On March 3, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the year ended December 31, 2021 (Press release, Elevation Oncology, MAR 3, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-fourth-quarter-and-full-year-2021-financial-results [SID1234609449]).

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 year of substantial growth and accomplishment for Elevation Oncology, one where we built the foundation for a multi-asset, precision oncology company to deliver on the promise of precision medicine with first-in-class therapeutics for patients with genomically defined cancers," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are excited about the prospect of reporting initial clinical data in 2022, providing proof-points around the potential clinical benefit of seribantumab in patients harboring NRG1 fusions. In addition, we are eager to explore opportunities to expand our product candidate pipeline and advance new discoveries through our Caris Life Sciences collaboration and ongoing business development activities. We are committed to uncovering additional true oncogenic drivers, developing therapies to target them, and identifying the patients who will most likely benefit."

2021 Key Corporate Achievements

Seribantumab

Launched new global clinical trial sites. The Phase 2 CRESTONE study is now enrolling patients across the US, Australia, and Canada.
Announced an investigator-presented case study. A patient with pancreatic cancer harboring an NRG1 fusion was treated with seribantumab under a compassionate use program. Data from the case study showed a confirmed partial response and durable clinical benefit.
Established 3 grams weekly as the optimized dose. As part of our ongoing Phase 2 CRESTONE study, the Company established the optimal dosing for seribantumab.
Presented new preclinical data. Preclinical data on additional tumor models harboring an NRG1 fusion was presented at AACR (Free AACR Whitepaper) 2021.
Published a preclinical manuscript. A preclinical manuscript on the effect of seribantumab in NRG1 fusion models was published in Clinical Cancer Research.
Corporate

Entered into a joint discovery and development collaboration with Caris Life Sciences. Under the terms of the agreement, the partners will utilize Caris’ diagnostic data to accelerate the identification of new, actionable genomic alterations for potential future drug development.
Formed new strategic diagnostic collaborations. In 2021 the Company organized a diagnostic consortium of 10 patient identification collaborators for the Phase 2 CRESTONE study.
Completed a successful initial public offering. The company raised $106.5 million in gross proceeds, before deducting underwriting discounts, commissions, and estimated offering expenses.
Strengthened corporate leadership team. With the addition of Joseph Ferra as Chief Financial Officer, the promotion of Valerie Malyvanh Jansen, MD, PhD to Chief Medical Officer and the appointment of R. Michael Carruthers to the Board of Directors, the Company continues to build a world class, experienced leadership team.
Expected 2022 Milestones and Operational Objectives

Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Ongoing target evaluation and continued execution of our strategy for future pipeline expansion
Fourth Quarter and Full Year 2021 Financial Results

Research and development expenses for the fourth quarter 2021 were $6.2 million, compared to $8.4 million for the fourth quarter 2020. The decrease in R&D expense was primarily related to a decrease in manufacturing activity in the fourth quarter of 2021. For the year ending December 31, 2021, research and development expenses were $23.6 million, compared to $15.5 million for the year ended December 31, 2020. The increase in R&D expense was primarily related to an increase in manufacturing, personnel costs and clinical trial expenses associated with the CRESTONE study.

General and administrative expenses for the fourth quarter 2021 were $3.4 million, compared to $0.5 million for the fourth quarter 2020. For the year ending December 31, 2021, G&A expenses were $8.5 million, compared to $1.8 million for the year ended December 31, 2020. The quarterly and yearly increases in G&A expense were primarily related to personnel costs, professional services and consulting, and other administrative costs.

Net loss for the fourth quarter 2021 was $9.6 million, compared to a net loss of $8.9 million for the fourth quarter 2020. For the year ending December 31, 2021, the Company reported a net loss of $32.0 million, compared to a net loss of $17.3 million for the year ended December 31, 2020.

Financial Outlook

As of December 31, 2021, the Company had cash and cash equivalents totaling $146.3 million, which is expected to fund current operations into the second quarter of 2023.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On March 3, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, MAR 3, 2022, View Source [SID1234609448]):

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 listing of the Flamingo-01 Phase III trial on clinicaltrials.gov provides clinicians and patients with an important source of information including trial updates and design, participating clinical sites, and contact information.

Three abstracts/posters were accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2022. The AACR (Free AACR Whitepaper) plans to publish the 3 abstracts on April 8, 2022 and the 3 posters on April 11-12, 2022.

The Company anticipates making various patent filings that cover clinical use of GLSI-100, use of immune response data to improve patient treatment, manufacturing of GP2, and the administration and preparation of GLSI-100. If these patent claims are issued, they have the potential to extend the patent life of GP2 beyond 2040.

About the AACR (Free AACR Whitepaper) Annual Meeting 2022

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. In the double-blinded cohort of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo and an open label cohort of up to 100 patients will be enrolled including all other HLA types. The trial has been designed to detect a hazard ratio of 0.3 in IBCFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial, NCT05232916, is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On March 3, 2022 xCures, Inc. and BioSpark, Inc. reported their strategic partnership to harmonize and commercialize a joint oncology Real World Data (RWD) offering (Press release, xCures, MAR 3, 2022, View Source [SID1234609447]). The partnership unlocks new insights into the treatment and outcomes of cancer patients through a novel dataset spanning 40,000+ cancer patients. The data results from the combined structuring of published case reports and comprehensive, cross-provider, Electronic Health Reports (EHRs) collected through XCELSIOR (NCT03793088).

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!

RWD is necessary to provide direct insight and clinical decision support to patients and their treating oncologists through the xCures platform. The RWD is also available to support clinical research and development, health economics and outcomes research, and the generation of strategic insights across the life sciences and healthcare continuum.

"Our partnership with BioSpark rapidly expands the scope of the RWD that xCures is using to deliver on our promise to help patients and their physicians understand the best treatment options," said Mika Newton, CEO of xCures. "Together, xCures and BioSpark are driving a fundamental shift in the quality, utility, and value of real-world evidence. The research and commercial insights from this data will be unparalleled."

The RWD data set contains a diverse set of patient records, including:

15,000+ breast cancer cases
10,000+ colorectal cancer cases
7,500+ pancreatic cancer cases
5,500+ bladder cancer cases
5,000+ lung cancer cases
All the data will be harmonized into Case Report Form (CRF) structure and allow for complete data source verification. The final data is in a CFR Part11 compliant database suitable for research and regulatory submissions. Highly useful for precision medicine, these data are particularly rich in genetic markers and biomarkers and offer complete longitudinal research-grade oncology outcomes, such as formal criteria-based tumor response or progression-free survival.

Mark Shapiro, COO of xCures, stated, " The data BioSpark provides represents some of the most relevant and high-quality Real World Data available. Our companies share highly similar values and goals, and their data will provide a significant boost to our clinical decision support platform as well as our RWD offerings."

"Our partnership with xCures is both unique and ideal. The XCELSIOR platform that xCures has developed is state-of-the-art and allows our data to be utilized in several important capacities that would not otherwise have been possible at this stage," said Kristian Thorlund, Co-Founder and President of BioSpark.

On March 3, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results and highlights for the fourth quarter and year ended December 31, 2021 (Press release, GlycoMimetics, MAR 3, 2022, View Source [SID1234609446]). Cash and cash equivalents at December 31, 2021 were $90.3 million.

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!

"During 2021, we focused on completing enrollment of our pivotal trial evaluating uproleselan in AML. Towards the end of the year, within two weeks of each other, GlycoMimetics completed enrollment of our Phase 3 trial and the NCI completed enrollment of the Phase 2 portion of its Phase 2/3 trial. This represents a significant achievement for our entire organization, particularly during a global pandemic that has negatively impacted enrollment rates for numerous clinical studies. The top-line data from these two trials of uproleselan in AML will undoubtedly be transformative for the organization. As the survival data matures, we are actively preparing for a potential regulatory submission and subsequent commercialization of uproleselan," commented Harout Semerjian, Chief Executive Officer.

Operational Highlights

Uproleselan

●GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML completed enrollment of 388 patients across 70 sites in the U.S., Australia and Europe. The Company reiterates its projection of a topline data release after year-end 2022.
●In parallel, the NCI-sponsored Phase 2/3 clinical trial, which is evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, completed its Phase 2 enrollment of 267 patients. The Company intends to share topline results from the NCI’s planned interim analysis of Phase 2 data based on event-free survival.
●Efficacy and safety data from a Phase 1/2 clinical study of uproleselan were published online September 16, 2021, in the journal BLOOD. An analysis of minimal residual disease (MRD) showed an MRD negative rate of 69 percent in patients with relapsed/refractory AML, indicating an enhanced depth of response following addition of uproleselan to salvage therapy.
●Investigator-sponsored clinical trials to evaluate expanded indications for uproleselan were initiated at the University of California-Davis, Washington University at St. Louis, MD Anderson Cancer Center and the University of Michigan.
●Apollomics, our exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy designation from the China National Medical Products Administration and initiated a Phase 3 registrational study in November 2021.

GMI-1687

●In 2021, the Company advanced an IND-enabling program for GMI-1687, with sickle cell disease acute VOC as the lead indication. The Company reiterates its plan to submit an IND to the FDA in the first half of 2022.

GMI-1359

●At the 63rd Annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December, the Company’s collaborators at MD Anderson highlighted the potential for GMI-1359 in breaking resistance in AML, particularly in patients with FLT-3 ITD mutations. Subject to available funding, the Company plans to evaluate potential indications for further clinical development.

GMI-2093

●At the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, preclinical data was provided for the first time, as a late-breaking abstract, on the impact of one of the Company’s galectin-3 inhibitors on tumor fibrosis, mononuclear cell infiltration, and antitumor activity in a pancreatic adenocarcinoma model when given in combination with an anti-PD-L1 inhibitor.
●In late 2021, the Company nominated GMI-2093 as a development lead candidate after observing high affinity and selectivity for galectin-3 with oral bioavailability. The role of galectin-3 in cancer, fibrosis and other inflammatory disease is emerging as a therapeutic target, and the Company plans to advance this program through potential strategic partnerships.
Executive Management Team

●The Company expanded its executive management in late 2021 and early 2022:
●Lisa DeLuca, Ph.D., was hired in November as Vice President, Regulatory Affairs
●Bruce Johnson was hired in February 2022 as Senior Vice President and Chief Commercial Officer
●Deepak Tiwari was hired in March 2022 as Vice President, Technical Operations
Fourth Quarter and Year-end 2021 Financial Results:

●Cash position: As of December 31, 2021, GlycoMimetics had cash and cash equivalents of $90.3 million as compared to $137.0 million as of December 31, 2020.

●Revenue: During the years ended December 31, 2021 and 2020, the Company recognized revenue of $1.2 million and $10.2 million, respectively, all of which was the result of payments received under our license and collaboration agreement with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China.

●R&D Expenses: The Company’s research and development expenses increased to $12.9 million for the quarter ended December 31, 2021, as compared to $11.7 million for the fourth quarter of 2020 due to higher development expenses related to manufacturing costs for the uproleselan validation batches and increased costs for IND enabling activities of GMI-1687.

Research and development expenses for the year ended December 31, 2021 increased to $47.5 million as compared to $44.9 million in the prior year. The increase in expenses was due to higher clinical development expenses related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML, increased manufacturing costs and increased IND enabling activities related to GMI-1687.

●G&A Expenses: The Company’s general and administrative expenses increased to $4.5 million for the quarter ended December 31, 2021, as compared to $4.0 million for the fourth quarter of 2020. General and administrative expenses for the year ended December 31, 2021, increased to $17.1 million as compared to $16.7 million in the prior year. These increases were due to higher recruiting, consulting and legal expenses incurred in 2021 offset by lower personnel-related expenses due to the CEO transition.

●Shares Outstanding: Shares of common stock outstanding as of December 31, 2021 were 52,313,894.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 4048456. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 4048456.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that represents a potential life-cycle extension to uproleselan. GMI-1687 has been shown in animal models to be fully bioavailable following subcutaneous administration. As such, GMI-1687 is being positioned as a potentially self-administered drug to be used in the outpatient setting for the treatment of hematologic malignancies, such as AML and MDS, as well as inflammatory diseases such as acute vaso-occlusive crisis of sickle cell disease.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4 — both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

About GMI-2093

GMI-2093 is a galectin-3 inhibitor discovered and being developed by GlycoMimetics. Available evidence indicates that the galectin-3 class may activate a variety of profibrotic factors, promote fibroblast proliferation and transformation, and mediate collagen production. Recent studies have defined key roles for galectin-3 in fibrogenesis in diverse organ systems, including liver, kidney, lung, and heart. Additionally, galectin-3 has been shown in preclinical models to be closely involved in tumor cell transformation, migration, invasion, and metastasis. GMI-2093 is being developed as a therapeutic strategy against tissue fibrosis and the treatment of certain cancers.

On March 3, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the year ended December 31, 2021 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, MAR 3, 2022, View Source [SID1234609445]).

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 Key Highlights

May 2021: Commenced patient enrollment in the potentially pivotal study (CNS-201) evaluating efficacy of Berubicin in the treatment of adult recurrent Glioblastoma Multiforme (rGBM), one of the most aggressive types of brain cancer;
June 2021: FDA granted Fast Track Designation to CNS Pharmaceuticals for Berubicin for the treatment of recurrent GBM;
September 2021: Dosed first group of patients with Berubicin in the potentially pivotal study for the treatment of GBM;
December 2021: Received approval from "swissethics," the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent GBM; and
January 6, 2022: Announced a $11.5M private placement, priced at-the-market under Nasdaq rules.
"Operationally 2021 was a terrific year for the Company as we established the global framework for building and expanding our potentially pivotal clinical study of berubicin for the treatment of GBM. Our priority remains focused on advancing berubicin to bring a meaningful treatment to patients, families and clinicians, who currently have extremely limited and often ineffective treatment options. I am continually impressed by the speed and efficiency with which our small team has executed our Berubicin trial. At the onset of 2022 we completed a $11.5 million private placement which enables us to continue driving the development of berubicin this year towards the milestones ahead of us," commented John Climaco, CEO of CNS Pharmaceuticals. "While staying steadfast in our primary goal of bringing berubicin to GBM patients, we are also continually evaluating platform opportunities for expansion into additional oncology indications to bolster our pursuit of therapies for patients through developing novel treatments for primary and metastatic cancers. I am very pleased with the progress we’ve made over the past year, but am even more so looking forward to what lays ahead for CNS Pharmaceuticals."

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. In mid-2021 the Company announced it has dosed the first group of patients in its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Further patient enrollment, randomization and dosing is currently underway as well as a robust lineup of clinical sites located globally which are advancing toward activation and enrollment.

The FDA granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Upcoming Milestones

Expand potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM into additional countries;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected during first half of 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. The Company’s development work has produced a new mesylate salt of WP1244, now identified as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244 portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.

Upcoming Milestones

File IND in 2023.
Summary of Financial Results for the Full Year 2021

The net loss for the year ended December 31, 2021 was approximately $14.0 million compared to approximately $9.5 million for the comparable period in 2020. The change in net loss is attributable to increased personnel and activity associated with preparing for and commencing the Company’s potentially pivotal clinical trial of Berubicin for recurrent glioblastoma multiforme in 2021. The Company reported research and development expenses of $9.3 million for the year ended December 31, 2021 compared to approximately $5.1 million for the comparable period in 2020. The expenses incurred during the period were related to drug manufacturing and labor related to the preparation for and commencement of the Company’s potentially pivotal Berubicin study. General and administrative expense was approximately $4.7 million for the year ended December 31, 2021 compared to approximately $4.4 million for the comparable period in 2020.

As of December 31, 2021, the Company had cash of approximately $5.0 million and working capital of approximately $5.3 million. In early January 2022, the Company completed an offering of common stock and warrants for gross proceeds of $11.5 million. Our current expectation is that our cash on hand and the proceeds from the offering during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.