On March 7, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported that the first two patients have been dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 7, 2023, MAIA Biotechnology Doses First Patients in Europe in Ongoing Phase 2 Trial (THIO-101) Evaluating THIO for Non-Small Cell Lung Cancer Treatment [SID1234628291]). Following regulatory clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated in these three European countries.

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The primary objectives of the THIO-101 trial are to evaluate the safety and tolerability, as well as preliminary clinical efficacy of THIO, a first-in-class cancer telomere targeting agent, in patients with advanced NSCLC, who either progressed or relapsed through the initial treatments with an immune checkpoint inhibitor alone, or in combination with chemotherapy. The Company dosed its first patient in the THIO-101 trial in Australia in July 2022 and commenced dosing patients in Europe in March 2023.

"We are very excited to commence enrolling patients in Europe in THIO-101 as five sites are being activated in three countries. THIO represents a potential treatment for patients with Non-Small Cell Lung Cancer, which currently has limited treatment options and continues to be defined by high unmet need and mortality," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We are very pleased with the progress we have made thus far as we are now enrolling patients in Australia and three European countries in this ongoing Phase 2 trial with THIO."

Mihail Obrocea, MD, MAIA’s Chief Medical Officer, added, "The initiation of dosing in MAIA’s Phase 2 clinical trial of THIO-101 in Europe depicts important progress for MAIA towards understanding the pharmacokinetics and safety of this first-in-class investigational medicine, and we very much look forward to potentially sharing the clinical data later this year."

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On March 7, 2023 Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) (Press release, Shorla Oncology, MAR 7, 2023, View Source [SID1234628290]). Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage. This marks the first product approved in the US market for Shorla.

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"We are very proud to see our research in oncology innovation and dedication to patient care culminate in this U.S. FDA approval," said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. "Nelarabine Injection is a critical treatment for patients living with T-cell Leukemia, particularly for children with leukemia, and it is our hope that today’s approval addresses the clinical need in this patient community."

Added Orlaith Ryan, CTO and Co-founder of Shorla Oncology, "We are honored to bring this much needed product to patients in the U.S. and hopefully to patients worldwide in the near future. This milestone further fuels our passion and commitment to develop innovative oncology treatments, with a focus on rare cancers where existing treatments are limited, in short supply or inadequate."

T-cell leukemia is an aggressive blood and bone marrow cancer which progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children, with this particular treatment often in shortage.

"Successful treatment of children, adolescents and young adults with cancer, such as children with T-cell acute lymphoblastic leukemia, is dependent on stable access to critical chemotherapy agents. Drug shortages directly impact patient outcome," said Stephen P. Hunger, MD, Chief of the Division of Oncology and Director of the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia. "We are encouraged by the approval of Nelarabine Injection and the significant impact that we expect it will have on treatment access and patient care."

Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

"We are delighted to announce this first U.S. FDA approval for Shorla Oncology, and we look forward to a successful launch in the U.S.," said Dennis Purcell, Chairman of the Board at Shorla. "This is an important milestone, as it paves the way for the approval and commercialization of the company’s promising portfolio of oncology drugs."

In preparation for the immediate commercial launch of Nelarabine Injection, Shorla is working with its commercialization services partner, EVERSANA, which it announced August 2021.

On March 7, 2023 URECT Corporation (Nasdaq: DRRX) reported financial results for the three months and year ended December 31, 2022 and provided a corporate update (Press release, DURECT, MAR 7, 2023, View Source [SID1234628287]).

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"We are poised to complete enrollment in our potentially pivotal AHFIRM trial in the second quarter of 2023 and report topline data in the second half of 2023. If the AHFIRM trial outcome is positive, we intend to have discussions with the FDA and other regulatory authorities regarding a possible NDA filing," stated James E. Brown, D.V.M., President and CEO of DURECT. "Larsucosterol has the potential to be the first FDA-approved treatment for alcohol-associated hepatitis, representing a significant step forward in treating patients afflicted with this highly lethal condition."

AHFIRM Trial Update:

DURECT has enrolled more than 260 patients in the AHFIRM trial to date, which exceeds 85% of the target enrollment for the 300-patient trial. We have over 60 AHFIRM study sites open at leading hospitals in the U.S., Australia, E.U. and U.K., including prominent transplant centers. We continue to expect to complete enrollment in the AHFIRM trial in the second quarter of 2023, which should enable topline data to be reported in the second half of 2023.

Financial Highlights for Q4 and Full Year 2022:

•
Total revenues were $3.3 million and net loss was $10.5 million for the three months ended December 31, 2022 compared to total revenues of $7.3 million and net loss of $7.0 million for the three months ended December 31, 2021. Total revenues were $19.3 million and net loss was $35.3 million for the year ended December 31, 2022, compared to total revenues of $14.0 million and net loss of $36.3 million for the year ended December 31, 2021.
•
At December 31, 2022, cash, cash equivalents and investments were $43.6 million, compared to cash, cash equivalents and investments of $70.0 million at December 31, 2021. Debt at December 31, 2022 was $21.2 million, compared to $20.6 million at December 31, 2021.
•
In February 2023, we completed a $10.0 million registered direct offering of common stock and warrants with a leading institutional healthcare investor and an existing institutional investor. Net proceeds from the financing were approximately $8.8 million excluding the proceeds, if any, from the exercise of the warrants issued in the offering.

Earnings Conference Call

We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss fourth quarter and 2022 results and provide a corporate update:

Wednesday, November 2 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

Toll Free: 1-877-869-3847

International: 201-689-8261

Conference ID: 13736560

Webcast: View Source

A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section

About the AHFIRM Trial

Enrollment is ongoing in our Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol (DUR-928) treatMent (AHFIRM). The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms receive the same supportive care without steroids. In order to maintain blinding, patients in the two active arms receive matching placebo capsules if the investigator prescribes steroids. The primary outcome measure will be the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company is enrolling patients at more than 60 clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation for the treatment of AH. We believe a positive outcome in the AHFIRM trial could support a New Drug Application filing. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026

About Alcohol-associated Hepatitis (AH)

AH is an acute form of alcohol-associated liver disease (ALD), associated with long-term heavy intake of alcohol and often occurs after a recent period of increased alcohol consumption (i.e., a binge). AH is typically characterized by severe inflammation and destruction of liver tissue (i.e., necrosis), potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of approximately 20% and 31%, respectively. Stopping alcohol consumption is necessary, but frequently not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) patients and the use of treatments to reduce liver inflammation, such as corticosteroids, are limited by contraindications and have not been shown to improve survival at 90 days or one year, and have demonstrated an increased risk of infection. While liver transplantation is becoming more common for ALD patients, including AH patients, the procedure often involves a long waiting period, a burdensome selection process, costs exceeding $875,000 on average, and patients requiring lifelong immunosuppressive therapy to prevent organ rejection

About Larsucosterol (DUR-928)

Larsucosterol is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.

On March 7, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company reported full year 2022 financial results and provided a Company update (Press release, Cumberland Pharmaceuticals, MAR 7, 2023, View Source [SID1234628286]). Net revenues grew 17% over the prior year to $42 million, resulting in $8 million in cash flow from operations.
As of December 31, 2022, the Company’s total assets were $93 million, including $20 million in cash. Total liabilities were $57 million and total shareholders’ equity was $36 million.
"We were able to manage our business in 2022 to deliver significant revenue growth despite facing external challenges in our operating environment," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We were delighted to add and begin providing Sancuso in support of oncology patients, as we further expanded our portfolio of FDA-approved brands."
HIGHLIGHTS FOR THE YEAR INCLUDE:
New Headquarter Office Location
In the fourth quarter of 2022, Cumberland relocated its headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new, state-of-the-art headquarters keeps the Company close to Vanderbilt University Medical Center, enabling their continued collaboration as Cumberland works to develop new medicines for the future.
The move also allows Cumberland to accommodate recent and future growth. Following the relocation, Cumberland expects to expand its organization to over 100 individuals, with a majority working from the Nashville headquarters. The move will help to support the Cumberland team, its patients, customers and partners.
2022 Sustainability Metrics
Cumberland continues to monitor and report on its activities and impact on the environmental, its employees and the community. The Company’s key sustainability metrics for 2022 include:
•Providing 2.2 million doses of products to patients
•Safely disposing of over 2,750 pounds of expired or damaged products
•No products recalled or clinical trial terminated due to a failure to practice good clinical standards.

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Sancuso Acquisition
During 2022, Cumberland acquired and successfully completed the transition of Sancuso from Japan-based Kyowa Kirin, Inc. – assuming responsibility for the brand’s sales, distribution and promotion in the U.S. Sancuso is an FDA-approved prescription patch that prevents nausea and vomiting in patients undergoing certain types of chemotherapy.
To promote and support Sancuso, Cumberland formed a new sales division, Cumberland Oncology, comprised of former Kyowa Kirin sales representatives who brought extensive experience with the brand.
Caldolor International Update
In 2022, Cumberland announced its agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor, its non-narcotic pain relief product, in Mexico.
Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies. PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.
Vibativ International Updates
In March 2022, Cumberland announced the launch of Vibativ in Puerto Rico. The announcement follows an agreement between Cumberland and Verity Pharmaceuticals that provides Verity the rights to introduce the product for patients in that market. Verity has a strong presence in Puerto Rico, which is in need of a product with Vibativ’s features, as it has a large number of residents living with chronic diseases, like diabetes, that increase the risk of hospitalization and infections. Vibativ can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections including the flu and COVID-19.
Cumberland also announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical to introduce Vibativ into the Middle East. The arrangement provides Tabuk exclusive rights and obligations to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk is a fully owned subsidiary of the Astra Industrial Group, a leading and publicly traded conglomerate in Saudi Arabia.
In addition, Cumberland entered into an agreement with D.B. Pharm Korea to register and commercialize the Vibativ product in South Korea. The submission for approval is underway.
Cumberland’s Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in China accepted for review in September 2021. During 2022, Cumberland continued to support SciClone and their requests associated with review of that submission.
Nordic Pharma RediTrex Agreement Restructured
In 2022, Cumberland restructured its agreement with Nordic Pharma, who previously provided Cumberland with the license for the U.S. rights associated with the RediTrex brand. Nordic Pharma will assume the responsibility for distributing the product in the U.S. after June 30, 2023.
In addition, Cumberland has transferred the marketing responsibilities associated with the brand to Nordic Pharma and will continue to distribute and support RediTrex during the transition period.

Ongoing Clinical Development
Cumberland continues to sponsor and progress three Phase II clinical programs featuring the Company’s ifetroban product candidate. These studies involve patients with:
•Aspirin-Exacerbated Respiratory Disease, or AERD, a severe form of asthma;
•Systemic Sclerosis, a debilitating autoimmune disorder; and
•Duchenne Muscular Dystrophy, a genetic neuromuscular disease.
In addition, Cumberland has been working toward an application to the FDA for a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
FINANCIAL RESULTS:
Net Revenue: In 2022, net revenues were $42.0 million, a 17% increase over the prior year. Net revenues by product for the year were $15.2 million for Kristalose, $13.2 million for Sancuso, $7.5 million for Vibativ and $4.8 million for Caldolor.
During the fourth quarter of 2022, net revenues totaled $9.1 million. Net revenue by product for the quarter included $2.4 million for Sancuso, $3.8 million for Kristalose, $1.5 million for Vibativ and $1.8 million for Caldolor.
Operating Expenses: The 2022 operating expenses were $47.7 million, compared to $43.7 million for 2021. Total operating expenses for the fourth quarter were $11.4 million compared to $12.7 million for the prior year period.
Earnings: Net loss for the fourth quarter of 2022 was $2.4 million, and $5.6 million, or $0.38 per share, for the year.
Adjusted Earnings: For the full year of 2022, adjusted earnings were $2.1 million, or $0.14 per share, a significant improvement on the adjusted loss of $1.2 million in 2021. The adjusted loss for the fourth quarter of 2022 was $0.7 million, or $0.05 per share, a significant improvement over the $1.9 million adjusted loss during the same period in 2021.
The adjusted earnings calculation does not include the $1.5 million cash benefit of Vibativ and Sancuso cost of goods during the quarter, which were received with the product acquisition. For the full year, the cash benefit from those cost of goods was $4.8 million.
Cash Flow: In 2022, cash flow from operations was $8.5 million, a 33% increase over the $6.3 million during the prior year period.
Balance Sheet: At December 31, 2022, Cumberland had $93 million in total assets, including $20 million in cash and cash equivalents. Total liabilities were $57 million, including $16 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36 million.

EARNINGS REPORT CALL:
Cumberland will provide its 2022 financial results via a conference call today at 4:30 p.m. Eastern Time. To join the call, register at:
https://register.vevent.com/register/BIc9d03deed82d47389284c0538fb62962.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided. They can also choose a "Call Me" option to have the system automatically call them at the start of the conference call.
Available on Cumberland’s website for one year, a replay of the call can be accessed by visiting View Source
ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in the Mid-South and is focused on the delivery of high-quality, prescription brands designed to improve patient care. The Company develops, acquires, and commercializes products for the hospital acute care, gastroenterology, rheumatology and oncology market segments.
The Company’s portfolio of FDA-approved brands includes:
•Acetadote (acetylcysteine) injection, for the treatment of acetaminophen poisoning;

•Caldolor (ibuprofen) injection, for the treatment of pain and fever;

•Kristalose (lactulose) oral, a prescription laxative, for the treatment of constipation;

•Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;

•RediTrex (methotrexate) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;

•Sancuso (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;

•Vaprisol (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and

•Vibativ (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Aspirin-Exacerbated Respiratory Disease.
For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website at www.cumberlandpharma.com.

On March 7, 2023 Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, reported the receipt of multiple contract awards from the PathLAKE consortium to provide Artificial Intelligence (AI) solutions to support cancer diagnosis at 25 NHS Trusts (Press release, Ibex Medical Analytics, MAR 7, 2023, View Source [SID1234628284]).

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PathLAKE is a UK center of excellence consortium, founded by Innovate UK, that is delivering AI innovation in pathology across leading NHS Trusts and UK universities including Nottingham University Hospitals, University Hospitals Coventry & Warwickshire, and Oxford University Hospitals. The contract award follows a rigorous selection process which recognized Ibex as the top scoring solution provider for both the breast and prostate cancer categories, allowing up to 25 NHS Trusts to directly procure the Ibex Galen Breast and Galen Prostate solutions. Cambridge University Hospitals is one of the Trusts to subsequently select Ibex to support its pathologists by augmenting diagnostic workflows with enhanced quality, accuracy and efficiency.

"Cambridge University Hospitals is very proud to be a founding partner of PathLAKE Plus, teaming up to help secure the £13.5 million grant from the Industrial Strategy Challenge Fund," said Dr. Rebecca Brais, Clinical Lead for Digital Pathology and Major Projects in Diagnostics and Consultant Histopathologist at Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust. "We see ourselves, and the UK as a whole, at the cutting edge of innovation in digital pathology and look forward to implementing the Ibex Galen solution here in Cambridge as part of our Histopathology Team’s digital transformation."

The worldwide shortage of pathologists combined with a rise in the number of cancer cases and their complexity has led to growing workloads imposed on pathology departments and delays in cancer diagnosis across the UK. With approximately 275,000 women undergoing breast biopsies and 100,000 men undergoing prostate biopsies in the UK each year1,2, there is a growing need for AI-powered solutions and decision-support tools that help pathologists detect cancer rapidly with the utmost accuracy.

The Galen suite of solutions from Ibex is the first and most widely deployed AI technology for pathology, used in routine clinical practice at laboratories, hospitals, and health systems worldwide. It supports pathologists in a variety of tasks during the diagnosis of breast, prostate, and gastric biopsies and helps improve the accuracy of cancer diagnosis, reduce turnaround time, boost productivity, and improve user experience. Galen demonstrated outstanding outcomes across multiple clinical studies performed on various tissue types and diagnostic workflows3,4,5,6,7.

"We are extremely honored to be recognized by PathLAKE as the leading provider of AI solutions in pathology," said Richard Nicholson, Director of Sales, UK at Ibex. "Our team looks forward to supporting additional regions of the UK with our suite of Galen solutions. Building upon our successful AI deployments in NHS Wales, and our existing projects with hospitals and labs in England, we are uniquely positioned to further strengthen the adoption, deployment and routine use of AI in pathology across the UK."