Good afternoon, ladies and gentlemen. Welcome to the Rain Oncology, Inc. Second Quarter 2023 Earnings Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during the call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 10th, 2023. I would now like to turn the conference call over to Mr. Dan Ferry of LifeSci Advisors. Please go ahead.
Thank you, operator, good afternoon, everyone. With me today on the phone is Avanish Vellanki, Chief Executive Officer of Rain Oncology, and Nelson Cabatuan, Acting SVP of Finance. Following the call, Dr. Robert Doebele, Chief Scientific Officer and Chief Medical Officer, will be joining Avanish and Nelson for a short Q&A. Earlier today, Rain issued a news release announcing the company's results for the second quarter of 2023. Copies of this news release and SEC filings can be found in the investors section of our website. Full details on updates from the quarter can be found in our news release and 10-Q issued today. Before we begin, I would like to remind you that statements made during this conference call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based upon Rain's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties as described in Rain's most recent quarterly reports on Form 10-Q and annual report on Form 10-K, filed with the Securities and Exchange Commission and other SEC filings. All forward-looking statements made during this conference call are based on management's assumptions and estimates as of today, August 10, 2023. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after today, except as required by law. With that, I'd like to turn the call over to Avanish Vellanki, CEO of Rain Oncology. Avanish?
Thank you, Dan, and thanks to everyone for joining us for our second quarter 2023 earnings call. The second quarter was an important time at Rain Oncology as we provided the top-line data readout on our Phase 3 global registrational trial for milademetan, our oral small molecule inhibitor of the MDM2 p53 complex in dedifferentiated liposarcoma, or DDLPS. We reported that the Phase 3 trial for milademetan did not meet its primary endpoint. We also announced that we would suspend the enrollment of our second clinical study, the MANTRA-2 study. We have begun the process of closing down MANTRA-2. Despite what we feel is very clear activity from the MANTRA-2 study, we do not feel its monotherapy activity rises to a level sufficient for registrational purposes, and closure of this study will ensure we remain judicious with our use of capital.
We hope to present final data from the MANTRA phase three study and updated data from the MANTRA-2 phase two study of milademetan in MDM2-amplified solid tumor patients in the fourth quarter of this year. We note the MANTRA-2 presentation will reflect a significant number of additional patients beyond what was presented last year. We continue to believe that reactivating p53 is an important therapeutic strategy to add to the armamentarium of anticancer therapies. At Rain, we're proud that we were able to move as quickly as we did to test the hypothesis in a robust trial, as we did for a global phase 3 study, despite the results not being what we had hoped.
Given these top-line data for milademetan, we determined that Rain would be best positioned to achieve its business objectives by taking action to streamline operations, reprioritize its activities, and implement certain cost-saving measures, including a reduction in force. We were able to implement those actions very quickly, resulting in substantial moderation of cash burn that will be apparent in the third quarter and beyond. Looking forward, we believe there are exciting opportunities ahead. It is no surprise that the challenging climate in biotech over the last few years has resulted in a number of interesting programs, companies, and technologies being underfinanced and often without strong cross-departmental leadership. Our corporate development team has been rapidly reviewing an extraordinary number of actionable opportunities to license or acquire clinical-stage programs and technologies that may allow Rain to continue to try to make a difference for cancer patients.
Although we won't comment on programs under diligence, there are a number of opportunities that could be a great fit for Rain, with fascinating technology and novel therapeutic strategies for patients. We will update investors when appropriate on how we intend to push forward to add value for our shareholders. Let me now hand it over to Nelson Cabatuan to discuss our financials. Nelson?
Thank you, Avanish. Before I proceed in providing updates for the financial results for the three months ended June 30, 2023, I would like to invite you to review our quarterly report and Form 10-Q filed today for more details. For the three months ended June 30, 2023, Rain reported a net loss of $22.1 million, as compared to a net loss of $17.6 million for the same period in 2022. The increase was primarily related to clinical trial costs for our phase three MANTRA trial and phase two tumor-agnostic basket trial, MANTRA-2, as well as personal costs.
General and administrative expenses were $5.4 million for the three months ended June 30, 2023, as compared to $3.5 million for the same period in 2022. The increase was primarily due to higher costs associated with launch preparation in anticipation to commercial launch milademetan liposarcoma, personnel, legal, outside consulting, and accounting and audit fees. In May 2023, we announced a reduction in our workforce in connection with the reprioritization of the company's clinical strategy, designed to optimize company resources. We recorded restructuring charges of $2.8 million in the statements of operations for the three months ended June 30, 2023, comprised of $2.8 million cash severance, bonus, and related employee benefits and taxes of affected employees, as well as $37,000 of stock-based compensation expense related to option modification.
Total non-cash stock-based compensation expense were approximately $0.8 million for the three months ended June 30, 2023, as compared to $1.4 million for the same period in 2022. As of June 30, 2023, Rain had $86.3 million in cash, cash equivalents and short-term investments. Rain anticipates that its quarter-end cash position will provide runway into year-end 2026, in the absence of a corporate transaction and further financing. As of June 30, 2023, Rain had approximately 36.4 million shares of common stock outstanding. Let us now turn it back to Avanish.
Thanks, Nelson. With that, we'll turn it over to the operator to take any questions. Operator?
Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a 3-tone prompt acknowledging your request, and your questions will be pulled in the order that they are received. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Michael Schmidt from Guggenheim. Please go ahead.
Hey, good afternoon. It's Yige on for Michael. Thanks for taking our questions. Maybe a quick one on the potential new opportunities you guys are reviewing. I'm going to show you, I know you can't talk much on it, but maybe on a high level, can you talk about what modality are you more interested at this moment?
Hi, Yige. Thanks for the question. At a very high level, we're trying to be opportunistic across a multitude of opportunities. I think we have certainly been approached with a variety of precision oncology strategies, but across both small molecule and large molecule approaches. That's, that's what we have certainly been, been reviewing so far, but I, I won't comment more broadly than that.
Okay. That's very helpful. Thank you.
Thank you. Your next question comes from Yigal from Citi. Please go ahead.
Hi, guys. This is Ashiq Mubarack on Yigal. Thanks for taking my questions. I guess I wanted to ask about the future of milademetan at this point. Is it more or less on the shelf at this point for the foreseeable future, or are there plans in the background that you're thinking about? My second question was, I recall in the past you had a RAD52 asset, which you had in development. I'm just wondering if you have any thoughts on that asset and if maybe there's a world in which you reactivate that program. Thanks.
Hi, Ashiq. Thanks. I think we can be brief here. There are no plans at the current time for milademetan, and there's certainly no intention for deploying capital to support milademetan today. Same for the RAD52 program. We are not, we're not moving that forward, and we stopped all investment over a year ago.
Okay, understood. Last question from me. I guess, what's embedded in your cash runway guidance at this point? It doesn't sound like it includes any considerations for any potential deal you might do. Just curious what, what's in there right now.
Sure. I'll start that, and, and then I'll ask Nelson to, to follow up with any additional detail. In the, in the cash runway guidance, we are certainly reflecting the closure of the existing studies that we had alluded to, and maintenance of a, of a lean organization that we think is sufficient for, for developing multiple earlier stage clinical programs. Nelson, do you have any additional comments?
Yeah, I just want to highlight that, you know, when we speak about cash runway, through the end of 2026, it does not incorporate additional corporate transaction as well as additional financing. I just want to highlight that in the second half of this year, 2023, we will see a significant reduction in cash runway.
Got it. Thanks very much.
Thank you. Your next question comes from Joe Catanzaro from Piper Sandler. Please go ahead.
Hey, guys. I just had one quick question actually on milademetan, though I appreciate that you won't be moving forward with that program at all. I'm wondering if, since you've had more time to digest the MANTRA trial, whether you've been able to sort of hone in on, you know, any potential reasons as to why milademetan underperformed, you know, the previous data you had generated in DDLPS. Thanks.
Hi, Joe. Thanks for the question. This is Bob Doebele. You know, I think for that question, we'll refer you to our upcoming, planned presentations in the fourth quarter, at a medical conference.
Okay, got it. Thank you.
Thank you. Your next question comes from Sam Slutsky from LifeSci Capital. Please go ahead.
Hey, everyone, this is Anshul on for Sam. Thanks for taking our question. One question I had is, you know, basically, as you're looking into these licensing and bringing other assets, is there sort of a sweet spot of deals you're looking for in terms of stage of development or deal structure and so forth?
We'll share... first of all, thanks for the question, Sam or Anshul. I think what we would comment there is, we want to be able to leverage our clinical organization. Again, I think the expertise that, that the team demonstrated through the MANTRA, MANTRA-2 studies, we think is exemplary. So clinical stage is, is an important attribute, of where we're looking. ... and I'll leave the comments there.
Great. Thank you. That makes sense.
Thank you. Your next question comes from Graig Suvannavejh from Mizuho Securities. Please go ahead.
For Greg, just a question from me. How do you weigh the pluses and minuses between starting essentially a new, almost like a new type of Rain Oncology with a new asset, versus other corporate options, like a potential reverse merger or with some public or private company?
Hi, Lantika. Thanks for the question. It's a great question. I- the way that we approach that is to take a look at the attractiveness of the options that we are presented, the options that we find, and, and the actionability of those opportunities. If we can find an avenue that we think we can add value to, that certainly becomes more attractive than one of the other alternatives. We are certainly looking at all of those avenues, and in the absence of, of, of an investable option with our existing cash resources and, and even our personnel, then other options become available. At the current time, I think with my comments on the call, this is a unique time in biotech where, where there's a multitude of opportunities that, that are available to companies in our current position.
Got it. Thank you.
Thank you. Ladies and gentlemen, just as a reminder, should you have a question, please press Star followed by the 1. Your next question comes from Mitchell Kapoor from HCW. Please go ahead.
Hi, team. Hope you're doing well, thanks for taking the questions. First of all, I just wanted to ask about the, just broadly, the options on the table. Obviously, you mentioned, a new precision oncology therapy, a new technology platform. I wanted to learn a little bit more about what you're thinking about a technology platform. What could that look like? What, broadly does that mean? Then, you know, how many assets might you in-license? Is there kind of a limit there? Then is there a hope for how long this could take?
All great questions, Mitchell. Thanks for the question. We're, we're not gonna respond in any meaningful depth with, to, to any of those, those questions. They, they... We want to leave it sufficiently broad at this point until they reach a point where it, like, warrants further articulation to the, to the public. We'll, we'll provide those commentaries when we can, but now is not the appropriate time to provide that color.
Okay, understood. Maybe this is a question for Nelson. I just wanted to ask, a finance question. As expenses, you know, have changed to kind of moderate the cash burn, what kind of broadly could we see for the next few quarters in terms of SG&A and R&D, in the absence of any kind of transaction?
Thanks, Mitchell. In terms of the cash burn expense in Q3 onwards is going to be significantly, you know, lower compared to what you've seen in the first two quarters of this year and the prior year. You know, I, I don't want to go through the details of this, but you'd expect a runaway as really low compared to the runaway in the $20 million in the first two quarters of this year.
Okay, great. Thank you, guys.
Thank you.
Thank you. There are no further questions at this time. Avanish, you may continue your conference.
Thank you, operator. We look forward to keeping everyone abreast of our plans once a forward plan has been solidified. Thank you.
Ladies and gentlemen, this concludes your conference call for today. We thank you very much for participating and ask that you please disconnect your lines. Have a great day. Goodbye.