On March 24, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, reported that new interim data from 2nd line NSCLC patients (Part B) of its phase II TACTI-002 trial has been published in an abstract today in advance of ESMO (Free ESMO Whitepaper)’s European Lung Cancer Congress (ELCC) 2022. ELCC 2022 will now be taking place in a virtual only format from 30 March 2022 to 2 April 2022 (Press release, Immutep, MAR 24, 2022, View Source [SID1234610980]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: Results of a phase II study investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in 2nd line PD-1/PD-L1 refractory metastatic non-small cell lung carcinoma pts
Abstract: Available at
View Source conference/ELCC 2022_TACTI-002 Part B_Abstract_Final.pdf
The related poster presentation with new and updated data that are not part of the abstract will now be released by ELCC on 29 March 2022 at 12:00 noon, CEST and will subsequently be made available on Immutep’s website at www.immutep.com.

About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

Part A – first line Non-Small Cell Lung Cancer (NSCLC), PD-X naïve – given the promising results of the first two stages of Part A, an expansion stage with additional patients was commenced in November 2020 to assist with trial design in subsequent late-stage settings

Part B – second line NSCLC, PD-X refractory

Part C – second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naïve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC.

On March 24, 2022 Formosa Pharmaceuticals reported the approval of a resolution by the boards of directors of both Formosa Pharmaceuticals and EirGenix, Inc. for the co-development of anticancer ADC, TSY-0110 (EG12043) (Press release, Formosa Pharmaceuticals, MAR 24, 2022, View Source [SID1234630879]). This agreement strengthens the existing relationship between both companies and fortifies TSY-0110’s clinical development pathway and subsequent licensing prospects.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TSY-0110 is a biosimilar of the antibody-drug conjugate, Kadcyla, which combines Herceptin with the cytotoxic payload, mertansine, to achieve an enhanced antitumor effect with manageable safety profile. Kadcyla, developed by Roche Pharmaceuticals, was first approved by the US FDA in 2013 for the treatment of HER2-positive metastatic breast cancer (MBC) and later gained additional approval for early breast cancer (EBC) in 2019. Kadcyla is currently utilized as a single-agent 2nd-line treatment for breast cancer and is being tested in numerous clinical trials as a combination agent with other biologics and chemotherapeutics. Kadcyla’s global sales from 2021 is approximately USD $2.1 billion and annual sales are expected to remain strong.

Per the terms of the agreement, Formosa Pharmaceuticals will receive upfront and milestone payments for a total of USD $30 million from EirGenix in exchange for profit-sharing rights to TSY-0110. Additionally, EirGenix is named the exclusive supplier of its Herceptin biosimilar (EG12014) as the key intermediate toward the manufacturing of TSY-0110. EirGenix, who recently completed a USD $110 million cash capital increase and $175 million private placement, submitted Marketing Authorization (MAA) and Biologics Licensing (BLA) Applications to the EMA (EU) and FDA (US), respectively, for EG12014 with marketing partner, Sandoz AG, in December, 2021.

Formosa Pharmaceuticals’ chairman and founder, Dr. CY Cheng, said, "We are pleased to broaden our relationship with EirGenix for the development of HER2-related cancer therapies and leverage their proven clinical development expertise. We look forward to sharing the commercial benefits."

On March 24, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that an investigator-initiated trial (IIT) will commence shortly in the US investigating 64Cu SAR-bisPSMA in prostate cancer (NCT05286840)1 (Press release, Clarity Pharmaceuticals, MAR 24, 2022, View Source [SID1234610816]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The X-Cancer’s investigator-led trial of SAR-bisPSMA in known or suspected prostate cancer (X-Calibur) is a Phase I/II IIT in up to 150 patients at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, sponsored by Dr Luke Nordquist. It will investigate a broad spectrum of prostate cancer patients by imaging with 64Cu-SAR-bisPSMA on the day of administration and at later timepoints. The X-Calibur trial will be assessing the safety of 64Cu SAR-bisPSMA as well as looking at the impact of the product on staging and clinical management of participants with prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to support Dr Nordquist’s trial, who has had first-hand experience with our products in the theranostic 64Cu/67Cu SAR-bisPSMA SECuRE trial (NCT04868604)2. We look forward to continuing to work together on progressing the development of our optimised SAR-bisPSMA agent in prostate cancer and exploring the many benefits of this product as part of Clarity’s Targeted Copper Theranostics (TCT) program in pursuit of our ultimate goal of improving treatment outcomes for cancer patients."

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program, where the IIT at GURN is the fourth clinical trial utilising the SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)2, has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)3, is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). The most recent diagnostic 64Cu SAR-bisPSMA trial in the US, COBRA (NCT05249127)4, has received a Study May Proceed Letter from the FDA in February 2022, with recruitment of participants with biochemical recurrence of prostate cancer planned to commence in the second quarter of 2022. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Luke Nordquist, CEO and Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very impressed with the PET imaging data collected at GURN from the SECuRE trial which indicates high tumour targeting and retention, especially compared to first-generation PSMA agents that use a single PSMA binding motif and have very short half-lives of 1-2 hours. As such, we were excited to seize the opportunity and continue the development of SAR-bisPSMA in the diagnostic IIT at GURN, continuing to further expand the clinical benefits of the product and to provide our own prostate cancer patients with the very best technologies available.

"In addition to the clinical advantages, we have also been excited about the supply and logistical benefits of SAR-bisPSMA as a TCT, which can be distributed on-demand and in large scale from central manufacturing facilities. TCT can provide universal access to radiopharmaceuticals in every zip-code in the continental US, something that is lacking with current approved agents. GURN has a significant backlog of patients who cannot access sufficient quantities of PSMA imaging agents based on gallium-68 (Ga-68) or fluorine-18 (F-18) due to the logistical issues of short half-life isotopes. We have already experienced the benefits of Cu-64 based products and their longer shelf-life of up to 48 hours with our current trial with Clarity, and we expect minimal delays and interruptions as we look to address the large backlog of treatments, providing up to 150 prostate cancer patients with the critical imaging required to improve patient outcomes."

Dr Taylor said, "This fourth clinical trial of SAR-bisPSMA will build on the exciting data to date as we progress this product towards the market. The trial will also continue to demonstrate the numerous benefits of the centrally manufactured, on-demand distribution model of ready-to use cGMP TCT products over the first-generation short half-life products using Ga-68 and F-18. We look forward to Dr Nordquist advancing the X-Calibur trial and hope it will improve cancer diagnosis and ensure that critical treatments will be available to patients and their treating staff on time and at a convenient location when and where they need it most."

This announcement has been authorised for release by the Executive Chairman.

On March 24, 2022 Celsius Therapeutics, a biotechnology company leveraging its human tissue-based platform to develop precision medicines for patients with cancer and autoimmune disease, reported a summary of recent corporate highlights, including the nomination of its first clinical candidate for inflammatory bowel disease (IBD), an additional $83 million in financing and key initiatives for 2022 (Press release, Celsius Therapeutics, MAR 24, 2022, View Source [SID1234610869]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2021 was a pivotal year of growth and advancement for Celsius," said Tariq Kassum, M.D., president and CEO of Celsius. "We have successfully scaled our SCOPE (Single Cell Observations for Precision Effect) platform to allow us to discover therapeutic targets of high interest in IBD and solid tumors. In addition, our approach allows us to identify patient stratification hypotheses based on cell types and cell signatures, expanding the reach of precision medicine into new territory. We have now performed single cell RNA sequencing of over 1,000 clinical tissue samples using this platform technology and our dataset continues to grow rapidly. We are excited to be fulfilling the vision of Celsius as we advance a potential first-in-class TREM1 antibody program for IBD and look to design smarter clinical studies based on biologic insights from our proprietary platform."

Announcement of lead clinical candidate for IBD

Celsius reported its first clinical candidate, CEL383, an anti-TREM1 antibody, for the treatment of IBD. TREM1, a myeloid target with a central role in IBD, was identified through single cell analysis of hundreds of clinical samples using machine learning algorithms via the company’s SCOPE platform. Through this approach, Celsius was able to identify and deeply characterize subsets of a pathogenic cell type that drive resistance to anti-TNF therapies and has defined a series of targets modulating behavior of these cell subtypes. TREM1, an amplifier of inflammation that resides at the intersection of the microbiome and the immune system, is the first of these targets.

The company anticipates filing an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) within the next year, with a Phase 1 study expected to commence in early 2023. Celsius also plans to enable a precision medicine approach for CEL383 in IBD and has developed multiple biomarker hypotheses for evaluation in early clinical studies.

Progress in oncology pipeline

Beyond CEL383, Celsius has two ongoing drug discovery programs in oncology, both directed towards targets identified through analysis of hundreds of clinical solid tumor samples using the company’s SCOPE platform. The company plans to release more information on these programs in 2022. Additionally, the first candidate target in the company’s colorectal cancer collaboration with Servier, a global independent pharmaceutical group, has recently been selected, triggering a milestone payment to Celsius.

Additional $83 million in financing secured

Celsius also announced that it has raised $83 million in additional financing, comprised of a Series A extension and a Series B financing. The Series B financing was led by Casdin Capital, with participation from original investors Alexandria Venture Investments, GV, Heritage Provider Network and Third Rock Ventures and new investors Amgen Ventures, Amplitude Ventures, Catalio Capital, Co-Win Ventures, Fast Track Initiative, Section 32, as well as other undisclosed institutional investors. In connection with the completion of the Series B, Suzanne Jung Angell from Casdin Capital joined Celsius’ board of directors.

Key initiatives for 2022

Celsius expects 2022 to be an important year as the company continues to advance its mission to create new precision medicines for complex diseases such as autoimmunity and cancer. In 2022, the company plans to pursue the following key initiatives:

Continue to build the company’s clinically annotated, proprietary collection of human tissue data in IBD and cancer, and mine this dataset for new targets and patient stratification approaches
Prepare an IND for CEL383, the company’s lead antibody program for IBD
Advance the company’s oncology programs towards development candidate nomination
Nominate additional novel targets, derived from the company’s SCOPE platform, as drug discovery programs
Further progress the identification and validation of targets for colorectal cancer under the company’s ongoing drug discovery collaboration with Servier

On March 24, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Ocuphire Pharma, MAR 24, 2022, View Source [SID1234610904]).

"2021 proved to be a highly productive year for Ocuphire with 2022 setting up to be a more transformative year given our series of late-stage data read-outs in MIRA, LYNX and ZETA trials throughout the year, ending with our first planned NDA filing. We have an ambitious vision in ophthalmology targeting highly prevalent refractive and diabetic retinal diseases with our 2 lead small molecule drug candidates," said Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma. "We are pleased to rapidly exceed enrollment in and complete 4 clinical trials across Nyxol and APX3330 in the first months of 2022. At our R&D Day in January, we reported for the first time positive Phase 2 results in presbyopia for Nyxol as a single-agent. With this new chronic opportunity for Nyxol alone as a pupil modulation agent, we can potentially realize synergies in presbyopia and NVD patients. We recently held a FDA Type-C meeting and gained clear guidance for the VEGA Phase 3 presbyopia program, for which we plan to initiate in mid-2022. With the successful enrollment of the 24-week study for our retinal candidate APX3330 and the continued favorable systemic and ocular safety profile that we shared at our recent R&D Day, we are also excited to lead the retinal landscape with an oral option for diabetic retinopathy patients and report our topline data from our placebo-controlled, double-masked, Phase 2b ZETA-1 trial in the second half of 2022."

Jay Pepose, MD, PhD, Ocuphire’s Medical Advisor and Board Member stated, "Ocuphire’s product candidates, if approved, would give eye care practitioners the ability to enhance their patients’ vision and overall experience. As a refractive surgeon, I am particularly excited about Nyxol for RM because there is currently no FDA approved commercially available product to treat this major clinical need and patient complaint. For presbyopia, I am impressed by Nyxol’s favorable tolerability profile and durable near vision improvements for at least 12 hours across a broad age of patients (40 to 64 years old) in the recent VEGA-1 Phase 2 trial. Nyxol is differentiated from the other miotics in the presbyopia landscape by its mechanism of action inhibiting the iris dilator muscle to achieve an optimal pupil size. Since Nyxol does not engage the iris sphincter or ciliary muscle, as a single drop, this may become a viable treatment option for presbyopia patients with high myopia, for whom miotics are contraindicated because of the risk of retinal detachment."

Cam Gallagher, Chairman of the Board for Ocuphire added, "In the past year, Ocuphire has elevated its profile within the ophthalmology and optometry medical community and we are delighted to have expanded our prestigious Medical Advisory Board to over 15 refractive and retinal KOLs. The team led by Mina has executed and delivered on several key clinical development milestones and set the momentum for a catalyst-rich 2022 that has the potential to build significant value for our company and shareholders."

Key Anticipated Future Milestones

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

•Reversal of Mydriasis (RM):

•MIRA-3: Report topline results from the Phase 3 MIRA-3 registration trial at the end of 1Q 2022

•MIRA-4: Report topline results from pediatric safety trial in 2Q 2022

•New Drug Application (NDA): If the results are positive from the ongoing MIRA trials, expect to file an NDA with the FDA for Nyxol in RM indication in late 2022 with potential launch as first dilation reversal drop in 2H 2023

•Presbyopia: Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% LDP as adjunctive treatment; and, if successful, expect to file an NDA in 2023

•Night Vision Disturbances (NVD): Report top-line results in 2Q 2022 from the Nyxol Phase 3 LYNX-1 trial

•Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022

Fourth Quarter and Recent Business Highlights

Corporate

•In January 2022, the Company held an Investor R&D Day webinar that featured six ophthalmic Key Opinion Leaders (KOLs): Jay Pepose, MD, PhD, James Katz, MD and Mitchell Jackson, MD from refractive surgery, Paul Karpecki, OD from optometry, and David Boyer, MD and Peter Kaiser from retina practice areas who discussed the unmet needs in RM, presbyopia and DR being addressed by Ocuphire’s two late-stage clinical drug assets, Nyxol and APX3300. A replay of the event can be found on the company’s corporate website here.

•In December 2021, the Company strengthened its Medical Advisory Board with the addition of six world-class KOLs: David Brown, MD, FACS; David Lally, MD; Y. Ralph Chu, MD; James Katz, MD; Mitchell Jackson, MD; and Douglas Devries, OD.

Clinical Development

•In March 2022, the Company completed enrollment of 103 (target of 80-100) diabetic retinopathy patients in the ZETA-1 Phase 2b trial of first-in-class oral APX3330. Masked safety data from the trial, announced during the R&D Day event in January 2022, demonstrated a favorable safety profile, consistent with prior studies with additional exposure data in diabetic patients with retinal disease.

•In March 2022, the Company completed enrollment in MIRA-4 Trial for Nyxol in RM by enrolling 23 healthy (target of 20) pediatric subjects ages 3-11 years.

•In February 2022, the Company completed enrollment in MIRA-3 Pivotal Phase 3 Trial for Nyxol in RM, surpassing its enrollment target of 330 with 368 patients ages 12 years and over.

•In February 2022, Ocuphire held a Type-C meeting with the FDA from which it obtained guidance regarding the design of pivotal studies and clarification of the CMC and other data requirements for filing an NDA to seek approvals of Nyxol for the treatment of presbyopia, both as a single agent and with LDP as adjunct eye drops. This represents our third Type-C or Type-B End of Phase 2 meeting with FDA for the Nyxol program across indications.

•In January 2022, the Company completed enrollment of LYNX-1 Phase 3 Trial investigating Nyxol for the treatment of night vision disturbances (NVD) in 145 patients (target of 140).

•In January 2022, the Company announced new positive data from the VEGA-1 Phase 2 trial for Nyxol as a single agent in presbyopia, showing that one drop of Nyxol had statistically significant improvement in efficacy and long durability compared to placebo at 12 hours post-dosing. The Company plans to proceed with the Phase 3 VEGA program to potentially support 2 NDAs: Nyxol as a single drop and Nyxol with low-dose pilocarpine (LDP) as adjunctive treatment.

Presentations, Publications, and Conferences

•In February 2022, David Boyer, MD, presented at the Angiogenesis, Exudation, and Degeneration Conference, highlighting the favorable safety data from the ongoing ZETA-1 Phase 2 trial of APX3330 in DR.

•In February 2022, Inder Paul Singh, MD, presented at the Cataract Surgery: Telling It Like It Is Conference in Orlando. Dr. Singh presented the positive results from the completed VEGA-1 Phase 2 trial of Nyxol in presbyopia as a single agent and in combination with adjunctive LDP.

•In January 2022, Mina Sooch, Founder and CEO participated in the panel discussion titled "The Role of Gender Equality in Changing the Life Sciences Investment and Innovation Landscape" at the 11th LifeSci Partners Corporate Access Event.

•In November 2021, clinical data on Nyxol and APX3330 were presented at poster sessions at the American Academy of Ophthalmology (AAO) 2021 annual meeting held in New Orleans. In addition, Ocuphire presented new data on improvement in intermediate vision and Snellen equivalent near vision at the Eyecelerator@AAO 2021 conference. Ocuphire was one of two companies presenting clinical data for presbyopia at this meeting.

•In October 2021, the Company announced the publication of a review article titled "Inhibition of APE1/Ref-1 for Neovascular Eye Disease: From Biology to Therapy" in the Special Issue "Advances in Molecular Activity of Potential Drugs" of the International Journal of Molecular Sciences. The article underscores the role of the APE1/Ref-1 protein in pro-angiogenic pathways associated with neovascular eye disease including diabetic retinal diseases and age-related macular degeneration.

•In October 2021, the Company announced the publication of a review article in Cells titled "Potential Therapeutic Candidates for Age-Related Macular Degeneration" noting the potential of APX3330 (referred to as "E3330"). The authors conclude that APE1/Ref-1 inhibitors such as APX3330 could inhibit the abnormal blood vessel formation seen in AMD by reducing retinal endothelial cell proliferation, migration, and tube formation.

•In October 2021, Michael J. Allingham, MD, PhD presented at the 39th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) (Diabetic Retinopathy 1 Symposium) held in San Antonio, highlighting the favorable safety and tolerability data for APX3330 in over 300 healthy volunteers and cancer/hepatitis patients across 11 Phase 1 and Phase 2 studies. In addition, Mina Sooch, CEO, presented APX3330 history and the design of the ongoing Phase 2 trial in DR at the OIS Retina Innovation Summit@ASRS on October 7, 2021 in San Antonio, TX.

Fourth Quarter and Year Ended December 31, 2021 Financial Highlights

As of December 31, 2021, the Company had cash and cash equivalents of approximately $24.5 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Net cash used in operating activities for the quarter and year ended December 31, 2021 was $5.6 million and $19.4 million, respectively.

No collaboration revenue was recorded in the fourth quarter. Collaborative revenue was $0.6 million for the year ended December 31, 2021. Revenue was derived from the collaboration and license agreements with Processa and Biosense related to certain Rexhan products and technology transfers. There was no collaboration revenue recognized during the comparable prior year periods.

General and administrative expenses for the quarter and year ended December 31, 2021 were $1.4 million and $8.1 million, respectively, compared to $1.3 million and $2.8 million for the quarter and year ended December 31, 2020, respectively. The $5.3 million increase for the year over year periods was primarily attributable to administrative employee headcount, stock-based compensation, insurance, legal and settlement costs, costs associated with operating as a public company subsequent to the reverse merger, and professional services and other operating costs. General and administrative expenses included $0.3 million and $0.2 million in non-cash stock-based compensation expense during the quarters ended December 31, 2021 and 2020, respectively, and $1.1 million and $0.7 million in non-cash stock-based compensation expense during the years ended December 31, 2021 and 2020, respectively.

Research and development expenses for the quarter and year ended December 31, 2021 were $4.7 million and $15.2 million, respectively, compared to $4.3 million and $6.6 million for the quarter and year ended December 31, 2020, respectively. The $8.5 million increase for the year over year periods was primarily attributable to clinical trial expense, manufacturing activities to support clinical advancement of Nyxol and APX3330, consulting services as well as regulatory and other research and development efforts. Research and development expenses also included $0.2 million and $0.3 million in non-cash stock-based compensation expense during the quarters ended December 31, 2021 and 2020, respectively, and $0.8 million in non-cash stock-based compensation expense during each of the years ended December 31, 2021 and 2020.

The loss from operations for the quarter ended December 31, 2021 was $6.2 million, compared to $14.0 million for the quarter ended December 31, 2020. The loss from operations for the year ended December 31, 2021 was $22.7 million, compared to $20.0 million for the year ended December 31, 2020. Net loss for the quarter ended December 31, 2021 was $6.3 million, compared to $18.7 million for the quarter ended December 31, 2020. Net loss for the year ended December 31, 2021 was $56.7 million, compared to $24.6 million for the year ended December 31, 2020. Net loss per share for the quarter ended December 31, 2021 was $0.35, compared to $2.46 for the quarter ended December 31, 2020. Net loss per share for the year ended December 31, 2021 was $3.82, compared to $5.28 for the year ended December 31, 2020.

The fair value change in derivative and warrant liabilities was a non-cash expense of zero for the quarter ended December 31, 2021 compared to a non-cash expense of $1.6 million for the quarter ended December 31, 2020. The fair value change in derivative and warrant liabilities was a non-cash expense of $33.8 million for the year ended December 31, 2021 compared to a non-cash expense of $1.5 million for the year ended December 31, 2020.

For further details on Ocuphire’s financial results, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 to be filed with the Securities and Exchange Commission.