On March 28, 2022 Avera Health (Avera), an integrated regional health care system that serves 300 locations across the Upper Midwest, and Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision medicine company with a novel phosphoprotein-based assay for breast cancer reported a strategic collaboration to advance comprehensive molecular profiling, enabling Avera Health’s providers and patients to benefit from data-driven insights that inform targeted cancer treatments (Press release, Avera Pharmaceuticals, MAR 28, 2022, View Source [SID1234611072]).

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Avera has a long-standing history of leading the way in precision oncology with patients’ tumors being genetically sequenced to guide individualized cancer care. Theralink, with its patented protein and phosphoprotein biomarker platform and lab developed test, is the only commercially available assay for clinical use that measures the tumor cell levels of activated proteins, which are the primary targets of most FDA-approved therapies and biopharmaceutical investigational drugs.

Theralink will provide key patient-specific information about which drug targets are activated and "in use" in each patient tumor sample. This information, coupled with the genomics findings, will provide a comprehensive molecular profile for all Avera oncology patients by way of a multiomic report used for physician treatment decisions.

"Avera has been a cancer care leader in our region for many years. Avera Cancer Institute is focused on actionable insights for our physicians and patients to make treatment decisions that are personalized," said Casey Williams, Chief Scientific Officer and Executive Director of Cancer Research. "We understand the role this innovative approach plays in generating better health outcomes for our patients, and Theralink will play a key role in that process."

"We believe that the Theralink protein/phosphoprotein data, combined with the next generation sequencing data, may give Avera Cancer Institute the most cutting edge and best precision oncology data in the world, potentially creating a step change in cancer care," said Mick Ruxin, M.D., President & CEO of Theralink. He went on to say, "It is gratifying to know that a large, prestigious, midwest cancer program, Avera Health, has realized the significant potential value of our Theralink assay for their cancer patients." Dr. Ruxin continued, "We expect great results from working with Avera and their patients in our goal to decrease the morbidity and mortality of cancer patients."

As part of this collaboration, Avera will assist Theralink Technologies in validating new clinical assays for additional tumors (such as GYN, Head and Neck, GI, Lung, Kidney, Liver and Prostate) through retrospective case analysis and population-based data. This may bring new capability and insights to precision oncology care and allow for the Theralink assay to become a pan-tumor assay.

On March 28, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months and year ended December 31, 2021 (Press release, Nuvo Pharmaceuticals, MAR 28, 2022, View Source [SID1234611036]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Consolidated Financial Statements for the three months and year ended December 31, 2021 which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments Three months ended December 31, 2021 include the following:
• Total revenue was $17.7 million, an increase of 2% compared to $17.3 million for the three months ended December 31, 2020. Adjusted total revenue(1) was $17.8 million, an increase of 3% compared to $17.3 million for the three months ended December 31, 2020.
• Net loss was $5.6 million compared to net income of $2.4 million for the three months ended December 31, 2020. Adjusted EBITDA(1) was $3.4 million, a decrease of 46% compared to $6.2 million for the three months ended December 31, 2020.
• Revenue related to Blexten, Cambia and Suvexx was $8.8 million, an increase of 30% compared to revenue of $6.8 million for the three months ended December 31, 2020. Total Canadian prescriptions of Blexten, Cambia and Suvexx increased by 20%, 3% and 80%, respectively compared to the three months ended December 31, 2020.
• The Company repaid $3.1 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
• As at December 31, 2021, cash and cash equivalents were $30.9 million. Year ended December 31, 2021 include the following:
• Total revenue was $68.9 million, a decrease of 7% compared to $73.8 million for the year ended December 31, 2020. Adjusted total revenue(1) was $69.4 million, a decrease of 2% compared to $71.0 million for the year ended December 31, 2020.
• Net loss was $32.2 million compared to net loss of $4.1 million for the year ended December 31, 2020. Adjusted EBITDA(1) was $22.2 million, a decrease of 22% compared to $28.4 million for the year ended December 31, 2020. • Revenue related to Blexten, Cambia and Suvexx was $32.3 million, an increase of 27% compared to revenue of $25.5 million for the year ended December 31, 2020. Canadian prescriptions of Blexten and Cambia increased by 21% and 8%, respectively compared to the year ended December 31, 2020.
• The Company repaid $13.4 million (US$10.8 million) of the Amortization Loan to Deerfield. (1) Non-IFRS financial measure. These measures are not recognized under IFRS and do not have standardized meanings prescribed by IFRS. See the Non-IFRS Measures section for definitions, reconciliations and the basis of presentation of the Company’s non-IFRS measures. Business Update
• In February 2022, the United States District Court for the District of New Jersey granted a motion for summary judgment filed by Dr. Reddy’s Laboratories Inc. (Dr. Reddy’s). As a result, the asserted claims of Nuvo Pharmaceuticals (Ireland) DAC’s (Miravo Ireland) U.S. Patent Nos. 8,858,996 (the ‘996 Patent) and 9,161,920 (the ‘920 Patent) related to Vimovo in the U.S. were found to be invalid. Miravo Ireland and its partner are not planning on appealing this decision.
• In February 2022, Blexten for pediatric use in patients 4 years of age and older* was commercially launched in Canada by. The pediatric use includes two new dosage formats; a 2.5mg/mL oral solution and a 10mg orodispersible tablet (quick melt) for the treatment of the symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (such as itchiness and hives). The pediatric formats will be available to patients with a prescription from their healthcare provider.
• In October 2021, Resultz was commercially launched in the U.S. market by The Mentholatum Company. Resultz is marketed in the U.S. under the brand name Mentholatum Kids Headlice Removal Kit. The Company’s Irish subsidiary, Miravo Ireland receives revenue from the supply of finished product to The Mentholatum Company.

* Blexten (bilastine) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (e.g. pruritus and hives) in patients 4 years of age and older with a body weight of at least 16 kg.

"Our key promoted brands have demonstrated continued strong performance with Blexten, Cambia, Suvexx and NeoVisc achieving year-over-year gains in prescription and revenue growth despite COVID-19 pandemic related headwinds. We are encouraged by the increasing numbers of in-person patient visits at healthcare providers and anticipate a return to pre-pandemic levels over the coming quarters," said Jesse Ledger, Miravo’s President & CEO. "Our product portfolio has continued to expand with the approval and subsequent launch of the pediatric formats of Blexten in Canada; and our EU and South Korean marketing authorization applications for Suvexx continue to move through the review process in their respective territories." 2021 and Fourth Quarter Financial Results Adjusted total revenue was $69.4 million for the year ended December 31, 2021 compared to $71.0 million for the year ended December 31, 2020.

The $1.6 million decrease in adjusted total revenue in the current year was primarily attributable to a decrease of $6.7 million of revenue from the Licensing and Royalty Business segment and a decrease in revenue of $0.7 million in the Production and Service Business segment, slightly offset by an increase of $5.8 million in the Commercial Business segment. Revenue attributable to the Commercial Business segment increased during the year ended December 31, 2021 due to a $7.3 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), offset by a $1.5 million decrease in sales of the Company’s mature products. The Production and Service Business segment revenue decreased during the year ended December 31, 2021, primarily due to a decrease in Pennsaid 2% and Resultz product sales, as well as the stronger Canadian dollar against the U.S. dollar and euro, which reduced the contribution from certain U.S. and euro denominated product revenue streams, slightly offset by an increase in sales of Pennsaid.

The decrease in revenue attributable to the License and Royalty business segment during the year ended December 31, 2021 was primarily attributable to a $4.5 million reduction in U.S. Vimovo royalty revenue due to a competitor launch of a generic version of Vimovo in the U.S. during March 2020, as well as the stronger Canadian dollar against the U.S. dollar and euro, which reduced the contribution from certain U.S. and euro denominated royalty streams during the current year. In addition, in the comparative year, the Company received a $2.5 million (US $1.8 million) milestone payment, net of withholding taxes related to the use of its Yosprala intellectual property in Japan. Adjusted total revenue for the three months ended December 31, 2021 increased to $17.8 million compared to $17.3 million for the three months ended December 31, 2020.

Adjusted EBITDA was $22.2 million for the year ended December 31, 2021 compared to $28.4 million for the year ended December 31, 2020. During the year ended December 31, 2021, a $5.5 million increase in gross profit from the Company’s Commercial Business segment (net a $1.4 million decrease in inventory step-up expense) was more than offset by a $6.7 million decrease in the contribution from the Company’s License and Royalty Business segment, a $1.5 million decrease in gross profit contribution from the Production and Service Business segment, a $1.9 million increase in sales and marketing expenses and a $0.1 million increase in general and administrative (G&A) expenses (net a $0.1 million increase in stock-based compensation). Adjusted EBITDA for the three months ended December 31, 2021 was $3.4 million compared to $6.2 million for the three months ended December 31, 2020. Non-IFRS Measures The Company discloses non-IFRS financial measures (adjusted total revenue, adjusted EBITDA, and cash value of loans) and a non-IFRS ratio (adjusted EBITDA per share) that are not recognized under and do not have standardized meanings prescribed by IFRS. Accordingly, such measures are not necessarily comparable and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding and assessing the Company’s financial performance.

We utilize these measures in managing our business, including as means of performance measurement, cash management and debt compliance. Because non-IFRS financial measures and non-IFRS ratios do not have standardized meanings prescribed under IFRS, securities regulations require that such measures be clearly defined, identified, and for non-IFRS financial measures, reconciled to their nearest IFRS measure.

The applicable definition, calculation and reconciliation of each such measure used in this MD&A is provided below. Adjusted Total Revenue The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations. Adjusted EBITDA EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery).

The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, loss on fair value of derivative liabilities, loss on fair value of contingent and variable consideration, impairment loss, foreign currency loss, other losses less revenue recognized upon recognition of a contract asset, stock-based compensation recovery, gain on fair value of derivative liabilities, gain on fair value of contingent and variable consideration, impairment recovery, foreign currency gain and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

(1) Income tax expense for the year ended December 31, 2021 includes $2.4 million for deferred income tax due to the utilization of loss carryforwards that were previously recognized. The Company did not recognize deferred income tax expense in the comparative year.
(2) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the increase in the share price in the current year and an increase in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities increased, and the Company recognized net losses of $15.6 million on the change in fair value of derivative liabilities for the year ended December 31, 2021.
(3) During the year ended December 31, 2021, the Company recorded impairment of $17.9 million of goodwill and certain intangible assets in the Commercial Business and Licensing and Royalty segments. Additional details regarding the Company’s methodology and assumptions are disclosed in Note 9, Intangible Assets and Note 10, Goodwill to the Consolidated Financial Statements for the year ended December 31, 2021. See Impairment and Risk Factors in the Management’s, Discussion and Analysis for the year ended December 31, 2021.

Management to Host Conference Call/Webcast Management will host a conference call to discuss the results today (Monday, March 28, 2022) at 11:00 a.m. ET. To participate in the conference call, please dial (289) 536-4777 or 1 (888) 550-2239 / Conference ID: 6216508. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins. A live audio webcast and replay webcast of the conference call will be available through View Source

On March 28, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported recent business highlights and financial results for its fourth quarter and full year ended December 31, 2021 (Press release, HCW Biologics, MAR 28, 2022, View Source [SID1234611058]).

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Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, stated, "We accomplished a number of significant achievements in the past year. We fortified our balance sheet through an initial public offering. We advanced our clinical development programs, overcoming headwinds from the COVID-19 pandemic, supply chain disruptions, and critical supply shortages. We begin 2022 poised to initiate multiple clinical trials to evaluate HCW9218 in cancer indications. We are hopeful later this year we begin to see human data that demonstrate the potential for our immunotherapeutics in the treatment of chemotherapy-resistant cancer, and validate our focus on the elimination of cellular senescence, which is the etiology for many age-related diseases."

Year in Review – Business Highlights:

In the year ended December 31, 2021, the Company achieved several milestones:

IPO. On July 22, 2021, the Company closed its IPO resulting in net proceeds of approximately $49.2 million, after deducting underwriting discounts and commissions and offering expenses paid by the Company.

HCWB added to Total Market Index. The Company was added to the S&P Total Market Index ("TMI") on September 20, 2021.

FDA clearance for Company-sponsored Phase 1b clinical trial in cancer. On October 28, 2021, the Company announced that it was cleared by the FDA to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer.

FDA clearance for Investigator-sponsored Phase 1 clinical trial in cancer. On January 24, 2022, the Company announced that the Masonic Cancer Center at the University of Minnesota, a National Cancer Institute designated Comprehensive Cancer Center, was cleared by the FDA to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies.

Two new independent board members. The Company increased the skill set of its Board of Directors with the addition of two new board members: Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, and has held senior leadership positions with AbbVie and Abbott.

Dr. Hing C. Wong, Company’s Founder and CEO, Weaver H. Gaines Entrepreneur of the Year. Hing C. Wong, Ph.D., the Company’s CEO and Founder, was named the 2021 Weaver H. Gaines Entrepreneur of the Year by BioFlorida. Presented annually at the BioFlorida Conference, the award recognizes an individual who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. This marks the second time Dr. Wong was recognized for his outstanding contributions with this award.

Expanding IP Portfolio. The Company continues to expand its intellectual property portfolio through filing provisional and utility U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. The Company’s earlier filed applications are progressing through the prosecution phase.

Three publications in peer-reviewed journals. Publications in peer-reviewed journals, which are based on inventions and discoveries made by the Company, are a pillar in the Company’s strategy to establish leadership in oncology and other age-related diseases especially with the scientific and clinical communities. As of today, the Company has published three papers:

An article in Cancer Immunology Research describing its platform: Becker-Hapak MK, et al. A Fusion Protein Complex Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-like NK Cells for Cancer Immunotherapy. September 9, 2021.

An article in Molecular Therapy on the characterization of its lead molecules, HCW9218: Liu B et al., Bifunctional TGF-ß Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8 + T Cell Immunity Against Solid Tumors. October 6, 2021.

An article in Molecular Therapy which discusses HCW9218 and its ability to augment anti-tumor activity and reduce side effects of chemotherapy regimens: Chaturvedi, P et al., Immunotherapeutic HCW9218 Augments Anti-tumor Activity of Chemotherapy via NK Cell Mediated Reduction of Therapy Induced Senescent Cells, January 17, 2022.

Fourth Quarter and Year-End Financial Results:

Cash and cash equivalents: On December 31, 2021, the Company’s cash balance was $11.7 million, short-term investments were $25.0 million and long-term investments were $9.9 million. The net proceeds from the IPO were $49.2 million. The Company estimates that it has sufficient cash to fund operation expenses to the end of 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from new or existing out-licensing agreements.

Revenues: Revenues for the fourth quarter and year ended December 31, 2020 and 2021 were $4.1 million and none, respectively. On December 24, 2020, the Company entered an exclusive worldwide licensing agreement granting Wugen, Inc. limited rights to two of our molecules. Revenues were generated from the sale of cGMP clinical materials, R&D knowledge transfer, and an in-kind payment consisting of shares of Wugen common stock. In the year ended December 31, 2021, the Company recognized $1.8 million in deferred revenue to the extent cash was received for sales of clinical and research-grade materials to Wugen prior to the finalization of contractual terms of purchase.

Research and development (R&D) expenses: R&D expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.4 million and $1.5 million, respectively. R&D expenses for the year ended December 31, 2020 and 2021 were $7.3 million and $8.2 million, respectively. The annual increase of 13% was primarily attributable to an increase in expenses associated with IND-enabling activities, offset by a reimbursement for certain R&D expenses as provided for in the Wugen license.

General and administrative expenses (G&A): G&A expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.0 million and $1.6 million, respectively. G&A expenses for the year ended December 31, 2020 and 2021 were $2.7 million and $5.2 million, respectively. The annual increase of 93% was primarily due to an increase in costs related to operating as a public company, including legal fees for corporate work, intellectual property protection, other professional services, and insurance.

Net income (loss): Net income for the fourth quarter ended December 31, 2020 was $2.1 million. Net loss for the fourth quarter ended December 31, 2021 was $3.2 million. Net loss for the year ended December 31, 2020 and 2021 was $5.8 million and $12.9 million, respectively.

On March 28, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the year ended December 31, 2021, and provided an update on key highlights for 2022 (Press release, CASI Pharmaceuticals, MAR 28, 2022, View Source [SID1234611073]).

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Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, "We are pleased to report $9.12 million in EVOMELA revenues for the fourth quarter of 2021. We have achieved our goal for full-year 2021 revenue growth to reach 100% growth. Through the efforts of the global CASI team and our commercial group of more than 100 hematology sales and medical marketing specialists in China, we have built a strong foundation for our commercial franchise. We plan to continue building our commercial franchise throughout 2022 and beyond."

Dr. He continued, "As we assemble a world-class pipeline of assets and drive existing development forward, we continue to execute on several key milestones across our broad portfolio. In 2021, our team prepared for the anticipated China NDA filing of the CD19 CAR-T program, which we currently expect to be in the second half of 2022. We anticipate that EVOMELA will continue to be the core of our commercial operations in the quarters ahead. During 2022, we also expect the start of the BI-1206 Phase I trial in China, receipt of CTA approval from NMPA for CB-5339, and the continued progression of the Phase I study of CID-103."

Key Highlights for 2022

EVOMELA (melphalan for injection)

Prior to EVOMELA’s entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma treatment setting. Following EVOMELA’s launch in August 2019, CASI worked closely with key opinion leaders to drive market awareness and expedite EVOMELA adoption in the Chinese market. In 2021, EVOMELA was used in the treatment of nearly 6,000 patients in China. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further the adoption of stem cell transplantation as a standard of care in the multiple myeloma treatment setting and will continue working to address the persistent high unmet need in this patient population.

CNCT19 (CD19 CAR-T)

Our partner, Juventas Cell Therapy Ltd (Juventas), continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling. In December 2020, CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized, dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. Earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Juventas, for CNCT19, for the treatment of patients with Acute Lymphoblastic Leukemia (ALL). Currently, there are no CD-19 CAR-T therapies marketed in China based on domestically developed CAR-T technology. CASI intends for CNCT19 to be locally developed and manufactured to be more affordable and widely accessible to patients.

BI-1206 (Anti-FcyRIIB antibody)

Along with our partner, BioInvent, we continue to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated outside of China in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors. Earlier this year, the U.S. FDA granted Orphan Drug Designation, for BI-1206, for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma.

CB-5339 (VCP/p97 inhibitor)

CB-5339 CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is ongoing in France and the UK.

Full-Year 2021 Financial Highlights

Revenues consist primarily of product sales of EVOMELA. Revenue was $30.0 million for the year ended December 31, 2021, compared to $15.0 million for the year ended December 31, 2020.
Costs of revenues were $12.6 million for the year ended December 31, 2021, compared to $9.5 million for the year ended December 31, 2020, which includes royalty payment of $5.9 million and $3.0 million for the same period. Costs of revenues excluding royalty were approximately $6.6 million and $6.6 million for the year ended December 31, 2021, and December 31, 2020 respectively. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly for the year ended December 31, 2021, compared to 2020; and, secondarily, such decrease in costs of revenues, excluding royalty as a percentage of revenues, resulted from a decrease in the unit cost of inventories of EVOMELA.
Research and development expenses for the year ended December 31, 2021, were $14.4 million, compared with $11.5 million for the year ended December 31, 2020.
General and administrative expenses for the year ended December 31, 2021, were $23.8 million, compared with $19.7 million for the year ended December 31, 2020.
Selling and marketing expenses for the year ended December 31, 2021, were $14.7 million, compared with $7.8 million for the year ended December 31, 2020. The increase in selling and marketing expenses primarily was due to the expansion of the sales team in China in 2021.
Net loss for the year ended December 31, 2021, was $35.8 million compared to $47.5 million for the year ended December 31, 2020, primarily due to the increase in revenues.
As of December 31, 2021, CASI had cash and cash equivalents of $38.7 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The conference call can be accessed by dialing 1-877-870-4263 (U.S.) or 1-412-317-0790 (international) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and enter 4990100 to access the replay.

On March 28, 2022 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2022 financial results on Wednesday, April 20, 2022, before the market opens (Press release, Abbott, MAR 28, 2022, View Source [SID1234611043]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.