Spectrum Pharmaceuticals, Inc.

Thank you, Operator, and good afternoon to everyone.

Thank you for joining us today for Spectrum Pharmaceuticals' fourth quarter and full year 2021 financial results conference call. Our fourth quarter and full year financial results press release was sent out earlier this afternoon and is available on our website at www.sptirx.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 that we 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 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 today's call. It is a pleasure to address this audience for the first time as the President and CEO of Spectrum. The responsibility of representing our employees, investors, and corporate partners is both a privilege and a responsibility I take with great pride. I accepted this position with the full understanding of the past realities and the future opportunities of the company. I believe the company is at a pivotal moment in its history, and I expect to provide a disciplined, pragmatic, and objective leadership approach to capitalize on the opportunities in front of us. It has been helpful to engage, listen, and communicate with many of our investors, analysts, and stakeholders. I've appreciated the open, candid, and productive discussions thus far and intend for those engagements to continue as we chart our path forward. The first two months of the role have been fast-paced, productive, and focused on advancing our late-stage program. Let me provide the highlights. In January, we made a strategic decision to restructure and streamline our operations to focus on our late-stage product opportunities with the ultimate goal of gaining two FDA approvals this year. The restructuring was an opportunity to take a hard look at the organization and to right-size the company to meet the core business objectives while also optimizing our cash runway. We reduced our staff by approximately 30% and expect to see a reduction in our operating cash burn by 20% to 25%. When making decisions that impact staff, it is never easy, but in this case, necessary. We also strengthened our partnership with Homney Pharmaceuticals, which included a $20 million equity investment 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. Furthermore, we recently announced the addition of Joo Young Lim to the Board of Directors. Joo Young currently serves as the President of Global Strategy and Planning at Homni Pharmaceuticals. We look forward to her leadership and input on our Board as we seek to achieve our shared goal of bringing both products to market in the U.S. A sound partnership with HOMNI is critically important to Spectrum, as our late-stage assets stem from their development pipeline, and FDA approvals will allow them to advance their position in the U.S. At this point, the partnership dynamics between our companies has never been stronger. As it relates to our late-stage assets, let me start with Poseidonis. On February 11th, we announced the FDA accepted our NDA and assigned a PDUFA date of November 24th with the initial indication for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 mutations. This product has a fast track designation, and there are currently no approved treatments for this indication. We believe that posiotinib could have first mover advantage in this area of high unmet medical need. Our team is actively working with the agency as they conduct their review of posiotinib. Gaining FDA approval for this indication is a top priority. Since filing, we announced additional positive data at the ESMO TAT meeting for the first-line treatment-naive lung cancer patients harboring HER2 exon 20 insertion mutations. Francois will cover this in more detail in his remarks. As we think about the broader strategy for posiotomy, we will focus our resources in areas of significant unmet medical need and high patient prevalence. This strategy is shaped by the clinical data that we observe from our own studies, the competitive landscape, relative risk, and cost of the investment required. For example, beyond HER2, there was interesting preclinical data presented at the AACR triple meeting showing synergy between posiotinib and KRAS G12C inhibitors. This combination would fit our strategic intent, as the unmet medical need is real and the target patient population is significant. Equally as important to our strategy is defining where we will not spend our resources going forward. To date, our studies in EGFR axon 20 insertion mutations have not met their primary endpoints, despite demonstrating strong clinical activity. In addition, there are now two drugs approved in this space. As a result, we will no longer be pursuing posiotinib as a standalone therapy for EGFR patients. In summary, we have an NDA under review with an action date in November. Additionally, we see a clear development strategy for this asset that will be guided by clinical data and analytics to optimize our resources and help patients in need. Now let me shift to EFLA progressive. Today we announced that the VLA has been resubmitted to the FDA for review. This is a significant step forward in bringing this novel therapy to patients. We would expect this to be a class two review, with a 30-day acceptance and a six-month review cycle. The resubmission followed the remediation of manufacturing deficiencies at our drug substance facility. At our type A meeting with the FDA, they have indicated that an in-person re-inspection of the facility in South Korea will be required. We look forward to working with the FDA through their review process. Moving forward, we will be referring to the product as EFLA and no longer calling it Rolantis. We were informed by the FDA that our conditionally approved name would no longer be valid as there is now a potential conflict with another product which is currently under review. We have proposed a new name for the agency with the resubmission, but until that new name is approved, we will revert to the scientific name. As you can see, we are working diligently on our two key programs with a strong sense of urgency and excitement. we are focused on gaining two FDA approvals later this year. Over the past few months, we have made substantial progress on these programs, streamlined our operations, elevated our corporate partnerships, and are executing on our core business objectives. Finally, I'd like to take a moment to thank Kurt for his years of service to Spectrum and the valuable insight he has provided as his time of CFO. He played an important role in the company and we all wish him well in his future endeavors. We have an active search underway to replace the CFO role, and we'll keep you posted as we make progress. With that, I will now turn the call over to Dr. LaBelle for a more detailed update on our clinical development programs.