On March 5, 2024 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win platform, reported financial results for the fourth quarter and year-ended December 31, 2023 (Press release, IO Biotech, MAR 5, 2024, View Source [SID1234640780]).

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"In 2023, we reached a significant milestone in our pivotal Phase 3 trial evaluating our lead therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA, completing enrollment in this trial in mid-November," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "The acceleration in enrollment observed in this study in the second half of 2023 is a testament to the need that exists today for more efficacious and better tolerated first-line treatment options for patients with advanced melanoma."

Dr. Zocca continued, "The coming months will prove to be a critical period in the development of IO Biotech, with the outcome of the pivotal Phase 3 interim analysis expected in the third quarter of 2024, and, more importantly, the primary endpoint of progression free survival estimated to follow in the second half of 2025. Our team is dedicated to continuing our diligent work to efficiently bring IO102-IO103 to patients in need, potentially as early as 2025."

Fourth Quarter 2023 and other Recent Highlights

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In November 2023, the company completed enrollment of 380 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in advanced melanoma. The primary endpoint of the pivotal Phase 3 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, a planned interim analysis of overall response rate (ORR) will be conducted when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024.

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In December 2023, the first patient was dosed in the company’s Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab given before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN).

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The company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or recurrent or metastatic SCCHN is ongoing. Encouraging preliminary data that support the potential of IO102-IO103 in combination with pembrolizumab as first-line treatment in NSCLC and SCCHN were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting in October 2023.

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Progress continued in several investigator-initiated trials the company is supporting including dosing of the first patient in the Phase 2 trial evaluating its lead therapeutic cancer vaccine candidate, IO102-IO103, and pembrolizumab as neoadjuvant followed by adjuvant treatment of patients with SCCHN (NCT05977907), as well as continuing enrollment in both the Phase 2 trial of IO102-IO103 given in combination with nivolumab-relatlimab in patients with untreated, unresectable Stage III/IV melanoma (NCT05912244) and the Phase 1 study of the IO102-IO103 vaccine in combination with pembrolizumab for patients with BCG-unresponsive or intolerant high-risk non-muscle invasive bladder cancer (NCT05843448).

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Three posters were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting in November 2023 with data providing further evidence of the differential biological impact of therapeutic vaccines IO102, IO103 and IO112.

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The company expanded its Board of Directors with the appointment of Helen Collins, MD in November 2023.

Fourth Quarter 2023 Financial Results

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Net loss for the three months ended December 31, 2023, was $26.2 million, compared to $20.1 million for the three months ended December 31, 2022.

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Research and development expenses were $21.8 million for the three months ended December 31, 2023, compared to $14.4 million for the three months ended December 31, 2022. The increase was primarily related to clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s Phase 3 clinical trial. The company recognized $0.5 million in research and development equity-based compensation for the three months ended December 31, 2023, compared to $0.6 million for the three months ended December 31, 2022.

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General and administrative expenses were $6.4 million for the three months ended December 31, 2023, compared to $6.0 million for the three months ended December 31, 2022. The increase was primarily related to personnel costs due to an increase in head count that was offset by a decrease in professional services, consultant and other costs. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended December 31, 2023, compared to $1.1 million for the three months ended December 31, 2022.

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Cash and cash equivalents as of December 31, 2023 were $143.2 million, compared to $142.6 million at December 31, 2022. During the three months ended December 31, 2023, the company used cash, cash equivalents and restricted cash of $22.9 million from operating and investing activities.

About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) and/or programmed death-ligand 1 (PD-L1) cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Patients have been enrolled from centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About the IOB-013/KN-D18 Clinical Trial Endpoints

The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p≤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint.

On March 5, 2024 Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported successful completion of Good Manufacturing Practice ("GMP") manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate (Press release, Epsilogen, MAR 5, 2024, View Source [SID1234640779]). This included process development and cGMP manufacturing of this complex molecule for clinical supply in less than ten months at Lonza’s Slough (UK) site.

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IgE antibodies represent powerful alternatives to more commonly used IgG antibodies. They bring exciting opportunities for oncology thanks to their strong potency, long tissue half-life, and the ability to target tumour cells expressing very low antigen levels. Current research and monitoring indicate that this is the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale. Epsilogen intends to use this new material for its upcoming Phase Ib study in platinum-resistant ovarian cancer (PROC) patients, scheduled to start later in 2024.

Dr. Tim Wilson, Chief Executive Officer, Epsilogen, commented: "The successful GMP manufacture at scale of MOv18 IgE marks another major milestone in realizing the potential of IgE antibodies as a new and differentiated class of cancer therapies for the treatment of patients with solid tumours. Decades of technical achievement and financial investment have made GMP manufacture of the IgG class of therapeutic antibodies a routine process. Lonza and Epsilogen have worked together to apply Lonza’s knowledge and experience to MOv18 IgE. As a part of the IgE antibody class, it is structurally and functionally distinct from IgG. It is very gratifying to see this effort and investment pay off.

Having generated encouraging safety and tolerability data in our Phase I safety study for MOv18 IgE in patients with platinum-resistant ovarian cancer, we look forward to exploring further the signals of efficacy observed in that clinical trial and anticipate starting a Phase Ib efficacy study in this setting later in 2024. We remain optimistic about the potential of IgE antibodies as a new treatment modality to improve outcomes for patients with difficult-to-treat cancers."

Stefan Egli, Global Head of Mammalian Biologics, Lonza, added: "This marks a significant milestone for Epsilogen, bringing its promising IgE-based product closer to the clinic. Having produced the GMP batch of this non-platform complex molecule under record time is also a statement that demonstrates the strategic value of our manufacturing services offering tailored to each molecule’s unique properties, and analytical and purification needs."

MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and Epsilogen believes that this was the first, and remains the only, IgE antibody in clinical development. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in platinum-resistant ovarian cancer patients where it was found to be safe and well-tolerated, with evidence of anti-tumour activity observed. This study and its results were reported in Nature Communications.

On March 5, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the fourth quarter and full year ended December 31, 2023 and provided recent corporate and clinical updates (Press release, Gritstone Bio, MAR 5, 2024, View Source [SID1234640778]).

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"As we rapidly approach the first randomized dataset from our flagship oncology program, GRANITE, we remain focused on leveraging our innovative technologies to drive transformative advances in oncology and infectious disease," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "The continued collaboration with Dr. Rosenberg and the National Cancer Institute involving our ‘off-the-shelf’ oncology vaccine highlights the pioneering vision and scientific rigor upon which we have built the SLATE and GRANITE platforms. And the recent decision to incorporate GMP-grade materials in the manufacture of our self-amplifying mRNA (samRNA) candidate enhances the potential regulatory utility of the Phase 2b CORAL-BARDA study, as well as our broader platform, an important development as we prepare to launch the study later this year."

Dr. Allen added, "Preliminary Phase 2 data from the Phase 2/3 study of GRANITE in metastatic MSS-CRC are rapidly accruing and remain expected this quarter. Positive signal in this metastatic context would likely unlock enormous opportunity in both adjuvant and metastatic solid tumors. As the calendar flips further into 2024, Gritstone continues marching forward toward potentially enabling the full potential of our novel vaccine platforms in both oncology and infectious disease."

Corporate Update

In February 2024, Gritstone bio reduced its workforce by approximately 40% to reduce costs and preserve capital. The reduction primarily impacted employees associated with vaccine manufacturing and clinical infectious disease operations, who were not active in the ongoing Phase 2 study of GRANITE, Gritstone’s personalized cancer vaccine. The reduction occurred approximately two weeks following the previously announced delay of the proposed CORAL Phase 2b study, which resulted in Gritstone not receiving external funding it previously anticipated beginning in 1Q 2024, associated with the initiation of the study.
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)
GRANITE – Personalized neoantigen vaccine program
SLATE – "Off-the-shelf" neoantigen vaccine program

The Phase 2 portion of the Phase 2/3 study evaluating GRANITE as a front-line maintenance therapy in metastatic MSS-CRC remains ongoing and preliminary efficacy data from the Phase 2 portion remain expected in the first quarter of 2024. Gritstone met its enrollment target of 100 patients randomized in August 2023.

The clinical trial collaboration with the National Cancer Institute (NCI) to evaluate an autologous mutant KRAS-directed TCR-T cell therapy in combination with Gritstone’s KRAS-directed "off the shelf" vaccine candidate, SLATE-KRAS, is ongoing. The study is led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research and builds into the growing interest in combining tumor-antigen specific cell therapy with matched vaccines. The IND was cleared by the U.S. Food and Drug Administration (FDA) in October 2023.

Pending funding, Gritstone remains ready to initiate a randomized Phase 2 clinical trial within SLATE ("off-the-shelf" neoantigen vaccine program).
Infectious Disease Programs
CORAL – Next-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s samRNA platform and novel approach in infectious diseases

In February 2024, Gritstone announced it will incorporate GMP-grade materials in the manufacture of its self-amplifying mRNA (samRNA) candidate, resulting in a delay of the CORAL Phase 2b study (CORAL-BARDA). The move is expected to increase the regulatory utility of the anticipated 10,000 subject, comparative Phase 2b study contracted by the Biomedical Advanced Research and Development Authority (BARDA)(a). Gritstone is now preparing to launch the study in Fall 2024.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment

The collaboration with Gilead to research and develop a vaccine-based HIV immunotherapy treatment continues under Gilead’s direction.
Full Year 2023 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $86.9 million as of December 31, 2023, compared to $185.2 million as of December 31, 2022.

Research and development expenses were $127.2 million for the year ended December 31, 2023 compared to $111.4 million for the year ended December 31, 2022. The increase was primarily due to increases in personnel-related costs and clinical trial expenses.

General and administrative expenses were $28.8 million for the year ended December 31, 2023 compared to $29.0 million for the year ended December 31, 2022. The decrease was primarily attributable to a decrease in outside services for legal, finance, recruiting and other professional services to support our ongoing operations due to the recruitment of full-time equivalents, offset by an increase in personnel-related and facility related costs.

Collaboration, license, and grant revenues were $16.3 million for the year ended December 31, 2023 compared to $19.9 million for the year ended December 31, 2022. During the year ended December 31, 2023, we recorded $9.0 million of grant revenue from the BARDA Contract, $4.3 million of grant revenue related to the CEPI Agreement and $1.7 million in grant revenue related to the Gates Agreement. During the year ended December 31, 2023, we recorded $1.0 million in collaboration revenue related to the 2seventy Agreement and $0.3 million in collaboration revenue related to the Gilead Collaboration Agreement.

On March 5, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, MAR 5, 2024, View Source [SID1234640777]).

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"Based on 2023 achievements and planned 2024 milestones, we intend to move our lead targeted radiotherapeutic into registrational trials in 2025," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our ReSPECT clinical trials in both LM and recurrent glioblastoma (rGBM) continue to demonstrate encouraging safety and efficacy signals for rhenium (186Re) obisbemeda and we plan U.S. Food and Drug Administration (FDA) meetings during 2024 to discuss next steps toward product approval."

UPCOMING EVENTS AND MILESTONES

In 2024 the Company plans to accomplish the following key business objectives:

Leptomeningeal Metastasis:

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Present interim safety and feasibility data from the ReSPECT-LM trial at the SNO/ASCO CNS Cancer Conference in August 2024.
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Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated dose, and recommended Phase 2 dose.
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Present complete ReSPECT-LM Phase 1 data at the SNO Annual Meeting in November 2024.
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Implement Plus’ CNSide cerebral spinal fluid (CSF)-based tumor cell quantification assay as an exploratory clinical endpoint in all ReSPECT-LM trial patients in Q1 2024.
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2024 FDA meeting to align on the design for a pivotal Phase 2/3 ReSPECT-LM trial for the treatment of breast cancer with leptomeningeal metastases, anticipated to begin in 1H 2025.
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Develop a new, multiple dosing ReSPECT-LM clinical trial in 2024.
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Complete preclinical combination studies of rhenium (186Re) obisbemeda with PD-1 and PD-L1 checkpoint inhibitors.

Glioblastoma:

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Continue to advance Phase 2 ReSPECT-GBM trial and present data in the second half of 2024.
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Finalize ReSPECT-GBM pivotal design with FDA.

Pediatric Brain Cancer (PBC)

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Obtain FDA IND approval to begin enrollment of ReSPECT-PBC trial for children with high grade glioma and ependymoma.

Manufacturing:

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Increase GMP manufacturing capacity of rhenium (186Re) obisbemeda to support forecasted Phase 3 and commercial supply requirements.

Q4 2023 AND RECENT HIGHLIGHTS AND MILESTONE ACHIEVEMENTS

Leptomeningeal Metastasis:

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Completed dosing in Cohort 4and initiated dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation trial of rhenium (186Re) obisbemeda for the treatment of LM.
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Added a total of 5 new sites to the ReSPECT trials.
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Partnered with K2bio for implementation of the CNSide cerebrospinal fluid (CSF)-based tumor cell capture and enumeration assay, acquired from Biocept, being utilized in the ReSPECT-LM clinical trial. CNSide assay implementation is now complete.
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Orphan Drug Designation granted to rhenium (186Re) obisbemeda by the FDA for the treatment of breast cancer with LM.
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Presented preliminary safety and efficacy results from Phase 1/Part A of the ReSPECT-LM clinical trial at the SNO/ASCO CNS Cancer Conference. Following the presentation, the Company hosted a key opinion leader roundtable on data presented at the conference.
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Received advance payment of grant funds of approximately $3.3 million from CPRIT as part of its overall $17.6 million award contract. To date, the Company has received $7.1 million in grant funding from CPRIT.
Glioblastoma:

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Presented interim safety and efficacy results from the ongoing ReSPECT-GBM Phase 2 clinical trial at the SNO Annual Meeting. Following the presentation, the Company hosted a key opinion leader webinar to discuss the data presented at the conference.

FULL YEAR 2023 FINANCIAL RESULTS

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The Company’s cash balance was $8.6 million at December 31, 2023, compared to $18.1 million at December 31, 2022.
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The Company recognized $4.9 million and $0.2 million of grant revenue during the years ended December 31, 2023 and 2022, respectively, which represents CPRIT’s share of the costs incurred for our rhenium (186Re) obisbemeda development for the treatment of patients with LM.
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Total operating loss for the year ended December 31, 2023 was $13.3 million compared to $19.7 million in the same period of 2022. The decrease is primarily due to an increase in grant revenue of $4.7 million, offset by a decrease in general and administrative expenses of $1.7 million due to lower professional fees.
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Net loss for the year ended December 31, 2023 was $(13.3) million, or $(4.24) per share, compared to a net loss of $(20.3) million, or $(11.58) per share, for the same period the prior year.

FOURTH QUARTER AND FULL YEAR 2023 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On March 5, 2024 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $40 million in 2023 and provided $6 million in cash generated from operations (Press release, Cumberland Pharmaceuticals, MAR 5, 2024, View Source [SID1234640775]).

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Cumberland ended the year with $82 million in total assets – including $18 million in cash, $53 million in liabilities and $30 million of shareholders’ equity.

"In many ways 2023 was a building year for Cumberland, as we continued to integrate our newest products, while also delivering several significant achievements," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "We were pleased to expand the labeling for our Caldolor product to include use in infants, while continuing to build our other brands and progress our clinical programs."
Cumberland will report its 2023 financial results and provide a Company update via a conference call today, March 5, 2024, at 4:30 p.m. Eastern Time.

HIGHLIGHTS FOR THE YEAR INCLUDE:
New Mission Statement
In 2023, Cumberland refined its mission statement to better capture the spirit of the Company. It now reads: working together to provide unique products that improve the quality of patient care.
In designing this statement, Cumberland considered several factors.
The Company wanted its mission to address the constituencies it serves, which include patients in need of care, as well as health care providers and its employees, shareholders, partners and community.
It needed to reflect Cumberland’s culture, where teamwork is prized, emphasized and expected – in order to achieve the company’s goals.
It also demonstrates Cumberland’s focus on developing, acquiring and distributing differentiated brands.
And finally, Cumberland wanted to emphasize that the patient is at the core of everything it does. Its collective efforts are directed at providing unique products that serve as better alternatives for poorly met medical needs.

Caldolor FDA Approval for Treating Infants and Supporting Study Publication
The FDA approved expanded labeling for Cumberland’s Caldolor product, an intravenously delivered formulation of ibuprofen, to include its use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients 3 to 6 months of age. With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection.
Cumberland also announced positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborns, published in the journal Pediatric Drugs. The results of the study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic option available to practitioners for the treatment of fever and pain in infants, children and adults.
Federal NOPAIN Act
In early 2023, the federal NOPAIN Act was passed, which the Company expects, will provide special, favorable reimbursement for non-opioid products like Caldolor. Cumberland submitted a request to the Centers for Medicare & Medicaid Services (CMS), to include Caldolor in the favorable reimbursement and expects to learn more this year in preparation for the Act’s implementation in 2025.
Expanded Oncology Sales Division
Cumberland expanded its oncology sales division as it works to deliver its newest brand – Sancuso – to help cancer patients tolerate their chemotherapy treatments. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy.
Vibativ Pediatric Study Results Published
Cumberland announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of its Vibativ product in children 2 to 17 years of age.
Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections caused by certain gram-positive bacteria.
The results of the study suggest that a single dose of Vibativ is safe in children and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.
2023 Sustainability Metrics
Cumberland updated its annual sustainability metrics, detailing the company’s activities pertaining to its environmental, social and governance matters. Cumberland reported its key findings for 2023, including providing 3 million doses of its FDA-approved products to patients and safely disposing of nearly 6,000 pounds of damaged and expired products. Additionally, Cumberland had no products recalled and no clinical trials terminated due to failure to practice good clinical standards in 2023.

Clinical Development Programs
Throughout 2023, Cumberland continued to progress its pipeline of innovative products designed to improve patient care and patients’ quality of life. Cumberland’s ifetroban product candidate – a potent and selective thromboxane receptor antagonist – is being evaluated in three Phase II clinical trials for patients with a series of unmet medical needs. It has now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in those individuals. Patient enrollment is well underway in two of those Company-sponsored Phase II clinical programs.
The first clinical program involves patients with Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs.
The other clinical program is evaluating ifetroban in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, or DMD. DMD is a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles. Cumberland is sponsoring the FIGHT DMD trial, a multicenter, randomized, placebo-controlled Phase II study enrolling patients across 10 centers in the United States that specialize in DMD. The Company has completed enrollment in the younger age group of patients and now is working to finish enrollment in the older patient group with DMD. The FDA has provided grant awards of over $1 million to support this study.
Cumberland is also developing an oral capsule to treat Idiopathic Pulmonary Fibrosis, or IPF, the most common form of progressive fibrosing interstitial lung disease. Following FDA clearance of its investigational new drug application in May 2023, the Company is now in the process of initiating its Phase II FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the United States. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
The Company’s plan going forward is to complete each of its company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which the Company continues to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.
FINANCIAL RESULTS:
Net Revenue: For 2023, net revenues were $40 million and included $16 million for Kristalose, $8.8 million for Vibativ, $8.1 million for Sancuso and $4.3 million for Caldolor.
Operating Expenses: Total operating expenses for 2023 were $49.1 million.
Net Income (Loss): The net loss for the fourth quarter of 2023 and the year ended December 31, 2023, was approximately $6.3 million. Results include a one time non-cash charge to intangible assets of $3.3 million associated with a product discontinuation.
Adjusted earnings: Adjusted earnings for the year ended December 31, 2023, were $2.4 million, or $0.17 a share. The adjusted earnings calculation does not include the benefit of the $2.3 million of Vibativ and Sancuso cost of goods, which were received as part of each product’s acquisition.
Balance Sheet: At December 31, 2023, Cumberland had $82 million in total assets, including $18 million in cash and cash equivalents. Liabilities totaled $53 million, including $12.8 million on the company’s credit facility. Total shareholders’ equity was $30 million at December 31, 2023.

EARNINGS REPORT CALL:
Cumberland will report its 2023 financial results via a conference call today, March 5, 2023, at 4:30 p.m. Eastern Time. To participate in the call, please register at
https://register.vevent.com/register/BI77538b1a0c52414b9e2772846f5498ae.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source