On May 23, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, reported it would resume its existing Stock Repurchase Program (Press release, Greenwich LifeSciences, MAY 23, 2022, View Source [SID1234614944]).

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Under the repurchase program previously authorized by the board of directors, Greenwich LifeSciences may repurchase its outstanding shares of common stock from time to time in open market or privately-negotiated transactions, including accelerated share repurchase transactions, block trades, or pursuant to 10b5-1 trading plans. Any repurchases will be at management’s discretion and will be subject to market conditions, the price of the Company’s shares and other factors. The stock repurchase program may be modified, suspended or terminated by the Board of Directors at any time.

The Company has approximately $4.5 million available under the current program. As of its most recently reported quarter-end March 31, 2022, the Company had 12,951,453 shares of common stock outstanding.

On May 23, 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, MAY 23, 2022, View Source [SID1234614943]):

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We have completed the manufacturing of GP2, released 3 clinical lots, and started the stability testing program for these lots. Previously, the FDA informally asked us to allow them to review an updated chemistry and manufacturing section on drug product before initiating the Phase III trial as our manufacturing information for the final drug product was incomplete and the lots were being tested for the first time. Subsequently, we received a formal clinical hold letter. Greenwich has provided a response and is working with the FDA to resolve all outstanding issues. All hold issues are associated with manufacturing and pharmacy procedures.

We continue to work toward study initiation. We are scheduling site initiation visits to train clinicians, nurses, coordinators, and pharmacists to activate and open clinical sites. We, along with our CRO, continue to actively recruit and prepare sites for site initiation.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "We continue to make progress towards opening up our first sites. We just completed our first Data Safety Management Board (DSMB) meeting and are currently scheduling our initial Steering Committee Meeting with the lead clinicians of FLAMINGO-01. Our electronic data capture and inventory management systems are anticipated to go live in June. We are working to address all FDA issues rapidly so that the study can be initiated shortly."

Three abstracts and two posters were accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2022. The titles of the abstracts are as follows:

Abstract Number: LBA550; Poster Number: 322; Abstract Title: Evaluation of booster injections in maintaining peak immunity in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus GM-CSF alone after adjuvant trastuzumab in HER2 positive women with breast cancer.
Abstract Number: e12519; Abstract Title: Baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer.
Abstract Number: TPS1110; Poster Number: 485b; Abstract Title: A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 (Co-authored with Baylor College of Medicine)
CEO Snehal Patel commented, "These abstracts and posters highlight the first steps to optimizing the use of GLSI-100. We are planning to study the peak immunity of GP2 and how to assess when to administer booster injections. The current methodology is to deliver 6 primary injections over the first 6 months and 5 booster injections 6 months apart, thus totaling 11 injections over 3 years. However, in the future, we envision using immune response and T-cell profiles to determine when boosters may be needed. This may allow GLSI-100 to protect breast cancer survivors over longer periods of time against recurring metastatic breast cancer. In addition, approximately 20% of patients in the Phase IIb trial had a GP2 immune response before being treated with GP2, possibly due to a potential impending recurrence. We found that some patients with baseline immune response to GP2 tended to recur at faster rates. We are planning to study this observation in the Phase III trial, which could lead us to being able to use GP2 immune response as an independent prognosticator for impending recurrence. This would allow doctors to detect recurrences sooner than current standard of care and to thus start aggressive treatments sooner with potentially better outcomes."

Mr. Patel further added, "This will be the first ASCO (Free ASCO Whitepaper) meeting in person since 2019, attended by oncologists from around the world. Greenwich is in discussions with 2 of the largest oncology networks in Europe for participation in FLAMINGO-01, and we look forward to expanding our outreach to potential international sites at ASCO (Free ASCO Whitepaper). In the US, we anticipate that the largest oncology network will provide one of the first sites to treat patients and that a second oncology network in the US may participate along side. We believe that the participation of clinical trial networks focused on cancer treatment will help to increase the enrollment rate in FLAMINGO-01 and expand the geographic footprint to allow more patients to participate."

About the ASCO (Free ASCO Whitepaper) Annual Meeting

Founded in 1964, ASCO (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

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 May 23, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended March 31, 2022, and highlighted recent corporate events (Press release, MEI Pharma, MAY 23, 2022, View Source [SID1234614942]).

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"The third fiscal quarter of 2022 was underscored by a meeting with the FDA in which we were informed that data from randomized studies are now needed to adequately assess the benefit-risk of PI3K inhibitor drug candidates, including zandelisib, and where it was emphasized that we should continue efforts with the ongoing randomized COASTAL study. Accordingly, we no longer plan to submit an FDA marketing application under the accelerated approval pathway using the single arm TIDAL study. However, we continue to have confidence in zandelisib’s differentiated therapeutic profile as observed in our data generated to date, and remain committed to advancing the program to a marketing authorization submission with our partner, Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.

Dr. Gold continued: "While progression free survival is the primary endpoint for COASTAL, we are actively working with our partner, Kyowa Kirin, to determine if a more expeditious approach exists to bring zandelisib to the market sooner which we will then discuss with the FDA and we will plan to provide an update as appropriate. We remain well capitalized with $169 million to advance our pipeline and continue operations for over two years."

Third Quarter Fiscal Year 2022 Recent Developments and Financial Highlights

On May 12, 2022, we announced that two abstracts highlighting data and information for zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress to be held June 9 – 17, 2022.
On April 8, 2022, we announced that two posters reporting preclinical data for zandelisib, an orally administered investigational PI3Kδ inhibitor, and ME-344, a tumor selective mitochondrial inhibitor, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
On March 24, 2022, we reported that the FDA had recently informed us of its position that randomized data is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. At this FDA meeting, the agency discouraged a planned filing based on the Phase 2 TIDAL study data and emphasized that the company continues efforts with the ongoing, randomized Phase 3 COASTAL study as planned. Accordingly, in line with the FDA’s recommendation, the company reported it no longer plans to submit an FDA marketing application based on the single arm Phase 2 TIDAL study.
On February 7, 2022, we announced the expansion of our management team with the addition of two experienced industry executives: Alejandro Ricart, M.D., joined as senior vice president, clinical development, a role reporting to Richard Ghalie, M.D., chief medical officer, and Yomara Gomez-Naiden joined as senior vice president, quality, reporting to Daniel P. Gold, Ph.D., chief executive officer.
Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Provide a more complete report of the Phase 2 TIDAL data announced on November 30, 2021 at upcoming medical meetings in 2022.
Initiate CORAL, a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib at an upcoming scientific congress in 2022.
Report updated data from the Phase 2 TIDAL study arm in follicular lymphoma intended for an upcoming scientific congress in the fourth calendar year quarter of 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Initiate Phase 1b study evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia mid calendar year 2022.
ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 1b study of ME-344 in relapsed colorectal cancer by the end of calendar year 2022.
Third Quarter Fiscal Year 2022 Financial Results

As of March 31, 2022, MEI had $169.0 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended March 31, 2022, cash used in operations was $17.0 million, compared to $15.6 million used in operations for the quarter ended March 31, 2021. The increase in cash used in operations reflects increased development activity in 2022 and changes in working capital balances.
Research and development expenses were $22.3 million for the quarter ended March 31, 2022, compared to $17.9 million for the quarter ended March 31, 2021. The increase was primarily related to costs to support ongoing zandelisib studies, and expenses related to voruciclib and ME-344.
General and administrative expenses were $8.9 million for the quarter ended March 31, 2022, compared to $6.2 million for the quarter ended March 31, 2021. The increase primarily relates to personnel costs, professional services and general corporate expenses.
MEI recognized revenue of $9.7 million for the quarter ended March 31, 2022, compared to $8.1 million for the quarter ended March 31, 2021. The increase in recognized revenue relates to the partial satisfaction of the research and development obligations under the license agreement with Kyowa Kirin.
Net loss was $8.7 million, or $.07 per share, for the quarter ended March 31, 2022, compared to net loss of $25.6 million, or $.23 per share for the quarter ended March 31, 2021. The Company had 133,152,045 shares of common stock outstanding as of March 31, 2022, compared with 112,591,778 shares as of March 31, 2021.
The adjusted net loss for the quarter ended March 31, 2022, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $21.5 million, compared to an adjusted net loss of $16.4 million for the quarter ended March 31, 2021.
Figures for the quarter ended March 31, 2021 and year ended June 30, 2021 shown above and in the following tables for revenue, net loss, net loss per share, and adjusted net loss reflect the previously announced restatement of certain of the Company’s historical financial statements, which was completed today.
Restatement of the Company’s 2021 Quarterly Periods

As disclosed in the Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on May 13, 2022, the Company determined that it made certain errors in the manner in which it recognized revenue from its License, Development, and Commercialization Agreement with Kyowa Kirin Co., Ltd. (the "KKC Commercialization Agreement"), with the result that revenue was overstated in some quarters and understated in other quarters in the Company’s financial statements during 2020 and 2021. The errors relate to the appropriate timing and amounts of revenue recognized over time under the cost-to-cost method associated with the KKC Commercialization Agreement. These errors and the required restatement had no effect on the Company’s previously reported operating expenses, cash flows or cash and short-term investments. The cumulative effect of these errors was a misstatement of deferred revenue and accumulated deficit of $3.9 million. As a result, the Company restated its previously filed annual and quarterly financial statements for periods from June 30, 2020 forward, which were included in the Annual Report on Form 10-K/A for the fiscal year ended June 30, 2021 and Quarterly Reports of Form 10-Q/A for the quarters ended September 30, 2021 and December 31, 2021, filed with the SEC today. For more information concerning the restatement, please see those filings.

On May 23, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present in at the Jefferies Healthcare Conference on Wednesday, June 8, 2022, at 3:30 pm ET at the Marriot Marquis in New York City (Press release, Aligos Therapeutics, MAY 23, 2022, View Source [SID1234614941]).

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Jefferies Healthcare Conference

Date: Wednesday, June 8th, 2022
Time: 3:30 to 3:55 pm Eastern Time
Presenter: Lawrence Blatt, Ph.D., MBA, CEO of Aligos
Webcast: Registration Link – Click Here
A replay of the session will be available following the conference for 90-days through the Aligos investor section of the website View Source

The Aligos management team will also participate in investor 1×1 meetings during the conference. Please contact your Jefferies representative to schedule one-on-one meetings with Aligos during the conference.

On May 23, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAY 23, 2022, View Source [SID1234614940]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

With the transactions stated above, Novo Nordisk owns a total of 13,166,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 20 May 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 11,426,818 B shares at an average share price of DKK 755.99 per B share equal to a transaction value of DKK 8,638,533,594