On August 10, 2021 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics,reported financial results for the second quarter ended June 30, 2021 (Press release, Ideaya Biosciences, AUG 10, 2021, View Source [SID1234586190]).

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"We reported clinical data across multiple programs in the second quarter of 2021, including early clinical pharmacodynamic data for IDE397 in MTAP-deletion patients, as well as overall survival data for darovasertib monotherapy and early clinical efficacy for the darovasertib / binimetinib and darovasertib / crizotinib combinations in metastatic uveal melanoma patients. We also continued to advance our broad synthetic lethality pipeline and platform, with two potential development candidates anticipated in the fourth quarter of 2021 and multiple potential first-in-class preclinical targets and programs advancing against genetically defined patient populations. These clinical data and our synthetic lethality pipeline demonstrate our clinical progress and commitment to deliver precision medicine oncology therapies to patients with high unmet medical needs," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

Program Updates
Key highlights for IDEAYA’s pipeline programs include:

IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors. IDEAYA is leading early clinical development of IDE397. Subject to exercise of its option, GlaxoSmithKline (GSK) will lead later stage global clinical development. Highlights:

Actively enrolling patients into the dose escalation and tumor biopsy cohorts of the Phase 1 clinical trial IDE397-001 (ClinicalTrials.gov Identifier: NCT04794699)
Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS
Enrolled patients having multiple solid tumor types with MTAP-deletion, including non-small cell lung cancer, pancreatic cancer, thymic cancer and adenoid cystic carcinoma
IDE397 has been generally well tolerated, with observed drug-related adverse events as of June 25, 2021 of only grade 1 drug-related adverse events, including constipation, nausea and fatigue; there were no reported drug-related serious adverse events and no reported myelosuppression, or changes to bilirubin or to aminotransaminase (AST) or alanine aminotransferase (ALT) enzymes
Observed reduction of plasma S-adenosylmethionine, or SAM, a proximal pharmacodynamic marker, in each of the first two cohorts of the IDE397 Phase 1 dose escalation study, satisfying the clinical protocol threshold of approximately 60% or greater to initiate the tumor biopsy cohort of the IDE397 Phase 1 clinical trial
Targeting initiation of the tumor biopsy cohort in the third quarter of 2021 to evaluate tumor PD biomarkers, including tumor SAM as well as tumor symmetric dimethylarginine, or SDMA.
Targeting to obtain additional PD data, including plasma SAM, tumor SAM and tumor SDMA, in the fourth quarter of 2021
Subject to satisfactory completion of the dose escalation portion of the Phase 1 clinical trial, IDEAYA plans to enroll MTAP deletion patients into expansion arms in NSCLC and potentially in other solid tumor indications such as esophageal, gastric, bladder, head and neck, or pancreatic cancers
Demonstrated preclinical efficacy of monotherapy IDE397 in a study of over forty solid tumor patient derived xenograft (PDX) models with homozygous MTAP deletions across a range of solid tumor types, including NSCLC, esophageal, gastric, bladder, head and neck, and pancreatic cancers; study data was reported at AACR (Free AACR Whitepaper) 2021
Observed preclinical in vivo efficacy of IDE397 in combination with a taxane, showing enhanced TGI in pancreatic cancer PDX models
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in patients having tumors with a defined biomarker based on genetic mutations and/or molecular signature. PARG is a novel target in the same clinically validated biological pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA owns or controls all commercial rights in its PARG program. Highlights:

Identified a novel and proprietary HRD biomarker to guide patient selection, with validation in vitro and in vivo in CDX models across multiple solid tumor indications
Demonstrated PARGi dose-dependent in vivo efficacy as monotherapy with tumor regression or stasis in ovarian, gastric and breast cancer CDX models
Observed in vivo efficacy with enhanced TGI or tumor regressions relative to niraparib, a PARPi, in multiple CDX models, including in a niraparib-resistant CDX model
Showed tumor regressions in multiple breast cancer PDX models with defined genetic and subtyping profiles, including in niraparib resistant PDX models
Showed pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines and in CDX and PDX models; study data reported at AACR (Free AACR Whitepaper) 2021
Subject to further preclinical studies, IDEAYA is targeting to identify a PARG inhibitor development candidate in the fourth quarter of 2021
Pol Theta
IDEAYA’s DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or other homologous recombination deficiency, or HRD, mutations. IDEAYA and GSK are collaborating on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program. Highlights:

Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft model with IDEAYA Pol Theta inhibitor in combination with niraparib, a GSK PARP inhibitor; and
Subject to further preclinical studies, IDEAYA is targeting selection of a Pol Theta inhibitor development candidate in the fourth quarter of 2021
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program. Highlights:

observed dose-dependent cellular viability effect and dose-dependent cellular PD response in multiple endogenous MSI high cell lines
Demonstrated efficacy and PD response in relevant MSI high in vivo models
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to identify small molecule inhibitors for an MTAP-synthetic lethality target, as well as for multiple distinct DNA Damage Targets for patients with solid tumors characterized by proprietary biomarkers or gene signatures.

Darovasertib (IDE196)
IDEAYA continues to execute on its clinical trial strategy to evaluate darovasertib (IDE196), a potent and selective PKC inhibitor.

IDEAYA is evaluating darovasertib in metastatic uveal melanoma (MUM) as monotherapy and in combination therapies, including combinations of darovasertib / binimetinib and independently, darovasertib / crizotinib. The company is continuing to enroll MUM patients into each of the combination arms of the Phase 1/2 clinical trial and is targeting to provide a clinical data update for the darovasertib combination(s) in the fourth quarter of 2021.

IDEAYA is planning to seek FDA regulatory guidance for darovasertib monotherapy based on observed overall survival data in MUM in the second half of 2021, and/or for darovasertib combination(s) on potential registration-enabling trial design in MUM in the first half of 2022.

The company is also evaluating darovasertib as monotherapy outside of MUM, with a focus in GNAQ/11-mutation skin melanoma.

Darovasertib Monotherapy
IDEAYA has completed enrollment into its ongoing Phase 1/2 clinical trial evaluating darovasertib as monotherapy in MUM patients. The company is continuing enrollment into its ongoing basket trial evaluating darovasertib as monotherapy in patients having non-MUM tumors harboring GNAQ or GNA11 activating mutations. The company’s development strategy in the monotherapy non-MUM GNAQ/11 arm of the clinical trial is focused on skin melanoma. Highlights:

Clinical data from Phase 1/2 clinical trial arm evaluating monotherapy darovasertib in MUM patients showed 57% 1-year overall survival (OS) with 95% confidence interval (44%, 69%) and median OS of 13.2 months with 95% confidence interval (10.7 months, not reached), in predominantly 2L/3L and heavily pretreated to 7L/8L patients, as of data and analyses cutoff on April 13, 2021 based on preliminary data from an unlocked database (n=81 patients evaluable for safety and n=75 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines)
Historical 37% 1-year OS and median OS of ~7 months have been reported in similar 2L/3L+ MUM patient population (Rantala 2019)
Clinical data from Phase 1/2 clinical basket trial arm evaluating monotherapy darovasertib in skin melanoma patients showed tumor reduction in 80% (n=4) of 5 evaluable skin melanoma patients pursuant to RECIST1.1 guidelines, including one confirmed PR, as of data and analyses cutoff of April 13, 2021 based on preliminary data from an unlocked database (n=7 patients evaluable for safety and n=5 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines)
An aggregate of 88 patients were evaluable for safety across Phase 1/2 arms evaluating darovasertib in MUM and skin melanoma patients. As of the April 13, 2021 data and analyses cutoff, and based on preliminary data from an unlocked database, the overall safety profile of darovasertib monotherapy is consistent with prior experience and includes primarily common low grade but manageable GI and skin toxicities
Preliminary clinical data from darovsertib monotherapy arm shows that darovasertib activity is independent of HLA status
Darovasertib / Binimetinib Combination Therapy
IDEAYA is continuing patient enrollment into the darovasertib / binimetinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer. Highlights:

Clinical data from Phase 1/2 clinical trial arm evaluating the darovasertib / binimetinib combination in MUM patients showed 22% (n=2) partial responses (PR), including one confirmed PR and one unconfirmed PR who confirmed with a 51.7% tumor reduction in a subsequent scan, out of nine evaluable MUM patients with at least two post-baseline scans pursuant to RECIST 1.1 guidelines, in predominantly second line, third line (2L / 3L) or later lines of treatment, as of data and analyses cutoff of April 13, 2021 based on preliminary data from an unlocked database (n=24 patients evaluable for safety and n=14 patients evaluable for efficacy)
Drug-related adverse events observed in the darovasertib and binimetinib combination arm in MUM, as of April 13, 2021 data and analyses cutoff based on preliminary data from an unlocked database, primarily include: serious adverse events of liver toxicity, nausea and vomiting, and syncope; and adverse events that occurred in greater than 10% of patients of nausea, vomiting, diarrhea, rash, edema, aminotransaminase, or AST increase, alanine aminotransferase, or ALT, increase and creatine phosphokinase increase
Darovasertib / Crizotinib Combination Therapy
IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer. Highlights:

Initiated dose expansion for a cohort of the Phase 1/2 darovasertib / crizotinib combination arm in MUM, with additional dose exploration ongoing
Clinical data from the darovasertib and crizotinib combination in MUM patients showed one unconfirmed PR in a third-line patient, who confirmed with a 56.5% tumor reduction in a subsequent scan, as of data and analyses cutoff on May 5, 2021 based on preliminary data from an unlocked database (n=6 patients evaluable for safety and n=2 patients evaluable for response with at least one post-baseline scan)
Drug-related adverse events observed in the darovasertib and crizotinib combination arm in MUM as of May 5, 2021, based on preliminary data from an unlocked database, primarily include: serious adverse events of syncope and hypotension, each of which resolved with patients continuing dosing; and adverse events that occurred in at least two of the six treated patients of nausea, diarrhea, vomiting, edema, decreased appetite, and syncope
Amended Pfizer clinical trial collaboration and supply agreement to enable expansion for 40 additional patients on darovasertib / crizotinib combination
Observed preclinical synergies between darovasertib and crizotinib in relevant cellular models under conditions simulating a tumor microenvironment in the liver, the site of approximately 90% of uveal melanoma metastases; study data reported at AACR (Free AACR Whitepaper) 2021
Correlated cMET expression and activation to observed clinical response based on a retrospective analysis of human clinical biopsies from the Novartis darovasertib Phase 1 clinical trial, supporting cMET expression / activation as potential combination agent
Darovasertib – Other Potential Indications
IDEAYA is evaluating the potential for darovasertib in GNAQ mutation-mediated rare diseases, including Sturge-Weber Syndrome (SWS) and Port Wine Stains (PWS), neurocutaneous disorders characterized by capillary malformations and associated with mutations in GNAQ. The US/EU5 prevalence of SWS patients who may potentially benefit from chronic treatment is approximately 13,000 to 33,000 patients. PWS is a potential related indication with an estimated US/EU5 prevalence of patients with extensive involvement – who have port-wine-stain over the trunk and extremities as well as the head and neck, of approximately 235,000 patients. Highlights:

Targeting FDA clearance in the first half of 2022 to initiate a Phase 1 clinical trial to evaluate darovasertib in SWS and extensive involvement of PWS populations
General
IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Initiation of clinical trial sites, patient enrollment and ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted for IDEAYA clinical trials evaluating IDE397 and darovasertib; the specific impacts are currently uncertain.

Corporate Updates
IDEAYA’s net losses were $10.9 million and $9.0 million for the three months ended June 30, 2021 and March 31, 2021, respectively. As of June 30, 2021, the company had an accumulated deficit of $147.0 million.

As of June 30, 2021, IDEAYA had cash, cash equivalents and marketable securities of $312.4 million. IDEAYA supplemented its second-quarter-end cash, cash equivalents and marketable securities with an additional $86.5 million in aggregate net proceeds, after deducting underwriting discounts and commissions but before deducting other offering expenses, received subsequent to quarter end from the sale and issuance of 5,333,333 shares of common stock at an offering price of $17.25 per share pursuant to an underwritten public offering, including 695,652 shares of common stock upon the exercise in full of the overallotment option by the underwriters.

IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into 2025. These funds will support the company’s efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.

Our updated corporate presentation is available on our website, at our Investor Relations page: View Source

Financial Results
As of June 30, 2021, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $312.4 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $310.4 million at March 31, 2021. The increase was primarily due to $15.4 million in net proceeds received during the three months ended June 30, 2021 from issuance of common stock under at-the-market offerings pursuant to the January 2021 Sales Agreement with Jefferies as sales agent, offset by cash used in operations and purchases of property and equipment.

Collaboration revenue for the three months ended June 30, 2021 totaled $8.8 million compared to $7.2 million for the three months ended March 31, 2021. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2021 under the GSK Collaboration Agreement.

Research and development (R&D) expenses for the three months ended June 30, 2021 totaled $15.0 million compared to $11.6 million for the three months ended March 31, 2021. The increase was primarily due to an increase in fees to CROs, CMOs and external consultants related to our lead product candidates, an increase in R&D headcount costs, an increase in external clinical development expenses for darovasertib and an increase in costs for laboratory supplies used in support of our research programs, offset by a decrease in external clinical development expenses for IDE397.

General and administrative (G&A) expenses for the three months ended June 30, 2021 totaled $4.8 million compared to $4.8 million for the three months ended March 31, 2021. An increase due to G&A headcount costs was offset by a decrease in costs associated with audit fees for the comparative periods.

The net loss for the three months ended June 30, 2021 was $10.9 million compared to $9.0 million for the three months ended March 31, 2021. Total stock compensation expense for the three months ended June 30, 2021 was $2.1 million compared to $1.9 million for the three months ended March 31, 2021.

On August 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the second quarter ended June 30, 2021 (Press release, Alpine Immune Sciences, AUG 10, 2021, View Source [SID1234586223]).

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"We have had a highly productive second quarter with substantial progress made across our portfolio highlighted by the initiation of Synergy, our international Phase 2 trial of ALPN-101, or acazicolcept, in lupus patients, the achievement of $45 million in development milestones as part of our AbbVie agreement, and the first presentation of clinical data from ALPN-202 highlighting the potential differentiation of safely agonizing CD28. Alpine has evolved into a global development company with clinical programs in both Immunology and Oncology and two strong pharmaceutical partners in AbbVie and Merck," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Looking forward, we plan to initiate our Phase 1 study for ALPN-303 by the fourth quarter and look forward to providing other updates as we progress on all our clinical studies."

Second Quarter 2021 and Recent Corporate and Clinical Updates

Acazicolcept: Dual CD28/ICOS inhibitor
Initiated Synergy, an international, double-blind placebo-controlled Phase 2 study of acazicolcept in patients with Systemic Lupus Erythematosus (SLE).
Achieved $45 million in pre-option exercise development milestones as part of the 2020 Option and License Agreement with AbbVie, with the potential of an additional $30 million in pre-option exercise development milestones.
ALPN-202: Conditional CD28 costimulator and dual checkpoint inhibitor
Presented initial dose escalation experience with ALPN-202 monotherapy in the NEON-1 clinical trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. ALPN-202 was well-tolerated to date, with evidence of peripheral T cell modulation consistent with CD28 agonism, and clinical benefit observed in the majority of participants, despite the population consisting of heavily pre-treated, advanced tumor types traditionally considered unresponsive to immunotherapies.
Entered a clinical trial collaboration and supply agreement with Merck and initiated enrollment in NEON-2, a dose escalation and expansion study to evaluate the safety and efficacy of ALPN-202 in combination with KEYTRUDA (pembrolizumab).
ALPN-303: Dual APRIL/BAFF inhibitor
Presented an oral abstract at the 2021 European Alliance of Associations for Rheumatology (EULAR) virtual meeting demonstrating superior preclinical activity of ALPN-303 compared to multiple comparators, including wild-type TACI-Fc fusion proteins.
Targeting completion of activities to support initiation of a Phase 1 healthy volunteer study with ALPN-303 in the fourth quarter of this year.
General Corporate
Appointed Zelanna Goldberg, M.D., M.A.S. as Chief Medical Officer: Dr. Goldberg brings over 20 years of industry and clinical practice experience, including strategic and/or operational responsibility for multiple therapeutic products. Most recently Dr. Goldberg was Senior Vice President of Clinical Science at Iovance Biotherapeutics.
Added to the Russel 3000 Index.
Second Quarter 2021 Financial Results

As of June 30, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $100.4 million, which does not include the $45.0 million in achieved milestones from the AbbVie collaboration expected to be received in the third quarter. We recorded net losses of $11.0 million and $9.9 million for the quarters ended June 30, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended June 30, 2021 was $7.2 million compared to $0.7 million for the quarter ended June 30, 2020. The increase was primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the quarter ended June 30, 2021 were $14.6 million compared to $7.1 million for the quarter ended June 30, 2020. The increase was primarily attributable to contract manufacturing and process development of our product candidates, personnel-related expenses, clinical trial activities, and direct research activities.

General and administrative expenses for the quarter ended June 30, 2021 were $3.3 million compared to $3.3 million for the quarter ended June 30, 2020. While the costs remained relatively constant, decreases in professional and legal services were partially offset by increases in personnel-related expenses to support the growth and expansion of our business.

Alpine expects that its current cash resources, combined with the $45 million in achieved milestones and the potential additional $30 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of acazicolcept, are sufficient to fund Alpine’s planned operations through 2023.

Second Quarter 2021 Conference Call and Webcast Details

Alpine will host a conference call and live webcast to discuss the second quarter performance today, August 10, 2021 at 4:30 p.m. ET/1:30 p.m. PT.

To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 8145346. A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.

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 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;company-update-301352063.html [SID1234586262]). 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

On August 10, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $40.9 million and $1.0 million, respectively, for the month of July 2021 (Press release, Pacira Pharmaceuticals, AUG 10, 2021, View Source [SID1234586281]). EXPAREL average daily sales for the month of July 2021 were 117 percent of July 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 21 in July 2021 and 23 in July 2020.

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"The continued growth of EXPAREL reflects its accelerating deployment as the opioid-free local analgesic of choice given its enduring efficacy, excellent safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Following record-level revenue in the second quarter, EXPAREL demand remains strong leaving us confident in our ability to achieve our five-year goals of top line growth in at least the high teens and operating margins that exceed 50 percent."

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2021.