Plus Therapeutics, Inc. (PSTV) on Q1 2022 Results - Earnings Call Transcript
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics First Quarter 2022 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your questions following the presentation. [Operator Instructions]. Before we begin, we want to advice 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 reports on Form 10-K and quarterly reports 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. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics’ President and Chief Executive Officer. Sir, you may begin. Marc Hedrick: Thank you very much, Gretchen. Good afternoon, everyone. Thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2022 first quarter financial results. Joining me on the call today is Dr. Norman LaFrance, our Chief Medical Officer; and Andrew Sims, our Chief Financial Officer. I’ll begin the call by reviewing our recent corporate and clinical progress before turning the call over to Norman who will provide commentary on our clinical progress for 2022. And then following Norman, Andrew will review our financials. Despite the short interval since we last reported quarterly results, I continue to be very pleased with our overall progress as we work towards several meaningful catalysts and milestones throughout 2022. During the first quarter, we began enrolling patients in our ReSPECT-LM trial of 186RNL in patients with leptomeningeal metastases, or LM. The trial is a multi-center Phase 1/2a dose escalation study to determine the MTD, maximum tolerated dose, and MFD and safety and efficacy of RNL186 in LM. LM is a typically fatal complication associated with advanced cancers that affect the fluid line structures of the central nervous system or leptomeninges. Median survival with current aggressive treatment is about three to eight-and-a-half months depending on which primary tumor caused the LM and the one and two-year survival rate is 7% and 3%, respectively. Survival without treatment is only a few weeks. LM is diagnosed in approximately 5% of cancers with 20% of patients at autopsy. U.S. annual incidence is about 110,000 patients and growing, and the prevalence of neurologic impairment in these patients is about 50%. Most common tumors giving rise to LM are breast cancer, lung cancer, melanoma, and gastrointestinal malignancies. There are no FDA-approved therapies and standard treatment that is employed includes external beam radiation therapy to the affected sites, followed by chemotherapy given either orally or intravenously or even directly into the cerebrospinal fluid. Although we can only draw limited conclusions from our initial experience, we’re very pleased with the outcome and the first patient receiving a single administration of 186RNL. Specifically, we found that the drug circulated rapidly throughout the cerebrospinal fluid space. We found that radiation was released through leptomeninges and CSF for at least one week after treatment. The patient exhibited no adverse events, and 186RNL reduced the circulating tumor cell counts by over 90% at two weeks after treatment. This is really about as good as it gets in a first-in-man -- first patient in a Phase 1 trial, so we’re very excited about this very preliminary result. We now have two active sites screening LM patients, with another six sites being onboarded, as we speak. We’re on track to have at least the first two cohorts completed by the end of 2022, and hopefully a bit more than that. As to our ongoing clinical development program for 186RNL in recurrent glioblastoma, we have a number of updates. First, as a reminder, that trial is a dual Phase 1/2a multi-center sequential cohort open label volume and dose escalation study for recurrent glioblastoma or GBM. The trial is currently funded to a significant degree, as many of you may know by the U.S. National Institutes of Health and NCI. Glioblastoma affects about 13,000 patients annually in the U.S. and about the same number of patients in the EU, and it’s the most common and lethal form of brain cancer and treatment of this devastating disease remains a very significant unmet medical challenge. In terms of the clinical data, 23 patients have been treated and 186RNL appears to be safe and well tolerated, and this data presented most recently back in March can be found in detail on our website and that’s accessible to anyone. In summary, no dose limiting toxicities have been observed. Generally mild-to-moderate AEs have been seen in seven SAEs, all grade three or lower and most are not deem to be RNL-related. In terms of drug delivery, we are now reliably able to deliver over 100 gray of absorbed radiation dose to tumors, which is our empirically-determined minimal dose threshold of adequate absorbed radiation, and we can get well over 80% and we think 90% is achievable in terms of reliable dose delivery of 100 gray. Finally, we have observed both the median and mean overall survival signal that exceeds the best published rate for monotherapy bevacizumab. Based on this data, I’d like to just explain our big picture plan. We plan to bifurcate the current GBM clinical development plan based on tumor size. So for tumors of approximately 15 to 20 CCs in volume, which represents about one-half to about two-thirds of all recurrent glioblastomas, we plan to use the cohort six dose of 22.3 millicuries and 8.8 CCs of volume as our recommended first Phase 2 registrational dose. For tumors of larger size potentially requiring greater radiation dosages and treatment volumes, we intend to continue our Phase 1/2 dose escalation trial to establish the upper limits of dose and potential for DLTs or dose-limiting toxicities. In 2022, for GBM, we have two key regulatory milestones. We have already in 2022 submitted and asked for the first of two FDA meetings, specifically a Type C CMC meeting to determine the sufficiency of our CMC package for GMP 186RNL to support a registrational trial. And then relatedly to the CMC development, our team continues to make excellent progress in our drug scale-up and manufacturing activities. Specifically, the company has finalized key RNL drug development and characterization activities for GMP manufacturing to support our planned Phase 2 registrational trial and commercialization activities thereafter. The company remains on track to deliver GMP RNL by mid-2022. The second FDA meeting is a clinically focused meeting planned for Q2, Q3 to solicit FDA feedback on our planned Phase 2 registrational trial using our recommended Phase 2 dose as mentioned 22.3 millicuries and a little less than 9 CCs of volume. Also during Q1, we completed another key milestone. Specifically, we successfully completed the preliminary evaluation phase and entered into a broad partnership with Medidata to use its Synthetic Control Arm platform and Real World data as the comparators for our glioblastoma trials. The primary goal of this partnership is to develop an FDA compliant control group of patients identical to the patients thus far treated in our Phase 1/2a trial and in the planned Phase 2 registrational trial. That data will be used to support our planned end-of--phase meeting with the FDA and proposed Phase 2 registrational trial. More generally, Synthetic Control Arm or SCA platform facilitates the use of historical clinical trial data in a manner that has been favorably received by the FDA. These SCAs reduce the time and cost associated with complex clinical trials in rare diseases such as glioblastoma, allowing for fewer patients to be exposed to placebos or existing standard of care treatments that might not be effective for them. It offers them greater access to potentially life extending therapies. And although a recent advancement, the FDA has already agreed to recognize a Phase 3 clinical design incorporating an SCA in a registrational randomized control arm for recurrent glioblastoma. Besides initiating our Phase 2 registrational trial with RNL and recurrent GBM, as I mentioned above, we also continued enrollment in our Phase 1/2a dose escalation GBM trial, and that will continue. Finally, this quarter, we intend to open a Phase 2 multi-dosing extension trial of RNL in recurrent glioblastoma. As you know, if you follow the company, glioblastoma is notoriously difficult to cure and recurrent disease is the norm. This extension trial will give us important information about the utility of multiple potential doses of 186RNL in the overall treatment paradigm for these patients. The goal of the trial is to determine the safety, feasibility and potential efficacy of using additional doses of RNA in patients following the initial single administration of RNL as we have done previously in the Phase 1/2a trial. This is really important to our big dream. One day, if not curing GBM, returning it into a chronic disease in which we help patients live with brain cancer. Finally, in Q1, we announced our license of a novel radioembolic microparticle technology from the University of Texas. As we’ve said many times, we believe the future of cancer therapy is precise targeting of tumors with the most potent cancer killing agents while minimizing damage to normal tissues. This transaction builds upon our existing Rhenium NanoLiposome technology. And with this new technology, we can with a resorbable biomaterial embolic technology, coupled with a highly potent radiotherapeutic isotope, target almost any solid organ tumor in the body using the standard interventional radiologic means and leverage the breadth of the human vascular system. Rhenium-188, not 186 but Rhenium-188 NanoLiposome Biodegradable Alginate Microspheres we call 188 RNL-BAM or just BAM for short, is a next generation fully resorbable technology that solves many of the existing problems with current radioembolic technology that’s been out there for many decades. The BAM technology incorporates Rhenium-188 isotope for use as the radiotherapeutic source with a different admission criteria and characteristics than 186. It emits a high energy beta particle with a half life of only about 17 hours or longer path length of over 3 millimeters. It also produces gamma energy that we can use for high quality real-time imaging of the BAM construct in the organ. The company will initially focus on developing the BAM technology as a next-generation radioembolization therapy for liver cancer in which BAM blocks the hepatic artery segments that supply blood to the malignant tumor while also providing radiotherapy by directly irradiating the tumor. Liver cancer is a rare disease with an increasing annual incidence and a five-year overall survival rate of only about 20%. The global opportunity for localized embolization, chemoembolization, radioembolization for primary and secondary cancer in the liver is about 1.3 billion opportunity globally. We have three objectives in 2022 for our BAM program; the technology cancer phase, which has been completed and we are on track to complete key CMC feasibility studies, IND-enabling preclinical studies and an FDA pre-IND meeting this year. So with that, I’ll turn the call over to Dr. LaFrance. Norman? Norman LaFrance: Thank you, Marc. Following on Marc’s comments, in 2022 in our GBM clinical development plan to extend the existing ReSPECT-GBM trial and program into a strong development plan; first and most importantly is ReSPECT-GBM Phase 2 registrational trial using the cohort six recommended Phase 2 dose that Marc mentioned earlier. The company and its key advisors believe the safety profile and the clinical efficacy signal of a potential doubling of overall survival in patients with the absorb radiation doses greater than 100 gray has the potential to be an approvable NDA for recurrent GBM. Pending the outcome of our planned FDA meetings -- our two planned FDA meetings, we will initiate the first sites for that registrational trial by year-end. In the interim, we will be executing our clinical operations plan to be ready to achieve this milestone. Second is the continuation of the Phase 2 dose escalation trial supported by NCI for larger tumors. And third is a Phase 2 multi-dose extension trial for patients previously treated and patients that will be treated in the two trials just mentioned. In terms of GBM data presentations for 2022, we plan to provide key GBM clinical updates at the following medical meetings: the Society of Nuclear Medicine Meeting this June in Vancouver; the SNOW ASCO-sponsored Clinical Trials & Brain Mets Meeting in Toronto in August; EANO and ESMO in Vienna and Paris, respectively, both in September; and potentially EANM in Barcelona in October; and the SNOW Annual Meeting in Tampa in November. Additionally, I’ll be participating at the Medidata Synthetic Control Arm Focused Industry Roundtable next week on April 26. As Marc mentioned, our clinical team and investigators were very pleased with the first patient outcome in the ReSPECT-LM trial. Treating the first patient of any new condition with an investigational drug is always an exciting, but with many unknown. A few comments. The feedback from one of the very experienced investigators in the trial was that they had never seen such a clinical response in the first patient in the Phase 1 first-in-man trial. The delivery of RNL in this trial is very simple and straightforward with five-minute outpatient procedure through an existing Ommaya reservoir. There are substantial existing biomarkers such as tumor cell count, which we are measuring CSF, which is simple to obtain in these patients. There are also a number of additional exploratory biomarkers we are looking at as well. Additionally, Plus will perform several preclinical studies to evaluate additional LM treatment paradigms with 186RNL, specifically multi-dose administrations and combination treatment with immunotherapy such as PARP and checkpoint inhibitors, both known to be synergistic with radiation. Despite impressive initial results at the first dose with a single RNL monotherapy, Plus believes optimal patient benefit can be amplified with multiple RNL doses and/or combination therapies. For our current trial, I’m optimistic enrollment will proceed rapidly based on the significant unmet medical need, very well tolerated and easy dose administration and the enthusiastic responses received from investigative clinical sites, along with other oncologists once they hear of our trial. Developing preliminary clinical data and medical meeting presentations planned for LM in 2022 were presented a few minutes ago. And finally, RNL is being developed for pediatric brain cancer. The key goal here is to obtain FDA IND approval to investigate the use of 186RNL for children with brain cancer and we are working with our lead site, Lurie Children’s Hospital in Chicago and are on track to hit this milestone later this year. Next, I’ll turn the floor to our CFO, Andrew Sims, who will review financials. Over to you, Andrew. Andrew Sims: Thank you, Norman, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the 2022 first quarter ended March 31, 2022. As of March 31, 2022, cash and cash equivalents were $21.2 million compared to $18.4 million as of December 31, 2021. This represents 18 to 24 months of cash on hand. Cash used in operations for the three months ended March 31, 2022 was $3.9 million compared to $2 million in the first quarter of 2021. The main changes between 2021 and 2022 as follows. Total operating expenses for the first quarter 2022 were $3.9 million compared to total operating expenses of $2.5 million for the first quarter 2021. Approximately $0.7 million of this increase is due to research and development expenses and $0.6 million is due to legal, intellectual property and professional fees in 2022. Interest expense decreased from 247,000 in the first quarter of 2021 to 198,000 in the first quarter of 2022. This decreased cost reflects the principal paydown that commenced in November 2021 on the Oxford debt. Net loss for the first quarter of ‘22 was $4.1 million, or $0.19 per share, compared to a net loss of $2.7 million, or $0.33 per share for the first quarter of 2021. And now, I’ll turn it back to you, Marc. Marc Hedrick: Great. Thank you, Andrew. Before we move on to Q&A, let me just summarize key milestones anticipated for 2022. First, with respect to the 186RNL GBM trial, we’re planning for a clinically focused FDA meeting mid-year 2022 to propose a Phase 2 registrational clinical trial and trial design using the cohort six 8.8/22.3 millicuries dose, as detailed earlier. We expect to initiate the Phase 2 towards the end of the year. We anticipate the CMC focused FDA meeting in the second quarter of 2022 or perhaps the beginning of the third quarter. And to clarify, that’s to resolve any open CMC issues that may exist at that time. Regarding drug availability, very important that we have GMP drug availability to proceed with the trial. We’re on track with CMC activities for RNL. We plan to complete those and have that GMP Phase 3 ready drug supply available by mid-2022. Also in 2022, we’ll report Phase 1/2 data and enrollment updates in an ongoing manner, as Norman mentioned, for the ReSPECT-LM trial and our goal is to complete enrollment in at least initial two cohorts this year. Regarding the pediatric brain tumor trial, we plan to get our IND submitted relatively soon this year and be able to initiate that trial towards the end of the year. Regarding our recently acquired rights to the 188RNL-BAM radioembolization therapy technology, we plan to complete key CMC and FDA IND-enabling studies and a pre-IND meeting also this year. So at that point, I think we’ll move to Q&A, and I’ll turn the call over to Gretchen. Gretchen, back to you. Operator: [Operator Instructions]. Thank you. Our first question is coming from Ed Woo from Ascendiant. Your line is open. Operator: [Operator Instructions]. We’ll take our next question from Sean Lee at H.C. Wainwright. Operator: [Operator Instructions]. And it appears we have no further questions at this time. I will now turn the floor back over to Andrew Sims. Operator: No further questions over the phone. Marc Hedrick: Thanks. Thank you, Gretchen, and Andrew. So just to close, I want to say thank you to everybody that joined us on the call and for those that are listening on the recorded version. Thank you. And on behalf of the Board, I just like to thank once again our employees and the broader members of our team, our consultants and so forth, the physicians that we work with and of course the patients that trust us. Thank you very much for your participation and have a good evening. Operator: Thank you. This does conclude today’s conference call. Please disconnect your line at this time, and have a wonderful day.
Recent Market Movements Highlight Notable Stock Performances
- Plus Therapeutics, Inc. (NASDAQ:PSTV) saw a 177.57% increase in stock price, likely due to FDA's conditional acceptance of REYOBIQ™.
- Impact BioMedical Inc. (NYSE American:IBO) experienced a 170.06% surge, possibly reflecting investor optimism from its participation in The Microcap Conference 2025.
- SAG Holdings Ltd (NASDAQ:SAG) had a 67.41% rise in stock price following the successful closing of its initial public offering.
In recent market movements, several companies have shown significant price changes, capturing the attention of investors and market analysts alike. Among these, Plus Therapeutics, Inc. (NASDAQ:PSTV), Impact BioMedical Inc. (NYSE American:IBO), Rain Enhancement Technologies Holdco, Inc. (RAINW), Osisko Development Corp. Warrant expiring 5/27/2027 (ODVWZ), and SAG Holdings Ltd (NASDAQ:SAG) stand out due to their notable performance.
Plus Therapeutics, Inc. (NASDAQ:PSTV) experienced a remarkable surge, with its price jumping by 177.57% to $1.4184. This biotechnology firm focuses on developing treatments for cancer and other diseases. The significant price movement could be attributed to the U.S. Food and Drug Administration's conditional acceptance of the proprietary name REYOBIQ™ for its lead drug candidate, as highlighted by the company. This development is a positive step in the clinical investigation for Leptomeningeal Metastases and Recurrent Glioblastoma.
Impact BioMedical Inc. (IBO) also saw a substantial increase, with its stock price rising by 170.06% to $1.4313. The company engages in the discovery and development of specialty biopharmaceuticals and consumer healthcare products. The surge might reflect investor optimism about the company's participation in The Microcap Conference 2025, where CEO Frank D. Heuszel will present. This event is a key gathering for growth-focused companies and investors.
Rain Enhancement Technologies Holdco, Inc. (RAINW) witnessed an 83.03% increase in its stock price to $0.11. Although specific catalysts for this increase are not provided, such movements often result from positive news about technological advancements or successful pilot projects. The company focuses on ionization rainfall generation technology, which could be gaining attention for its innovative approach.
SAG Holdings Ltd (NASDAQ:SAG) experienced a 67.41% increase in its stock price to $1.13. This movement could be related to the successful closing of its initial public offering, raising $7 million through the sale of 875,000 ordinary shares at $8.00 per share. The company distributes automotive and industrial spare parts, and this financial boost may indicate strong growth prospects.
These companies, spanning diverse industries from biotechnology to gold development and automotive spare parts distribution, have shown impressive market performances. Their recent gains could be attributed to a variety of factors, including successful clinical trials, technological advancements, favorable market conditions, strategic partnerships, or financial growth. Investors and analysts will likely keep a close eye on these companies for further developments that could influence their stock prices.
Plus Therapeutics, Inc. (NASDAQ:PSTV) Sees Surge After FDA Orphan Drug Designation
- Plus Therapeutics, Inc. (NASDAQ:PSTV) stock surged by 311.4% following the FDA's Orphan Drug Designation for its lead radiotherapeutic candidate.
- The FDA's designation provides benefits like seven years of market exclusivity, tax credits, and fee exemptions, crucial for addressing the unmet medical need for treating leptomeningeal metastases.
- Despite financial challenges, including a negative price-to-earnings (P/E) ratio of -0.96 and a current ratio of 0.44, the recent FDA designation offers a promising outlook for PSTV's future.
Plus Therapeutics, Inc. (NASDAQ:PSTV) is a clinical-stage pharmaceutical company focused on developing innovative treatments for rare diseases. The company is set to release its quarterly earnings on March 11, 2025, with Wall Street estimating an earnings per share of -$0.51 and projected revenue of approximately $1.19 million. Despite these figures, recent developments have significantly impacted PSTV's stock performance.
On March 6, PSTV's stock price surged by 311.4% following the FDA's Orphan Drug Designation for its lead radiotherapeutic candidate, rhenium (186Re) obisbemeda. This drug targets leptomeningeal metastases in lung cancer patients, a rare and challenging condition. The FDA's designation provides benefits like seven years of market exclusivity, tax credits, and fee exemptions, as highlighted by the FDA.
The Orphan Drug Designation is crucial for Plus Therapeutics as it addresses the unmet medical need for treating leptomeningeal metastases. This condition involves the spread of cancer to the cerebrospinal fluid, posing significant treatment challenges. The designation, along with a previously granted Fast Track designation, marks a significant milestone for the company, as emphasized by Mike Rosol, Ph.D., the Chief Development Officer.
Despite the positive news, PSTV faces financial challenges. The company has a negative price-to-earnings (P/E) ratio of -0.96, indicating a lack of profitability. The price-to-sales ratio is 2.17, suggesting investors pay $2.17 for every dollar of sales. Additionally, the enterprise value to sales ratio is 2.68, providing insight into the company's valuation relative to its revenue.
PSTV's financial metrics also highlight potential liquidity concerns. The current ratio is 0.44, indicating the company may struggle to cover short-term liabilities with its short-term assets. The negative debt-to-equity ratio of -0.66 suggests a unique capital structure or financial strategy. Despite these challenges, the recent FDA designation offers a promising outlook for the company's future.
Plus Therapeutics, Inc. Gears Up for Q1 2024 Earnings Release
- PSTV is set to release its EPS estimate of -$0.25 and expected revenue of approximately $1.69 million for the quarter.
- Previous quarter performance showcased revenue of $1.31 million and a gross profit of $1.13 million.
- Significant improvement in EPS from -$0.84 to an estimated -$0.25, indicating a potential positive financial trajectory.
Plus Therapeutics, Inc. (NASDAQ:PSTV), a clinical-stage pharmaceutical company, is gearing up to share its quarterly earnings on Thursday, May 16, 2024, after the market closes. Specializing in the development of targeted radiotherapeutics for central nervous system cancers, PSTV's financial performance is closely watched by investors and analysts alike. The anticipation builds around the earnings per share (EPS) forecasted at -$0.25 and expected revenue of approximately $1.69 million for the quarter.
The upcoming earnings report follows a period where PSTV reported revenue of $1.31 million with a gross profit of $1.13 million. This financial snapshot indicates a company that, despite its challenges, is managing to generate revenue and maintain a certain level of gross profit. The cost of revenue standing at $182,000 for the same period further highlights the company's ability to control its production or service delivery costs, an essential factor for its financial health.
However, PSTV's financial journey is not without its hurdles. The company faced a significant net income loss of -$3.81 million and an operating income loss of -$3.86 million. These figures point to the challenges PSTV encounters in balancing its operational costs against its revenue. The reported EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) of -$3.68 million further underscores the financial strains the company is experiencing, reflecting broader operational challenges beyond mere net income figures.
Moreover, the earnings per share (EPS) for the quarter was reported at -$0.84, a critical metric for investors as it provides a direct insight into the company's profitability on a per-share basis. This figure is particularly significant when compared to the upcoming earnings forecast, which estimates the EPS to be -$0.25. The improvement in EPS, if realized, could signal a positive shift in PSTV's financial trajectory, offering a glimmer of hope for stakeholders looking for signs of recovery and growth.
As PSTV prepares to unveil its first quarter financial results for 2024, the management team plans to host a conference call and webcast to discuss the outcomes and provide updates on the company's operations. This event is not only a platform for financial disclosures but also an opportunity for PSTV to articulate its strategic direction and operational updates, offering a comprehensive view of its path forward in the competitive pharmaceutical landscape.
