On August 10, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the second quarter ended June 30, 2021, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, AUG 10, 2021, View Source [SID1234586246]).

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"We had a highly productive quarter in the clinic, including completion of enrollment in our 455-patient pivotal Phase 3 ROMAN trial of our lead product candidate, avasopasem, for SOM in patients with head and neck cancer, promising tumor outcome and survival data in an interim analysis of our 42-patient pancreatic cancer trial, and initiation of our 160-patient double-blinded placebo-controlled GRECO-2 pancreatic cancer trial," said Mel Sorensen, M.D., President and CEO. "We look forward to reporting clinical trial results from our key programs later this year. In parallel, Galera continues to strengthen our cash position and build our commercial capabilities as we work toward potential FDA approval of avasopasem in radiotherapy-induced SOM."

Recent Corporate Highlights

Severe Oral Mucositis (SOM)

Completed enrollment in the pivotal Phase 3 ROMAN trial of avasopasem for SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy, which triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences (Blackstone) received in July 2021. The Company expects to report topline data in the fourth quarter of 2021.

The Company expects to report topline data from the Phase 2a EUSOM multi-center trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy in the fourth quarter of 2021.
Locally Advanced Pancreatic Cancer (LAPC)

Reported updated data from the placebo-controlled 42-patient trial of Galera’s dismutase mimetic in patients with LAPC who are undergoing stereotactic body radiation therapy (SBRT). The updated results include a minimum follow-up of six months on all 42 patients. As of the interim data analysis, median overall survival in the treatment arm (20.1 months) was nearly twice as long as observed in the placebo arm (10.9 months); and positive results were also observed in local tumor control, time to metastases and progression-free survival. The Company expects to report final results from the trial, with at least one year of follow-up on all patients, in the third quarter of 2021.

Initiated the 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of GC4711, Galera’s second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC in May 2021, which triggered a $20 million milestone payment from Blackstone received in June 2021.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Esophagitis

Enrollment is ongoing in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company expects to report topline data in the first half of 2022.
Second Quarter 2021 Financial Highlights

Research and development expenses were $16.0 million in the second quarter of 2021, compared to $13.8 million for the same period in 2020. The increase was primarily attributable to avasopasem development costs due to increased clinical expenses, primarily related to the ROMAN trial, and an increase in manufacturing and regulatory activities.

General and administrative expenses were $5.1 million in the second quarter of 2021, compared to $3.9 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to pre-commercial activities for avasopasem, and increased insurance expense and professional fees.

Galera reported a net loss of $(22.4) million, or $(0.88) per share, for the second quarter of 2021, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2020.

As of June 30, 2021, Galera had cash, cash equivalents and short-term investments of $66.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the payment from Blackstone in the amount of $37.5 million received in July 2021, will enable Galera to fund its operating expenses and capital expenditure requirements for at least the next twelve months.

On August 10, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported its financial results for the quarter ended June 30, 2021 and provided a business update on its progress over the reporting period (Press release, Immatics, AUG 10, 2021, View Source [SID1234586245]).

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"An important development during the second quarter of 2021 was a significant increase in patient enrollment for our ACTengine programs," said Harpreet Singh, Ph.D., CEO of Immatics. "Following the positive initial results we provided in the first quarter, we now look forward to announcing more advanced data including safety, biological activity and the assessment of anti-tumor activity for a range of different cancer indications in the second half of 2021."

"In addition to the upcoming clinical data for our ACTengine trials, we are excited to move our second therapeutic modality towards the clinic," added Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We are encouraged by the entirety of the IMA401 data set, which following discussions with regulatory authorities puts us in a strong position to submit our IMA401 Clinical Trial Application during the fourth quarter of 2021. Our TCER pipeline is further strengthened by our second TCR Bispecifics program, IMA402, for which we recently presented preclinical proof-of-concept data."

Second Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA200 series – Patient recruitment remains on track and the additional trial sites initiated in Europe and the US have supported the acceleration of recruitment. As of end of July, 27 patients have been treated in the IMA200 series. The first-in-human basket trials for IMA201, IMA202 and IMA203 include patients with recurrent and/or refractory solid cancers utilizing TCR-engineered T cells (TCR-T) directed against the cancer targets MAGEA4/A8, MAGEA1 and PRAME, respectively.
In March 2021, Immatics reported initial safety and biological data as well as data showing first clinical anti-tumor activity for 10 patients enrolled in these trials. Patients were treated at initial dose levels below one billion transduced cells, which was presumed to be sub-therapeutic as per data published from across the industry.
The next data update, which will cover safety, biological activity, and the assessment of anti-tumor activity across different cancer indications, including patients treated at higher dose levels (dose levels 2 and 3), will be provided by the company within the second half of 2021.

TCR Bispecifics Programs

IMA401 – Immatics has discussed the proposed clinical trial design for its first TCER program IMA401, as well as the preclinical data package covering safety and efficacy data in a scientific advisory meeting2 with the Paul-Ehrlich Institute, the German regulatory authority. The company also completed the first Good Manufacturing Practices (GMP) production batch delivering a high production yield. IMA401 remains on track for submission of a CTA in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022.
IMA402 – The company presented preclinical proof-of-concept data on IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May. IMA402 is directed against a peptide derived from the cancer target PRAME, a protein that is frequently expressed in many solid cancers, thereby supporting the program’s potential to address a broad range of cancer patients and indications. Data demonstrated tumor cell killing in vitro and complete regressions of established tumors in an in vivo tumor model. Immatics has selected a lead candidate for the clinical program and initiated manufacturing activities.
Corporate Development

As of July 1, 2021, Immatics adopted a one-tier structure for its Board of Directors. As part of this process, the company’s CEO Harpreet Singh, Ph.D., has joined the Board.
Friedrich von Bohlen und Halbach, Ph.D., was appointed as successor of Christof Hettich, L.L.D. Dr. von Bohlen und Halbach is Managing Partner and co-founder of dievini Hopp BioTech Holding, managing the investments of Dietmar Hopp and family.
Second Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents as well as Other financial assets total €192.8 million ($229.1 million1) as of June 30, 2021, compared to €216.7 million ($257.5 million1) as of March 31, 2021.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €5.2 million ($6.2 million1) for the three months ended June 30, 2021, compared to €6.9 million ($8.2 million1) for the three months ended June 30, 2020.

Research and Development Expenses: R&D expenses were €20.3 million ($24.1 million1) for the three months ended June 30, 2021, compared to €16.5 million ($19.7 million1) for the three months ended June 30, 2020. The increase is mainly due to expanded clinical activities for the ACTengine IMA200 series, as well as GMP manufacturing for the TCER compound, IMA401.

General and Administrative Expenses: G&A expenses were €8.3 million ($9.9 million1) for the three months ended June 30, 2021, compared to €10.1 million ($12.0 million1) for the three months ended June 30, 2020. The decrease is mainly due to one-time expenses in connection with the listing of the Company in 2020.

Net Loss: Net loss was €23.8 million ($28.3 million1) for the three months ended June 30, 2021, compared to €21.3 million ($25.3 million1) for the three months ended June 30, 2020.

Upcoming Investor Conferences

BTIG Virtual Biotechnology Conference – August 9-10, 2021
Goldman Sachs London Biotech Symposium – September 7, 2021
Jefferies London Healthcare Conference – November 16-18, 2021

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2021 (1 EUR = 1.1884 USD).

2 in Europe, equivalent to a pre-IND meeting at FDA.

About ACTengine IMA200 series
Each of the product candidates of the IMA200 series is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.

On August 10, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it has withdrawn its proposed public offering (Press release, BioCryst Pharmaceuticals, AUG 10, 2021, View Source [SID1234586244]). With our strong balance sheet, and increasing revenues from ORLADEYO (berotralstat), we believe that current market conditions are not conducive to an offering on terms that would be in the best interests of our current stockholders. We are well capitalized, with cash, cash equivalents, restricted cash and investments of $222.8 million as of June 30, 2021. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

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On August 10, 2021 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported recent business and pipeline updates, as well as second quarter 2021 financial results (Press release, Beam Therapeutics, AUG 10, 2021, View Source [SID1234586243]).

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"We have made meaningful progress in advancing our base editing programs in the first half of the year, and importantly, remain on track to submit our first investigational new drug (IND) for BEAM-101 in the second half of this year," said John Evans, chief executive officer of Beam. "With the initiation of IND-enabling studies for BEAM-201, we are now bringing the versatility and precision of base editing to a second therapeutic area, targeting the high unmet need in T-cell cancers with the first quad-edited cell therapy. We’ve also continued to expand our innovative collaborator network, most recently through our partnership with Apellis to apply base editing to the more biologically complex disease area of the complement pathway. With a strong balance sheet, we are well positioned to advance our robust pipeline of novel base editing programs through IND filings and into the clinic as we strive to provide potentially life-long cures for patients suffering from serious diseases."

Base Editing Pipeline Progress

IND-Enabling Studies for BEAM-201 Initiated: Beam has initiated IND-enabling studies for BEAM-201 for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL). BEAM-201 is a potent and specific allogeneic CAR-T targeting CD7+ malignancies, which uses multiplex base editing to simultaneously make four knockout edits at over 96% efficiency for each gene. Relapsed/refractory T-ALL is a severe disease affecting children and adults with a five-year overall survival rate of less than 25%.

Additional Upcoming Milestones in Ex Vivo and In Vivo Base Editing Pipeline On Track: Beam anticipates filing an IND for BEAM-101, which reproduces single base changes seen in individuals with Hereditary Persistence of Fetal Hemoglobin, or HPFH, to potentially protect them from the effects of mutations causing sickle cell disease (SCD), and initiating IND-enabling studies for BEAM-102, which directly corrects the causative mutation in SCD by recreating a naturally-occurring normal human hemoglobin variant, both in the second half of 2021. Beam is also on track to nominate its first Development Candidate for in vivo base editing of the liver using LNP delivery by the end of 2021.

Data Highlighting Base Editing Approach for the Treatment of Alpha-1 Antitrypsin Deficiency Published in Molecular Therapy: In July 2021, data from a preclinical study led by the Center for Regenerative Medicine at Boston Medical Center and Boston University evaluating Beam’s base editors in induced pluripotent stem cells (iPS cells) from patients with alpha-1 antitrypsin deficiency (AATD) were published in Molecular Therapy. As part of the study, the researchers utilized patient-derived liver cells that mimic the biology of liver hepatocytes, the main producers of alpha-1 antitrypsin protein in the body, that likewise perform important metabolic, endocrine and secretory functions. The data showed that Beam’s base editors corrected the mutation in the gene responsible for AATD and reduced the effects of the disease in the hepatocytes, demonstrating successful base editing in human cells.
Upcoming Base Editing Data Presentations

Data from Sickle Cell Disease Program to be Presented at Cold Spring Harbor Laboratory’s Genome Engineering: CRISPR Frontiers: Beam plans to present preclinical data highlighting its approach to using adenine base editing (ABE) for the treatment of sickle cell disease, including updated safety data during an oral session at the Cold Spring Harbor Laboratory’s Genome Engineering: CRISPR Frontiers Conference. Details of the presentation are as follows:

Title: Adenine base editing strategy for the treatment of sickle cell disease by elimination of the pathogenic globin protein
Session: Disease/Therapeutic
Date: Friday, August 20, 2021, 2:30 -5:30 p.m. ET

Updated Data on Optimization of LNP Delivery Approach to be Presented at TIDES 2021: Beam plans to present preclinical data highlighting work to optimize its lipid nanoparticles (LNPs) for the delivery of mRNA encoding a base editor and guide RNA to hepatocytes in the liver during an oral session at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference. Details of the presentation are as follows:

Title: Optimization of LNP for in vivo Base Editing in Liver
Track: mRNA and Genome Editing TRACK: Emerging Genome Editing Technologies
Date/Time: Thursday, September 23, 2021, 11:15 a.m. – 11:45 a.m. ET
Business Highlights

Groundbreaking on Internal Manufacturing Facility to Support Future Product Development: In July 2021, Beam broke ground on its 100,000 square foot current Good Manufacturing Practice (cGMP) compliant manufacturing facility in Research Triangle Park, North Carolina. The facility will be designed to support manufacturing for Beam’s ex vivo cell therapy programs in hematology and oncology and in vivo non-viral delivery programs for liver diseases, with flexibility to support manufacturing of its viral delivery programs, and ultimately, scale-up to support commercial supply. Beam expects the facility to be operational in 2023.

Exclusive Research Collaboration Executed with Apellis to Apply Base Editing to Discover Novel Therapies for Complement-Driven Diseases: In June 2021, Beam and Apellis Pharmaceuticals, Inc. (Apellis) announced an exclusive five-year research collaboration focused on the use of Beam’s proprietary base editing technology to discover new treatments for complement-driven diseases. Under the terms of the collaboration agreement, Beam will apply its base editing technology and conduct preclinical research on up to six base editing programs that target specific genes within the complement system, including C3, in various organs, including the eye, liver and brain. Apellis will have exclusive rights to license each of the six programs and will assume responsibility for subsequent development. Apellis agreed to pay a total of $75 million in upfront and near-term milestones to Beam. Beam is also eligible to receive development, regulatory and sales milestones, as well as royalty payments on sales of licensed products. Beam may also elect to enter into a 50-50 U.S. co-development and co-commercialization agreement with Apellis with respect to one program licensed under the collaboration.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $615.3 million as of June 30, 2021, compared to $299.7 million as of December 31, 2020.

Research & Development (R&D) Expenses: R&D expenses were $45.6 million for the second quarter of 2021, compared to $19.4 million for the second quarter of 2020.

General & Administrative (G&A) Expenses: G&A expenses were $13.4 million for the second quarter of 2021, compared to $6.9 million for the second quarter of 2020.

Net Loss: Net loss attributable to common stockholders was $76.3 million, or $1.23 per share, for the second quarter of 2021, compared to $34.2 million, or $0.69 per share, for the second quarter of 2020.

On August 10, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported a company update and second quarter 2021 financial results (Press release, Cumberland Pharmaceuticals, AUG 10, 2021, View Source [SID1234586242]). Net revenues from continuing operations during the quarter were $9.1 million and totaled $19.6 million for the first half of 2021. The company also recorded an additional $500,000 in revenue during the second quarter and $1 million year to date, associated with divested product rights for two brands it is no longer distributing.

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While there was a slight decline in revenues during the second quarter 2021 compared to the prior year period, net revenues for the first half of 2021 were up 9.3% compared to the same period in 2020. The Company also posted year-to-date net income of $1.4 million during the first half of 2021, compared to a loss of $2 million during the prior year period.

The Company’s financial position included $89 million in total assets, with $26 million in cash, $41 million of total liabilities, and $48 million of shareholders’ equity at the end of the quarter.

"Cumberland continued to face headwinds due to the pandemic, but we are fortunate to have a diversified product portfolio that helped us counter the negative effects on our business," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We have adjusted our strategies and reinvented the way we operate in order to support our customers and the patients who can benefit from the delivery of our medicines."

RECENT COMPANY DEVELOPMENTS:

ESG Report

In July 2021, Cumberland released its second annual Sustainability Report (the "ESG Report"), which details the Company’s activities pertaining to environmental, social and governance ("ESG") matters. After issuing an inaugural ESG report last year, the Company remains committed to sustainability and to maintaining transparency of its corporate operations. As the largest biopharmaceutical company founded and headquartered in the Mid-South, Cumberland holds itself to the highest standards of ethical practices and understands the importance of recognizing and addressing the Company’s impact on its constituents, the community and the environment.

The ESG Report notes that in 2020, Cumberland provided nearly 2.5 million patient doses of its products, safely disposed of over 4,000 pounds of expired and damaged products and had no product recalls. The Company also had no brands that were listed on the U.S. Food and Drug Administration’s ("FDA") MedWatch Safety Alerts for Human Medical Products, no brand issues that were identified by the FDA from their Adverse Event Reporting System and no clinical trials that were terminated due to failure to practice good clinical standards.

The ESG Report also highlights several initiatives Cumberland implemented as part of its commitment to delivering high-quality pharmaceutical products to improve patient care. For example, the Company continued a program to serialize all commercial products sold in the United States, allowing it to track every unit distributed, which helps to prevent counterfeit drugs from entering the market under the Cumberland brand. In addition, through its coupon program, Cumberland covers up to 90% of patient prescription costs for the Company’s gastrointestinal products.

The ESG Report also highlights Cumberland’s investment in its employees through continuing education programs, employee development initiatives and employee recognition awards. Cumberland’s workforce is 46% women – and 18% of the Company’s employees are minorities.

Vibativ Case Studies

In June 2021, Cumberland released a series of case reports describing the effectiveness of Vibativ (telavancin) in treating secondary bacterial infections in COVID-19 patients – particularly those with other significant health problems, such as obesity, diabetes and heart disease. Cumberland’s Vibativ product has been used across the country to help COVID-19 patients who develop secondary bacterial infections in their lungs. Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia that can result from COVID-19, flu and other infections.

The Company compiled a dossier of patient case studies from across the country outlining several real-world instances where Vibativ effectively and safely treated the hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia resulting from MSSA and MRSA infections that developed in patients hospitalized with COVID-19.

Hyponatremia Publication in Support of Vaprisol

In late 2020, the Health Outcome Predictive Evaluation (HOPE) COVID-19 Registry Analysis, an international study of over 4,000 patients, found that patients hospitalized with COVID-19 had a high risk of developing hyponatremia. These COVID-19 patients also had a higher incidence of mortality due to their hyponatremia. The study results support the use of an intravenous vaptan to treat hyponatremia in critically ill patients afflicted with COVID-19.

Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients. Cumberland’s Vaprisol product is one of two branded prescription products indicated for the treatment of hyponatremia, and the only intravenously administered branded treatment. Vaprisol has a proven day one response to help normalize serum sodium levels in hyponatremic patients and move them out of the ICU as efficiently as possible.

New Chief Financial Officer Appointment

On May 17, 2021, Cumberland appointed John Hamm as its new Senior Director Finance & Accounting and Chief Financial Officer. In this role, his responsibilities include management of all the Company’s finance and accounting activities, while he continues to oversee corporate development and legal matters.

Mr. Hamm has more than 25 years of finance and accounting experience, including 20 years in health care. He previously held the positions of Chief Operating Officer and Chief Financial Officer, Pharmacy at HealthSpring, Inc., a managed care organization now operating as Cigna-HealthSpring.

He was also the Vice President Finance at Emdeon Business Services. Emdeon Inc., a healthcare technology firm that now operates as Change Healthcare Inc., a NASDAQ listed company with over $3 billion in annual revenues.

Mr. Hamm holds a Bachelor of Science in Business Administration with a minor in Accounting from Wheeling University. He earned his Master’s in Business Administration with an emphasis in Accounting from West Virginia University. He is a Certified Management Accountant (CMA) and Certified Financial Manager (CFM).

Prior to this new appointment, Mr. Hamm served as Cumberland’s Director Corporate Development.

Paycheck Protection Program

On April 20, 2020, Cumberland received a loan from Pinnacle Bank in the aggregate amount of $2,187,140 pursuant to the Paycheck Protection Program (the "PPP") under the Federal Coronavirus Aid, Relief and Economic Security Act ("CARES Act"), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business Administration ("SBA").

Pursuant to the PPP requirements, loan funds were used to maintain payroll, continue group health care benefits, and pay for rent and utilities during the pandemic. Cumberland applied for this loan after carefully considering, with Pinnacle Bank, the eligibility criteria to participate in this program, and determining that it met those criteria. The Company evaluated and provided information on its payroll and other qualifying expenses to determine the amount of PPP funds to apply for. Due to assistance from the PPP loan, the Company did not lay off or furlough any employees as a result of the COVID-19 pandemic.

Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. Cumberland used the PPP loan funds for such qualifying expenses. In October 2020, Cumberland submitted a request for the loan’s forgiveness and on June 11, 2021, the Company received a formal notice from the SBA that the full amount of the loan was forgiven.

RediTrex Launch

During late 2018, Cumberland completed the submission of and filed with the FDA a New Drug Application for its RediTrex methotrexate injection product. RediTrex is a new line of pre-filled syringes specifically designed for ease of handling and dosing accuracy for the subcutaneous administration of methotrexate in patients with arthritis and psoriasis.

In December 2019, the Company received FDA approval for RediTrex and began planning for the launch of the product line. Cumberland provided initial shipments of RediTrex to accounts in November 2020 and is planning to launch the product line nationally in late September 2021.

Ifetroban Phase II Studies

Cumberland is sponsoring Phase II clinical programs to evaluate its ifetroban product candidates in 1) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles, 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 3) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

In addition, the Company has completed two pilot Phase II studies involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure and 2) patients with Portal Hypertension that is associated with chronic liver disease.

Additional pilot preclinical and clinical studies of ifetroban are underway, including several investigator-initiated trials.

Enrollment in these clinical studies was interrupted due to the COVID-19 pandemic. While enrollment of new patients has been limited in 2021, many of the clinical study sites have reopened and resumed screening of patients for potential enrollment into the studies. Cumberland is awaiting results from the studies underway before deciding on the best development path for the registration of ifetroban, the Company’s first new chemical entity.

FINANCIAL RESULTS:

Net Revenues: For the three months ended June 30, 2021, net revenues from ongoing operations were $9.1 million, compared to $9.6 million for the prior year period. The company also recorded an additional $500,000 in revenue during the second quarter associated with divested rights to products that the company no longer distributes.

Net revenue by product for the second quarter 2021 included $5.3 million for Kristalose, $1.8 million for Vibativ, $0.9 million for Caldolor and $0.4 million for Vaprisol.

Year-to-date 2021 net revenues were $19.6 million, compared to $17.9 million during the first half of 2020. There were additional revenues of $1 million during the first six months of 2021 associated with the divested product rights.

Year-to-date 2021 net revenues by product were $8.3 million for Kristalose, $6.9 million for Vibativ, $2.5 million for Caldolor and $1.5 million for Vaprisol.

Operating Expenses: Total operating expenses for the three months ended June 30, 2021 were $10.5 million, compared to $11.2 million during the prior year period.

Earnings: Net income for the second quarter 2021 was $1.2 million, or $0.08 a share, compared to a loss of $0.9 million, or $0.06 a share for the prior year period. The adjusted loss for the second quarter was $16,000, compared to an adjusted loss of $120,000 for the prior year period.

Year-to-date net income in 2021 was $1.4 million, compared to a loss of $2 million during the first six months of 2020. Adjusted earnings for the first half of 2021 were $1 million, compared to an adjusted loss of $0.5 million during the same period in 2020.

Balance Sheet: At June 30, 2021, Cumberland had $88.9 million in total assets, including $25.7 million in cash and cash equivalents. Total liabilities were $41 million, including $14 million outstanding on the Company’s revolving line of credit, resulting in total shareholders’ equity of $48 million.

CONFERENCE CALL & WEBCAST:

A conference call and live internet webcast will be held on Tuesday, August 10, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 3985462. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source