Spectrum Pharmaceuticals, Inc.

Thank you for standing by. And welcome to Spectrum Pharmaceuticals' first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to Mr. Michael Grabo, Senior Vice President of Corporate Strategy and Operations. Please go ahead, sir.

Thank you, operator. Good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceutical's first quarter 2022 financial results conference call. Our first quarter financial results press release was sent out earlier this afternoon. and is available on our website at www.sppirx.com. Joining me on the call today from Spectrum Pharmaceuticals will be Tom Riga, President and CEO, and Dr. Francois Lebel, Chief Medical Officer. Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements they will make this afternoon. These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in the future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. With that, let me hand the call over to Tom Riga, CEO of Spectrum.

Good afternoon, and thank you for joining us on the call today. The year is off to a strong start as we anticipate FDA approvals later this year for our late-stage assets, Poseyotinib and EFLA, the Grastim. Both are under active review with the agency. In the first quarter, we continued to make progress on our core business objectives, which are, one, gaining FDA approvals and further advancing our two late-stage assets, two, streamlining our company and optimizing our cash burn. And three, ensuring we are prepared to successfully launch both products. Let me provide some highlights starting with Poseyotinib. Our NDA is under active review and the agency has set a PDUFA date of November 24th, 2022. with the initial indication for the treatment of patients with previously treated or locally advanced or metastatic non-small cell lung cancer harboring HER2 Axon 20 insertion mutations. This product has a fast-track designation, and there are currently no approved treatments for this indication. In the first quarter, we initiated a global confirmatory study in support of our application. This is an important and required step in the approval process. Additionally, we presented positive frontline data at the AACR meeting, which is our second successful cohort in the HER2 exon 20 insertion mutation space. Finally, we announced today that the FDA plans to host an ODAC meeting in connection with its review of the posiotinib NDA. We are preparing for this advisory meeting and look forward to the opportunity to highlight the role that posiotinib can play in addressing an important unmet medical need in the treatment of previously treated patients with HER2 exon 20 insertion mutations. The fall ODAC meeting is scheduled for September 22nd and 23rd. We will share the specific date and time for the posiotinib discussion when it becomes available. Now, let me shift to EFLA-Pigrastim. In the quarter, the FDA accepted our resubmitted VLA and assigned a PDUFA date of September 9, 2022. This is a significant step forward in bringing this novel therapy to patients. We are actively working with our partner, HOMNI, to prepare for the upcoming pre-approval inspection of the drug substance facility. Furthermore, we have kicked off our commercial readiness efforts, and our enthusiasm to enter this market remains high. Our commercial leadership infrastructure is in place and ready to engage key customers, group purchasing organizations, and third-party payers to ensure we optimize the launch trajectory if approved. The long-acting GCSF market remains a competitive yet substantial market, and we are looking forward to the opportunity to compete. We will share our detailed commercial plans as we move closer to launch. Moving to our operations, we began the strategic restructure of the organization in January, and we continue to evaluate ways to optimize our cash burn and streamline our operations while investing in our future success. The initial results of those efforts can be seen in our Q1 financials. We also strengthened our partnership with Hominy Pharmaceuticals. This included a $20 million equity investment by HOMNY and amendments to the licensing and supply agreements for both Poseyotinib and Effla-Pograstim. The amendments will allow us to maximize our near-term cash flows and provide improvements to our cost of goods. A strong partnership with HOMNY is critically important to Spectrum as our late-stage assets stem from their research engine. The Spectrum-Homni relationship and partnership dynamics have never been stronger than they are today. We welcome Ms. Joo Young Lim to our Board of Directors in the first quarter. Ms. Lim currently serves as the President of Global Strategy and Planning at Homni Pharmaceuticals. Joo Young has been an exceptional advocate for our partnership, and she's having an immediate impact on our board. Additionally, we announced last week that Ms. Brittany Bradrick has also joined our Board of Directors and will serve as our Audit Chair as of the second quarter. Ms. Bradrick is a seasoned executive with 25 years of experience in the life sciences sector, including M&A, investment banking, finance, strategy, and corporate development. She currently serves as the Chief Financial Officer at Norellis. Just yesterday, we announced the appointment of Ms. Nora Brennan as the new CFO of Spectrum. Nora has been on the board of directors and serving as the audit chair to the company. Her intimate knowledge of the company and familiarity with the team will allow her to hit the ground running in her new role. I'm thrilled to welcome Nora to our senior leadership team as she will officially join the company on May 25th. Given this, I would like to review our financials for the quarter. Total research and development expenses were $4.2 million for the first quarter of 2022, as compared to $19.4 million in the same period of 2021. The favorability is primarily related to the non-cash reversal of an $11.2 million eflipagrastim drug substance accrual that was no longer payable to HOMNI Pharmaceuticals. SG&A expenses were $9.9 million in the quarter, compared to $14.3 million in the same period of 2021, driven by our recent restructuring. The net loss for the quarter was $15.4 million, or 9 cents per share, compared to net loss of $35.7 million, or 25 cents per share, in the comparable period in 2021. On a non-GAAP basis, the net loss was $9.6 million, or $0.06 per share, compared to a non-GAAP net loss of $29.4 million, or $0.20 per share in the comparable period in 2021. We ended the first quarter with approximately $89.2 million in cash plus marketable securities, compared to $100.6 million at December 31st of 2021. As previously reported, we received a strategic equity investment from HOMNY in January of $20 million, which is included in the ending balance. Our operating cash burn was approximately $30.3 million as compared to $34.5 million in the prior period and was elevated due to one-time restructuring costs. The cash, combined with the restructuring announced in January, will extend the company's runway into 2023. With that, I will now turn the call over to Dr. LaBelle for a more detailed update on our clinical development progress.