F-star Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the F-Star Therapeutics fourth quarter 2021 four-year earnings conference call. At this time, we'll purchase a pincer and a listen-only move. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one 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 your speaker today, Lindsay Trickett, Vice President, Investor Relations and Communications. Please go ahead.

Hi. Good morning, everyone. Thank you for joining us. With me today is Elliot Forster, our CEO, and Darlene Deptula-Hicks, our CFO. We announced financial results pre-market today for the year ended December 31, 2021. You can access the press release on the Investor Relations page of our website at 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 that could cause the actual results to differ materially from those anticipated. These risks include risks and uncertainties detailed in FSTARS 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, I'll hand the call over to Elliot.

Thank you, Lindsay. Good morning, everyone. Welcome and thanks for joining F-Star's fourth quarter 2021 earnings call. It's great to speak with you today. I'm very pleased to review the past year of accomplishments and excited to provide an outlook on all we hope to achieve in 2022. 2021 was our first full year as a NASDAQ-listed company. It was a stellar year for F-Star. It was real progress across every aspect of our business. All four of our clinical programs progressed well, successfully navigating COVID. We added two new partners, continued to strengthen our patent portfolio, and closed a significant financing. I'm pleased to say that we've carried this momentum into 2022, despite some of the obvious market headwinds. This year, we're positioned to deliver meaningful data across all four of our clinical programs. Without question, these are the most important value drivers for F-Star. Success in even just one of these, and of course we expect more, will be transformational for the companies. for our shareholders and for patients with cancer. Additionally, our clinically validated platform technology will continue to add novel molecules to our own portfolio as well as to our partners' portfolios. We continue to strengthen the senior team, and I'm delighted that James Sandy joined the company earlier this month as Chief Development Officer. Through his leadership of development operations, James is an expert in accelerating cancer treatment programs through early and late-stage development, and has brought eight drugs to market over the course of his career. His arrival adds yet more momentum to our ability to deliver timely, high-quality clinical data. 2022 is the most important year so far for F-Star as a clinical stage company. It's also a year in which bispecifics are coming of age. This is at least in part demonstrated by collaborations involving bispecific technologies, having reached over $18 billion in value over the past two years. It's also clear that the needs of patients with cancer extend well beyond that which can be delivered by first-generation immune oncology therapies. Despite their successes, many patients do not respond to or progress after treatment. The four approved bispecific drugs now being delivered to patients by others demonstrate the benefit of this format in these hard-to-treat cancers. It's in this context that we'll be providing data on all four of our programs during the course of this year. It's also worth noting that several of our 20-plus partner programs also advanced this year, providing a meaningful source of non-dilutive income to FSTAR. At present, we've more than $2 billion in potential remaining future milestones from our ongoing partnerships. Along with responsible management by cash, any partner income will extend our runway. We believe that tetravalency is the best approach to bispecifics and the best approach for designing second-generation immune oncology therapeutics that will transform the lives of patients with cancer. FSTAR's technology and clinical pipeline are at the forefront of this transformation in cancer treatment. As we like to say at FSTAR, bispecifics for life. Our bispecific antibody technology allows us to create two new additional and distinct antigen binding sites in the FC region of a natural human antibody, giving us 2 plus 2 or tetravalent binding. These two new binding sites allow simultaneous targeting of two different antigens and, importantly, enable a unique set of pharmacology that we call the three Cs, cross-linking, clustering, and conditionality. Cross-linking provides the bridge between two cells, and our platform has the architecture to perform this function with great effectiveness. Clustering is needed for our chosen receptor targets to elicit their pharmacology. By balancing affinity, the binding to a single antigen, with avidity, the cross-linking across multiple antigens, we believe our tetravalent bispecifics are amongst the best in class. Finally, with respect to conditionality, the third C, For our potent bispecifics, we only want pharmacology to happen in the right place. Therefore, our conditionally active molecules deliver their effects only where both of the cancer targets can be engaged simultaneously, pointing their activity directly to the tumor. All of this means our plug-and-play platform enables rapid, prospective design of natural, full-length human bispecific antibodies for safe, potent immune activation at the site of the tumor. And with so few changes to this natural human antibody format, manufacturing becomes a straightforward process, giving us antibody-light yields and stability. It's important to note that over the last several months, our senior management has met with many existing shareholders, as well as potential new investors. These meetings allow us to explain and ensure that the company and its plan for the year ahead is properly understood. FSTAR has multiple significant clinical readouts throughout this year in all four programs. As I mentioned earlier, this means four opportunities for success, and with it enormous implications for patients, the company, and in my view for our present valuation, even against the backdrop of the current market conditions. I'll now talk through our program, starting with FS118. As a reminder, FS118 targets two clinically validated inhibitory checkpoints, PD-L1 and LAG-3. FS118 is currently being tested in two different patient settings, checkpoint inhibitor-naive patients with non-small cell lung cancer or diffuse large B-cell lymphoma, and also in head and neck cancer patients with PD-1 acquired resistance. We're anticipating a clinical safety and efficacy readout in the middle of this year for this latter trial. And despite some challenges with biopsy sample viability, we'll also report biomarker data for LAG3 and PD-L1 co-expression in this patient group. I'd like to say a few words about the tragic events in Ukraine. No one can have missed the human tragedy unfolding in Ukraine, and we'd like to express our support and solidarity with the many millions who've been affected by the war. According to the FDA, over 250 drugs and devices are in clinical trials in Ukraine, which is selected as one of a number of countries for FS118 and checkpoint inhibitor naive patients. As you'd expect, there will now be delays with this study in Ukraine. But contingency planning is well underway and we'll continue to monitor the situation closely. On a more positive note, recent economic forecasts of BMS's dual antibody program inhibiting LAG3 and PD1 is expected to add over $4 billion to its immune oncology revenues by 2029, illustrating the tremendous potential value of targeting these two clinically validated checkpoint inhibitors in patients where there are few other treatment options. We remain very excited about the prospects for FS118 and eagerly anticipate clinical data later this year. FS222 is another important program in the FSTAR portfolio and continues to promise best-in-class status as we make ever more progress in the clinic. This program has the potential to be truly transformational for patients not getting the full benefit of first-generation immune oncology therapies. FS222 is designed to target a wide range of patients, including those with PD-L1, low PD-L1-expressing tumors, and benefits from all of the unique aspects of our platform technology. It's worth highlighting that in preclinical studies, we observed 100% survival and tumor clearance with FS222, and that's without having to combine with PD-1 inhibitors. As we've previously described, FS222 is designed to have unique balance of avidity and affinity profile against both the co-stimulatory CD137 and the inhibitory PD-L1 targets to provide dose-dependent, PD-L1-driven CD137 T-cell redirection. As CD137 continues to gain momentum as a promising target in immune oncology in a wide range of settings, we're looking forward to providing a clinical update on FS222 later this year. This will include safety and tolerability, pharmacokinetics, pharmacodynamic biomarkers, and early signs of efficacy, including objective responses. So far, I'm very excited to see the program translating beautifully from the preclinical setting into the clinical setting. More to follow. In the second half of this year, we're also expecting to provide a clinical update on the Phase I trial of FS120. It aims to improve checkpoint inhibitor or chemotherapy treatment outcomes for patients building on the potential of current standards of care whilst being tumor agnostic. As a reminder, FS120 co-stimulates OX40 and CD137, two key targets found on the surface of T cells. Later this year, ahead of schedule, we'll also plan to initiate a study of FS120 in combination with Merck's Pembrolizumab. We look forward to sharing these data from the ongoing Phase I study. And finally... SB11285, our next-generation intravenously-administered novel sting agonist. Last year, we provided an interim update on the safety, tolerability, and pharmacokinetics of SB11285. At that time, alone and in combination with atazolizumab, SB11285 was well-tolerated across five monotherapy and three combination dose levels. Based on these data, we're continuing to dose escalate and provide a clinical update on these further dose levels later this year. Under the terms of the contingent value rights for SB 11285, we're exploring partnering options for the program. Of course, this adds a potential further source of non-diluted funding for the company. In addition to the data readouts on our four programs that I've just described, we plan to actively participate in scientific conferences such as AACR, ESMO, and CITSE. Now, turning to our partnerships. The most recent partner announcements highlight the ongoing potential of our buy-specific platform to generate new partnerships and also reaffirms the consistent delivery to our existing partners. In the fourth quarter of 2021, we were delighted to welcome Janssen, a member of the J&J family of companies, as a new partner. The deal included a $17.5 million upfront payment and up to $1.35 billion in potential milestones. Also, our long-term partner Merck KGAA Darmstadt, Germany exercised the fourth licensing option for a bispecific molecule under the ongoing immune oncology collaboration. We're also pleased to add AstraZeneca as a new partner in the middle of last year. We're excited to progress with all of our partners in 2022 and we'll continue to consider new partnering opportunities in non-core areas. Also in 2021, two composition of matter patterns were granted to FSTAR, for FS118 in the EU and for SB11285 in the US, adding to our growing intellectual property estate, which now includes over 500 granted and pending patents. Since our founders performed the first experiments on the pathway to tetravalency, we've been committed to developing novel therapies with potential to transform the lives of patients with cancer. As I've highlighted, we're embarking on a very important year as a clinical stage company, and we look forward to four programs delivering meaningful data in 2022. With the right experience and resource in place, we're very much looking forward to sharing these data with you. As well as the four programs, we'll also bring forward exciting new molecules into the pipeline to find different ways to serve patients' needs, and more on this towards the end of the year. 2021 was a year full of achievements. We've delivered on our promises and are poised to reap the benefits of those efforts this year. Our platform is generating novel, differentiated pharmacology in the clinic in a way that has potentially huge implications for our understanding of immunology in the tumor microenvironment. Biospecifics are clearly not monoclonal antibodies or even a combination of monoclonal antibodies. They behave differently and have the potential to deliver different, better outcomes for patients. Buy specifics have come of age. And with the recent approval of Tabendafus from my former company, we see the difference that buy specifics can make. We're committed to continuous outreach to the investment community and are grateful for the investor support that we've received to date. It's been a pleasure to share this corporate update with you, providing insight in how we both plan to transform the lives of patients with cancer and unlock longer-term shareholder value. And with that, I'll hand over to our CFO, Darlene, to give you an update on our financials. Darlene.