On March 10, 2021 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, reported financial results for the full year 2020 and provided a corporate update (Press release, Rexahn, MAR 10, 2021, View Source [SID1234576483]).

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"2020 was a transformative year for Ocuphire, with significant achievements on clinical, corporate and financial fronts. We became a Nasdaq-listed company through our reverse merger with Rexahn Pharmaceuticals and raised just over $21 million concurrent with the merger," said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "Despite the challenges of the COVID-19 pandemic, we consistently hit our planned milestones throughout the year, including initiating multiple Phase 3 and Phase 2 clinical trials and completing enrollment on one Phase 3 trial, and publishing results of two prior Phase 2 trials. We look forward to building on this progress in 2021 as we move forward with our promising Nyxol and APX3330 programs."

Key Anticipated Future Milestones

Phase 3 MIRA-2 trial investigating Nyxol for Reversal of Mydriasis with top line data expected in March 2021
Phase 2 VEGA-1 trial investigating a kit combination of Nyxol and low-dose pilocarpine for treatment of Presbyopia with top line data expected end of Q2 2021
Phase 3 LYNX-1 trial investigating Nyxol for Night Vision Disturbances with top line data expected end of Q3 2021
Phase 2 ZETA-1 trial investigating APX3330 for Diabetic Retinopathy and Diabetic Macular Edema: enrollment initiation expected in Q1 2021 with top line data expected early 2022
Recent Business Highlights

Clinical

Phase 3 MIRA-2 trial investigating Nyxol for Reversal of Mydriasis enrollment initiated and completed
Phase 3 LYNX-1 trial investigating Nyxol in Night Vision Disturbances initiated
Phase 2 trial VEGA-1 to evaluate a combination kit of Nyxol and low-dose pilocarpine in presbyopia initiated
Publications / Grants

Results from ORION-1 Phase 2b trial evaluating the safety and efficacy of Nyxol in glaucoma and presbyopia published in Clinical Ophthalmology
Results from MIRA-1 Phase 2b trial evaluating the safety and efficacy of Nyxol in the reversal of mydriasis (dilation of pupil for eye exams) published in Optometry and Visual Science
Data on the benefits of Ref-1 inhibition via APX3330 demonstrating its potential to treat multiple inflammatory and angiogenic disease processes published in Drug Discovery Today and Inflammatory Bowel Disease
Corporate

Completed reverse merger with Rexahn Pharmaceuticals and are a publicly traded company listed on the Nasdaq Capital Market as OCUP as of November 6, 2020
Raised $21.15 million in a private placement led by institutional healthcare and accredited investors
Participating in multiple Presbyopia events in early 2021 – Discussion on New Advances for Presbyopia, OIS Presbyopia Innovation Forum, and Eyeing Key Events and Programs in the Ophthalmology Space in 2021
2020 Financial Highlights

At December 31, 2020, the company had cash and cash equivalents of approximately $16.4 million.

General and administrative expenses for the year ended December 31, 2020 were $2.8 million compared to $1.8 million for the year ended December 31, 2019. The $1.0 increase was primarily attributable to an increase in stock-based compensation, professional services, insurance, and legal costs associated with the reverse merger in the current period.

Research and development expenses for the year ended December 31, 2020 were $6.6 million compared to $2.4 million for the year ended December 31, 2019. The $4.3 million increase was primarily attributable to clinical trials and manufacturing activities to support clinical advancement of Nyxol as well as regulatory and business development efforts.

Net loss attributable to common stockholders for the year ended December 31, 2020 was $24.6 million compared to $6.2 million for the year ended December 31, 2019.

On March 10, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021 at 1:50 pm (ET) (Press release, Mannkind, MAR 10, 2021, View Source [SID1234576452]). Interested parties can access a link to the webcast from the Events & Presentations section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

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On March 10, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that it will participate in two upcoming virtual investor conferences (Press release, Arvinas, MAR 10, 2021, View Source [SID1234576451]). John Houston, Ph.D., President and Chief Executive Officer, will participate in panel discussions at both conferences.

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Guggenheim Targeted Protein Degradation Day panel discussion on Tuesday, March 16, 2021 at 10:30 a.m. ET
33rd Annual Roth Conference panel discussion on Wednesday, March 17, 2021 at 5:00 p.m. ET
A live audio webcast of each panel will be available on Arvinas’ website at www.arvinas.com. A replay of each webcast will be archived on Arvinas’ website for 30 days following the presentation.

On March 10, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that preclinical data informing indication selection for the clinical development of its lead macrophage program, JTX-8064, will be presented in a poster session at the upcoming 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting being held April 10- 15, 2021 (Press release, Jounce Therapeutics, MAR 10, 2021, View Source [SID1234576450]).

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Poster Title: Tumor associated macrophages and resistance to immune checkpoint blockade: Consideration of cancer indications for the clinical development of JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody
Authors: Lara McGrath, Amy Mueller, Tanzila Rahman, Jeffrey Smith, Mark Yore, Edward Stack, Kristin O’Malley, Andrew Dunn, Kristen Legendre, Reva Shenwai, Margaret Willer, Allison Naumovski, Johan Baeck, and Ben Umiker (Jounce Therapeutics, Inc.)

Session Title: Immunomodulatory Agents and Interventions
Abstract Number: 1727
Date and Time: Saturday, April 10, 2021; 8:00am ET

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899), for JTX-8064 as a monotherapy and in combination with either JTX-4014, or pembrolizumab, is currently enrolling patients with advanced solid tumors.

On March 10, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months and full-year ended December 31, 2020 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, MAR 10, 2021, View Source [SID1234576449]).

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"During 2020, we substantially strengthened our balance sheet by eliminating 95% of our debt and returned to our roots by focusing on the advancement of our research and development pipeline," said Lonnel Coats, Lexicon’s president and chief executive officer. "We took key steps to advance our pipeline by initiating two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia. We efficiently closed out the sotagliflozin Phase 3 clinical program and, based on positive data from two of those Phase 3 studies, SCORED and SOLOIST, we believe that sotagliflozin has the potential to become an important new treatment option for heart failure patients with type 2 diabetes. We will be working expeditiously to file an NDA for sotagliflozin in heart failure in the second half of this year. With minimal debt and cash sufficient to fund our planned operations for two years, we entered 2021 in a solid financial position to execute on these objectives."

Fourth Quarter Highlights

LX9211

Patient enrollment continued in RELIEF-DPN-1, a Phase 2 clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at approximately 30 clinical sites.
Patient enrollment commenced in RELIEF-PHN 1, a Phase 2 clinical study of LX9211 for the treatment of post-herpetic neuralgia. Enrollment is expected to total approximately 74 patients at approximately 30 clinical sites.
Lexicon received Fast Track designation from the FDA for the development of LX9211 in diabetic peripheral neuropathic pain.
Sotagliflozin

SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.
Data from both studies were presented at the Late-Breaking Science Session of the American Heart Association Scientific Sessions 2020 and simultaneously published in two separate articles in The New England Journal of Medicine.
Corporate Activities

Lexicon raised $70 million in net proceeds from common stock sales.
2021 Anticipated Milestones and Events

NDA filing for sotagliflozin in heart failure.
Active efforts to secure strategic alliance for sotagliflozin in heart failure.
Phase 2 study results from RELIEF-DPN-1 for LX9211 in diabetic peripheral neuropathic pain.
Phase 2 study results from RELIEF-PHN-1 for LX9211 in post-herpetic neuralgia.
Additional publications for sotagliflozin and LX9211.
Fourth Quarter and Full-Year 2020 Financial Highlights

Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2020 compared to the fourth quarter and full year of 2019.

Revenues: Revenues for the fourth quarter of 2020 decreased to $0.2 million from $8.7 million for the corresponding period in 2019, primarily due to the elimination of product revenues as a result of the sale of XERMELO during the third quarter of 2020. Full-year 2020 revenues decreased to $24.0 million from $322.1 million in 2019. Full-year 2019 revenues included collaborative revenues of $289.2 million, primarily from the termination of the alliance with Sanofi and recognition of the remaining amounts for performance obligations from the initial agreement with Sanofi.

Research and Development (R&D) Expenses: Due to a reduction in external clinical development cost estimates primarily related to sotagliflozin, research and development expenses for the fourth quarter of 2020 decreased to $1.0 million from $40.6 million for the corresponding period in 2019. Full-year R&D expenses for 2020 increased to $153.6 million from $91.9 million in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi in September 2019.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2020 decreased to $6.4 million from $14.6 million for the corresponding period in 2019, primarily due to lower salaries and benefits as a result of reductions in personnel and elimination of marketing expenses following the sale of XERMELO in the third quarter of 2020. Full-year SG&A expenses for 2020 decreased to $47.2 million from $56.8 million, primarily due to lower salaries and benefits and marketing costs.

Gain on Sale of XERMELO: A gain of $132.6 million was recognized during 2020 from the sale of XERMELO and related assets to TerSera Therapeutics LLC in September 2020.

Net Income (Loss): Net loss for the fourth quarter of 2020 was $5.5 million, or $0.04 per share, as compared to a net loss of $51.1 million, or $0.48 per share, in the corresponding period in 2019. For the three months ended December 31, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $2.7 million and $3.5 million, respectively. Net loss for the year ended December 31, 2020 was $58.6 million, or $0.53 per share, as compared to a net income of $130.1 million, or $1.16 per diluted share, in 2019. For the years ended December 31, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $13.3 million and $14.2 million, respectively.

Cash and Investments: As of December 31, 2020, Lexicon had $152.3 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 3793713. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.