On March 31, 2022 Sanofi reported that successfully priced yesterday, March 30, 2022, its offering of a dual-tranche EUR 1.5 billion of notes (the "Notes") (Press release, Sanofi, MAR 31, 2022, View Source [SID1234611245]). It comprises an inaugural issue of sustainability-linked bond for a nominal amount of EUR 650 million of notes, tied to Sanofi’s commitment to improve access to essential medicines in low- and lower-middle-income countries via its global health nonprofit unit. This transaction demonstrates Sanofi’s commitment to society, to ensure access to healthcare for the world’s vulnerable people.

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Jean-Baptiste de Chatillon
Chief Financial Officer of Sanofi
"A year after pioneering sustainable finance with our sustainability-linked revolving credit facilities, we further contribute to the development of the sustainable finance market through the successful pricing of our first sustainability-linked bond" said Jean-Baptiste de Chatillon, Chief Financial Officer of Sanofi. "We continue to make progress in our environmental, social and governance activities that are an essential part of our strategy and embedded into our business."

The Notes consist of two tranches:

€850 million fixed rate notes, due April 2025, bearing interest at an annual rate of 0.875%.
€650 million fixed rate notes, due April 2029, bearing interest at an annual rate of 1.250%. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5 million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026.
Sandrine Bouttier-Stref
Global Head of Corporate Social Responsibility of Sanofi
"Linking the cost of financing to the achievement of concrete targets in terms of access to medicines confirms our determination to put social responsibility at the center of our ambitions."

Sanofi’s expanded social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people and bringing a much needed focus to the development of treatment for childhood cancer. Integrated into the company’s Play to Win business strategy, Sanofi’s commitment to society will continue the fight against infectious diseases such as sleeping sickness and poliomyelitis, while accelerating its goals to reduce the environmental impact of its products and its worldwide operations. Key to tackling the global challenges that face society are its people, who each have a role to play in building a diverse and inclusive workplace.

To become an issuer of sustainable finance instruments, Sanofi has established a dedicated Sustainability-Linked Bond Framework, designed as a living document to enable future bond issues in a sustainability-linked format.
The Sustainability-Linked Bond Framework is aligned with ICMA’s Sustainability-Linked Bond Principles (2020) and has received a Second Party Opinion from ISS ESG.

The proceeds of the bond issue will be used for general corporate purposes.

The transaction has been led by Morgan Stanley and Natixis CIB as Global Coordinators & Sustainability-Linked Structuring Advisors and, Barclays, MUFG and RBC Capital Markets, all as Joint Active Bookrunners.

On March 31, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fiscal year ended December 31, 2021 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 31, 2022, View Source [SID1234611244]).

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"2021 was a year of continued progress towards our key operational, clinical and regulatory goals," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We had a productive Type A meeting with the FDA in the fall during which the FDA, in principle, agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. We also, together with Chiesi, submitted an MAA to the EMA, which was subsequently validated by the EMA. The submission followed an October 2021 meeting with the EMA’s Rapporteur and Co-Rapporteur at which we and Chiesi discussed the scope of the anticipated submission, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission."

"We are grateful to all of our key stakeholders for their dedication towards our mission of delivering new medicines to patients with high clinical unmet needs. 2022 has the potential to be a meaningful year for the company as we move towards our BLA resubmission in the United States, await feedback on our MAA submission in Europe and continue to advance our early stage pipeline. We look forward to updating you on our progress as the year moves on."

2021 Full-Year and Recent Business Highlights

Regulatory Advancements

●On February 24, 2022, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced the submission and subsequent validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PRX-102, the Company’s product candidate, for the treatment of adults with Fabry disease. The MAA included final data from the Company’s phase III BRIDGE and BRIGHT clinical trials; 12-month interim data from the Company’s phase III BALANCE clinical trial; and final data from the Company’s phase I/II clinical trial data from naïve/untreated patients, including the extension study related thereto, using 1 mg/kg every other week dosing.
●On October 11, 2021, the Company, together with Chiesi, completed a Type A (End of Review) meeting with the U.S. Food and Drug Administration (FDA) regarding the biologics license application (BLA) for PRX-102 for the treatment of adult patients with Fabry disease, following the complete response letter received on April 27, 2021
from the FDA. The Company gained clarity regarding the FDA’s expectations and the FDA, in principle, agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. A BLA resubmission is planned for the second half of 2022.
Clinical Advancements

●On March 18, 2022, the Company, together with Chiesi, announced positive final results from the phase III BRIGHT clinical trial, a multicenter, multinational open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of treatment with 2 mg/kg of PRX-102 administered every four weeks for 52 weeks (a total of 14 infusions) in adult patients previously treated with a commercially available enzyme replacement therapy (ERT) (Fabrazyme or Replagal). Results of the BRIGHT study indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was well tolerated, and Fabry disease assessed by eGFR slope and plasma lyso-Gb3 was stable throughout PRX-102 treatment in adult Fabry patients.
●On October 15, 2021, the Company, together with Chiesi, announced the last patient from the phase III BALANCE clinical trial received the final dose in the study. The Company anticipates announcing top-line results from the study next week and final data in the second half of 2022.
● On June 2, 2021, the Company together Chiesi, announced topline results from an interim analysis of the phase III BALANCE clinical trial. The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments (PRX-102 and Fabrazyme) was below the non-inferiority margin pre-specified for this interim analysis in the ITT analysis set and above such limit in the PP analysis set. At the time of this analysis, two patients had discontinued participation due to treatment emergent adverse events (TEAEs). Of these two patients, one discontinued participation due to a related adverse event. There were no deaths. Overall, safety data appears favorable and consistent with what was observed in previous clinical studies with PRX-102.
Corporate & Financial Developments

●On August 25, 2021, the Company strengthened its balance sheet through exchanges of a substantial majority of its then outstanding 7.50% Senior Secured Convertible Notes due 2021 for a combination of cash and new notes. The Company issued new 7.50% Senior Secured Convertible Notes due 2024 with a $28.75 million aggregate principal amount, and made principal and interest payments of approximately $27.00 million. The remaining 2021 Notes were repaid on the November 2021 maturity date.
●On July 2, 2021, the Company entered into a Sales Agreement with H.C. Wainwright & Co., LLC, as sales agent, or the Agent, pursuant to which the Company may sell from time to time up to $20.0 million worth of shares of its common stock in at-the-market transactions through the Agent. Upon execution of the Sales Agreement, the Company terminated the then existing ATM Equity OfferingSM Sales Agreement entered into on October 1, 2020 with BofA Securities.
●On May 13, 2021, the Company and Chiesi entered into a binding term sheet pursuant to which they amended the two exclusive license and supply agreements for PRX-102 in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million milestone payment to the Company in exchange for a $25.0 million reduction in a longer-term regulatory milestone payments in the Ex-US Exclusive License and Supply Agreement. All other regulatory and commercial milestone payments remained unchanged. The Company and Chiesi also agreed to negotiate certain manufacturing related matters. The Company received the payment in June 2021.
●On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering, which was led by BofA Securities and Oppenheimer & Co.
Financial Results

For the year ended December 31, 2021, compared to the year ended December 31, 2020

●The Company recorded revenues from selling goods of $16.7 million for the year ended December 31, 2021, an increase of $0.5 million, or 3%, compared to revenues of $16.2 million for the same period of 2020.
●Revenue from licenses and R&D services for the year ended December 31, 2021 were $21.6 million, a decrease of $25.1 million, or 54%, compared to $46.7 million for the year ended December 31, 2020. Revenue from license agreements is recognized, mainly, in conjunction with the license and supply agreements with Chiesi. The decrease is primarily due to lower R&D costs related to PRX-102 incurred in the year ended December 31, 2021.
●Cost of goods sold for the year ended December 31, 2021 was $16.3 million, an increase of $5.4 million, or 50%, compared to cost of goods sold of $10.9 million for the same period in 2020. The increase was primarily the result of certain one-time manufacturing costs incurred while preparing for the then anticipated FDA approval of the PRX-102 BLA and higher manufacturing costs.
●Research and development expenses, net, for the year ended December 31, 2021 were $29.7 million, a decrease of $8.5 million, or 22%, compared to $38.2 million for the same period of 2020. The decrease is primarily due to the completion of the three phase III clinical trials of PRX-102.
●Selling, general and administrative expenses were $12.7 million for the year ended December 31, 2021, an increase of $1.6 million, or 14% from $11.1 million for the year ended December 31, 2020. The increase resulted primarily from an increase in corporate costs of $1.7 million related mainly to insurance.
●Financial expenses, net, were $7.1 million for the year ended December 31, 2021, a decrease of $2.1 million, or 23%, compared to financial expenses of $9.2 million for the year ended December 31, 2020. The decrease resulted primary from the exchange of our 2021 notes; a $0.7 million decrease in interest expenses; a $0.8 million
decrease in amortization of debt discount; and a $1.3 million decrease in related expenses, offset by a $0.8 million loss on extinguishment related to the Exchanges.
●Cash, cash equivalents and short-term bank deposits were approximately $39.0 million at December 31, 2021.
●Net loss for the year ended December 31, 2021 was approximately $27.6 million, or $0.62 per share, basic and diluted, compared to a net loss of $6.5 million, or $0.22 per share, basic and diluted, for the year ended December 31, 2020.
Conference Call and Webcast Information

The Company will host a conference call today, March 31, 2022, at 8:30 a.m. Eastern Daylight Savings Time, to review the corporate, clinical and regulatory developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 31, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported its financial results for the year ended December 31, 2021 (Press release, PDS Biotechnology, MAR 31, 2022, View Source [SID1234611243]).

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"I’m very pleased to report that we have undergone a 12-month period of incredible productivity here at PDS Biotech," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. "We’ve made significant clinical progress on our lead oncology candidate, PDS0101, and presented at leading oncology conferences on the promising efficacy and safety results of PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for patients with oropharyngeal cancer prior to transoral robotic surgery. We also recently announced encouraging pre-clinical data from our NIAID-funded universal flu vaccine program. We continue to leverage our unique T-cell activating platforms to advance additional pre-clinical oncology and infectious disease candidates."

Dr. Bedu-Addo continued: "Over the past year, we completed two licensing transactions and secured additional intellectual property for our expanding pipeline. We also received approval of a US composition of matter and use patent for PDS0101. We strengthened our scientific advisory and leadership teams by adding distinguished immuno-oncology experts to our scientific advisory board and welcomed Matthew Hill as our Chief Financial Officer. We also added more than $52 million to our balance sheet in 2021, significantly extending our cash runway and ability to continue to advance our clinical and pre-clinical programs. We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic."

Fourth Quarter 2021 and Recent Business Highlights:

Achieved several milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA (pembrolizumab) for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:

Presented preliminary safety data on a total of 18 checkpoint inhibitor naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium. Highlights from the presentation include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or any significant immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA (range 1-13).

Achieved preliminary objective response benchmarks that enabled us to advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.

Initiated enrollment in the checkpoint inhibitor-refractory cohort.

Announced initiation of an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence. The trial will evaluate PDS0101 as monotherapy and in combination with KEYTRUDA.

Announced encouraging preclinical data for the universal flu vaccine that demonstrated a potent neutralization response against multiple strains of the influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of influenza in preclinical animal subjects.

Granted U.S. Patent Application by the United States Patent and Trademark Office for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.

Achieved enrollment objective of 30 patients in the checkpoint inhibitor refractory arm of the NCI-led triple combination trial in March 2022.

Achieved median overall survival at December 31, 2021 of 12 months for 30 HPV16-positive patients who had received at least one evaluation in the NCI-led triple combination trial. Approximately 73% of the patients had failed 3 prior treatment regimens including checkpoint inhibitor therapy.

Full-Year 2021 Financial Results

For the year ended December 31, 2021, the net loss was approximately $16.9 million, or $0.66 per basic share and diluted share, compared to a net loss of approximately $14.8 million, or $0.89 per basic share and diluted share for the year ended December 31, 2020.

For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million and personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million.

For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7.0 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1.0 million, non-cash stock-based compensation of $2.5 million, and facilities costs of $0.1 million, partially offset by a decrease in professional fees of $0.4 million.

Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to total operating expenses of approximately $14.9 million for the year ended December 31, 2020.

The Company’s cash balance as of December 31, 2021 was $65.2 million. Based on the Company’s available cash resources and cash flow projections, the Company believes this balance is sufficient to fund Company operations and research and development programs through the end of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am EDT on Thursday, March 31, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com. After the live webcast, the event will be archived on PDS Biotech’s website for six months.

On March 31, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the opening for patient enrollment of its Acclaim-2 clinical trial. Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Keytruda (pembrolizumab) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda (Press release, Genprex, MAR 31, 2022, View Source [SID1234611241]). In 2021, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

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"We are pleased to have opened Acclaim-2 for patient enrollment and expect to promptly begin screening patients for their eligibility to participate in the trial," stated Mark S. Berger, M.D., Chief Medical Officer of Genprex. "This marks an important milestone in our clinical development program for REQORSA as we continue to engage with prestigious clinical trial sites to build patient enrollment and provide hope to lung cancer patients who suffer from this devastating disease and who are in desperate need of new treatment options. We look forward to completing the Phase 1 portion of Acclaim-2 by the end of the first quarter of 2023 and to generating data to show the synergistic effects REQORSA combined with immunotherapies can have in patients."

Previously presented preclinical data have shown synergy between REQORSA and Keytruda. Those data showed that REQORSA combined with the checkpoint inhibitor Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancer. Those studies in mice with a humanized immune system also documented multiple effects of REQORSA on the immune system, such as an increase in Natural Killer cells and a decrease in myeloid derived suppressor cells in the tumor, that are likely to contribute to the synergy seen with Keytruda.

The Company expects the Phase 1 portion of the Acclaim-2 trial to enroll up to 30 patients in a dose escalation study to determine the maximum tolerated dose of the combination of REQORSA and Keytruda. The Phase 2 portion of the study is expected to enroll approximately 126 patients to be randomized 2:1 to receive either REQORSA and Keytruda combination therapy or docetaxel and/or ramucirumab. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed after 50 events. Genprex expects to complete the Phase 1 portion of Acclaim-2 by the end of the first quarter of 2023.

In 2020, Genprex entered into a worldwide, exclusive license agreement with a major cancer research center in Houston, Texas for the use of REQORSA in combination with immunotherapies, including Keytruda, and also for the use of REQORSA in a three-drug combination of TUSC2, immunotherapy and chemotherapy.

Keytruda is a registered trademark of Merck & Co. and is its largest selling drug with 2021 sales of more than $17 billion.

About REQORSA

REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex’s unique, proprietary ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials.

The active ingredient in REQORSA is the TUSC2 gene, a tumor suppressor gene. REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.

On March 31, 2022 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the year ended December 31, 2021 (Press release, Galectin Therapeutics, MAR 31, 2022, View Source [SID1234611240]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "Reiterating my comments from our shareholders meeting in December, I am proud of our team and their accomplishments during 2021. It was a challenging year for many companies, particularly in biotech and drug development. Our experienced new team coalesced in identifying and addressing pertinent issues with a prescience that was indicative of their accumulated experience and extensive backgrounds. While we are always cognizant of the ultimate goal of registering a new drug, our primary focus throughout 2021 and now continues to be the enrollment of our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis. Many clinical trials in the past two years have experienced difficulties in enrollment, and we have been no exception. For several reasons, the pandemic makes enrolling patients for the NAVIGATE trial more challenging than most trials. Patients eligible for the NAVIGATE trial have liver cirrhosis and, as such, are at a greater health risk of complications from COVID-19. Additionally, our patient population tends to display other comorbidities, including diabetes and obesity. It is also important to consider the safety of our candidate participants first, as cirrhotic patients with portal hypertension are immunocompromised. We believe that as we continue to emerge from the COVID-19 pandemic, site recruitment and patient enrollment will accelerate and we have experienced increases in enrollment, particularly in the U.S and Mexico. However, we have not seen the enrollment in Europe that we anticipated, and conditions there remain uncertain. Consequently, we have activated multiple sites in Latin America and believe this will overcome our challenges in Europe. This decision was made in advance of current conditions. At this time, while we continue to target enrollment completion for June 30, 2022, ultimately it may require an additional quarter to complete."

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Mr. Lewis continued, "Late in 2021, we engaged three noted physicians – Dr. Chetan Bettegowda, from Johns Hopkins, and Dr. Nishant Agrawal and Dr. Ari Rosenberg, both from University of Chicago Medical Center – as consultants to help define the path forward in oncology. In consultation with our oncology experts, we have now selected the treatment of recurrent or metastatic head and neck cancer as the lead indication to pursue for belapectin in combination with Keytruda, an immune checkpoint inhibitor. The decision is notably based on the lack of available treatments for these patients, the low response rates of monotherapy, the limited number of therapies in development, and the resulting very high medical need. We are currently working to compile an Investigational New Drug (IND) package, including the development of a phase 2 trial protocol, with the objective for the Company to file an IND with the FDA oncology division."

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Dr. Pol Boudes, Chief Medical Officer stated, "I continue to be confident that the NAVIGATE trial will be fully enrolled despite the challenges we have seen related to the COVID-19 pandemic. Additionally, I am pleased to report we recently completed enrollment in a Hepatic Impairment Study, a very important study to include in our New Drug Application (NDA) dossier. The Hepatic Impairment Study was being conducted at four sites and involved 38 subjects (divided amongst normal healthy volunteers, and patients with mild, moderate, and severe hepatic impairment). Each subject received a single infusion of belapectin (4 mg/kg LBM) and their serum belapectin levels were monitored for up to approximately two weeks to define the effects of various stages of cirrhosis on belapectin pharmacokinetics. The tolerance and safety of belapectin are also being evaluated."

Financial Results

For the year ended December 31, 2021, the Company reported a net loss applicable to common stockholders of $30.7 million, or ($0.52) per share, compared to a net loss applicable to common stockholders of $23.6 million, or ($0.41) per share for the year ended December 31, 2020. The increase is largely due to an increase in 2021 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the year ended December 31, 2021, was $23.8 million compared with $18.0 million for the year ended December 31, 2020. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the year ended December 31, 2021, were $6.4 million, compared to $5.5 million for the year ended December 31, 2020. The increase was primarily due to non-cash stock-based compensation expense and insurance expense.

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As of December 31, 2021, the Company had $39.6 million of cash and cash equivalents. On December 20, 2021, the Company received $10 million in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company received a total of $30 million in unsecured promissory notes from Mr. Uihlein in 2021. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least March 31, 2023.

The Company expects that it will require more cash to fund operations after March 31, 2023, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $45-$50 million to cover costs of the NAVIGATE trial to reach the planned interim analysis estimated to occur around the end of the first quarter of 2024, along with drug manufacturing and other research and development activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

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About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," began enrolling patients in June 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.