On February 1, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported an update on the Phase III clinical trial, FLAMINGO-01 (Press release, Greenwich LifeSciences, FEB 1, 2022, View Source [SID1234607576]).

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The Company has made significant progress towards study initiation:

– Contract Research Organization (CRO) has been contracted for study start-up, project management, data management, and clinical data monitoring

– Manufacturing of third clinical lot of GP2 using a commercial line has been completed

– Commercial lots of GP2 active ingredient for filing of BLA have been contracted

– Central Laboratory has been contracted for screening of HLA type

– Drug and biological sample storage sites and other study infrastructure have been put in place

– Central Institutional Review Board (IRB) approval has been granted for the study

– Clinical trial sites continue in the study start-up process and the Company continues to solicit additional US and international sites and networks for participation in the study

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, 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 being registered on clinicaltrials.gov. 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 February 1, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that management has answered top-voted questions submitted by verified IMMX shareholders at the IMMX Investors Day Event on February 1, 2022 at 9:30am ET (Press release, Immix Biopharma, FEB 1, 2022, View Source [SID1234607575]). ImmixBio welcomed verified shareholders to submit and upvote questions to management from January 6 through January 20, 2022. Answers to top-voted investor questions are viewable at www.immixbio.com/Feb2022QA .

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"Investors are an integral part of our community at ImmixBio," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Today we addressed questions upvoted by our investors, and are looking forward to an ongoing dialogue through our Q&A platform open to all IMMX shareholders."

On February 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the fourth quarter and full year ended January 2, 2022 (Press release, PerkinElmer, FEB 1, 2022, View Source [SID1234607574]).

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Fourth Quarter 2021

The Company reported GAAP earnings per share from continuing operations of $1.41, as compared to GAAP earnings per share from continuing operations of $3.38 in the fourth quarter of 2020. GAAP revenue for the quarter was $1.36 billion, as compared to $1.35 billion in the fourth quarter of 2020. GAAP operating income from continuing operations for the quarter was $310 million, as compared to $510 million for the same period a year ago. GAAP operating profit margin was 22.7% as a percentage of revenue, as compared to 37.7% in the fourth quarter of 2020.

Adjusted earnings per share from continuing operations for the quarter was $2.56, as compared to $3.96 in the fourth quarter of 2020. Adjusted revenue for the quarter was $1.36 billion, as compared to $1.36 billion in the fourth quarter of 2020. Adjusted operating income from continuing operations for the quarter was $459 million, as compared to $571 million for the same period a year ago. Adjusted operating profit margin was 33.6% as a percentage of adjusted revenue, as compared to 42.2% in the fourth quarter of 2020.

Full Year 2021

The Company reported GAAP earnings per share from continuing operations of $7.99 in 2021, as compared to GAAP earnings per share from continuing operations of $6.50 in 2020. GAAP revenue for the year was $5.067 billion, as compared to $3.783 billion in 2020. GAAP operating income from continuing operations for the year was $1,332 million, as compared to $979 million in 2020. GAAP operating profit margin was 26.3% as a percentage of revenue, as compared to 25.9% in 2020.

Adjusted earnings per share from continuing operations for the year was $11.36, as compared to $8.30 in 2020. Adjusted revenue for the year was $5.070 billion, as compared to $3.784 billion in 2020. Adjusted operating income from continuing operations for the year was $1.771 billion, as compared to $1.203 billion in 2020. Adjusted operating profit margin was 34.9% as a percentage of adjusted revenue, as compared to 31.8% in 2020.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"The last three years have been a period of positive transformation for the Company, which we accomplished through agility, teamwork and perseverance," said Prahlad Singh, president and chief executive officer of PerkinElmer. "Thanks to these efforts, I believe we are better positioned than ever to serve as a trusted, strategic partner of choice for our customers, while ensuring we create an inspiring and engaging place to work for our employees."

Financial Overview by Reporting Segment for the Fourth Quarter and Full Year 2021

Discovery & Analytical Solutions

Fourth quarter 2021 revenue was $655 million, as compared to $503 million for the fourth quarter of 2020. Reported revenue increased 30% and organic revenue increased 9% as compared to the fourth quarter of 2020. Full year 2021 revenue was $2.135 billion, as compared to $1.716 billion in 2020. Full year reported revenue increased 24% and organic revenue increased 12%.
Fourth quarter 2021 operating income from continuing operations was $76 million, as compared to $73 million for the fourth quarter of 2020. Full year 2021 operating income was $190 million, as compared to $183 million in 2020.
Fourth quarter 2021 adjusted operating income was $144 million, as compared to $92 million for the fourth quarter of 2020. Full year 2021 adjusted operating income was $415 million, as compared to $267 million in 2020.
Diagnostics

Fourth quarter 2021 revenue was $709 million, as compared to $852 million for the fourth quarter of 2020. Reported revenue decreased 17% and organic revenue decreased 20% as compared to the fourth quarter of 2020. Full year 2021 revenue was $2.932 billion, as compared to $2.067 billion in 2020. Full year reported revenue increased 42% and organic revenue increased 35%.
Fourth quarter 2021 operating income from continuing operations was $254 million, as compared to $460 million for the fourth quarter of 2020. Full year 2021 operating income was $1.220 billion, as compared to $874 million in 2020.
Fourth quarter 2021 adjusted operating income was $335 million, as compared to $502 million for the fourth quarter of 2020. Full year 2021 adjusted operating income was $1.433 billion, as compared to $1.010 billion in 2020.
Initiates First Quarter and Full Year 2022 Guidance

For the first quarter of 2022, the Company forecasts revenue of approximately $1.17-1.19 billion and adjusted earnings per share of $2.05-$2.10.

For the full year 2022, the Company forecasts revenue of $4.42-$4.50 billion and adjusted earnings per share of $6.80-$7.00.

Guidance for the first quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Conference Call and Webcast Information

The Company will discuss its fourth quarter and full year 2021 results and its outlook for business trends during a conference call on February 1, 2022 at 5:00 p.m. Eastern Time. A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

On February 1, 2022 Hubro Therapeutics reported that on 31 January the first dose of FMPV-1 was successfully administered to the first subject in our phase I study FMPV-1-01 in healthy volunteers (Press release, Hubro Therapeutics, FEB 1, 2022, View Source [SID1234607573]). In the study FMPV-1 is co-administered with adjuvant GM-CSF. The study will assess safety and immune response in up to 16 subjects. In a first cohort eight subjects will be enrolled and, depending on the results, a second cohort of another eight subjects given a higher dose of FMPV-1 will follow. It is aimed at completing enrolment and active treatment in the study within the next six months.

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On February 1, 2022 GlaxoSmithKline plc (LSE/NYSE: GSK) reported that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. (Gilead) concerning ViiV Healthcare’s patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus (HIV) (Press release, GlaxoSmithKline, FEB 1, 2022, View Source [SID1234607572]).

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ViiV Healthcare, GSK and Shionogi alleged that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir. As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued.

ViiV Healthcare, GSK, Shionogi and Gilead have entered into a global settlement agreement and a patent license agreement under which Gilead has been granted a worldwide licence to certain ViiV Healthcare patents relating to dolutegravir and a covenant not to enforce any patents controlled by ViiV Healthcare, GSK or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy. ViiV Healthcare, GSK and Shionogi have also agreed not to enforce their patents against any future product containing bictegravir, to the extent that the patent enforcement relates to the bictegravir component of the product.

Financial Considerations
Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s U.S. Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. Regulatory paediatric exclusivity would extend the period of exclusivity after the expiry of the ‘385 patent by six months from 5 October 2027 to 5 April 2028.

The upfront payment and royalty income will be distributed in proportion to the ordinary shareholding in ViiV Healthcare (GSK 78.3%, Pfizer 11.7%, Shionogi 10%) net of the contingent consideration liability (CCL) to Shionogi and applicable tax.

The upfront payment of $1.25 billion will be recorded in GSK’s financial results as an adjusting item in the income statement for the first quarter of 2022. The future royalty income will be recorded in total and adjusted results in the income statements for 2022 to 2027 inclusive. Both the settlement and the future royalty income increase the fair value of the CCL to Shionogi, and the Pfizer put option.* These increases in fair value will be reflected in GSK’s 2021 full-year and fourth-quarter results, and the associated charges will be recorded within adjusting items.

Cash in-flows from the upfront payment and future royalty income and cash out-flows from the CCL will be recorded in cash generated from operations. The resulting increased dividends to Shionogi and Pfizer will be included within financing cashflows. Full details of the operational accounting of the CCL can be found on pages 52-53 of GSK’s 2020 Annual Report.