$NVIV...a nice recap posted on the NVIV board...hog
FactMan777 Thursday, 01/29/15 05:26:54 PM
Re: None
Post # of 3548
The year in review. It’s all about management.
A wise man once told me...
If you are investing in real estate the 3 most important things to consider are: Location, Location and Location. And if you are investing in a company the 3 most important things to consider are: Management, Management and Management.
So let’s review how the current management team at InVivo has performed since Jan 2014 when the current CEO Mark Perrin was appointed.
Jan 6, 2014 – Mark Perrin appointed CEO.
Jan 29, 2014 – Thomas R. Ulrich MD appointed Chief Scientific Officer.
Mar 17, 2014 – Tamara L Joseph appointed Senior VP, General Counsel and Chief Compliance Officer.
Mar 17, 2014 - business update: One clinical site has now received IRB approval and finalized its contract and a second site is nearing completion.. Additional sites are progressing through this process.
Apr 28, 2014 – InVivo Initiates First Clinical Trial of Neuro-Spinal Scaffold.
May 5, 2014 – announces proposed public offering at $1.15. FactMan: Even though this was a very unpopular and difficult decision by management, it was the right decision at the time to raise money in a difficult market with the former disgruntled CEO dumping shares on the market. This increased the cash runway out to Nov 2015.
May 12, 2014 – business update: patient enrollment will be opened by the end of May.
May 14, 2014 – InVivo announces Its Second Clinical Study Site for Neuro-Spinal Scaffold, the Carolinas Medical Center in Charlotte, NC.
Jun 23, 2014 – InVivo announces realignment of R&D strategy. FactMan: Another difficult correct decision by management to eliminate the hydrogel drug delivery program and focus even stronger on the company’s core mission: developing meaningful treatments for spinal cord injury. The company also announced that it is making a reduction in force (RIF) of 14 employees, or 28% of its workforce which will result in annualized savings of $3 million and extend the cash runway through March 2016.
Jun 24, 2014 - InVivo announces New Responsibilities for Senior Management Team Members. William D’Agostino, PE has been appointed Senior Vice President, Operations. Kristin Neff has been appointed Vice President, Clinical Operations & Project Management. Lisa Crockett has been appointed Vice President, Regulatory Affairs & Reimbursement Planning. FactMan: it is my understanding that Kristen Neff is a tireless worker and is responsible for getting the clinical sites ready to enroll patients.
Jun 26, 2014 – InVivo announces Barrow Neurological Institute As Third Clinical Trial Site for Neuro-Spinal Scaffold. BNI at St. Joseph's Hospital and Medical Center is the largest dedicated neurosurgical center in the world.
July 1, 2014 - InVivo appoints Christopher McNulty as Vice President, Business Development & Investor Relations
Aug 6, 2014 – business update: InVivo announces that our new highly-experienced leadership team represents the best people to drive the development of our two major products: the Neuro-Spinal Scaffold and the Neuro-Spinal Scaffold plus stem cells programs. These two major assets form the foundational core of our newly focused mission, which is to lead as the experts in the field of spinal cord injury.
Aug 11, 2014 - InVivo receives Notice of Allowance on Patent Covering Neuro-Spinal Scaffold and Neuro-Spinal Scaffold Plus Stem Cells.
Sep 29, 2014 - InVivo announces Appointment of Daniel R. Marshak, PhD to Its Board of Directors.
Oct 15, 2014 – InVivo announced that the first subject has been enrolled in the pilot study of its Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury (SCI) at the Barrow Neurological Institute.
Oct 20, 2014 - InVivo announces Barnes-Jewish Hospital at Washington University as its fourth Clinical Trial Site for Neuro-Spinal Scaffold.
Oct 29, 2014 - InVivo receives FDA Approval to Broaden Inclusion Criteria and Add 14 Additional Sites (20 Total) for Ongoing Pilot Trial.
Nov 5, 2014 – business update: InVivo has made substantial progress on all fronts during the third quarter and have continued to build upon that momentum in the weeks since. In that timeframe, we enrolled our first subject in our first-in-human pilot trial, expanded the number of potential clinical sites, broadened subject eligibility criteria, increased our communications outreach through scientific, medical, and investor conferences, and significantly strengthened our intellectual property portfolio.
Nov 11, 2014 - InVivo announces Appointment of Ann Merrifield to Its Board of Directors
Nov 21, 2-14 - InVivo announces Oregon Health & Science University as the Fifth Clinical Trial Site for Neuro-Spinal Scaffold
Nov 25, 2014 - InVivo announces University of Pittsburgh Medical Center Presbyterian as the Sixth Clinical Trial Site for Neuro-Spinal Scaffold
Dec 16, 2014 - InVivo announces FDA Approval to Expedite Enrollment for Ongoing Pilot Trial. FactMan: very significant since it clearly confirms the outstanding relationship the company has developed with the FDA while also significantly shortening the timeframe of the ongoing pilot trial.
Jan 9, 2015 - InVivo announces Reopening of Enrollment for Ongoing Pilot Trial and no reported serious safety events in the study’s first subject
.Jan 21, 2015 - InVivo reports three-Month Update of First Acute Spinal Cord Injury Subject Implanted with Neuro-Spinal Scaffold - Motor, Sensory, Bowel, and Bladder Function Improvement with No Reported Serious Adverse Events. Dr. Theodore said, “I am very pleased with the first subject’s progress since the scaffold was implanted. In my experience, this degree of sensory and motor improvement is unexpected.” FactMan: it doesn’t get much better than this!!!
Jan 22, 2015 - InVivo announces Enrollment of Second Subject in Pilot Spinal Cord Injury Trial. FactMan: very significant since this took only 13 days since enrollment was reopened and it is now very likely ongoing pilot study will be completed in 2015.
Jan 29, 2015 - InVivo announces $12 Million Registered Direct Offering. FactMan: I believe the price of $1.50 was negotiated weeks ago. Management surely didn’t know the price of the stock was going to be over $2.00 on Jan 28, 2015. With the $1.4375 warrant exercise that will raise an additional $10 million they should be funded for all of 2015, 2016 and 2017.
So to summarize, in the past year InVivo Therapeutics has:
-built a solid highly-experienced leadership team.
-received a patent covering Neuro-Spinal Scaffold and Neuro-Spinal Scaffold Plus Stem Cells.
-developed an outstanding relationship with the FDA which is so very important for a small bio-tech company.
-opened 6 Clinical Study Sites for Neuro-Spinal Scaffold and received FDA approval to open up to 20 sites.
-enrolled the first patient with this patient showing “unexpected gains”.
-significantly reduced the timelines for the current 5 patient pilot study.
-completed the enrollment of the 2nd patient in only 13 days.
-funded the company out to 2018 so a partner will not be needed going forward. As per mikerconfer from the Yahoo message board “Shares issued in Secondaries can always be bought back but a development and marketing partnership is the gift that keeps on picking your pocket forever.” InVivo now has solid control of their financial future which will better serve them in all future negotiations.
Final management grade = A+
Just the facts,
-FactMan777
AI
