On March 30, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent developments (Press release, IGM Biosciences, MAR 30, 2023, View Source [SID1234629589]).

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"During 2022 we continued to extend the application of our IgM antibody platform by preparing imvotamab for clinical trials in autoimmune diseases and signing an exclusive worldwide collaboration agreement with Sanofi to develop novel IgM agonist antibodies for oncology and autoimmune diseases," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Also, and perhaps most significantly, the initial clinical results from IGM-8444, our anti-death receptor 5 IgM antibody, highlight the exciting potential of IgM antibodies as agonist antibody medicines. We are announcing today that we have dosed the first patient in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients. We are also pleased with the expanded safety and efficacy data for imvotamab at 100 mg that we have developed through our non-Hodgkin’s lymphoma clinical trials, and we believe that imvotamab’s encouraging safety profile may be an important differentiating factor in the exciting new field of T cell engagers in autoimmune disease."

Mr. Schwarzer continued, "We expect that 2023 will also be an important year for the expansion and validation of IGM’s platform. Already this year, we have treated the first patients in our initial clinical study of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, which could be used for the treatment of patients with solid and hematologic malignancies, potentially in combination with cellular therapies, such as CAR-T and CAR-NK cells. We are also initiating clinical studies of IGM-2644, our CD38 x CD3 T cell engaging IgM antibody, which we hope will prove to be a safe and more potent form of anti-CD38 therapy for multiple myeloma, including for patients who have previously been treated with daratumumab. We also plan to file Investigational New Drug applications and initiate clinical studies for imvotamab in multiple autoimmune diseases this year, beginning with systemic lupus erythematosus and rheumatoid arthritis."

Pipeline Updates

IGM-8444 (DR5)

First patient dosed in randomized colorectal cancer clinical trial. The Company announced today that it has treated the first patient in a randomized clinical trial of IGM-8444, an IgM agonist antibody targeting death receptor 5 (DR5), plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer. The study is designed to assess the benefit of IGM-8444 when combined with the current standard of care regimen of FOLFIRI and bevacizumab. The Company will be assessing both the 3 mg/kg and 10 mg/kg dose levels of IGM-8444 with a primary endpoint of progression free survival and secondary endpoints of overall response rate and overall survival as compared to the current standard of care treatment arm.
Encouraging data in combination with FOLFIRI. As announced in January 2023, IGM-8444 showed an encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, no signs of drug related clinically significant hepatotoxicity were observed, as only Grade 1 and Grade 2 transient drug related liver enzyme elevations were seen. In patients with metastatic colorectal cancer, the combination of IGM-8444 and FOLFIRI showed promising activity at 3 mg/kg, with multiple confirmed responses observed, including some in patients who had previously progressed on FOLFIRI.
Clinical biomarker data supports activity and dose response across multiple dose levels. Clinical biomarker data from 64 patients treated in monotherapy and combination dose cohorts across multiple dose levels of IGM-8444 in the Company’s ongoing Phase 1 clinical trial showed that virtually all of these patients (60 of 64) showed an increase in levels of the cell death biomarker caspase-3 following treatment with IGM-8444. This increase began to be seen after the initial dose of IGM-8444 and showed a trend towards a dose dependent increase between the two highest dose levels tested of 3 mg/kg and 10 mg/kg.
First patient dosed in venetoclax combination. The Company also announced today that it has dosed the first patient in its IGM-8444 plus venetoclax and azacytidine Phase 1 combination cohort in subjects with acute myeloid leukemia.
Dosing ongoing in the fifth birinapant dose cohort. The Company further announced today that it is currently treating patients in its fifth birinapant Phase 1 combination dose escalation cohort. To date, there have not been any observed dose limiting toxicities in combination with birinapant.
Imvotamab (CD20 x CD3)

Advancing into multiple autoimmune clinical trials. The Company announced today that it plans to file Investigational New Drug (IND) applications in the second quarter of 2023 this year to begin clinical testing of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis. The Company believes that the clinical safety and efficacy profile of imvotamab positions it very well for the exciting new area of treating autoimmune disease with T cell engagers.
Cytokine release incidence of less than 10% at 100 mg dose level. The Company announced today that as of its most recent data assessment the incidence of cytokine release syndrome was nine percent (9%) combined over all safety evaluable patients treated with the 100 mg titration weekly dosing regimen in its Phase 1 and Phase 2 non-Hodgkin’s lymphoma (NHL) studies.
DLBCL complete response rate greater than 30% at 100 mg dose level. The Company also announced today that, although the patient numbers are very small and additional patients currently on treatment may respond, as of its most recent data assessment it has achieved a complete response rate of greater than 30% combined over all efficacy evaluable diffuse large B cell lymphoma patients treated with the 100 mg titration weekly dosing regimen in its Phase 1 and Phase 2 NHL studies.
Redirecting clinical development efforts to autoimmune disease. In light of its plans for the extensive clinical development of imvotamab in autoimmune diseases and the limited commercial opportunities in monotherapy treatment of NHL, the Company announced today that it has decided to cease further monotherapy clinical development efforts for imvotamab in NHL. The Company continues to believe that the safety and efficacy profile of imvotamab positions it well as a combination partner for the treatment of NHL, and it plans to focus its future efforts in NHL on evaluating combination opportunities and partnerships for imvotamab.
IGM-7354 (IL-15 x PD-L1)

Phase 1 trial initiated. As previously announced, the Company has initiated a clinical trial exploring the safety, efficacy and biomarker activity of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
First two patients dosed. The Company announced today that it has successfully dosed two patients in its clinical trial of IGM-7354 without any drug related safety issues to date.
Preclinical data presented. In November 2022, the Company presented preclinical results at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data was featured in a poster titled "IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo".
IGM-2644 (CD38 x CD3)

IND clearance. The Company announced today that the U.S. Food and Drug Administration has cleared its IND application for a Phase 1 dose escalation trial of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma. This study will investigate the initial safety and efficacy of IGM-2644 in patients who have progressed on previous therapies. The Company’s ultimate clinical development goal is to establish IGM-2644 as a safe and more potent anti-CD38 therapy, particularly for patients who have received prior daratumumab treatment.
Preclinical data. In December 2022, the Company presented preclinical data for IGM-2644 at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results were featured in a poster presentation titled "IGM-2644, a Novel CD38 x CD3 Bispecific IgM T Cell Engager Demonstrates Potent Efficacy on Myeloma Cells with an Improved Preclinical Safety Profile", which highlighted IGM-2644’s greater complement dependent cytotoxicity activity as compared to conventional IgG anti-CD38 antibodies. Additionally, IGM-2644 achieved potent T cell dependent cellular cytotoxicity (TDCC) killing of daratumumab-resistant cell lines with minimal cytokine release and potent TDCC killing of myeloma patient samples.
Fourth Quarter and Full Year 2022 Financial Results

Cash and Investments: Cash and investments as of December 31, 2022 were $427.2 million, compared to $229.5 million as of December 31, 2021.
Collaboration Revenue: For the fourth quarter and year ended 2022, collaboration revenues were $0.4 million and $1.1 million, respectively, compared to no revenue for the same period in 2021.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2022, R&D expenses were $45.0 million and $179.3 million, respectively, compared to $39.2 million and $127.0 million for the fourth quarter and year ended 2021, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2022, G&A expenses were $11.6 million and $49.7 million, respectively, compared to $11.5 million and $38.3 million for the fourth quarter and year ended 2021, respectively.
Net Loss: For the fourth quarter of 2022, net loss was $52.6 million, or a loss of $1.19 per share, compared to a net loss of $50.6 million, or a loss of $1.50 per share, for the fourth quarter of 2021. For the year ended 2022, net loss was $221.1 million, or a loss of $5.32 per share, compared to a net loss of $165.2 million, or a loss of $4.93 per share, for the year ended 2021.
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of $290 million to $300 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with a balance of approximately $200 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2024.

Conference Call and Webcast
IGM will host a live conference call and webcast at 4:30 p.m. EDT today, March 30, 2023, to discuss the Company’s financial results and provide a corporate update. The webcast can be accessed by clicking the link: View Source and will also be available on the "Events and Presentations" page in the "Investors" section of the Company’s website.

On March 30, 2023 iBio CDMO LLC, a wholly owned subsidiary of iBio, Inc. (the "Company") and Woodforest National Bank ("Woodforest") reported that it has entered into the Fourth Amendment to the Credit Agreement (the "Fourth Amendment") that was entered into on November 1, 2021, as amended (the "Credit Agreement"), which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its equipment from 40% to 20%, and (iii) allow the Company to retain $2,000,000 million of the $5,100,000 million that the Company received from Fraunhofer USA Inc. ("Fraunhofer") as part of its legal settlement with them (the "Fraunhofer Settlement Funds"), with the remaining $3,000,000 million being held in a Company account at Woodforest (Filing, iBioPharma, MAR 30, 2023, View Source [SID1234629588]). In addition, the Company is obligated to (y) deliver to Woodforest an executed copy of a purchase agreement (the "Purchase Agreement") for the sale of the 130,000 square foot cGMP manufacturing facility in Bryan, Texas, no later than April 14, 2023, and (z) pay to Woodforest a fee in the amount of $75,000 on the earlier of the date of the closing of the Purchase Agreement, or the Maturity Date (as defined in the Credit Agreement). No assurance can be given that the Company will be able to enter into a Purchase Agreement no later than April 14, 2023, as required by the Fourth Amendment despite ongoing negotiations undertaken for such sale. The failure to enter into a Purchase Agreement no later than April 14, 2023 is an immediate default under the Credit Agreement.

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On March 17, 2023, the Company received a payment of $5,100,000 from Fraunhofer related to the Fraunhofer Settlement Funds and in accordance with the Fourth Amendment, transferred $3,000,0000 to a Company account at Woodforest on March 24, 2023.

In addition, on March 24, 2023, the Company, as guarantor, entered into the Fourth Amendment to the Guaranty, which was executed on November 1, 2021, as amended (the "Guaranty"), which reduced the Liquidity Covenant (as defined in the Credit Agreement, which required the Company to maintain a certain level of unrestricted cash) from $7,500,000 to $1,000,000.

The descriptions of the Fourth Amendment to the Credit Agreement and the Fourth Amendment to the Guaranty do not purport to be complete and are qualified in their entirety by reference to the Fourth Amendment to the Credit Agreement and the Fourth Amendment to the Guaranty, copies of which are filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 2.02. Results of Operations and Financial Condition.

The information set forth in Item 8.01 is incorporated by reference into this Item 2.02.

Item 2.03. Creation of Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 is incorporated by reference into this Item 2.03.

Item 8.01. Other events

During the first calendar quarter of 2023, the Company has received an aggregate of approximately$3.8 million from (i) the sale of the Company’s common stock by Cantor Fitzgerald & Co. as sales agent pursuant to the Controlled Equity Offering SM Sales Agreement, dated as of November 25, 2020, and (ii) the exercise of a portion of the Series A and Series B warrants issued by the Company in the offering that closed on December 9, 2022.

On March 30, 2023 Gandeeva Therapeutics, Inc., a precision medicine company focused on designing and developing novel therapeutics guided by cryogenic electron microscopy (cryo-EM) and machine learning, reported the initiation of a research collaboration with Moderna Inc. (NASDAQ: MRNA) to explore applications of Gandeeva’s differentiated technology platform for a Moderna program (Press release, Gandeeva Therapeutics, MAR 30, 2023, View Source [SID1234629587]).

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"We are excited to begin working with Moderna on a specific application of our AI-enabled cryo-EM platform that leverages our technology infrastructure and deep experience in structural biology and medicinal chemistry," said Sriram Subramaniam, Ph.D., Founder and CEO of Gandeeva Therapeutics. "Through our internal pipeline programs and collaborations, we are aggressively pursuing the development of first-in-class modalities in targeting difficult-to-drug protein-protein interactions."

Under the research agreement, Gandeeva and Moderna will study and validate the application of Gandeeva’s proprietary cryo-EM platform approach for an undisclosed Moderna target. Gandeeva will receive research payments from Moderna. Additional terms of the agreement were not disclosed.

On March 30, 2023 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, 2022 (Filing, 3 mnth, DEC 31, Galectin Therapeutics, 2023, MAR 30, 2023, View Source [SID1234629586]). 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:
"As previously reported, we completed recruitment in late December 2022 and randomization by the end of February 2023 in our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis with a total of 357 patients. We randomized more patients than we had anticipated, potentially adding power to the study. From the beginning of December until the end of February, we randomized more than 5 patients per week, notwithstanding the holiday season. Typically, clinical trials become more efficient as time elapses over the screening window.

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We look forward to managing this trial and obtaining interim analysis results from the Phase 2b portion in the fourth quarter of 2024. The Company’s results will be the first, and as of now, the only late-stage trial in compensated cirrhosis that has advanced to include portal hypertension caused by NASH. This patient population has no current therapeutic option, other than a liver transplantation.

Additionally, we are furthering our efforts by continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination with Keytruda in patients with advanced head and neck cancers. Our team is fully committed to maximize the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Compared to NASH pre-cirrhotic stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression to portal hypertension and, ultimately, liver failure. As recently announced, the third Data Safety Monitoring Board ("DSMB") evaluation of NAVIGATE was positive, and the study can continue as planned. This is a significant milestone for us because with 357 patients randomized we now have a large database of patient exposure to belapectin, and some of these patients have received more than a year and a half of treatment. The safety and tolerance of candidate drugs can be a significant problem for cirrhotic patients who are compromised by their liver disease and may have difficulty metabolizing drugs. We are very encouraged by the developing safety profile of belapectin, and we to continue to be optimistic that the results of NAVIGATE can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate a liver transplantation as a therapeutic option."

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Financial Results

For the year ended December 31, 2022, the Company reported a net loss applicable to common stockholders of $38.9 million, or ($0.65) per share, compared to a net loss applicable to common stockholders of $30.7 million, or ($0.52) per share for the year ended December 31, 2021. The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the year ended December 31, 2022, were $31.7 million compared with $23.8 million for the year ended December 31, 2021. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities, including hiring additional employees. General and administrative expenses for the year ended December 31, 2022, were $6.6 million, compared to $6.4 million for the year ended December 31, 2021. The increase was primarily due to non-cash stock-based compensation expense partially offset by decreases in legal and insurance expenses.

As of December 31, 2022, the Company had $18.6 million of cash and cash equivalents. Additionally, the Company has $50 million remaining available under a $60 million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.

The Company expects that it will require more cash to fund operations after December 31, 2024 and believes it will be able to obtain additional financing as needed. 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.

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," completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, 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), also known as fatty liver disease, 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.

On March 30, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent business developments (Press release, CorMedix, MAR 30, 2023, View Source [SID1234629585]).

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Recent Corporate Highlights:

CorMedix submitted a Type A meeting request to the U.S. Food and Drug Administration ("FDA"), in mid-March seeking guidance for resubmission of its DefenCath New Drug Application, and FDA subsequently granted the meeting request, with a date scheduled for mid-April.
CorMedix was informed by its primary contract manufacturing organization ("CMO") that all corrective actions stemming from the FDA’s June 2022 inspection have been completed, and the CMO has provided to FDA documentation showing effectiveness of the corrective actions. The FDA has acknowledged receipt of that close out report.
CorMedix was informed by its primary heparin active pharmaceutical ingredient ("API") supplier that it too has completed the implementation of corrective actions arising from the FDA’s June 2022 Warning Letter for a non-heparin API. In addition, CorMedix was informed that updates have been made to the Heparin API Drug Master file clarifying which activities take place at the site referenced in the warning letter and which activities take place at a different facility, which has been previously inspected by FDA.
CorMedix announced an agreement to validate manufacturing of DefenCath at Siegfried AG’s site in Hameln, Germany, which has previously been inspected by FDA. The Hameln site previously manufactured Neutrolin, which was sold in Europe as a medical device. The Company intends to utilize Siegfried as a back-up CMO.
CorMedix announced two promotions in January: Erin Mistry’s promotion to EVP and Chief Commercial Officer and Dr. Tushar Mukherjee’s promotion to SVP and Head of Technical Operations. In addition, the Company has made several key hires in commercial, medical affairs and legal to prepare the organization for the potential commercial launch of DefenCath.
Cash and short-term investments, excluding restricted cash, at December 31, 2022 amounted to $58.8 million.
Joe Todisco, CorMedix CEO, commented, "we are very pleased that FDA has granted our meeting request and classified the meeting as a Type A, allowing us to seek FDA’s guidance in mid-April. The CorMedix team has made solid progress on all fronts, working diligently in support of the primary CMO as it completed the corrective actions to address previously identified deficiencies, as well as continuing to build out the team, processes and systems to be ready for commercialization as quickly as possible following a potential FDA approval. We have further refined our parallel supply chain pathways to mitigate risk, with the goal of pursuing FDA approval of DefenCath in 2023. We look forward to providing additional updates as we aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters, and potentially other therapeutic settings."

4th Quarter 2022 Financial Highlights

For the fourth quarter of 2022, CorMedix recorded a net loss of $8.2 million, or $0.20 per share, compared with a net loss of $7.8 million, or $0.20 per share, in the fourth quarter of 2021. The increase in net loss in the fourth quarter of 2022 compared with 2021 was primarily driven by increases in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath. Operating expenses during the fourth quarter of 2022 were $8.4 million, compared with $7.8 million in the fourth quarter of 2021, an increase of approximately $0.6 million.

Full Year 2022 Financial Highlights

For the year ended December 31, 2022, CorMedix recorded a net loss of $29.7 million, or $0.74 per share, compared with a net loss during the year ended December 31, 2021 of $28.2 million, or $0.75 per share. The increase in net loss was driven primarily by increases in operating expenses.

Operating expenses during the year ended December 31, 2022 amounted to $30.7 million compared with $29.5 million during the comparable period in 2021, an increase of $1.2 million, or 4%, due to a 22% increase in SG&A expense, offset by a 18% decrease in R&D expense.

Total cash on hand and short-term investments as of December 31, 2022 amounted to $58.8 million, excluding restricted cash of $0.2 million. CorMedix received approximately $7.2 million in net proceeds from ATM issuance during the first quarter of 2023. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of our Annual Report on Form 10-K.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 30, 2023, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Thursday, March 30th @ 8:30am ET
Domestic: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13736467
Webcast: Webcast Link