On August 3, 2022 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported second quarter 2022 financial results and provided a corporate update (Press release, Arca biopharma, AUG 3, 2022, View Source [SID1234617360]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "We are in the process of evaluating options for creating stockholder value, including potential development of our assets, partnering and other strategic options."

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.

Second Quarter 2022 Summary Financial Results

Cash and cash equivalents were $46.4 million as of June 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 $1.5 million for the quarter ended June 30, 2022, compared to $3.6 million for the corresponding period in 2021. The $2.1 million decrease in R&D expenses in the second quarter was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021. R&D expenses in 2022 are expected to be lower than 2021.

General and administrative (G&A) expenses were $1.7 million for the quarter ended June 30, 2022, compared to $1.3 million for the corresponding period in 2021. The $0.5 million increase in G&A expenses was primarily a result of increases in professional fees and consulting costs. G&A expenses in 2022 are expected to be consistent with those in 2021 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended June 30, 2022 were $3.2 million compared to $4.8 million for the second quarter of 2021.

Net loss for the quarter ended June 30, 2022 was $3.1 million, or $0.22 per basic and diluted share, compared to $4.8 million, or $0.34 per basic and diluted share in the second quarter of 2021.

On August 3, 2022 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.94 per share dividend for the third quarter of 2022 (Press release, Amgen, AUG 3, 2022, View Source [SID1234617359]). The dividend will be paid on September 8, 2022, to all stockholders of record as of the close of business on August 18, 2022.

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On August 3, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that management plans to participate in three upcoming investor conferences (Press release, Allogene, AUG 3, 2022, View Source [SID1234617358]).

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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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42nd Annual Canaccord Genuity Growth Conference
Thursday, August 11, 2022
Noon PT/3:00PM ET

H.C. Wainwright 24th Annual Global Investment Conference
Monday, September 12, 2022
Presentation time to be posted to www.allogene.com

Baird 2022 Global Healthcare Conference
Tuesday, September 13, 2022
12:45PM PT/3:45PM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

On August 3, 2022 Aeterna Zentaris Inc. (Nasdaq: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the second quarter ended June 30, 2022 and recent highlights (Press release, AEterna Zentaris, AUG 3, 2022, View Source [SID1234617357]).

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"Throughout the quarter, we continued to execute against our strategic priorities," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "As we look ahead, we are laser focused on building on the positive momentum we’ve achieved across our therapeutics, diagnostics and vaccine development pipelines, all with an eye towards generating value in the near and long term for our valued stakeholders."

Recent Highlights

Announced that licensing partner, Consilient Health, launched Ghryvelin (macimorelin) for diagnosing adult growth hormone deficiency (AGHD) in Europe;
Achieved proof-of-concept for the treatment of neuromyelitis optica spectrum disorder (NMOSD) with AIM Biologicals program in animal experiments; and
Entered into a research and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane, Australia, to advance the development of macimorelin as a potential therapeutic for the treatment of Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig’s Disease).
Results of operations for the three-month period ended June 30, 2022
All amounts in this press release are in U.S. dollars unless otherwise noted.

For the three-month period ended June 30, 2022, we reported a consolidated net loss of ($4.2 million), or ($0.87) net loss per common share (basic), as compared with a consolidated net loss of ($2.1) million, or ($0.43) net loss per common share (basic) for the three-month period ended June 30, 2021. The $2.1 million increase in net loss is primarily due to an increase of $0.7 million in total operating costs, $1.8 million decline in total revenues and offset by favorable foreign currency exchange rates of $0.4 million.

Revenues

Our total revenue for the three-month period ended June 30, 2022 was ($0.2) million as compared with $1.6 million for the same period in 2021, representing a decline of $1.8 million. The 2022 revenue was comprised of ($0.2) million in licensing revenue (2021 – $0.5 million), ($0.1) million in development revenue (2021 – $1.0), $0.03 million in supply chain revenue (2021 – $0.04 million), $0.02 million in royalty income (2021 – $0.2 million).

Our negative revenue balances for the quarter are driven by revenue reversals associated with the DETECT project. Using management’s best estimate, we determined the additional overall costs associated with the project and its effect on the accounting treatment from a revenue recognition perspective. These additional costs are attributed to the Ukraine/Russia conflict and its delays on the project, reducing the amount of revenue recordable within the quarter.
Operating expenses

Our total operating expense for the three-month period ended June 30, 2022 was $4.5 million as compared with $3.7 million for the same period in 2021, representing an increase of $0.8 million. This increase arose primarily from a $0.6 increase research and development, $0.2 million increase in general and administrative expenses.
Net finance (costs) income

Our net finance (costs) for the three-month period ended June 30, 2022 was $0.5 million as compared with net finance income of $0.1 million for the same period in 2021, representing an increase in net finance income of $0.4 million.
The Company had $58.2 million cash and cash equivalents at June 30, 2022 (December 31, 2021 – 65.3 million).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the second quarter, as well as the Company’s unaudited consolidated interim financial statements as of June 30, 2022, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

Nasdaq Update

The Company is pleased to announce that, on August 3, 2022, the Company received notice of compliance from Nasdaq (the Compliance Notice), confirming the Company’s continued listing on Nasdaq. As previously announced to shareholders, notwithstanding the successful completion of the Company’s share consolidation on July 21, 2022, due to the timing of the share consolidation, the Company did not meet the Minimum Bid Requirement that required the Company’s common shares to trade above $1.00 per share for a minimum of ten trading days on or before July 25, 2022. As a result of this technical non-compliance, the Company had received notice of delisting on July 28, 2022. The Compliance Notice confirms that the Company is currently in compliance with those Nasdaq listing requirements.

On August 3, 2022 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended June 30, 2022 (Press release, Adaptive Biotechnologies, AUG 3, 2022, View Source [SID1234617356]).

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"We are pleased to deliver another strong quarter across both the MRD and Immune Medicine businesses," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "I am encouraged by the MRD business momentum as more clinical data and reimbursement decisions continue to drive clonoSEQ adoption. In parallel, data emerging from our immune medicine platform has led to growing interest from pharma partners that will drive revenue and may accelerate diagnostic use cases and potential drug discovery opportunities."

Recent Highlights

Revenue of $43.7 million for the second quarter 2022, representing a 13% increase from the second quarter 2021.
clonoSEQ test volume in the second quarter 2022 grew 53% versus the second quarter of prior year and 17% over the first quarter of 2022.
Received expanded Medicare coverage of clonoSEQ for assessment of MRD in patients with Diffuse Large B-Cell Lymphoma (DLBCL).
Signed a new pan-portfolio agreement with major partner for the use of clonoSEQ to measure MRD as a clinical endpoint.
Sharpened focus on Immune Medicine commercialization strategy to prioritize pharma partnering and drug discovery opportunities.
Second Quarter 2022 Financial Results

Revenue was $43.7 million for the quarter ended June 30, 2022, representing a 13% increase from the second quarter in the prior year. Immune Medicine revenue was $22.4 million for the quarter, representing a 3% decrease from the second quarter in the prior year. MRD revenue was $21.3 million for the quarter, representing a 38% increase from the second quarter in the prior year.

Operating expenses were $96.2 million for the second quarter of 2022, compared to $88.3 million in the second quarter of the prior year, representing an increase of 9%.

Net loss was $52.1 million for the second quarter of 2022, compared to $49.3 million for the same period in 2021.

Cash, cash equivalents and marketable securities was $450.7 million as of June 30, 2022.

2022 Financial Guidance

Adaptive Biotechnologies reiterates full year 2022 revenue to be in the range of $185 million to $195 million.

We now expect full year 2022 operating expenses to be between $410 million and $415 million compared to the previous expectation of $425 million to $435 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its second quarter 2022 financial results after market close on Wednesday, August 3, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.