Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Investor Conference Call. At this time, all participants have been placed in a listen-only mode and the floor will be open for questions following the presentation.

[Operator Instructions] Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics future operating results and financial position.

All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section, included in Plus Therapeutics Annual Results on Form 10-K and Quarterly Results on Form 10-Q filed with the Securities and Exchange Commission from time-to-time.

Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. With us today of from Plus Therapeutics Dr.

Marc Hedrick, President and Chief Executive Officer; and Desiree Smith, Corporate Controller. It is now my pleasure to turn the floor to Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics. Sir, you may begin..

Good afternoon. Thank you, Erica, and welcome to our Q3. As Erica said, I’m Marc Hedrick, President and CEO of Plus Therapeutics and I’m happy to have for the first time joining me today our Corporate Controller and Principal Accounting Officer, Ms. Desiree Smith.

I’m extremely pleased to report the operating results for the third quarter 2019 for Plus Therapeutics, which identically is a first reported quarter under the Plus Therapeutics Company. It was indeed a milestone quarter for us and honestly perhaps the most important in the Company's history.

In three short months, Plus Therapeutics reinvested itself as a clinical stage oncology company. Let me hit a few of those highlights for you.

First of all, we achieved long-term viability in a directed series of actions including adding approximately $20 million in cash to the balance sheet through both a $15 million public offering and a $4.6 million reimbursement payment from the U.S. Department of Health and Human Services for our work on our BARDA contract.

Second, we moved the Company headquarters from California to a lower cost, lower cap state Texas where we had a preexisting facility and an active center of operations.

That move was timely and that it coincided with the November 2019 approval by Texas voters of a ballot measure that doubled to $6 billion, the value of bond issuances look forward to Cancer Provision and Research Institute of Texas also calls CPRIT. CPRIT is the nation's second largest public funder of cancer research after the U.S. Government.

We believe that as a Texas-centric company, there will be greater opportunities to partner with CPRIT now that we have relocated. Finally, we made a sweeping structural change to our business focus and development model.

As previously described, we very deliberately virtualized our development model in order to maximize capital efficiency, specifically returned our full-time employees base and real estate footprint to the essential core, as we saw not only for capital efficiency, but importantly, for speed and quality.

We now intend to use the best third party experts and service providers to supplement our small agile core team. With these moves we've architected our base cost structure design to able long-term viability and supported drive to dramatic future growth. It's a lean platform that is built for scale and sustainable margin that we intend to maximize it.

In summary, Plus Therapeutics emerges from the third quarter with financial strength, focused development strategy, and a cost structure to maximize the opportunity for long-term viability and growth.

Now, we intend to proceed at a brisk pace, in large part by strategically utilizing FDA regulatory opportunities designed to accelerate drug commercialization such as the Orphan 505(b)(2) path.

Plus Therapeutics current core expertise is in drug redesign and specifically in nanoparticle drug formulation, including the formulation of complex drug as well as drug manufacturing and scale up. We are also focusing specifically on late preclinical and early clinical stage drugs that can be moved cost effectively and rapidly through Phase 2.

So, we're confident with our core asset, married to a growing pipeline, we can produce extraordinary therapeutics that can provide tremendous benefits to patients and shareholders in line. As a guide to decision making going forward as it relates to our portfolio development, Plus has set forth three straight forward medical and commercial criteria.

First, every Plus Therapeutics drug must address an unmet or substantially underserved medical need. Second, it should combine the tried and true with the new by taking known active pharmaceutical ingredients that have extensive safety and efficacy information and using new technology to deliver there more safely and more effectively.

And finally, we must believe that there is addressable market of at least $250 million for those selected indications. Now, let me pivot over to our lead agent to discuss that. DocePLUS is a proprietary clinical stage development asset, which is an albumin-stabilized pegylated liposomal docetaxel. DocePLUS checks like all three boxes I just mentioned.

There is a Phase 2 ready asset that squarely address a widely recognized unmet need in small cell lung cancer and also quite possibly other. More specifically DocePLUS is complex reformulated new chemical entity based on the clinically proven API docetaxel. DocePLUS, which earlier this year was granted U.S.

orphan designation for small cell lung cancer, represents a peak U.S. sales opportunity with an estimated $750 million a year annually. This drug is intended to be something of a version 2.0, namely a substantially improved version of the market leading oncology drug by Sanofi TAXOTERE.

The FDA in our communications with them as accepted in principle, the sufficiency of a completed non-clinical studies package, the appropriateness of the 505(b)(2) pathways for drug.

The potential for accelerated approval for small cell lung cancer generally considered the most lethal lung cancer subtype with five-year relative survival rates ranging from 8% to 31%, filing the suitability of objective response rate as a primary endpoint or plan to pivotal Phase 2 trial.

We believe strongly that the FDA's feedback illustrates a very positive path forward for this drug. I won't reiterate our previous investor calls discussion of why we believe DocePLUS could be meaningfully superior to conventional docetaxel.

However, we're happy to share this of course with any investor who's -- but we do believe that DocePLUS has the potential to improve efficacy while simultaneously providing the safety profile that is similar or better than conventional docetaxel. To reiterate in terms of the clinical data, our competed U.S.

FDA approved 29 patients Phase 1 dose escalation trial of DocePLUS indicated that DocePLUS appears to offer advantages over docetaxel injection specifically in terms of safety and the avoidance of hypersensitivity reactions related to Tween 80, morbidity, the avoidance of docetaxel pre-medication and perhaps the lower dosage of API as well as within the limits of the phase one study evidence of efficacy in heavily pretreated patients, even those resistant to conventional dose attacks.

As a result, we are on plan to accelerate development of DocePLUS as a liposomal formulation of docetaxel for the treatment of small cell lung cancer in patients with platinum sensitive disease following first line treatment.

On establishment of this indication, we intend to execute the clinical program, sufficient to expand use of DocePLUS and to other forms of cancer. In the near term, we intend to submit our phase two trial protocol, small cell patients, platinum sensitive disease who progressed at least 60 days after the initiation of first line.

But we tend to develop the small cell lung cancer indication on our own we are actively seeking potential partners for indications beyond that scope. Regarding our secondary asset, DocePLUS or liposomal doxorubicin, we are in active discussions with parties interested in acquiring this drug as a new generic version of Caelyx in Europe.

The final point, we are reviewing a number of other in licensing opportunities to expand our pipeline consistent with the corporate objectives. And now, I'm very pleased to turn it over to Ms. Desiree Smith, our Corporate Controller for a financial review.

Desiree?.

Thank you, Mark, and good afternoon everyone. I am very excited to be part of the team at Plus Therapeutics and I will be discussing Plus Therapeutics' financial results for the third quarter of 2019, as presented in our earnings release today. I'll get right to the financial results.

For the nine month ended 9/30/2019, our operating cash burn was 6.9 million or to 9.5 million in '18. Our Q3 2019 operating cash burn was approximately 2.1 million compared to 2.6 million on Q3 2018. The reduction in annual cash burn was mostly related to this discontinued operation which resulted in reductions in operating expenses.

Net income for Q3 2019 was 520,000 as compared to a net loss of 2.3 million in 2018. The increase in net income was mainly due to the BARDA development revenue of 4.6 million, which was offset by 1.2 million a warrant issuance. For the nine months ended 9/30/2019, the net loss was 11.8 million compared to 10.4 million for 2018.

For research and development expenses, Q3 2019 our research and development expense was 900,000 as compared to a $1.2 million expense in Q3 2018 [Audio gap]. For the nine months ended 9/30/2019, R&D expenses were 3.6 million compared to 3.9 million in [Audio gap].

The decrease in research and development year-over-year spending was primarily attributed to a decrease in professional services, finance services, and product samples offset by increased in BARDA related product studies.

Now onto our sales and marketing, sales and marketing expenses decreased this quarter to approximately 94,000 compared to approximately 118,000 in Q3 2018. For the nine months ended September 30th 2019, 9/30/2018, our sales and marketing expenses were 305,000 compared 596,000 respectively.

A decrease in sales and marketing expenses was mainly due to a reduction of salaries and benefits as well as professional services due to our plan move toward R&D focused company. G&A expense was 1.1 million this quarter as compared to 1.3 million in Q3 2018.

For the nine months ended 9/30/2019 and 2018, G&A expense was 3.3 million compared to 4.6 million. The Q3 reduction in G&A expenses was mainly related to reductions in salaries, benefits and professional services.

The decreased for the nine months period as driven by a onetime expense related to the termination of a lease agreement for office space in San Diego. In addition, there was also a decrease in corporate and legal professional fee. Now with respect to revenues, Q3 2019 total revenues were 4.8 million as compared to 454,000 in Q3, 2018.

For the nine months ended 9/30/2019, total revenues were 5.8 million compared to 2.3 million in Q3 2018. The increase in revenues is mainly due to the recognition BARDA revenue. Turning to the balance sheet, as of September 30th, 2019, we had $16.8 million of cash, 4.6 million in accrued revenue from BARDA and 10.9 million of debt principal.

In December 2018, we amended our debt with Oxford provided additional flexibility by sufficient out our interests only period through April 1st, 2020. Our liabilities increased to 25.6 million for the nine months ended nine months 9/30/2019 compared 18.8 million. This increase is primarily related to the warrants issued for 2019.

Now, I will turn it back..

Thank you, Desiree. Let me just briefly provide some color on key forthcoming milestones. Typically, regarding DocePLUS, the rest of 2019 CMC development is our focus.

Focus specifically on manufacturing validation lives, developing key test methods, finalizing contracts with the PMO providers and on the clinical side, finalizing our phase two protocols with FDA. By mid 2020, we intend to have drug supply, approved Phase 2 trial and be ready to begin enrollment.

Regarding our DocePLUS asset, discussions in partnership with a number of parties, as mentioned are ongoing. Finally, we continue to evaluate new potential and licensing candidates in an ongoing manner. So with that, I'll turn it over to Erica and if there are any questions, floor is now open..

[Operator Instructions] Our first question comes from Emad Samad with WBB..

Mark, you've mentioned potentially finding other assets, now that the Company divested itself of the assets.

Can you give us a little more information on the pipeline expansion plans, the kinds of characteristics you're looking for, the types of assets you're targeting, et cetera? And as a bit of a follow on and twist on that, do you also sort of explain how specifically Texas and the incentive there could affect you, both your current pipeline and help you in your strategies for pipeline expansion as well?.

Thank you for the question. So, we talked about the new assets, things that we're looking for. That was pretty clear in the presentation of what kinds of assets we're looking for. Let me highlights something that I think are most relevant to your question. First of all, we're looking for things that are late preclinical, through early clinical phase.

We don't want early preclinical related asset. We like drugs that have a regulatory advantage or regulatory edge such as 505(b)(2) or we're looking for things that also have a market opportunity that equal to greater than $2 billion. So, we do like drugs that are in the oncology orphan space.

And I'll get -- I'll talk about the oncology related opportunity as it relates to CPRIT in a moment. To cut a close out the question you just asked, I think what's our balance sheet being much stronger. In fact, relative to burn, it's strongest than it's ever been as I've been with the Company.

We've also decreased our structural burn, our core burn, in other words, what we spend every day is down [Audio gap] been before. It gives us enormous flexibility in terms of types of active assets that we can bring in. But I think, bottom line, we still roll that down, we're looking for things near term impact this year.

Now with respect to moving to Texas, and not only is sort of the core, cost structure better than [indiscernible] for obvious reasons. We were relatively confident that these CPRIT funding would be re-upped by the Texas voters this November, which we're happy to see.

That gives us some opportunity with our lead drug DocePLUS perhaps in terms of funding for the core or potentially, noncore indications, in other words, spending that opportunity with that as well as potentially other assets that we might bring in. We can leverage that funding for those assets as well.

So that's definitely something that's on our radar screen, and we think that's a potential advantage for us as a public company in Texas with an oncology focus..

[Operator Instructions] Our next question is from a Sydney Trevor, an Investor..

If you can explain to me, says warranty liability 10,400,000.

What does that mean?.

Hi, Sidney, yes. So, in a recent transaction with FC Wainwright, there were warrants as part of that deal and those [Audio gap] liability..

But why is there a liability, if someone has warrant to buy it?.

There are features in that warrant that, dictated that to be booked as my liability, not as stockholders' equity..

The voice hasn’t coming in good. I mean, someone has a warrant to buy your stock it means that the potential inject money into the Company in the future.

So why would it be a liability?.

We appreciate the question. Thank you..

[Operator Instructions] Your next question is from Ed Woo with Ascendiant Capital. Okay, it looks like Mr. Woo withdrew his question. So, there are no further questions at this time. Dr Hedrick, I'll turn the call back over to you for additional or closing remarks..

Hi, Erica, Thank you. Once again to conclude, Plus Therapeutics emerges from the third with financial strength, focus development strategy and the cost structure to maximize the chances of long-term viability and growth. We're extremely excited about the road ahead and I want to thank you for participating in this call. Please have a good evening..

Thank you. This does conclude today's conference call. Please disconnect your lines at this time and have a wonderful day..