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CNS Pharmaceuticals, Inc. (CNSP)

Q4 2019 Earnings Call· Thu, Mar 12, 2020

$2.26

-1.10%

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Transcript

Operator

Operator

Welcome to the CNS Pharm Business Update Conference Call. At this time, all participants are in listen only mode. Following management's prepared remarks, we’ll hold a Q&A session. [Operator Instructions] As a reminder, this conference is being recorded March 12, 2020. I would like to turn the conference over to Yvonne Briggs. Please go ahead, ma'am.

Yvonne Briggs

Analyst

Thank you, operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining CNS’s Pharmaceuticals business update conference call. Earlier today, CNS issued a news release announcing financial results for the 2019 fourth quarter and full year. If you'd like to be added to the company's email distribution list to receive future announcements, please register on the CNS website at cnspharma.com or call LHA in Los Angeles at 310-691-7100 and speak with Casa Chen [ph]. Before we begin, I'd like to remind you that any statements made during this call by management, other than statements of historical facts will be considered forward-looking, and as such will be subject to risks and uncertainties that could materially affect the company's expected results. Those forward looking statements include without limitation, the various risks described in the company's annual report on Form 10-K for the year ended December 31, 2019 filed today and subsequent filings with the SEC. Importantly, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast today, March 12, 2020. Except as required by law, CNS undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this call. Joining me from CNS Pharmaceuticals are John Climaco, Chief Executive Officer; and Chris Downs, the company's Chief Financial Officer. During today's call, management will provide an overview of the company's clinical development programs and future milestones and its recent financial results. At the conclusion of the prepared remarks, we'll open up the call to your questions. With that, let me turn the call over to John. John?

John Climaco

Analyst

Good afternoon, everyone. And thank you for joining the call today. Since completing our IPO exactly four months ago, it has been an eventful time for the company. We've expanded our pipeline, received positive feedback from the U.S. FDA regarding our lead clinical program and completed GMP manufacturing of our lead drug candidate, all of which I will discuss in a moment. However, as this is our first conference call as the public company. Let me begin by giving some background on CNS Pharmaceuticals, and our lead drug candidate Berubicin. Berubicin was developed by Dr. Waldemar Priebe, a professor of medicinal chemistry at the MD Anderson Cancer Center in Houston. Dr. Priebe is also the Founder of CNS and serves as Chairman of our Scientific Advisory Board. Dr. Priebe's research combines biology and chemistry with a focus on the design and development of drugs that selectively target DNA and the inhibitors of signaling and metabolic pathways that are important to tumor progression and survival. CNS drugs are in clinical trials and several others are in various stages of preclinical development. Berubicin is currently being developed for the treatment of patients with glioblastoma multiforme, or GBM, which is the most aggressive form of primary brain cancer. GBM Cancer cells reproduce quickly and are supported by a large network of blood vessels, making this cancer highly invasive and virtually incurable. Approximately 15,000 new GBM cases are diagnosed each year in the U.S. with optimal therapy, including surgical resection, radiation and chemotherapy with the current standard of care drug temozolomide, patients have a median survival of only 15 to 23 months. Sadly, only approximately 40% of patients are genetically predisposed to respond to temozolomide. And even these patients will almost all eventually relapse following first line therapy. The remaining 60% of patients currently…

Chris Downs

Analyst

Thanks, John. As John mentioned, the company completed its initial public offering of common stock in November of 2019, and raised gross proceeds of $9.8 million, including the underwriters exercise of the overlock adoption. As of December 31, 2019, our cash position totaled $7.2 million. With this cash balance, we believe we have the runway to advance our current clinical development programs into approximately mid-2021. Let me summarize some of the key financial items for our fourth quarter financial results, which we issued in a news release earlier today. There will be more commentary on our results and our business in our Form 10-K, which was filed simultaneously. General and administrative expense was $1.0 million for the fourth quarter of 2019, compared with $0.2 million for the prior year period. I would highlight here that there is -- the year-over-year comparability is limited due to the prior year comparison period being prior to the IPO. As such, it is a time when the company had not yet accelerated its clinical development efforts due to capital availability, nor was there yet the necessary G&A infrastructure fully in place to allow for the clinical development work to proceed. The fourth quarter 2019 G&A expense of $1.0 million also included $0.3 million of non-cash stock-based compensation at one-time non-recurring expenses. Research and development expense for the fourth quarter of 2019 was $1.5 million, compared with $0 for the fourth quarter of 2018. The expense in the quarter was largely related to the front-loaded costs of reprocessing and validating the existing batch of Berubicin to be able to commence our trials, as well as starting the production of a new batch of the drug to allow us to complete the clinical trials, both in the U.S., and in Poland. The net change in cash in the fourth quarter was $6.3 million. As of December 31, 2019, CNS had cash and cash equivalents of $7.2 million, which included $8.8 million in net proceeds from our IPO. We've publicly stated that our total cost for our Phase 2 trial is between $8 million and $13 million. And that to ensure we have adequate capital to complete the trial, we would need to raise up to $7 million of additional funding. We would also like to state that our expected cash burn for G&A overhead is expected to be approximately $2.5 million to $3.0 million annually, and that we are doing everything possible to keep that number as low as possible without impairing our ability to successfully conduct the trials. With that, I'd like to open the call for questions.

John Climaco

Analyst

While we're waiting for the operator to take questions, I also wanted to mention, we will be participating in the 32nd Annual ROTH Conference next week, which is now being held on a virtual basis. We are available to have virtual meetings with institutional investors on March 16th and 17th. If you're interested, please contact your ROTH salesperson or Yvonne Briggs at LHA. With that, I will turn it over to the operator for questions. Operator?

Operator

Operator

Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation and ask that you please disconnect your lines at this time.