F-star Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the F-Star Therapeutics 3rd Quarter 2021 Earnings Conference Call. At this time, all participants are in the listen-only mode. 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 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Ms. Lindsay Trickett. Please go ahead, ma'am.

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 September 30, 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 statement. 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, I'll hand the call over to Elliot. Elliot?

Thank you, Lindsay. Good morning, everyone. Welcome and thank you for participating in FSTAR's third quarter 2021 earnings call. It's great to speak with you today and provide a corporate update on what's been another positive past three months. As well as reviewing this past quarter, I'll also reflect on our first year since becoming a public company. But first, our progress in this past quarter further demonstrates the successful advancement of our clinical programs and an important expansion of our partnering activities, all in keeping with our financial plans. As a demonstration of our growing confidence in our most advanced program, FS108, we're initiating a trial in checkpoint inhibitor naive patients with non-small cell lung cancer and diffuse large bile cell lymphoma. As highlighted in our last earnings update, this reinforces our belief in the program and its potential impact in larger patient groups. Progress this quarter in FS120, our first-in-class dual agonist, and SB11285, our next-generation sting agonist, are clinically encouraging. And we're excited to make further progress in their respective ongoing phase one trials. And while I'll not be providing a specific update today, FS222 is also progressing well through its phase one trial. As important and further validation of our platform, we've entered into a new license and collaboration agreement with Janssen Biotech, one of the Janssen pharmaceutical companies of Johnson & Johnson. Under the terms of the agreement, F-Star will grant Janssen a worldwide exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies using F-Star's proprietary platform technology. The deal is worth up to $1.35 billion, including a $17.5 million upfront payment and as well as potential tiered royalties on product sales. We're delighted to have Janssen as our newest technology partner joining Merck KGAA, AstraZeneca, and Denali Therapeutics. It's been almost a year since FSTAR was listed on NASDAQ. Since then, in spite of being in the COVID pandemic, we've been resolute in our commitment to generate transformative immunotherapies for patients with cancer, having added three new programs into the clinic. And we've also leveraged our platform and established partnerships with AstraZeneca and Janssen. Our four next-generation immune oncology therapeutics in the clinic are directed towards some of the most promising immune oncology targets in drug development, including LAG3 and CD137. We continue to strengthen the protection of our programs and platforms with over 500 patents granted or pending. And finally, we've established a strong shareholder base with a new group of leading biotech investors joining the company. And from a standing start, we've attracted and gained coverage from seven respected analysts. As a reminder, our bi-specific 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 a 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 can form the bridge between two cells, and our platform has architecture to perform this function with great effectiveness. Clustering is needed for our chosen receptor targets to elicit their pharmacology, and by balancing affinity with avidity, 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 the 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, focusing their activity in the tumor microenvironment. All of this means our platform enables the prospective design of natural, full-length human bispecific antibodies for safe, potent immune activation in the tumor. And with so few changes to the natural human antibody format, with the additional benefit that our manufacturing process is straightforward, giving antibody-like yields and stability. As you can see on slide six, we continually expand our intellectual property estate, which now includes over 500 granted and pending patents, all relating to our platform technology and product pipeline. We have an exceptional team that has the experience to deliver with our existing differentiated and protected technology. On slide seven, we show the whole portfolio, including our two new partners, AstraZeneca and Janssen, bringing the total potential remaining value of our partnerships to over $2.2 billion. Moving to slide eight and starting with our most advanced asset, the first in class, FS118. You'll recall that FS118 targets two clinically validated inhibitory checkpoint, PD-L1 and LAG3. As proof of concept, trial is ongoing in checkpoint failure patients with PD-1 and PD-L1 acquired resistance in head and neck cancer. This study is progressing well, and despite the pandemic, we're anticipating a preliminary clinical FSC readout in mid-2022. Additionally, we're initiating a clinical trial in checkpoint inhibitor naive patients with non-small cell lung cancer and diffuse large B-cell lymphoma to expand the opportunity for FS118. We're excited about the prospects for FS118 in both checkpoint failure and checkpoint naive patient settings and look forward to updating you in due course. FS222 is designed to target a wide range of patients, including those with low PD-L1 expressing tumors and benefits from all of the differential advantages of our platform technology. FS222 is tuned for avidity against both the co-stimulatory CD137 and the inhibitory PD-L1 targets. We believe this will provide clinical outcomes that separates us from the competition. The Phase 1 trial continues best well and will provide a clinical update at the end of this year. FS120 aims to improve checkpoint inhibitor and chemotherapy treatment outcomes for patients. and its tumor type agnostic. It co-stimulates OX40 and CD137, two key targets found on the surface of T cells. In preclinical studies, FS120 generates a triple immune response. In the tumor microenvironment, that includes CD4, CD8, and Treg cells. During the ESMO meeting this past October, we provided a phase one trial-in-progress update on FS120. Today, we're pleased to report that FS120 has cleared the accelerated dose titration phase and is well tolerated to date. And moreover, whilst we're not ready to share data details, we're encouraged by the newly emerging pharmacology in patients from the ongoing clinical trial. And these are in line with the triple immune response mechanism of action. We're excited to continue the progress of FS120 in the clinic. We plan to initiate a study of FS120 in combination with pembrolizumab next year, and we'll present preclinical data on this mechanism of action at CITSE later this week. Earlier this year, we provided an interim update on safety tolerability and pharmacokinetics of SB11285, a next-generation intravenously administered novel sting agonist. Alone and in combination with tizolizumab, SB11285 was well tolerated. across five dose levels as a monotherapy and the three dose levels as combination. Based on these positive emerging clinical data, we've continued with dose escalations and further clinical update is planned for next year. Before I hand over to Darlene, slide nine shows the multiple programs and multiple clinical readouts this coming period continues to promise to be one of the opportunities for both patients and shareholders alike. Let me give you some highlights. At or around the end of this year, we anticipate a clinical trial update on FS222. And next year, we plan to share data on FS118 in the acquired resistance patient population, further updates on FS120 as we move towards that combination with Keytruda, preliminary efficacy data with FS222, and an update on the continued clinical progress of SB11285. As you can see, it's been a year full of accomplishments. and we have an exciting period ahead of us, made possible by the team at F-Star who tenaciously pursue our goals in order to keep to the promises we make. We're committed to continuous outreach to all the investment community and grateful for the investor support that we've received to date. It's been a pleasure to share this corporate update with you, another good quarter in a good first year as a public company. And with that, I'll hand over to our CFO, Darlene, to give you an update on our financials. Darlene.