On October 28, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the outcome of the meeting of the U.S. Food and Drug Administration ("FDA") Oncologic Drugs Advisory Committee ("ODAC"), which reviewed investigational 131I-omburtamab ("omburtamab") for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 28, 2022, View Source [SID1234622572]). The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.

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"We are disappointed by the outcome of today’s meeting, as patients with CNS/leptomeningeal metastasis from neuroblastoma are in need of effective and safe treatment options," said Thomas Gad, President, and Interim Chief Executive Officer. "Y-mAbs is committed to working closely with the FDA on their review of the Biologic License Application ("BLA") for omburtamab ahead of their decision. We want to thank all of the patients, caregivers, and healthcare providers who participated in the studies of this life-threatening condition."

ODAC reviewed data from omburtamab’s clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase 2 study) as well as the historical control group.

Y-mAbs BLA submission for omburtamab was accepted for Priority Review by the FDA on May 31, 2022, with a Prescription Drug User Fee Act ("PDUFA") target date of November 30, 2022. The FDA is not bound by the Advisory Committee’s recommendations but generally takes the recommendation into consideration when making its decision.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On October 28, 2022 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported third quarter 2022 financial results and provided a corporate update (Press release, Arca biopharma, OCT 28, 2022, View Source [SID1234622571]).

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In May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

Third Quarter 2022 Summary Financial Results

Cash and cash equivalents were $43.9 million as of September 30, 2022, compared to $53.4 million as of December 31, 2021. ARCA believes that its current cash and cash equivalents, will be sufficient to fund its operations at the current levels through at least the end of 2023. The Company’s review of its strategic options may impact this projection.

Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2022, compared to $3.4 million for the corresponding period in 2021. In the third quarter of 2022, ARCA implemented a strategic reduction of the workforce and recorded total restructuring charges of approximately $0.8 million, of which $0.5 million and $0.3 million were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The $2.4 million decrease in R&D expenses in the third quarter was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021, partially offset by the restructuring charges discussed above. R&D expenses in 2022 are expected to be lower than 2021.

General and administrative (G&A) expenses were $1.5 million for the quarter ended September 30, 2022, compared to $1.3 million for the corresponding period in 2021. The $0.2 million increase in G&A expenses was primarily a result of the restructuring charges discussed above. G&A expenses in 2022 are expected to be slightly higher than 2021 as we maintain administrative activities to support our ongoing operations along with the one-time termination benefits recorded in the third quarter 2022.

Total operating expenses for the quarter ended September 30, 2022 were $2.6 million compared to $4.7 million for the third quarter of 2021.

Net loss for the quarter ended September 30, 2022 was $2.3 million, or $0.16 per basic and diluted share, compared to $4.7 million, or $0.33 per basic and diluted share in the third quarter of 2021.

On October 28, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that Akari received a letter from Nasdaq Listing Qualifications indicating that Akari is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share (Press release, Akari Therapeutics, OCT 28, 2022, View Source [SID1234622570]).

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The rules also provide Akari a compliance period of 180 calendar days to regain compliance. According to the letter, Akari has from October 24, 2022 until April 24, 2023 to regain compliance with the minimum bid price requirement. Akari can regain compliance, if at any time during this 180-day period, the closing bid price of its ADSs is at least $1.00 for a minimum of ten consecutive business days, in which case Akari will be provided with a written confirmation of compliance and this matter will be closed. In the event Akari does not regain compliance after the initial 180-day period, Akari may then be eligible for an additional time if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period.

If Akari cannot demonstrate compliance by the end of the second 180-day period, Nasdaq staff will notify Akari that its ADSs are subject to delisting.

The letter has no immediate effect on Akari’s Nasdaq listing or the trading of its ADSs, and during the grace period, as may be extended, Akari’s ADSs will continue to trade on the Nasdaq Capital Market under the symbol "AKTX".

On October 28, 2022 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, OCT 28, 2022, View Source [SID1234622569]). The cash dividend is payable on December 30, 2022, to stockholders of record as of the close of business on December 15, 2022.

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On October 28, 2022 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.94 per share dividend for the fourth quarter of 2022 (Press release, Amgen, OCT 28, 2022, View Source [SID1234622568]). The dividend will be paid on December 8, 2022, to all stockholders of record as of the close of business on November 17, 2022.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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