Investor Resources

Information for Current InSitu Biologics Shareholders

FAQ

Find below the answers from our most frequently asked questions:

Question:
How does AnestaGel™ work?

Answer:

AnestaGel™ can be injected into tissue or smeared on the surgical site. As the Matrix absorbs water from the body tissues, the bupivacaine spreads in to the area, numbing the area for several days, providing post-surgical patients a viable option to avoid opioid use.

Question:
Why do you think this will be successful?

Answer:

In head to head pre-clinical studies against the only product cleared for regional post-surgical pain treatment, Exparel, AnestaGel™ provided statistically significant more pain relief than Exparel (study).

Question:
What exactly is this investment opportunity?

Answer:

This investment goes directly to our company so that we may conduct Phase I-III clinical trials required to bring AnestaGel™ to market.

In addition to being a financial opportunity for you, this effort will have a profound impact on one of our most debilitating national epidemics – the opioid crisis that has gripped so many of our communities and resulted in the overdose deaths of over 400,000 of our fellow citizens since 1999.

Question:
How can I invest?

Answer:

As of today, you are able to invest with ACH, check, credit/debit card or even your IRA/Roth IRA.

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.

Question:

How many shares are being issued? Will there be additional shares issued once you go public or if you need to raise additional capital?

Answer:

817,117 remaining shares of Class A Common Stock at $8.20 per share.  Additional shares may be issued as additional capital is raised in future funding rounds.

Question:

How much of the dollars used to develop this were tax payer dollars and subsidies?

Answer:

$0.00

Question:

What would be the point of investing/ how does this benefit the investor?

Answer:

Please reference the Offering Circular for information on the potential for revenue.

Question:

Will this work for CRPS?

Answer:

Our product is not focused on chronic pain conditions like complex regional pain syndrome (CRPS).  Anestagel is specifically formulated for post-surgery acute pain – the first 72+ hours when pain is most severe.

Question:

What is the status of the veterinary use of the product?

Answer:

Although the veterinary market represents an attractive opportunity, based on the economics/COGS of Anigel and the relatively low reimbursement/payment rates of the vet market, we have decided to focus our limited resources on the human market as our immediate primary objective.  We would then focus on addressing the vet opportunity and possibly license that opportunity to an entity with specific expertise and marketing experience in the veterinary market.  This is consistent with the strategy/timing/focus of our competitors who have gone before us.

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

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