F-star Therapeutics, Inc.

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Five Star Therapeutic, Inc. First Quarter 2021 Earnings Call and Corporate Update. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference will be recorded and available for replay. I would now like to introduce to you Lindsay Triggott, VP of Investor Relations for FSTAR. Please go ahead.

Good morning, everyone. Thank you for joining us. With me today is Elliot Forster, CEO, and Darlene Gertula-Hicks, our CFO. We announced financial results pre-market today for the quarter ending March 31st, 2021. You can access the press release on the Investor Relations page of our website at fstar.com. Before we get started, let's quickly run through the forward-looking statements. Please note that as a part of our discussion today, management will be making forward-looking statements. These statements are not guarantees of future performance, and therefore you should not place undue reliance on them. Investors are also cautioned that statements that are not strictly historical constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results to differ materially from those anticipated. These risks include risks and uncertainties detailed in FSTAR's filings with the SEC. The company undertakes no obligation to update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this conference call. With that, let me hand the call over to Elliott.

Thanks, Lindsay. Welcome everyone to our first quarter 2021 earnings call. It's a pleasure to provide an update on our achievements during what's been a very busy few months. So continuing our momentum from last year, we successfully raised $65 million in an underwritten public offering. This includes a group of top tier investors and means that the company is very well capitalized with a runway into the second half of 2023. This strengthened financial position ensures delivery of the future milestones we've laid out previously, and which I'll detail again here in a moment. On the clinical side, we've seen a surge of excitement around FS118. This is driven by our internal data and external validation of LAG3 in a pivotal clinical trial. In our view, LAG3 is rightfully earning its reputation as the next significant checkpoint inhibitor pathway in immune oncology. Protecting our assets and unique platform continues to be a priority, and we further expanded our comprehensive patent portfolio during the period. We're increasingly confident that FS222 is a potential best-in-class CD137 PDL1 bispecific. We outlined the differentiated way that we make these tetravalent bispecifics with the publication of additional data at AACR. In relation to our Sting Agonist SB11285, We highlighted an exciting finding relating to the synergy between radiation and the sting pathway in an article in Nature. Our partnerships continue to develop positively. Merck KGAA exercised a third of four options in our ongoing collaboration. Following positive preliminary Phase I-II data, Denali Therapeutics have been granted fast-track designation by the FDA for DNL310, derived from F-star's F-CAB technology. This is hugely encouraging, not least for patients with Hunder syndrome. And of course, we've continued to progress an exciting portfolio of four clinical stage assets. Moving to slide five, let me remind you of the F-star platform technology. We're the only company developing tetravalent bispecific antibodies with a 2 plus 2 binding functionality and the ability to simultaneously cross-link immune cells to tumors, cluster immune receptors, and conditionally activate the immune synapse, only when both targets are engaged. As you can see, we adapt the natural binding site of the antibody in blue and add two new binding sites in dark green, with only a small number of changes. This is a unique way to make bispecific antibodies, and we're the only company that can do this. and it's based and protected by our extensive IP portfolio. Finally, the natural IgG1 antibody format makes our bispecifics easy to manufacture with monoclonal-like production levels, good stability, and low levels of anti-drug antibodies in the clinic. The FSTAR platform continues to deliver with the expert guidance of our Chief Scientific Officer, Neil Brewis, and we'll have more projects to be taken forward in the future. Here on slide six, I'd like to take the opportunity to remind you of our four clinical stage programs led by our chief medical officer, Louis Cayetilaire. We believe each has the potential to be transformative for patients. The most advanced of the F-SAR bispecific antibodies is FS118, targeting PD-L1 and LAG3. Again, LAG3 has recently been validated as a checkpoint target in immune oncology in a late-stage clinical melanoma trial. showing superior efficacy over PD-1 monotherapy. We're very encouraged by these recent data. We believe LAG-3 will become an incredibly important pathway in patients with advanced cancer, and we look forward to seeing additional data supporting that belief. FS-118 is currently in a Phase II proof-of-concept study focused on patients with advanced head and neck cancer who are positive for PD-L1 and LAG-3 and who've become resistant to previous checkpoint therapies. The next program in our pipeline is FS222, a CD137 and PD-L1 targeting bispecific. As I mentioned earlier, we share data on FS222's differentiated approach at this year's AACR. Those data demonstrate that how specifically tuned affinity and avidity of both targets provides conditional binding, avoiding what others have seen as a hook effect. We believe FS222 can become best-in-class medicine. The third clinical stage program from our platform is FS120, the CD137 and OX40 targeting bispecific. This first-in-class program causes a coordinated activation of the immune system in the tumor, which we term triple immune activation. Uniquely, it brings together the combined properties of conditional pharmacology with cross-linking and clustering of the stimulatory targets of OX40 and CD137. Phase 1 clinical trial for FS120 started in late 2020, and the study is progressing. We'll share initial data later this year. We also have plans to begin a combination study with FS120 and an approved PD-1 inhibitor. And finally, F-star's fourth clinical asset is SB11285, a second-generation sting agonist. It can be delivered via an intravenous infusion with the potential for significant improvements over first-generation sting programs. We plan to share data on SB11285 later this year. Before we leave slide six, I want to mention really positive ongoing collaborations we have with Denali Therapeutics and Merck KGAA. Denali continues to develop its blood-brain barrier transport vehicles in the neuroscience space. And as mentioned, Merck KGAA, Darmstadt, Germany, recently exercised their third of four options in our longstanding and valued partnership. Turning to slide 7, you can see the multiple value inflection points and clinical data readouts we're anticipating in the near term. As I mentioned, over the course of this year, we'll share data on SB11285 and FS120, as well as data from the ongoing Phase 1 study with FS222. We also anticipate sharing data on the FS118 proof-of-concept trial around this time next year. And of course, we'll be attending and presenting data at upcoming medical and scientific conferences where we'll share our progress. So looking ahead to the next quarter and beyond, the company's financial outlook is strong, and we're incredibly pleased by the success of our first follow-on financing. This will power the delivery of our milestones over the next two years. I'm grateful for the support of our new and existing investors, who are with us on this journey to create a paradigm shift for patients with cancer. I'd also like to thank the team at F-Star who continue to deliver day by day to develop life-changing medicines and create value for shareholders. And now I'll hand over to Darlene to give you an update on our financials. Darlene.