8/6/2025

speaker
Operator
Operator

Reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. I will now turn the call over to Rich Lefke, Senior Director, Investor Relations. You may begin, Mr. Lefke.

speaker
Rich Lefke
Senior Director, Investor Relations

Thank you, and good afternoon. With me today are Dr. Marianne DeBacker, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, Jason O'Byrne, our Chief Financial Officer, and Dr. Mika During, our Executive Vice President of Oncology, who will be available during the Q&A session. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Marianne DeBacker. Please go ahead.

speaker
Dr. Marianne DeBacker
Chief Executive Officer

Good afternoon, everyone, and thank you for joining us for VIEW by Technology's Second Quarter 2025 earnings call. I'm excited to share our progress with you today as we've achieved several important milestones across our pipeline this quarter. The past few months have been remarkably productive with significant advances in both our hepatitis delta and oncology programs. These achievements reflect our team's commitment to our mission of powering the immune system to transform patients' lives, and I'm grateful for both their dedication and your continued interest in our journey. Our key accomplishments this quarter demonstrate our continued momentum across our pipeline. First, we've made significant progress in our Eclipse registration program for hepatitis delta. Following our first quarter milestone of enrolling the first patients in Eclipse 1, we have now recently enrolled the first patients in both Eclipse 2 and Eclipse 3, and all three registrational studies are now actively recruiting patients globally. Second, we've successfully initiated our phase one study for VIEW 5525, our ETSR targeted T cell engager, marking our third clinical stage T cell engager program. And third, we've continued to make progress in our existing T cell engager programs with both VIEW 5818 and VIEW 5500 advancing in their respective phase one studies. We also received IMD clearance to evaluate VIEW 5500 in earlier lines of prostate cancer treatment in combination with androgen receptor pathway inhibitors. Let me now elaborate on our chronic hepatitis delta program, which will present a significant near term commercial opportunity for VIEW bio. The Eclipse registration program is designed to address different patient populations across the treatment continuum, from treatment naive patients to those who have not adequately responded to existing therapies. This comprehensive approach builds on our compelling SOSIS phase two data, which demonstrated impressive biological responses with our combination therapy of tobevibart-class elapsolone. The hepatitis delta opportunity is particularly compelling from a commercial perspective for several reasons. Our comprehensive market analysis indicates approximately 7 million active ceramic HDV RNA positive patients globally, including approximately 61,000 patients in the United States and 113,000 patients in the EU member countries plus the UK. The patient population is geographically concentrated, particularly in the United States, where delta patients are predominantly clusters in major urban centers like New York, Chicago, Los Angeles, and San Francisco. This concentration would allow for an efficient commercial approach with a targeted specialty sales force focused on hepatologists and infectious disease specialists. This disease has severe clinical outcomes, including accelerated progression to cirrhosis and a more than 50% 5.0 mortality rate within 10 years, creating a compelling case for effective intervention. The EMA orphan disease designation and the lack of FDA approved treatments in the US support a value-based pricing model similar to other rare disease therapies. Additionally, the high economic burden of untreated disease progression provides a strong economic rationale for effective treatment, while the regulatory designations we've received may help accelerate our development timeline. As we advance our hepatitis delta program toward potential commercialization, our strategy includes pursuing commercialization partnerships in Europe and other key international markets. Turning to our oncology portfolio, as mentioned, I'm very excited about VIA 5525, our dual-masked EGFR targeted T cell engagers. This program addresses a significant unmet need across multiple solid tumor types where EGFR is expressed. Despite years of development of EGFR targeted therapies, including tyrosine kinase inhibitors and monoclonal antibodies, these approaches have limitations. TKIs are primarily effective only in the subset of patients with specific EGFR mutations, while antibodies like Cytoxymab and Panitumumab face resistance mechanisms and significant toxicities that limit their use. For example, these therapies are not used in tumors with KRAS or BRAS mutations in colorectal cancer and head and neck squamous cell carcinoma, as they typically derive minimal or no benefit from current EGFR targeted treatments, leaving a substantial unmet need. The pro-extent approach fundamentally changes this paradigm. By redirecting T cells to kill tumor cells expressing EGFR, VIA 5525 has the potential to work across a much broader patient population, regardless of their mutational status, including those with KRAS mutations. Because VIA 5525 harnesses the patient's own immune system to target EGFR expressing tumor, we believe the likelihood of developing resistance to treatment that often occurs in these diseases is low. Mark will provide more details on the clinical development plan, but I want to emphasize that VIA 5525 exemplifies how we're leveraging our platform to potentially address major limitations of existing therapies. For VIA 5818, our dual-masked HER2 targeted T cell engager, we have completed the monotherapy dose escalation portion of our study and are now analyzing that data as we continue dose escalation in combination with temporal isomet. For VIA 5500, our dual-masked PSMA targeted T cell engager, we continue our dose escalation study and recently obtained US IND clearance to evaluate the program in earlier lines of prostate cancer. This expansion into first-line metastatic castration-resistant prostate cancer and hormone-sensitive disease in combination with ARPIs represents an important step in exploring VIA 5500's full potential across the prostate cancer treatment continuum. The PRO-X10 universal masking approach continues to demonstrate potential advantages in terms of safety profile and dosing flexibility across our T cell engager portfolio. This platform technology allows us to apply an identical masking approach across multiple targets, accelerating our development timelines for future programs. Beyond our clinical stage programs, we continue to advance multiple preclinical T cell engager candidates targeting various tumor-associated antigens. For these preclinical candidates, we're taking a strategic approach to development, advancing some internally while exploring potential partnerships for others where combining our platform with complementary expertise could maximize value and accelerate development timelines. Our financial position remains strong with approximately $892 million in cash, cash equivalents and investments at the end of the second quarter. This provides us with a cash runway extending into mid-2027, giving us resources to advance our key programs through critical value inflection points. Looking ahead, we're focused on several key priorities. Driving enrollment across all three Eclipse studies to advance our chronic hepatitis delta program towards registration. Advancing our clinical stage T cell engager programs, including exploring fear 5500 potential in early alliance of prostate cancer treatment. And executing on our business development strategies to maximize the value of our assets. With that, I'll now turn the call over to Mark to provide a more detailed update on our clinical development program.

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