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8/13/2024
future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risk and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of the collector. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the cautionary notes set forth in the press release, which is available on the investor relations portion of the company's website, as well as the risk factors set forth in selectors annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selector. Mr. Caruso, please go ahead.
Thank you, Operator, and good morning, everyone. It is my pleasure to be here with you provide a corporate update for our second quarter of 2024. With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jared Longcore, Chief Operating Officer, Shane Lee, Chief Commercial Officer, and Chad Colleen, Chief Financial Officer. I will begin today with a brief recap of our progress over the past quarter and discuss anticipated near-term milestones. I will then ask Chad to provide an update on our financials. Andre will follow with additional insights regarding our Clover Wham pivotal study, followed by Jared, who will provide an operations update on the regulatory front and manufacturing. Finally, Shane will review our commercial progress. We will then open the call for Q&A. As you are likely aware, on July 23rd, we announced our full data results from our pivotal trial in WM, which were truly impressive and maintained the potential to meaningfully improve upon the current standard of care in WM. Andre will talk to you the quality of the data in an extremely challenging patient population. However, I'd like to emphasize to everyone that the patients in the clinical trial were by far the most refractory ever studied in this indication, with iaprofessine I-131 representing the fifth median line treatment. It is therefore impressive to observe comparable results obtained in Clover Wham to those reported in first and second line with other treatments. Of course, our near-term organizational focus remains locked on Iopopacin's WM regulatory and commercial objectives. Iopopacin has also demonstrated utility in other hematologic indications, such as relapsed refractory multiple myeloma and DLBCL. And clinical development is ongoing in our Phase 1b for pediatric high-grade gliomas. As you may recall, we initiated and enrolled the first patient in this Phase 1b study earlier this year. With iapofasine's ability to cross the blood-brain barrier, we remain excited about the potential it may provide in this high unmet medical need treatment setting. We plan to provide a study update in the second half of this year. Beyond iaproposine, our PDC platform continues to serve as the backbone to our radiotherapeutic franchise. We have now successfully conjugated nearly all available isotopes with our platform, including beta, OG, and alpha emitters, and have completed extensive preclinical proof of concept work in each area. We are currently advancing one of our actinium-based conjugates through IND enabling studies in preparation for a phase one in solid tumors. We continue to focus on completing the work for our NDA filing with plans to submit our filing to the FDA in the fourth quarter. Assuming we are granted priority review associated with our fast track designation, we expect a six month review. Finally, prior to turning the call to Chad for greater detail, I would like to emphasize that the 8K filed this past Friday, indicating that we are in process of restating our recent historical financial statements, although unfortunate, does not impact cash or cash burn, and the changes to historical earnings will all be non-operating and non-cash. Chad?
Thank you, Jim. Our cash and cash equivalence balance as of June 30, 2024, $25.9 million compared to $9.6 million as of December 31, 2023. Note that at the end of the first quarter, we had a cash balance of $40 million, resulting in the net cash used in operating activities during the second quarter being approximately $14.1 million. In addition to the cash on hand at the end of June, in July, nearly all of the investors from the September 2023 financing exercised their tranche fee warrants at a reduced as converted common stock price of $2.52 per share. Those investors who exercised their tranche fee warrants also received new warrants as part of the transaction, which generated gross upfront proceeds of approximately $19.4 million before customary expenses and fees. The company believes its cash on hand, inclusive of the July warrant exercised proceeds, adequate to fund budgeted operations into the second quarter of 2025. The three warrant tranches issued last month provide potential additional funding based upon their respective expiration dates, which occur with a first tranche of approximately $17 million after we receive a PDUFA date from the FDA. a second tranche of approximately $32.9 million after we receive approval of Hypopathy in I-131 from the FDA, and a third tranche of approximately $23.5 million after the first quarter in which we generate $10 million in revenue from Hypopathy in I-131. Assuming our discussions with the FDA go as planned, this funding would get SelectR to the point where we will be cash flow positive. Turning back to the second quarter, R&D expense was approximately $8.2 million compared to $6.3 million in the second quarter of 2023. The increase is largely driven by the timing of expenditures for our WM pivotal trial to support patients' final visits and perform the extensive analytical work necessary to complete the NDA submission. We have also continued investing substantially in our product sourcing, manufacturing, and logistics infrastructure by developing multiple sources for each aspect of Hypopathy production. G&A expense for the second quarter of 2024 was $6.4 million compared to $2.0 million last year. This incremental spend is focused on the establishment of the necessary commercialization capabilities to support product sales upon our expected 2025 NDA approval. As Jim stated earlier, we filed an AK with the SEC indicating that we are in the process of restating our historical financial statements for fiscal years 2022 and 2023 in the first quarter of this year. This was precipitated by a reevaluation of the accounting for the warrants issued in October 2022. At the time they were issued, the warrants were classified as equity. This was based on our assessment, which was supported by third-party expert evaluation. We now believe they should be classified as liabilities, necessitating a revision in our historical reporting. While previously reported earnings will be modified, the restatement does not impact cash or cash burn, and the changes to historical earnings will all be non-operating and non-cash. The work required to restate the historical results is in process and must be completed before we can file Section 10Q. which delays the 10Q filing. We're performing this work as rapidly as possible, and while we do not have a definite target date for completion, we expect it will take approximately six weeks. With that, I will now turn the call over to Andre.
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