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 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, AUG 3, 2022, View Source [SID1234617374]):

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As previously disclosed, clinical trial contracts and budgets have been executed at multiple hospitals and the largest oncology network in the US. Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. We continue to actively recruit and prepare additional US clinical sites.
The Company is continuing to make progress to initiate clinical sites in Europe through oncology networks, potentially including networks in Germany, Spain, and France.
Following site activation, patients will be screened, tested for HLA type, randomized, and enrolled into any of 3 clinical trial arms, and treatment of the first patients will begin. Certain aspects of each arm will be open label, and the 3rd arm exploring HLA types that are not HLA-A02 will be entirely open label.
Patients who are interested in participating in the trial can contact the Company by email at [email protected] and can keep up to date with the progress of the trial or can obtain clinical site contact information to contact sites directly on clinicaltrials.gov with identifier NCT05232916 (view here).
Pharmacy process testing is nearing completion, which is anticipated to be the final testing required to commence Flamingo-01 and to start treating patients.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Our team has been very busy preparing for, scheduling, and conducting clinical site initiations. We have begun shipping clinical trial supplies to sites. All plans, procedures, and electronic systems are in place to allow the clinical trial to commence. We are excited to be at this stage in study start-up with Flamingo-01."

CEO Snehal Patel commented, "With our previously disclosed financial strategy, including our cash position, which should fund us through the coming years, and our ATM with one of the leading biotech investment banks, we are poised to opportunistically use the ATM at our discretion. To date, we have not used the ATM."

Mr. Patel further added, "We look forward to commencing Flamingo-01, to sharing more information about the clinical sites, key opinion leaders, clinical networks, and countries participating in the Phase III trial, and to publishing the open label Phase III data during the trial. Initial Phase III data could be available before the end of this year. We anticipate dovetailing our use of the ATM with these major milestones and validating events as we compare the Phase III trial progress to our Phase IIb trial results. Our goal is to reproduce the Phase IIb clinical trial results, which showed no metastatic breast cancer recurrences in patients treated with GLSI-100 over 5 years of follow-up, if the patients were treated, followed, and remained disease free over the first 6 months."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On August 3, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a Joint Research Collaboration Agreement has been established with the Universities of Jaén and Granada, Spain (Press release, Propanc, AUG 3, 2022, View Source [SID1234617390]). Since late 2020, Mrs. Belén Toledo Cutillas MSc, has been investigating an important experimental thesis on the effects of proenzyme therapy and the impact on the tumor microenvironment, which is key to the development, invasion, metastatic spread and recurrence of solid tumors. The work is being conducted at the laboratory of Professor Macarena Perán PhD, who is the lead researcher on the project and is the second Joint Research Collaboration Agreement currently in progress with the two Spanish Universities.

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To date, encouraging results demonstrates that proenzymes have specific effects on tumor cells and CSCs, but also other tumor elements in the tumor microenvironment. However, the most significant conclusion is that proenzymes cause a reversal of the malignant phenotype (observable characteristics) towards a normal, or benign state. This process of reversing the tumor phenotype, called differentiation, is how proenzymes exert anti-tumor, anti-cancer and anti-metastatic effects. Therefore, proenzyme treatment may be considered differentiation therapy, which exerts these effects on malignant cells, but leaves healthy cells alone. To achieve these results, Mrs. Cutillas used integrated 3-dimensional bio-impressions of tumor cells from patients with advanced solid tumors, developed at the Centre for Biomedical Research, University of Granada, led by Professor Juan Marchal MD.

Along with lead researcher, Professor Perán, and Mrs. Cutillas, additional research team members from the University of Jaén are assisting on the project, as well as Professor Marchal and Dr Maria Angel Garcia, from the University of Granada. Propanc will own any intellectual property developed during the research, and publishing rights, in exchange for any net future royalties from intellectual property rights.

Dr Julian Kenyon, Md, MB, ChB, Propanc’s Chief Scientific Officer said, "Evaluating the effects of proenzyme therapy in the tumor microenvironment is of scientific interest, as it demonstrates whether proenzymes penetrate into this target area and exert its effects. At the same time, it confirms the selectivity of the drug on solid tumors, by targeting cancer cells and leaving healthy cells alone. The clinical implications are also potentially significant, which may result in novel discoveries and lead to exciting new ways to treat cancer patients suffering from solid tumors without the toxicity normally associated with standard treatment regimens."

"Continuing to expand our research efforts in the use of proenzymes and cancer leading to the identification of further discoveries can provide additional patentable subject matter and expand our intellectual property portfolio, which covers the invention relating to our lead product candidate, PRP. I look forward to working closely with Professor Perán and her team on this exciting project," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On August 3, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it will announce second quarter 2022 financial results on Wednesday, August 10, 2022 (Press release, Cyclacel, AUG 3, 2022, View Source [SID1234617410]). The company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day.

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For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On August 3, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical therapeutics to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its first quarter ended June 30, 2022, at 4:15 p.m. EST on Tuesday, August 9, 2022 (Press release, Aethlon Medical, AUG 3, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-first-quarter-financial-results-and-host-conference-call-on-august-9-2022-301599228.html [SID1234617427]).

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Management will host a conference call on Tuesday, August 9, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through September 9, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 2740523.