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.

1
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."

2
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

On March 30, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported recent business progress and financial results for the fourth quarter and full-year ended December 31, 2022 (Press release, Centessa Pharmaceuticals, MAR 30, 2023, View Source [SID1234629584]).

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"Centessa made substantial progress in 2022, highlighted by the achievement of important milestones toward our goal of bringing transformational medicines to patients," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We advanced key clinical and development objectives, prioritized our pipeline, and continued to manage our resources with timely data and science-driven decisions, consistent with our asset-centric model. As a result, we entered 2023 with solid momentum on our pipeline programs that we believe have the greatest potential to transform the lives of patients with unmet medical needs."

Dr. Saha continued, "Our most advanced product candidate is SerpinPC, a subcutaneously administered novel inhibitor of activated protein C (APC), which is in a registrational program for the treatment of hemophilia B. In December 2022, we presented data from a Phase 2a study showing SerpinPC to have a favorable safety and tolerability profile, as well as evidence of sustained efficacy in patients with hemophilia as measured by a reduction in the all-bleeds annualized bleeding rates (ABR). We believe these data support the potential for SerpinPC to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for individuals with hemophilia, subject to regulatory review and approval. We are excited to be enrolling subjects in PRESent-5, an observational feeder study, and are preparing to begin dosing in the PRESent-2 and PRESent-3 interventional studies this year."

"We are also very pleased to announce the dosing of the first subject in the Phase 1/2a clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from our LockBody technology platform for the treatment of solid tumors. LB101 is the first LockBody candidate we have brought to the clinic, and we look to this study to provide valuable insights regarding the safety and tolerability profile of LB101, as well as the performance of our LockBody platform in a clinical setting. Following LB101 is our second LockBody program targeting PD-L1xCD3, for which we expect to name a product candidate this year," said Dr. Saha.

"Lastly, our team is excited to be advancing ORX750, an orally administered, selective orexin receptor-2 (OX2R) agonist, as our product candidate for the treatment of narcolepsy with potential expansion into other sleep disorders. We believe ORX750 has the potential to be a best-in-class therapy for the treatment of narcolepsy and look forward to sharing the candidate profile at a scientific meeting later this year," said Dr. Saha.

Dr. Saha concluded, "We are thrilled with the momentum at Centessa and believe we are well positioned with a cash runway into 2026 to support the potential for multiple clinical readouts across our pipeline."

Recent Highlights
•In January 2023, the Company announced clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human clinical trial of LB101 for the treatment of solid tumors. The first subject was dosed in March 2023.
•In December 2022 and February 2023, the Company presented data from the open-label extension (OLE) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia during oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), respectively. With total exposure of over 40 patient-years across multiple dosing regimens, the Phase 2a data showed a continued favorable safety and tolerability profile for SerpinPC, as well as evidence of sustained efficacy, as measured by a reduction in the all-bleeds ABRs. There were no thromboembolic events and no treatment-related sustained elevations of D-dimer observed across the Phase 2a study, to date. D-dimer is a sensitive measure of excessive thrombin generation.
•In December 2022, the Company began enrolling subjects into PRESent-5, an observational study in the SerpinPC registrational program for the treatment of hemophilia B.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC)- The registrational program for hemophilia B is ongoing. PRESent-5, an observational study, is enrolling subjects and the Company expects to begin dosing in PRESent-2 and PRESent-3 later this year. In addition, the Company expects to share data from Part 5 of the OLE of the Phase 2a study of SerpinPC, subject to completion, at a scientific meeting this year.
•Solid Tumors
–PD-L1xCD47 LockBody (LB101)- The Phase 1/2a first-in-human clinical study is ongoing.
–PD-L1xCD3 LockBody (Undisclosed)- The Company expects to name a product candidate and share preclinical data this year.
•Narcolepsy and Other Sleep Disorders (ORX750)- ORX750 was named as a product candidate and is currently in preclinical development and undergoing IND-enabling activities. The Company expects to share preclinical data at a scientific meeting later this year.

The Company expects to provide further updates on preclinical programs, including MGX292, as they advance towards clinical studies.
Fourth Quarter and Full-Year 2022 Financial Results
•Cash and Cash Equivalents: $393.6 million as of December 31, 2022, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $27.8 million for the fourth quarter ended December 31, 2022, compared to $41.5 million for the fourth quarter ended December 31, 2021, and $155.1 million for the full-year 2022 compared to $95.7 million for the period from January 30, 2021 through December 31, 2021.
•General & Administrative Expenses: $13.8 million for the fourth quarter ended December 31, 2022, compared to $13.0 million the fourth quarter ended December 31, 2021, and $55.2 million for the full-year 2022 compared to $42.9 million for the period from January 30, 2021 through December 31, 2021.
•Net Loss Attributable to Ordinary Shareholders: $43.2 million for the fourth quarter ended December 31, 2022, compared to $60.8 million for the fourth quarter ended December 31, 2021, and $216.2 million for the full-year 2022 compared to $381.1 million for the period from January 30, 2021 through December 31, 2021.