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GSK delivers strong Q3 2022 sales of £7.8 billion +18% AER, +9% CER and Total EPS 255.9p +>100% AER, +>100% CER; Adjusted EPS of 46.9p +25% AER, +11% CER

On November 2, 2022 GlaxoSmithKline reported that strong Q3 2022 sales of £7.8 billion +18% AER, +9% CER and Total EPS 255.9p +>100% AER, +>100% CER; Adjusted EPS of 46.9p +25% AER, +11% CER (Press release, GlaxoSmithKline, NOV 2, 2022, View Source [SID1234622762])

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Highlights
Strong commercial execution drives continued sales growth across Specialty Medicines, Vaccines and General Medicines
Specialty Medicines £2.7 billion +36% AER, +24% CER; HIV +19% AER, +7% CER; Oncology +28% AER, +19% CER; Immuno-inflammation and other specialty +29% AER +17% CER; COVID-19 solutions (Xevudy) sales £0.4 billion
Vaccines £2.5 billion +14% AER, +5% CER; Shingrix £760 million +51% AER, +36% CER
General Medicines £2.6 billion +7% AER, +1% CER
Prioritised investment in growth with cost discipline
Total continuing operating margin 15.2%. Total EPS 255.9p >100% AER, >100% CER primarily reflecting the gain from discontinued operations arising on the demerger of the Consumer Healthcare business. Total continuing EPS 18.8p -14% AER, -35% CER
Adjusted operating margin 33.3%. Adjusted operating profit growth +18% AER, +4% CER. This included a contribution to growth from COVID-19 solutions of approximately +1% AER, +2% CER
Adjusted EPS 46.9p +25% AER, +11% CER. This included a contribution to growth from COVID-19 solutions of approximately +1% AER, +3% CER
Q3 2022 continuing cash generated from operations £1.9 billion. Free cash flow £0.7 billion
Continued strengthening of late-stage R&D pipeline with regulatory approvals, positive data read-outs and further complementary business development
US FDA approval for Boostrix maternal and Menveo single-vial presentation. Momelotinib for treatment of
myelofibrosis submitted to US FDA
Positive phase III data for RSV older adults candidate vaccine presented at ID Week 2022. Priority Review granted in the US and regulatory submission acceptance in EU and Japan
Completed Affinivax acquisition on 15 August 2022. Announced exclusive licence agreement with Spero Therapeutics for late-stage antibiotic tebipenem
Phase III data readouts expected in Q4 2022: Jemperli in 1L endometrial cancer, Blenrep in 3L multiple
myeloma and gepotidacin for treatment of uncomplicated urinary tract infection
Growing revenues and improving margin support confidence in outlooks
2022 Guidance raised: expect to deliver growth in sales of between 8% to 10% CER and growth in 2022 adjusted operating profit of between 15% to 17% CER
2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 13.75 declared for Q3 2022. No change to expected dividend from GSK of 61.25p/share for FY 2022
q3 2022 results
Emma Walmsley, Chief Executive Officer, GSK:
"GSK has delivered another quarter of excellent performance, with strong growth in Specialty Medicines, record sales for our shingles vaccine, Shingrix, and further improvements in adjusted operating profit. We are again raising our full-year guidance and expect good momentum in 2023, further strengthening our confidence in our performance outlooks, driven by Shingrix global expansion and expected new launches including our new RSV vaccine. We are also making good progress to strengthen our early-stage pipeline and will continue to invest in targeted business development to build optionality and support growth in the second half of the decade."

AIGEN Sciences Noveltinobility, AI-based ADC “joint development agreement”

On November 1, 2022 AIGEN Sciences reported the company signed a joint research and development agreement with Noveltinobility to develop an artificial intelligence (AI)-based antibody-drug conjugate (ADC) (Press release, AIGEN Sciences, NOV 1, 2022, View Source [SID1234643562]).

In this joint development, Eisen Science is responsible for designing and synthesizing drugs (payloads) with high selectivity and apoptosis function for cancer cells by applying its own artificial intelligence platform. Noveltinobility is responsible for new ADC design and evaluation of drug efficacy and toxicity using its expertise in antibody new drug development and the payload developed by Eisen Science. The goal of both companies is to develop ADC drugs that increase treatment effectiveness while minimizing side effects.

Eisen Science has a platform technology that can screen and design drugs with new structures that induce transcriptome changes similar to knock down expression of disease targets using transcriptome data-based artificial intelligence technology. The explanation is that through this, off-target side effects of the drug can be minimized.

Novelinobility is an antibody-based innovative new drug development company that has PREXISE-D, a fully human antibody discovery platform using humanized mice (Hu-mice). Novelty is developing pipelines such as single antibodies, ADCs, and double antibodies using antibodies discovered directly using this platform. In addition, Novelty is advancing the ADC linker platform technology PREXISE-L and promoting the development of next-generation ADC through cooperation with biotech companies specialized in developing new drugs for small molecule compounds.

Park Sang-gyu, CEO of Novelinobility, said, "Through cooperation with Igenscience, we have accelerated the development of the next-generation ADC pursued by the company." He added, "If we combine our know-how in developing new antibody drugs with Igenscience’s artificial intelligence platform, we can achieve diverse functionality and excellent drug efficacy." -We expect to be able to develop an ADC with toxicity balance," he said.

Jae-Woo Kang, CEO of Eisen Science, said, "We want to apply artificial intelligence to the development of ADC anticancer drugs through joint development with Nobel Innovation." He added, "The development of a new payload using Eisen Science’s artificial intelligence platform based on transcriptome data is expected to expand the ADC development market. "We expect it to contribute to the expansion," he said.

2022 3Q Earnings

On November 1, 2022 Hanmi reported financial results for third quarter 2023 (Presentation, Hanmi, NOV 1, 2022, View Source [SID1234624525]).

Investors Meeting Presentation
for Q2 FY2022

ON November 1, 2022 Sumitomo Dainippon Pharma reported its second quarter results (Presentation, Sumitomo Dainippon Pharma, NOV 1, 2022, View Source [SID1234624427]).

Entry into a Material Definitive Agreement

On November 1, 2022, Statera Biopharma, Inc., a Delaware corporation (the "Company"), reported that entered into a securities purchase agreement (the "Purchase Agreement") with a number of accredited investors to purchase from the Company, in a private placement (the "Private Placement"), (i) an aggregate of 10,200,000 shares (the "PIPE Shares") of the Company’s common stock, par value $0.005 per share (the "Common Stock") and (ii) warrants (the "Warrants") to purchase 20,400,000 shares of Common Stock (the "Warrant Shares") at an exercise price of $0.15, with a term of exercise of five years (Filing, 8-K, Cleveland BioLabs, NOV 1, 2022, View Source [SID1234623230]). Each share of Common Stock was offered with two accompanying Warrants for a combined purchase price of $0.075. The aggregate purchase price for the PIPE Shares and Warrants (collectively, the "Securities") to be sold in the Private Placement is approximately $0.8 million.

The Warrants are exercisable beginning six months after the date of issuance. The Warrants may not be sold, assigned, transferred, pledged or otherwise encumbered without the consent of the Company. The Company has the right to call the warrants on thirty days’ prior written notice at any time following such time that the Company has sold shares of Common Stock to a third party at a post-money company valuation equal to or greater than $100 million. Upon receipt of such notice, a holder of the Warrants will have 30 days to exercise their Warrants, after which time any unexercised Warrants will automatically expire.

The Company expects the Private Placement to close on or about November 15, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the Private Placement for working capital purposes.

The Purchase Agreement includes representations, warranties, and covenants customary for a transaction of this type. In addition, the Company agreed to indemnify the accredited investors from liabilities relating to the Company’s breach of any of the representations, warranties and covenants in the Purchase Agreement. The Securities were sold pursuant to the exemption provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder. The sale of the securities pursuant to the Purchase Agreement has not been registered under the Securities Act or any state securities laws. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.