On May 10, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company reported that the Company’s product portfolio of FDA-approved brands delivered combined revenues of $11.2 million during the first quarter of 2022, – which is a 6% increase over the prior year period (Press release, Cumberland Pharmaceuticals, MAY 10, 2022, View Source [SID1234614088]). Adjusted earnings for the quarter were $0.5 million, or $0.03 a share. The company ended the first quarter with $96.7 million in total assets, $55.9 million in total liabilities, and $41.0 million of shareholders’ equity. Cumberland will report its first quarter 2022 financial results and provide a company update via a conference call and live internet webcast today at 4:30 p.m. Eastern Time.

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At the start of the first quarter, Cumberland announced its acquisition of the oncology-supportive drug Sancuso from the U.S. subsidiary of Kyowa Kirin, Inc., a Japan-based specialty pharmaceutical company. Sancuso is the first and only FDA-approved prescription patch that prevents nausea and vomiting in cancer patients receiving certain types of chemotherapy treatment. Through the acquisition, Cumberland obtained full commercial responsibility for Sancuso in the U.S., including its marketing, promotion, distribution and manufacturing. Cumberland formed a new sales division, Cumberland Oncology, to support the brand.

On Monday, May 9, 2022, Cumberland announced that it has entered into a co-promotion agreement with Verity Pharmaceuticals to bring Sancuso to more patients across the U.S. Verity will feature Sancuso through its national oncology sales organization, covering a majority of the U.S. market for an initial three-year term.

Cumberland also announced several new partnerships for its Vibativ product during the first quarter. Vibativ is an antibiotic used to treat patients with pneumonia and serious skin infections resulting from gram-positive bacteria:

In March of 2022, the company announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical Manufacturing Company to introduce Vibativ in the Middle East. The arrangement provided Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk is a fully owned subsidiary of publicly traded Astra Industrial Group, a leading industrial conglomerate in Saudi Arabia. Tabuk is a well-respected pharmaceutical company with a strong distribution network throughout the Middle East.
Cumberland also announced the launch of Vibativ in Puerto Rico, again through a partnership with Verity Pharmaceuticals, which has a particular strength and experience in the Puerto Rican market.
The company continues to enroll patients in the three Phase II clinical programs that it is sponsoring. These studies are evaluating its ifetroban product candidate for:

Duchenne Muscular Dystrophy, a fatal, genetic neuromuscular disease;
Systemic Sclerosis, a debilitating autoimmune disorder; and
Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.
Cumberland is also designing a Phase II study to evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases. The company is currently preparing an application to the FDA to support the new program.

"We continue to seek opportunities to expand the use of our existing brands, while also building our portfolio of differentiated products," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We made significant progress toward that goal during the first quarter and are particularly encouraged by the addition of Sancuso. We believe in the product’s potential to help more cancer patients and expect it to be a meaningful contributor to our business."

To participate in today’s call, 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 7574078. Both the live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

FINANCIAL RESULTS:

Net Revenue: For the three months ended March 31, 2022, net revenues from continuing operations were $11.2 million.

Net revenue by product for the first quarter of 2022, included $3.9 million for Kristalose, $3.4 million for Sancuso, $2.5 million for Vibativ and $1.0 million for Caldolor.

Operating Expenses: Total operating expenses for the first quarter were $12.5 million.

Adjusted Earnings: Adjusted earnings for the first quarter of 2022 was $0.5 million, or $0.03 per share.

The adjusted earnings calculation does not include the benefit of the $0.9 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.4 million of Sancuso cost of goods, which were received with that product’s acquisition.

Cash Flow: Cash flow from operations for the quarter ended March 31, 2022 was $(0.15) million.

Balance Sheet: At March 31, 2022, Cumberland had $96.7 million in total assets including $17.3 million in cash and cash equivalents.

Total liabilities were $55.9 million, including $20 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $41 million.

On May 10, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that members of its management team will participate in the Bank of America Securities Healthcare Conference in Las Vegas, NV on Wednesday, May 11th at 7:40 pm ET (Press release, BridgeBio, MAY 10, 2022, View Source [SID1234614087]).

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To access the live webcast of BridgeBio’s presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcast will be available on the BridgeBio website for 90 days following the event.

On May 10, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the first quarter of 2022 and provided an update on recent corporate progress (Press release, Sunesis, MAY 10, 2022, View Source [SID1234614086]).

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"We have made encouraging progress in both clinical programs with our all-oral drug product candidate, Nana-val, which are advancing towards potential key catalysts in the second half of the year," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Since the first patient was dosed in January, our Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors has proceeded nicely and we anticipate reporting preliminary safety and efficacy data later this year. In addition, we are pleased to have expanded the clinical reach of NAVAL-1 beyond North America into Europe as well as Asia, and anticipate having an update on cohorts advancing into Stage 2 of the trial later this year."

First Quarter 2022 and Recent Highlights

Clinical

Continued global expansion and enrollment into NAVAL-1, the pivotal trial of Nana-val (nanatinostat and valganciclovir) for the treatment of patients with relapsed/refractory EBV+ lymphoma. NAVAL-1 employs a Simon two-stage design where patients are initially enrolled into six cohorts based on lymphoma subtype in Stage 1. If a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. Lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded. If successful, the Company believes NAVAL-1 could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. Clinical sites are open across the globe, including in the U.S., Canada, Europe, and Asia. The Company anticipates providing an update on the initial cohort(s) that may advance into Stage 2 of the trial in the second half of the year.
Dosed first patient in the Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other EBV+ solid tumors. Enrollment continues in the Phase 1b dose escalation part of the study, which is designed to evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to 60 patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. Viracta anticipates reporting preliminary Phase 1b safety and efficacy data from the trial in the second half of 2022.
Corporate

Hosted key opinion leader webinar on Nana-val for the treatment of advanced EBV+ solid tumors. The webinar featured presentations from key opinion leader Ezra Cohen, MD, FRCPSC, FASCO (University of California, San Diego) and members of the Viracta management team. Topics discussed included the current treatment landscape and unmet medical need in NPC, the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors, and preclinical data supporting the trial. A replay of the webinar is available here.
Anticipated 2022 Milestones

Provide preliminary Phase 1b safety and efficacy data from the Phase 1b/2 trial in advanced EBV+ solid tumors: 2H 2022
Update on NAVAL-1 cohort(s) that may progress from Stage 1 to Stage 2: 2H 2022
First Quarter 2022 Financial Results

Cash Position – Cash and cash equivalents totaled approximately $92.2 million as of March 31, 2022, which Viracta expects will be sufficient to fund its operations into mid-2024, excluding any borrowing under its previously announced $50.0 million credit facility from Silicon Valley Bank and Oxford Finance.
Research and development expenses – Research and development expenses were approximately $6.1 million for the three months ended March 31, 2022, compared to $4.0 million for the same period in 2021. The increase in research and development expenses for the three months ended March 31, 2022, was primarily due to increases in costs incurred to support the initiation of the NAVAL-1 and solid tumor trials as well as an increase in headcount and non-cash share-based compensation.
Acquired in-process research and development – For the three months ended March 31, 2021, the acquired in-process research and development included non-cash and non-recurring cost of $84.5 million associated with the estimated fair value of the in-process research and development projects acquired in the Sunesis asset acquisition with no alternative future use, which was charged to expense on the Sunesis merger date.
General and administrative expenses – General and administrative expenses were approximately $4.3 million for the three months ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase was largely due to incremental costs associated with being a publicly traded company including directors and officers’ insurance costs, and non-cash share-based compensation.
Gain on Royalty Purchase Agreement – For the three months ended March 31, 2021, the gain was associated with upfront proceeds of $13.5 million recorded in connection with the multi-license milestone and royalty monetization transaction with XOMA (US) LLC.
Adjusted loss from operations – There was not a comparative adjustment to loss from operations for the quarter ended March 31, 2022. Adjusted income from operations for the quarter ended March 31, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $5.6 million, compared to an unadjusted loss from operations of $78.8 million.
Net loss – Net loss was approximately $10.5 million, or $0.28 per share (basic and diluted) for the quarter ended March 31, 2022, compared to a net loss of $79.2 million or $5.22 per share for the same period in 2021.
About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

On May 10, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4957 per share out of the Company’s capital surplus (Press release, Cardinal Health, MAY 10, 2022, View Source [SID1234614085]). The dividend will be payable on July 15, 2022 to shareholders of record at the close of business on July 1, 2022.

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On May 10, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the first quarter ended March 31, 2022 and highlighted recent corporate progress (Press release, Avidity Biosciences, MAY 10, 2022, View Source [SID1234614084]).

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"This year will prove to be significant for Avidity as we look forward to sharing a mid-point update from the AOC 1001 MARINATM trial in adults with myotonic dystrophy type 1 in Q4 and advancing two additional programs, AOC 1020 and AOC 1044, into the clinic," said Sarah Boyce, president and chief executive officer. "We continue to build our infrastructure to support our goal of having three programs addressing three distinct rare diseases in clinical development by the end of this year. With our AOC platform technology, we aim to revolutionize the delivery of RNA therapeutics as we fulfill our mission of profoundly improving people’s lives affected by serious diseases."

"We are well funded into 2024 with a cash balance of $397 million at the end of Q1 2022. This will allow us to complete the AOC 1001 MARINA trial, advance our programs for facioscapulohumeral muscular dystrophy and Duchenne muscular dystrophy Exon 44 into the clinic and continue to progress our AOC platform in other indications," said Mike MacLean, chief financial and chief business officer.

Recent Highlights

Presented two oral and three poster presentations at the American Academy of Neurology (AAN) 2022 Annual Meeting. Key highlights included:
A review of the MARINA trial including a high level update on safety and enrollment. The company reiterated that the trial is on track for a preliminary assessment in approximately half of patients in Q4 2022
Data from an in vivo proof-of-concept study using the MDX mouse model supporting Avidity’s Duchenne muscular dystrophy programs and demonstrating that an AOC effectively delivered RNA therapeutics to muscle and heart tissues
Appointed Steve Hughes, M.D., as chief medical officer and, in April, expanded the role of Michael MacLean to chief financial and chief business officer.
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $397.1 million as of March 31, 2022, compared to $405.5 million as of December 31, 2021.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company and totaled $1.8 million for the first quarter of 2022 compared with $2.7 million for the first quarter of 2021.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $27.7 million for the first quarter of 2022 compared with $20.7 million for the first quarter of 2021. The increase was primarily driven by the advancement of AOC 1001, AOC 1020 and AOC 1044, as well as costs related to the expansion of the company’s overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $8.6 million for the first quarter of 2022 compared with $5.9 million for the first quarter of 2021. The increase was primarily due to higher personnel costs and professional fees to support the company’s expanded operations.