On February 9, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the year and the six months ended December 31, 2021 (Press release, Purple Biotech, FEB 9, 2022, View Source [SID1234607877]).

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"We achieved significant progress in the advancement of our promising oncology pipeline during this year with notable data releases in both of our lead candidates," said Gil Efron, President and Chief Financial Officer of Purple Biotech. "For NT219, we are currently treating patients in the fourth dose cohort monotherapy arm of the ongoing Phase 1/2 clinical trial and have initiated the first dose level in the combination arm of the study together with cetuximab for patients with squamous cell carcinoma of head and neck (SCCHN). For CM24, we are about to complete dose escalation of the phase 1b/2 of the study and will soon initiate the expansion arms of the study in non-small-cell lung cancer (NSCLC) and pancreatic cancer. We are encouraged by the preliminary data reported from the first patients treated in each of the studies released in 2021 and are planning to expand both programs to additional promising indications in 2022."

"We continue to be focused on development of our robust oncology programs, supported by a strong balance sheet. With $47.4 million in cash, cash equivalent, short and long-term deposits at the end of December 2021, our cash runway extends into 2024," concluded Mr. Efron.

Financial Results for the Year Ended December 31, 2021

Research and Development Expenses were $11.8 million, an increase of $4.6 million, or 64%, compared to $7.2 million in the same period of 2020. The increase was due to expenses related to the ongoing NT219 and CM24 clinical trials, including the manufacturing of drug for the studies.

Selling, General and Administrative Expenses were $6.1 million, compared to $6.0 million in the same period of 2020, an increase of $0.1 million.

Operating Loss was $17.9 million, an increase of $4.7 million, or 36%, compared to $13.2 million in the same period of 2020. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $15.8 million, an increase of $5.2 million, compared to $10.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these studies.

Net Loss for 2021 was $18.5 million, or $1.05 per basic and diluted share, compared to a net loss of $28 million, or $2.45 per basic and diluted share, in 2020. The decrease in net loss was mainly due to $15.7 million in expenses related to a change in the fair value of derivatives, offset by an increase of $4.7 million in operating expenses. Adjusted net loss for the year was $15.7 million, an increase from $10.4 million in the full year of 2020.

As of December 31, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $47.4 million, compared to $60.8 million on December 31, 2020. The Company believes that its cash position will provide sufficient resources to support its currently anticipated ongoing needs into 2024.

Discontinued Operation. As previously reported, COVID-19 adversely impacted the launch of Consensi in the United States. In October 2021, the Company agreed, together with its then U.S distributor for Consensi, Coeptis Pharmaceuticals Inc., to terminate the distribution agreement. Despite our efforts to identify an alternative distributor for Consensi in the U.S., we concluded that commercialization of Consensi, both in the U.S market and elsewhere, is not likely to generate significant revenue and achieve profitability in the near term. In order to reduce the expenses involved in maintaining the product, it was concluded to discontinue Consensi activities and to allocate the funds to our core oncology activities. In parallel, the agreements with Kuhnil Pharmaceuticals Inc.’s for the territory of South Korea and Hebei Changshan Biochemical Pharmaceutical Co., Ltd. for the territory of China were terminated. Consequently, the Company is reporting Consensi as a discontinued operation. Loss from discontinued operation in 2021 was $0.6 million compared to profit from discontinued operation of $0.6 million in 2020. The decrease in profit is mainly due to a decrease in Consensi revenues of $1.0 million generated in 2020.

Financial Results for the Six Months Ended June 30, 2021

Research and Development Expenses were $4.9 million, an increase of $0.6 million, or 14%, compared to $4.3 million in the same period of 2020. The increase was due to expenses related to the CM24 clinical trials that started in the first half of 2021.

Selling, General and Administrative Expenses were $2.9 million, compared to $3.9 million in the same period of 2020, a decrease of $1 million. The decrease was mainly due to a $0.9 million decrease in employee equity-based compensation (ESOP) costs.

Operating Loss was $7.8 million, a decrease of $0.5 million, or 6%, compared to $8.3 million in the same period of 2020.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $7.1 million, a decrease of $0.7 million, compared to $6.4 million in the same period of 2020, mainly to decrease in Selling, General and Administrative Expenses offset by increase in R&D expenses.

Net Loss for the second half of 2021 was $8.3 million, or $0.47 per basic and diluted share, compared to a net loss of $0.2 million, or $0.01 per basic share and $0.47 per diluted share, in the second half of 2020. The increase in net loss was mainly due to decrease of $7.9 million in income related to a change in the fair value of derivatives, offset by an increase of $0.5 million in operating expenses and decrease of $1 million in revenues. Adjusted net loss for the second half of 2021 was $7.0 million, an increase from $6.3 million in the second half of 2020.

On February 9, 2022 Kuraray reported that Business Results for the Fiscal Year Ended December 31, 2021 (Press release, Kuraray, FEB 9, 2022, https://pdf.irpocket.com/C3405/OMfg/YY6Q/Ybo2.pdf [SID1234607875])

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1. Consolidated Financial Results for Fiscal 2021 (January 1, 2021 to December 31, 2021)
(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)
(2) Consolidated Financial Position
(3) Consolidated Cash Flows

2. Dividends

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2022 (January 1, 2022 to December 31, 2022)

1. Unconsolidated Results for Fiscal 2021 (January 1, 2021 – December 31, 2021) (Percentages displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the previous fiscal year.)

(1) Unconsolidated Operating Results
(2) Unconsolidated Financial Position

On February 9, 2022 GSK reported that FY 2021 sales of £34 billion, stable at AER, +5% CER; Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER (Press release, GlaxoSmithKline, FEB 9, 2022, View Source [SID1234607874]).

Pharmaceuticals £17.7 billion +4% AER, +10% CER; New and Specialty medicines £10 billion +20% AER, +26% CER; Respiratory +21% AER, +28% CER; Immuno-inflammation +22% AER, +29% CER; Oncology +31% AER, +37% CER; total HIV -2% AER, +3% CER
Vaccines £6.8 billion -3% AER, +2% CER; Shingrix £1.7 billion -13% AER, -9% CER
COVID-19 solutions sales £1.4 billion; Xevudy £958 million; pandemic adjuvant £447 million
Consumer Healthcare £9.6 billion -4% AER, stable CER (+4% excluding brands divested/under review)
Continued momentum in R&D delivery and strengthening of pipeline
3 major product approvals during 2021; Apretude HIV long-acting medicine for prevention (Dec); Xevudy for COVID-19 (Dec); and Jemperli for endometrial cancer (April)
Strong pipeline of 21 vaccines and 43 medicines, many offering potential best or first-in-class opportunities for patients, and of which 22 are in pivotal trials
Positive Phase III data on daprodustat in anaemia due to chronic kidney disease presented at American Society of Nephrology. On track to file in EU and US in H1 2022
20+ deals executed securing access to 5 novel clinical assets, including with iTeos in immuno-oncology, Alector in immuno-neurology and Vir Biotechnology in flu, plus technologies that expand our capabilities in human genetics and AI
Expect to report milestones in 2022 on up to 7 of the 11 potential new vaccines and medicines identified as key future growth drivers including Older Adults RSV vaccine (H1 2022)
Cost discipline supports delivery of Adjusted EPS of 113.2p
Total Group operating margin 18.2%. Total EPS 87.6p -24% AER, -13% CER
Adjusted Group operating margin 25.8%. Adjusted EPS 113.2p -2% AER, +9% CER. This included a contribution to growth from COVID-19 solutions of approximately +8% AER, +9% CER (+17% AER, +20% CER for Q4 2021)
Full year 2021 net cash flow from operations £8.0 billion. Full year free cash flow £4.4 billion
On track to demerge a new world-leading Consumer Healthcare business mid-2022
Progress to create new Board with appointment of Chair Designate
Capital Markets Day on 28 February to highlight overall strategy, capabilities and operations, including detailed financial information and superior growth ambitions
2022 guidance for new GSK
New GSK, the biopharma business, expected to deliver growth in 2022 sales of between 5% to 7% at CER and growth in 2022 Adjusted operating profit of between 12% to 14% at CER including the anticipated benefit in royalty income from Gilead settlement
This 2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 23p declared for Q4 2021; 80p FY 2021

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Emma Walmsley, Chief Executive Officer, GSK said:
"We have ended the year strongly, with another quarter of excellent performance driven by first-class commercial execution, and we enter 2022 with good momentum. This is going to be a landmark year for GSK, with a step-change in growth expected and multiple R&D catalysts, including milestones on up to 7 key late-stage pipeline assets. 2022 is also the year when we demerge our world-leading Consumer Healthcare business. At our capital markets event later this month, we will set out the future growth ambitions and highly attractive financial profile of this business, and the outstanding opportunity it provides for shareholders."

On February 08, 2022 Congruence Therapeutics reported the company is using computational tools to discover and develop drugs that stabilize problem proteins and it’s now out of stealth with $50 million in funding (Press release, Congruence Therapeutics, FEB 8, 2022, View Source [SID1234648822]).

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The Series A round of funding announced Tuesday was led by Amplitude Ventures and Fonds de solidarité FTQ.

Montreal-based Congruence uses mathematical modeling, physics, and machine learning to characterize the defects of misfolded proteins. The company’s platform technology, called Revenir, designs small molecules that can rescue these mutated proteins—research that is all done on computers. The biotech contends its approach can discover and design novel small molecule stabilizers faster and at scale compared to traditional drug discovery methods.

Congruence was founded last year by CEO Clarissa Desjardins, who was the founder and former chief executive of Montreal-based Clementia Pharmaceuticals. In 2019, Ipsen acquired Clementia and its lead program, a drug for a rare bone disease. Congruence has not disclosed the therapeutic areas it aims to address, other than to say it is pursuing indications with high unmet medical need. Concurrent with that research, Congruence said it is also building a database housing the biophysical properties of mutated proteins, which can be used to develop stabilizes for diseases caused by proteins that are outside of the company’s focus.

"Our industry faces a watershed moment where the application of novel computational tools, including machine learning, is poised to disrupt traditional drug discovery," Desjardins said in a prepared statement."

Congruence said it will use the new funding to build up its drug hunting team. In addition to the financing, Congruent announced that Kenneth Valenzano has been appointed chief scientific officer. Valenzano was most recently senior vice president of drug discovery at Amicus Therapeutics, a rare disease drug developer whose first commercialized product, Galafold, is a small molecule designed to stabilize a key enzyme as a way of treating Fabry disease, an inherited metabolic disorder. At Amicus, Valenzano was involved in the discovery and development of Galafold and other small molecules.

Other disclosed investors participating in the funding round include Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management.

On February 8, 2022 Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, reported that following the Company’s signing of an exclusive global licensing agreement with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio has progressed the product and signed a significant service contract with Quotient Sciences Ltd ("Quotient Sciences") to support the formulation development of NXP001 (Press release, Oxilio, FEB 8, 2022, https://www.londonstockexchange.com/news-article/NFX/oxilio-nxp-001-formulation-development-contract/15319186 [SID1234621609]). NXP001 is a proprietary new form of aprepitant which is currently marketed for cancer chemotherapy induced nausea and vomiting ("CINV").

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Under the contract Oxilio will work with Quotient Sciences, a drug development and manufacturing accelerator, to identify and evaluate the cocrystal formulation of aprepitant to deliver optimal bioavailability for the treatment of CINV.

Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation, evaluating its performance in a relative bioavailability study versus EMEND (a branded aprepitant).

Quotient will prepare for Oxilio CMC (chemistry, manufacturing and controls) batches and stability data to support a clinical trial application for the new formulation of NXP001.

The Company looks forward to providing further updates on Oxilio’s progress with NXP001 in due course.

Commenting, Alastair Riddell, Executive Chairman of Nuformix, said: "We are very pleased to see the progress Oxilio is making with NXP001. Under the exclusive licence we signed with Oxilio we received an upfront payment, expect to receive milestone payments when the product completes clinical trials and ultimately royalties on any sales. This arrangement is allowing Oxilio to progress NXP001 without cost to the Company whilst we focus on progressing our two lead assets, NXP002 and NXP004. In relation to NXP002 and NXP004 we continue to make significant progress and I look forward to making further announcements in due course."