KALA BIO, Inc.

Good morning and welcome to the COLA Pharmaceuticals conference call to review its third quarter financial results in the acquisition of Combangio. Please note that this live presentation that was designed to accompany this conference call is available on COLA's website, colarx.com, as well as through the webcast player. At this time, all participants are in a listen-only mode. Following management's prepared remarks, a Q&A session will be held. As a reminder, this call is being recorded. I would now like to turn the call over to Jill Steyer, Executive Director, Investor Relations and Corporate Communications for Cala Pharmaceuticals. Please proceed.

Jill Steyer Thank you, Operator, and thank you all for participating in today's call. Earlier today, we issued two press releases, one announcing our third quarter financial results and recent business highlights, and the other announcing our acquisition of Cambagio and its lead asset, CNB 012, which we have renamed KPI 012. a novel cell-free secretome therapy currently in clinical development for persistent cornelial epithelial defect. Both releases, along with the slides we will be reviewing on today's call, are available on the investor section of Collar's website at www.collarrx.com. We will begin the call with prepared remarks by Mark Iwiki, our Chairman, President, and Chief Executive Officer, Kim Brazel, our Chief Medical Officer, Todd Bazemore, our Chief Operating Officer, and Mary Remus, Chief Financial Officer. Then we will open the call up for questions. During this call, we will be referring to non-GAAP financial measures which are not prepared in accordance with generally accepted accounting principles. A reconciliation of the non-GAAP financial measures to the most directly Comparable gap measures is available in our press release issued today, which can also be found on our website. On this call, we will make certain comments about CALA's future expectations, plans, and prospects that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements will include statements regarding the development program and market potential of KPI 012 and the benefits of our acquisition of Cambogio, observations associated with our commercialization of ISUBIS and INVELTUS, and the sufficiency of our cash resources. These and other forward-looking statements are based on the beliefs and expectations of management as of this conference call. Our actual results may differ materially from our expectations. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances that occur after this conference call, except as required by law. Investors should carefully read the risk and uncertainties described in today's press releases, as well as the risk factors, which identify specific factors that may cause actual results or events to differ materially from those described in our forward-looking statements. including the company's quarterly report on Form 10-Q and other filings we made for the SEC. The Form 10-Q will be filed with the SEC later today and will be available on our website. I will now turn the call over to CalA's CEO, Mark Iwitin.

Mark Iwitin Good morning, everyone, and thank you for joining us today to review our third quarter 2021 financial results and recent business highlights Our mission at Kala has been to provide patients and eye care professionals with a portfolio of innovative medicines that can better treat the often debilitating diseases that affect the front and back of the eye. Today, we are advancing toward that goal with the acquisition of Combangio, a clinical stage company developing a novel biotherapy for severe ocular surface diseases. With this acquisition, we are very excited to expand our clinical stage pipeline with KPI-012, a secretome product being developed to address persistent corneal epithelial defects, or PCED, and potentially other serious ocular diseases that involve impaired healing. KPI-012 is a clinical stage asset initially in development for PCED, a rare disease associated with vision-threatening morbidity and sequelae. Current treatments for PCED are limited and suboptimal, and we believe there's a clear need for new therapies to address the impaired wound healing that underlies PCED and similar corneal damage diseases. The KPI-012 Phase 1B clinical data in PCED patients are very promising, and we are planning to commence a Phase 2-3 clinical trial in 3Q next year. We are also evaluating additional indications with the goal of initiating clinical evaluation in one or more of these once we have filed the IND. Importantly, KPI-012 adds a late stage clinical asset to our pipeline of earlier stage programs, including our TKI that we expect to have initial preclinical PK and efficacy data early next year. For KPI-012, we are well suited to leverage our deep ophthalmic clinical and commercial capabilities to advance KPI-012 through development, beginning in PCED and potentially expanding into additional orphan patient populations with significant market potential in the U.S. and globally. As part of the acquisition, we are very excited to welcome Darius Karabi, President and CEO of Combangio, as COLA's new Chief Business Officer, as well as Mark Blumenkranz, an ophthalmologist, vitreo-retinal surgeon, and Professor Emeritus in the Department of Ophthalmology at Stanford, who will be joining our board. Before turning the call over to Kim, I'd like to comment on our third quarter commercial performance. The ramp of ISUVIS has been slower than expected. With ISUVIS, we are changing the treatment paradigm for dry eye disease which is a key, though time-consuming process for long-term success. Historically, steroids have been used only as a last-line, off-label therapy for patients with severe disease, and positioning Isovus as a first-line prescription therapy for people with mild or moderate disease requires significant investment and time. To that end, our initial launch strategy focused on education. We sought to drive proactive discussions with eye care professionals in order to educate on dry eye flares, the availability of Isovus as the first FDA-approved on-label steroid with limited risk of intraocular pressure elevation, and the potential for our therapy to effectively fill the gap between over-the-counter artificial tears and chronic prescription therapies. As we move into the second stage of our launch, and as Todd will elaborate on shortly, we are now implementing a number of new targeted strategies aimed directly at the patient, including our first digital direct-to-consumer campaign, which we plan to launch by year end. With this program, we aim to empower patients, providing them with the information and resources necessary to proactively discuss flares with their doctors. We believe in the long-term potential of ISUVIS and are confident that prescriptions and revenues will grow over time. We continue to receive encouraging feedback from eye care professionals who appreciate ISUVIS's rapid onset of action and comfort of administration. And we anticipate that physicians will become even more positive about ISUVIS as we obtain additional payer coverage in the months ahead. Patients also continue to report positive experiences on therapy, and we believe it is clear that ISUVIS effectively delivers rapid relief of the signs and symptoms of dry eye disease. I will now turn the call over to Kim and Todd to review the Combangio acquisition in greater detail. Kim?