On March 25, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) have recommended approval of Cabometyx as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy (Press release, Ipsen, MAR 25, 2022, View Source [SID1234610994]).

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Jaume Capdevila, M.D. PhD Medical Oncologist at the Vall d´Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, and a trial investigator, said "Currently, for people living with radioactive iodine-refractory differentiated thyroid cancer, there are no standard-of-care treatment options should the cancer progress after first-line therapy. As a practicing physician regularly seeing people living with this uncommon form of cancer, I am encouraged to see the potential Cabometyx may bring for these patients with so few options."

The CHMP positive opinion was based on results from the pivotal COSMIC-311 Phase III trial in which, at a planned interim analysis with a median follow-up of 6.2 months, Cabometyx demonstrated a significant reduction in the risk of disease progression or death by 78% versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; p<0.0001).1 Another primary endpoint, the objective response rate (ORR), also favoured Cabometyx with 15% vs. 0% for placebo (p=0.028) at a median follow-up of 8.9 months, but did not meet the criteria for statistical significance. A further analysis, with a median follow-up of 10.1 months, was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, whereby Cabometyx continued to demonstrate superior median progression-free survival of 11.0 versus 1.9 months and a maintained reduction in the risk of disease progression or death of 78% versus placebo (HR: 0.22, 96% confidence interval [CI]: 0.15-0.32; p<0.0001).2 The safety profile identified in the COSMIC-311 trial across the two analyses was consistent with that previously observed for Cabometyx, and adverse events were managed with dose modifications.1,2

Steven Hildemann, M.D. PhD, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Global Patient Safety at Ipsen, said "With the promising interim results from the COSMIC-311 trial further reinforced by the maintained significant progression-free survival benefit demonstrated in the final analysis, we are pleased that the CHMP has concluded that Cabometyx may offer an important treatment option for people affected by this uncommon cancer. Following this positive opinion, we look forward to receiving the final decision from the European Commission, potentially bringing Cabometyx one step closer to reaching a patient population in critical need of new treatment options."

This positive CHMP opinion follows the U.S. Food and Drug Administration’s approval in September 2021 of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following prior vascular endothelial growth factor receptor targeted therapy and who are radioactive iodine-refractory or ineligible.

About radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC)

In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.3 Thyroid cancer is the ninth most commonly occurring cancer globally and incidence is three times higher in women than in men, with the disease representing one in every 20 cancers diagnosed among women.3 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid cancer (DTC) makes up about 90 to 95% of cases.5,6 These include papillary, follicular and Hürthle cell cancer.5,6 DTC is typically treated with surgery, followed by ablation of the remaining thyroid tissue with radioactive iodine (RAI), but approximately 5 to 15% of cases are resistant to RAI treatment.7 Patients who develop RAI-R DTC have a poor prognosis with an average estimated survival of three to five years.8

About the COSMIC-311 trial

COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that enrolled

258 patients at 164 sites globally.1,2 Patients were randomized in a 2:1 ratio to receive either Cabometyx 60 mg or placebo once-daily.1 The primary endpoints were progression-free survival in the intention-totreat population as well as ORR in the first 100 randomly assigned patients (objective response rate intention-to-treat [OITT] population), both evaluated by a blinded independent radiology committee. Additional endpoints include safety, overall survival and quality of life.1 Exelixis is the sponsor of COSMIC311, and Ipsen is co-funding the trial. More information about this trial is available at ClinicalTrials.gov.

About Cabometyx (cabozantinib)

In the U.S., Cabometyx tablets are approved for the treatment of people living with advanced renal cell carcinoma (RCC); for the treatment of people living with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for people living with RAI-R DTC who have been previously treated with VEGFR-targeted therapy; and for patients living with advanced RCC as a first-line treatment in combination with nivolumab. Outside the U.S., Cabometyx is currently approved in 60 countries, including in the European Union, Great Britain, Norway, Iceland, Australia, New Zealand, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong Kong, Singapore, Macau, Jordan, Lebanon, the Russian Federation, Ukraine, Turkey, the United Arabic Emirates (U.A.E.), Saudi Arabia, Serbia, Israel, Mexico, Chile, Peru, Panama, Guatemala, the Dominican Republic, Ecuador, Thailand, Malaysia, Colombia and Egypt for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union, Great Britain, Norway, Iceland, Canada, Australia, New Zealand, Brazil, Taiwan, Hong Kong, Singapore, Lebanon, Jordan, the Russian Federation, Ukraine, Turkey, the U.A.E., Saudi Arabia, Israel, Serbia, Mexico, Chile, Peru, Panama, Guatemala, the Dominican Republic, Ecuador, Thailand, Egypt and Malaysia for previously untreated intermediate- or poor-risk advanced RCC; and in the European Union, Great Britain, Norway, Iceland, Canada, Australia, Switzerland, Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South Korea, Singapore, Jordan, the Russian Federation, Ukraine, Turkey, Lebanon, the U.A.E., Peru, Panama, Guatemala, Chile, the Dominican Republic, Ecuador, Thailand, Brazil, New Zealand, Egypt and Malaysia for HCC in adults who have previously been treated with sorafenib. Cabometyx is also approved in combination with nivolumab as first-line treatment for people living with advanced RCC, in the European Union, Great Britain, Norway, Iceland, Switzerland, Canada, Taiwan, Singapore, the U.A.E., Australia, Chile, Israel, Thailand, Malaysia, South Korea and the Russian Federation.

The detailed recommendations for the use of Cabometyx are described in the Summary of Product Characteristics (EU SmPC) and in the U.S. Prescribing Information (USPI).

Ipsen has exclusive rights for the commercialization of Cabometyx outside the U.S. and Japan. Cabometyx is marketed by Exelixis, inc. in the U.S. and by Takeda Pharmaceutical Company Limited in Japan. Cabometyx is a registered trademark of Exelixis, inc.

On March 25, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that it will report financial results for the full year ended December 31, 2021 on Thursday, March 31, 2022, after the close of U.S. markets (Press release, Inhibikase Therapeutics, MAR 25, 2022, View Source [SID1234610993]). Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET on Friday, April 1, 2022, to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 877-407-4018 (United States) or 201-689-8471 (International) with the conference code 13727872. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On March 25, 2022Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the fourth quarter and full-year ended December 31, 2021 (Press release, Delcath Systems, MAR 25, 2022, View Source [SID1234610992]).

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Recent Business Highlights

During and since the fourth quarter, Delcath:

Reported updated positive phase 3 FOCUS trial results for HEPZATO Kit (melphalan hydrochloride for injection/hepatic delivery system) for the treatment of patients with unresectable liver-dominant metastatic ocular melanoma, including initial survival data analysis
Confirmed guidance for the mid-year Class 2 resubmission of the NDA to FDA
Resumed direct responsibility for sales, marketing, and distribution activities for the CHEMOSAT Hepatic Delivery System in all of Europe
Achieved medical device regulation certification for CHEMOSAT in Europe
Appointed David Hoffman as General Counsel and Chief Compliance Officer and Anthony Dias as Vice President of Finance
In addition, during and since the fourth quarter, independent investigators published:

Repeated percutaneous hepatic perfusion with melphalan can maintain long-term response in patients with liver cancers in the journal Cardiovascular and Interventional Radiology1
Chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma in the journal Melanoma Research2
Percutaneous Hepatic Perfusion (PHP) with Melphalan in Liver-Dominant Metastatic Uveal Melanoma: The German Experience in the journal Cancers3
Initiation of Chemosaturation with Percutaneous Hepatic Perfusion Program in Interventional Radiology Department in the journal Cureus4
"Since the end of the third quarter, we have updated our previously reported positive phase 3 data with survival data, resumed direct sales of CHEMOSAT in Europe, and strengthened our leadership team," said Gerard Michel, CEO of Delcath. "Each of these achievements support our strategic priorities – filing of the HEPZATO NDA in mid-2022, preparing for the subsequent US launch when approved, and expanding the development of HEPZATO and CHEMOSAT into additional areas of high unmet need. We look forward to a pre-NDA meeting with FDA in the coming weeks."

Fourth Quarter 2021 Results

Income Statement Highlights.

Product revenue for the three months ended December 31, 2021, was approximately $0.2 million, compared to $0.4 million for the prior year quarter from sales of CHEMOSAT in Europe. Other income for the quarter was $1.9 million compared to $0.1 million in the prior year quarter with the increase primarily due to the acceleration of deferred revenue caused by the termination of the medac license agreement. Research and development expenses for the quarter were $3.6 million compared to $2.7 million in the prior year quarter. Selling, general and administrative expenses for the quarter were approximately $3.0 million compared to $4.5 million in the prior year quarter. Total operating expenses for the quarter were $6.6 million compared with $7.3 million in the prior year quarter. Expenses for the quarter included approximately $1.6 million of stock option expense compared to $3.5 million in the prior year quarter.

The Company recorded a net loss for the three months ended December 31, 2021, of $5.3 million, compared to a net loss of $7.0 million for the same period in 2020.

Full-Year 2021 Results

Product revenue for the year ended December 31, 2021, was approximately $1.3 million, compared to $1.2 million for the prior year from sales of CHEMOSAT in Europe. Other income for the year was $2.2 million compared to $0.5 million in the prior year with the increase primarily due to the acceleration of deferred revenue caused by the termination of the medac license agreement. Research and development expenses for the year were $13.8 million compared to $11.2 million in the prior year. Selling, general and administrative expenses for the year were approximately $13.6 million compared to $11.2 million in the prior year. Total operating expenses for the year were $27.4 million compared with $22.3 million in the prior year. Expenses for the year included approximately $7.8 million of stock option expense compared to $3.9 million in the prior year.

The Company recorded a net loss for the year ended December 31, 2021, of $25.6 million, compared to a net loss of $24.2 million for the year ended December 31, 2020.

Balance Sheet Highlights.

On December 31, 2021, the company had cash, cash equivalents and restricted cash totaling $27.0 million, as compared to cash, cash equivalents and restricted cash totaling $28.7 million on December 31, 2020. During the three months ended December 31, 2021 and December 31, 2020, we used $6.4 million and $5.0 million, respectively, of cash in our operating activities.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

On March 25, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the full year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAR 25, 2022, View Source [SID1234610991]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"2021 was a pivotal year for Vaccitech during which we achieved a number of strategic, operational, and financial objectives, advanced multiple immunotherapeutic and prophylactic candidates in clinical development and strengthened and expanded our T cell activating discovery engine platform via the acquisition of Avidea Technologies," commented Bill Enright, Vaccitech’s CEO. "All of this progress puts us in a strong position to deliver on our long-term plans. We anticipate that 2022 will be a year where we continue to advance our product pipeline with key data readouts in several programs. We look forward to reporting on these developments throughout the year."

2021 and Recent Corporate Developments

·Raised $166.5 million of proceeds in a Series B private financing, including $41.2 million from previously issued convertible loan notes that converted into Series B shares.
·Completed a public listing on NASDAQ, raising gross proceeds of $110.5 million through an offering of American Depository Shares.
·Initiated patient dosing in HPV001, a Phase 1/2 clinical trial of VTP-200, an immunotherapeutic candidate in development for the treatment of persistent infection with high-risk HPV.
·Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of patients with chronic Hepatitis B virus (HBV) infection who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor, or Nrtl, therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by Vaccitech’s immunotherapy candidate, VTP-300, in Nrtl-suppressed patients with chronic HBV infection.
·Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus in Oxfordshire, United Kingdom. The site will house Vaccitech’s headquarters, state-of-the-art wet laboratory, and offices. Vaccitech anticipates completing the relocation by mid-2022.
·Online publication in The Lancet Microbe results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, sponsored and conducted by researchers at The King Abdullah International Medical Research Centre in Saudi Arabia in partnership with Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.

·Presented at the AASLD The Liver Meeting data from a Phase 1 (HBV001) and Groups 1 and 2 of a Phase 1/2a (HBV002) clinical trial demonstrating that VTP-300 was tolerated and induced T cells against targeted HBV antigens in both healthy volunteers and patients with chronic HBV infection.
·Reported efficacy data from an interim analysis of the HBV002 clinical trial of VTP-300 in patients with chronic HBV infection. The data from 27 patients who completed three months in the trial demonstrated reductions in surface antigen (HbsAg) levels in patients receiving VTP300 both alone and in combination with nivolumab.
·Acquired Avidea Technologies, Inc. in a cash and stock transaction that added complementary synthetic T cell boosting technologies and expands Vaccitech’s pipeline to include autoimmunity to its current infectious disease and oncology therapeutic areas of focus. The transaction also furthers Vaccitech’s scientific expertise and establishes U.S.-based research and development capabilities.
·Cancer Research UK and the Ludwig Institute for Cancer Research initiated patient dosing in a Phase 1/2a clinical trial to test the safety and initial efficacy of VTP-600, an immunotherapeutic candidate in development for the treatment of non-small cell lung cancer. The therapeutic candidate employs Vaccitech’s viral vector prime-boost platform to induce T cell immunity against two cancer-associated proteins, MAGE-A3 and NY-ESO-1, found on some tumor cells.

Upcoming Milestones

·In the second quarter of 2022, the Company expects to present additional Phase 1/2a interim efficacy data of VTP-300 in patients with chronic HBV infection at the International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by Phase 1/2a full efficacy clinical trial data in the second half of this year.
·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer and also expects to initiate dosing of a Phase 2 clinical trial of VTP-300 in patients with chronic HBV infection.
·In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

Full Year 2021 Financial Highlights:

·Cash position: As of December 31, 2021, cash and cash equivalents were $214.1 million, compared to $43.3 million as of December 31, 2020. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised gross proceeds of $125.2 million, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the second half of 2024.

·Research and development expenses: Research and development expenses were $20.4 million in 2021 compared to $14.4 million in the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, and VTP-850.

·General and administrative expenses: General and administrative expenses were $25.1 million in 2021 compared to $10.5 million in the prior year. This includes the share-based payment charge of $14.2 million and $6.0 million unrealized foreign exchange gain on revaluation of Company’s cash balances recorded in 2021. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period and higher insurance costs associated with operating as a public company.

·Net loss: The Company generated a net loss attributable to its shareholders of $50.9 million, or $1.96 per share on both basic and fully diluted bases in 2021, compared to a net loss of $17.7 million, or $2.24 per share on both basic and fully diluted bases, for the prior year.

On March 25, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the year ended December 31, 2021 (Press release, Moleculin, MAR 25, 2022, View Source [SID1234610989]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"Over the course of 2021, we have made significant progress across multiple fronts. As we look ahead, I believe we are well positioned for an exciting 2022 with a number of clinical and regulatory milestones expected throughout the year," commented Walter Klemp, Chairman and CEO of Moleculin. "Our Annamycin development programs in STS lung mets and AML continue to progress and we remain encouraged by the data seen to date. Additionally, with the necessary regulatory approvals received, we are advancing parallel development of WP1122 for the treatment of COVID-19 and GBM. With our growing body of encouraging clinical data and our strong financing position, we remain laser focused on executing our initiatives, driving value for all stakeholders, and importantly, addressing unmet needs for people with highly resistant tumors and viruses."

Recent Highlights

●Appointed Joy Yan, M.D., Ph.D., an oncology physician-scientist with extensive experience in early and late clinical development with successful track record, to its Board of Directors.

●Successfully concluded the Company’s second Phase 1 trial (MB-105) in Poland evaluating Annamycin for the treatment of relapsed and refractory acute myeloid leukemia (AML), where Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D) and demonstrated no signs of cardiotoxicity (a common problem with currently prescribed anthracyclines).

●Reported an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting relapsed or refractory AML and the metastases of soft tissue sarcoma to the lungs (STS Lung), which concluded there was no evidence of cardiotoxicity. The review included analysis of ejection fraction, echo strain and certain troponin levels intended to assess potential for both acute and chronic heart damage. Additionally, the Company reported evidence that Annamycin may have a substantially lower incidence of alopecia (hair loss) than currently prescribed anthracyclines such as doxorubicin.

●Reported preliminary interim results from its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of STS lung metastases in its fourth cohort with three patients recruited and dosed which continues to document preliminary human activity for this drug. In this cohort one patient experienced a dose limiting toxicity (DLT) that resolved and continues in the trial. All three initial patients had their scans after two cycles and reported stable disease and are continuing in the study. This information is preliminary and subject to change.

●Received allowance from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of GBM. With this IND now cleared, Moleculin plans to identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

●Filed an amended protocol with both the Riverside Ethics Committee and Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom; once approved, the internally funded trial is expected to begin in the first half of 2022.

Programs Update

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.

For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Upcoming Milestones Expectations

●H1 2022: Initiate Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C.

●H1 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.

●H1 2022: Complete Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.

Metabolism/Glycosylation Inhibitor – WP1122

Moleculin has new compounds designed to target the roles of glycolysis and glycosylation in both cancer and viral diseases. The Company’s lead Metabolism/Glycosylation Inhibitor, WP1122, is a prodrug of 2-DG that appears to improve the drug-like properties of 2-DG by increasing its circulation time and improving tissue/organ distribution. Based on recently published research that has identified that 2-DG has antiviral potential against SARS-CoV-2 in vitro, Moleculin believes WP1122 has significant potential as a COVID-19 therapy. Its unique mechanism of action may also be well-suited for combinations that potentiate existing therapies, including checkpoint inhibitors.

The Company has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom. The Company also received a favorable opinion from the London – Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, United Kingdom. In early March 2022, the Company filed an amended protocol with both the Riverside Ethics Committee and the MHRA. The amendment updated the dilution of the oral solution to achieve full dissolution of WP1122. No risk/benefit to the study was affected because of this change. The Phase 1a study in healthy human volunteers will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of WP1122 administered as an oral solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and pharmacokinetics (PK), and subsequent clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 healthy volunteers in the United Kingdom.

Glioblastoma Multiforme

Additionally, the Company recently announced that the FDA is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of GBM to go forward. With this IND now cleared, Moleculin plans to identify investigators who are interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Upcoming Milestones Expectations

●H1 2022: Commence Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.

●H1 2022: Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19 outside of the US.

●2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

●Ongoing preclinical development work in additional anti-viral indications such as HIV, Zika, and Dengue. Collaborations targeted for 2022.

Summary of Financial Results for the Full Year 2021

Research and development (R&D) expense was $14.4 million and $12.8 million for the year ended December 31, 2021 and 2020, respectively. The increase in R&D of $1.6 million is mainly related to increase in the number of internally funded clinical trials and overall clinical trial activity, and costs related to manufacturing of additional drug product.

General and administrative expense was $8.4 million and $6.8 million for the year ended December 31, 2021 and 2020, respectively. The increase of $1.6 million is mainly related to an increase in headcount, consulting and advisory fees, and an increase in our corporate insurance.

For the year ended December 31, 2021 and 2020, the Company incurred net losses of $15.9 million which included non-cash gains of $6.7 million on warrants in 2021 as compared to $2.3 million in the prior year and approximately $2.4 million of stock-based compensation expense in 2021 as compared to $1.7 million in 2020.

The Company ended the year with $70.9 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.