer:

As you’ve noticed, our company has gone through a few substantial changes over the past few months and we are pleased to welcome our new President and CEO Kevin Bassett to InSitu Biologics. You can read more about the leadership changes in our company update from August 30th here on our site.

Additionally, your shares are held electronically with ComputerShare. If you have not yet set up an account with them, here are the steps you may take to do so. 

Question:

I can’t read the letter from the CEO in the email.

Answer:

A pdf version of the letter is linked to the letter image as well as the text that reads: “Click to Read My Letter to You”. Once the pdf letter opens you can download and should be able to save for you records, as well as enlarge to read if need be, or even print. 

Here is the link: Letter from our CEO

Question:

I was wondering how long do I have to invest into InSitu Biologics. I see where you have a date showing for November 30 2019. Is there going to be another opportunity for the A+ group to invest into the business for next year?

Answer:

At this point in time, the plan is to close the Regulation A+ Offering on November 30, 2019. 

After this offering is closed we plan to migrate to a more traditional Regulation D offering which will only be open to institutions and funds with deep pools of money who can invest large amounts of capital needed to conduct human clinical trials.

If you are interested in investing in the current offering, we invite you to do so prior to November 30.

Question:

Will investor shares continue to be held at ComputerShare?

Answer:

Yes, the plan if for shares to continue to reside at ComputerShare for the foreseeable future.

Question:

I thought InSitu was going to lease our rights to other companies. Is that still the plan?

Answer:

Our current plan is to follow a pathway through phase 1-3 clinical trials for our post-surgical pain management product (Anestagel).  We are acutely focused on raising money for that strategy and executing on that pathway. If, along the execution of that strategy and based on hitting milestones and positive clinical results, we have discussions with potential partners, acquirers, strategic investors, etc., that include licensing our technology, we will definitely evaluate those opportunities.  Success at Insitu Biologics requires our team to have a hyper-focus on a well-defined single pathway – we believe the best pathway for the Company (and ultimately our shareholders) is to focus on Anestagel for the human market.

Question:

Does InSitu still intend to compete in the veterinary medicine market?

Answer:

We are currently re-evaluating the economics of the companion pet/veterinary market.  Although the margins are much lower in the animal market than in the human market, it may be worth partnering with a company in the veterinary space in the short-term, as long as the efforts in the animal space do not cause Insitu to slow down our efforts to make rapid progress in human clinicals.  Our competitors in this space have waited until after they received FDA approval for humans to engage in the animal/pet market. We believe that was a sound strategy, but continue to evaluate the value/timing of the veterinary space.

Question:

Does InSitu Biologics plan to remain independent and eventually compete with Pacira and Heron Therapeutics? What do you see occurring in the next 3-5 years? Leasing rights or being independent?

Answer:

We intend to raise significant capital and conduct phase 1-3 human clinical trials with the intent to eventually compete with Pacira (Exparel) and Heron (HTX-011).  Over the next 3-5 years our current plan has us conducting phase 1 (2020), phase 2 (2021), and phase 3 (2022-2023) trials leading up to FDA approval in 2024. Note that each phase requires MULTIPLE INDIVIDUAL TRIALS to meet the FDA requirements, not just one in each phase.  Our clinical trial plan must be agreed upon with the FDA, so this is a rough estimate of timing and is subject to change with FDA input as well as timing changes that could occur based on the data coming out of each phase of the trials. Regarding your question on being independent, we do expect to remain independent with private equity funding for the foreseeable future.  With respect to licensing rights, our efforts will remain laser-focused on bringing Anestagel through the clinical process. We believe we need to show the safety and efficacy of our base product prior to expanding efforts and dollars on licensing deals with interested parties. However, if an entity came to us with a proposal that did not de-focus from our strategic pathway and made financial sense, we would definitely analyze and entertain that proposal.

Have a question that wasn’t answered here? Please send us an email and we’ll respond to you shortly.

Create a New Account with Computershare

As a shareholder you can view and manage your shares via Computershare. If you do not already have a Computershare account, please create one following the steps in this guide:

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