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3/11/2021
as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements, including the current and potential future impact of the COVID-19 pandemic on our business, results of operations, and financial position. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail. in the company's press release issued this morning containing financial results for the year-ended December 31, 2020, and the company's filings with the SEC. And with that, I'll turn the call over to Dr. Todd Brady, our President and Chief Executive Officer.
Thank you, Joshua, and good morning, everyone. Our year-end call is an opportunity to share with you the progress we've made and advancing our lead clinical programs, and equally important, the strategic vision for Aldera as we move to the next stage in our development. Over the past several quarters, we have focused on three primary objectives. First, advance roproxilab into two phase three trials in a clinically relevant sign of dry eye disease, ocular redness. augmenting the statistically significant symptom improvement we achieved in previous Phase II and Phase III trials, and positioning our compound as a novel, rapidly acting potential first-line therapy. Second, complete enrollment in our pivotal Phase III Invigorate trial in allergic conjunctivitis, facilitating the advancement of riproxilab as the first novel entrant for this disease in decades. And third, begin to explore the therapeutic potential of our retinal and systemic disease assets highlighted by ADX2191 and ADX629. I'm pleased to report that we have succeeded on all fronts. In February, we finalized the design of our Phase III Tranquility Trial of Raproxilab for the treatment of dry eye disease. As we have previously announced, the trial is expected to enroll approximately 150 patients per arm. The primary endpoint of tranquility is ocular redness over 90 minutes in a dry eye chamber with tear rasp levels, Shermer's test, and dry eye symptoms as secondary endpoints. The protocol will replicate the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort. Although in a relatively small number of dry eye disease patients in the run-in cohort, Reproxilab achieves statistical significance in ocular redness, as well as all assessed symptoms in the chamber. Symptom improvement was observed after a single day of dosing and in the dry eye chamber as soon as five minutes after a single dose. Likewise, improvement in redness also occurred within minutes following dosing. Reproxilab was observed to act prophylactically, preventing exacerbation of signs and symptoms, as well as therapeutically. reducing signs and symptoms following dosing in the middle of the dry eye chamber exposure. Tranquility and the confirmatory Phase III Tranquility II trial are on schedule to begin enrollment in the first half of this year, with top-line results expected in the second half of the year. Based on demonstrated symptom control in clinical trials and differentiated mechanisms of action, Reproxilab has the potential to provide first-line ocular symptom control for dry eye disease patients. There is no dry eye disease therapy today that acts rapidly, and health care providers at times must persuade patients to remain on therapy for weeks even as little or no benefit is experienced. I'm also pleased to report that enrollment has been completed in the Phase III Invigorate trial, a two-way randomized crossover trial assessing the safety and efficacy of Reproxilab compared to vehicle and subjects with allergic conjunctivitis. Patients undergo three and a half hours of continuous allergen exposure in an allergen chamber with dosing administered five minutes before and 90 minutes after chamber entry. The primary endpoint is statistical significance in ocular itching on a nine point scale at a majority of 11 time points between 110 and 210 minutes in the chamber. Top line results from invigorate are expected in the first half of this year. Progress in our lead retinal program also remains on track. Completion of enrollment of part one of the phase three GARD trial of ADX2191 for the prevention of proliferative vitreoretinopathy, or PVR, is expected by the end of this year. PVR is a serious sight-threatening retinal disease with no approved treatment. ADX 2191 has been granted orphan drug status and fast track designation from the FDA for the prevention of PVR. With regard to our systemic disease programs, we continue to expect top line results from our phase two clinical trials of ADX 629, the first orally available RASP inhibitor by the end of the year. The Phase II trials follow a successful Phase I clinical trial of ADX629, which demonstrated statistically lower RASP levels in drug-treated subjects relative to controls and no treatment-related adverse events at any dose tested. As part of our longer-term clinical development strategy, we are also readying new compounds for retinal and systemic disease. the lead molecules of which could be in the clinic as early as next year. A strong and well-capitalized balance sheet is obviously an important asset in our industry. With the completion in January of our underwritten public offering, which raised gross proceeds of nearly $75 million for Aldera, we began 2021 in great shape financially. We believe our current cash will be sufficient to fund our anticipated operating expenses and execute on our current operating plans through the end of 2023. We were gratified by the strong support from the existing and new institutional investors that participated in the offering. With that, I'll turn the call back over to Joshua to review our financial results for 2020.
Thank you, Todd. As Todd noted, in January, we announced the closing of an underwritten public offering of 7,868,421 shares of common stock at a price of $9.50 per share. The offering included 1,026,315 shares representing the full exercise of the underwriter's option to purchase additional shares. and generated gross proceeds of $74.7 million and net proceeds of approximately $70 million after deducting offering discounts, commissions, and estimated expenses. Cash and cash equivalents as of December 31, 2020, were $77.9 million. Based on our current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, We believe that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of 2023, including the completion of the Phase III Tranquility and Tranquility II trials in dry eye disease, the completion of the Phase III Invigorate trial in allergic conjunctivitis, the Phase II clinical trials of ADX 629 in psoriasis, atopic asthma, and COVID-19, and the completion of part one of the adaptive phase three GARD trial in PVR. Turning now to our full year financial results. Research and development expenses were $24.7 million for the full year 2020, compared with $44.4 million for the full year 2019. The decrease of $19.7 million in R&D expenses primarily reflected a reduction in clinical research and development expenditures partially offset by an increase in non-cash compensation costs related to a portion of a contingent acquisition milestone. Acquired in-process research and development expenses were $1.8 million for full year 2020 compared with $6.6 million for full year 2019. The $4.8 million decrease is related to lower in-process research and development expenses associated with the 2019 acquisition of HelioVision. General and administrative expenses were $10 million for full year 2020 compared with $12.2 million for the full year 2019. The decrease of $2.2 million in G&A expenses primarily reflected lower personnel costs, legal costs, public company costs related to continuing compliance with the Sarbanes-Oxley Act of 2002, and miscellaneous administrative costs. The net loss for full year 2020 was $37.6 million, or $1.11 per share, compared with a net loss of $60.8 million, or $2.24 per share, for full year 2019. With that, I will turn the call back to Todd for closing comments.
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