On December 30, 2021, Personalis, Inc., or the Company, reported that entered into an At-the-Market Sales Agreement, or the Sales Agreement, with BTIG, LLC, or BTIG, under which it may offer and sell its common stock having aggregate sales proceeds of up to $100.0 million from time to time through BTIG as its sales agent (Filing, 8-K, Personalis, DEC 30, 2021, View Source [SID1234597952]). Sales of the Company’s common stock through BTIG, if any, will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including without limitation sales made directly on the Nasdaq Global Market or any other existing trading market for its common stock. BTIG will use commercially reasonable efforts to sell the Company’s common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay BTIG a commission of up to 3.0% of the gross sales proceeds of any common stock sold through BTIG under the Sales Agreement. The Company has also provided BTIG with customary indemnification rights.

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The Company is not obligated to make any sales of common stock under the Sales Agreement. The offering of shares of the Company’s common stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Sales Agreement, or (ii) termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. This Current Report on Form 8-K also incorporates by reference the Sales Agreement into the Registration Statement (as defined below).

The Company’s common stock is being offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-251824) declared effective by the U.S. Securities and Exchange Commission, or SEC, on January 8, 2021, or the Registration Statement, and a prospectus supplement dated December 30, 2021.

On December 30, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that the company has successfully completed its previously announced acquisition of Lengo Therapeutics and lead compound LNG-451, a potential best-in-class oral precision therapy in development for the treatment of non-small cell lung cancer (NSCLC) in patients with EGFR exon 20 insertion mutations (Press release, Blueprint Medicines, DEC 30, 2021, View Source [SID1234597852]). An investigational new drug (IND) application for LNG-451 was submitted to the U.S. Food and Drug Administration (FDA) by Lengo Therapeutics in December 2021.

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"The acquisition of Lengo Therapeutics and its lead candidate LNG-451 enables Blueprint Medicines to expand our pipeline in lung cancer and harness our experience and expertise to advance precision oncology therapies for the patients who need them," said Fouad Namouni, M.D., President of Research & Development. "I want to thank the Lengo Therapeutics team, again for their work to advance the highly selective therapeutic candidate LNG-451, but also for completing the IND submission with a continued sense of urgency. Pending FDA clearance of the application, we plan to advance LNG-451 into the clinic in the first quarter of 2022."

As previously disclosed, under the terms of the agreement, Blueprint Medicines acquired Lengo Therapeutics for $250 million in cash plus up to $215 million in additional potential payments based on the achievement of certain regulatory approval and sales-based milestones.

On December 29, 2021 AstraZeneca reported that it has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX (Press release, AstraZeneca, DEC 29, 2021, View Source [SID1234597822]).

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The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.

Financial considerations
Under the terms of the agreement, the upfront payment from AstraZeneca to Ionis is $200m. AstraZeneca will make additional conditional payments of up to $485m following regulatory approvals. It will also pay up to $2.9bn of sales-related milestones based on sales thresholds between $500m and $6bn, plus royalties in the range of low double-digit to mid-twenties percentage depending on the region. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions.

The transaction will be funded with cash and is expected to be neutral to Core earnings in 2021. It will be accounted for as an intangible asset acquisition, recognised initially at the upfront amount, with any potential future milestone payments capitalised into the intangible asset as they are recognised.

Ionis will continue to manufacture and supply eplontersen for the existing clinical studies and process qualification. AstraZeneca will be responsible for commercial supply, with transition timing to be agreed by both parties. AstraZeneca will book all sales generated under the agreement.

The transaction does not impact AstraZeneca’s financial guidance for 2021.

Notes

Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA) investigational medicine designed to reduce the production of transthyretin, or TTR protein, to treat all types of TTR amyloidosis (ATTR), a systemic, progressive and fatal disease.

TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by aging or genetic mutations resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium and peripheral nerves, respectively. In patients with ATTR, both the mutant and wild type TTR protein builds up as fibrils in tissues, such as the peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow. The presence of TTR fibrils interferes with the normal functions of these tissues. As the TTR protein fibrils enlarge, more tissue damage occurs and the disease worsens, resulting in poor quality of life and eventually death. Worldwide, there are an estimated 300,000 – 500,000 patients with amyloid transthyretin cardiomyopathy (ATTR-CM)1,2 and 10,000 – 40,000 patients with amyloid transthyretin polyneuropathy (ATTR-PN).3

On December 29, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS) reported that the company will participate in two separate biotech events in January 2022: the H.C. Wainwright BIOCONNECT Virtual Conference and the 11th Annual LifeSci Partners Corporate Access Event (Press release, Aptose Biosciences, DEC 29, 2021, View Source [SID1234597824]). The Aptose management team will be hosting investor meetings during both events.

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Details of the events are as follows:

Event: H.C. Wainwright BIOCONNECT Virtual Conference
Date: January 10-13, 2022
Time: Presentations available starting at 7:00 a.m., ET on January 10, 2022
Webcast: Accessible for registered conference attendees via the conference’s virtual platform.

Event: 11th Annual LifeSci Partners Corporate Access Event
Date: January 5-7, 2022
1×1 Meeting
Requests: Register and submit 1×1 meeting requests here.

On December 29, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company is filing new patent applications in several countries for the treatment of all advanced solid tumors based on new clinical data showing that a patient with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, was cleared of all tumor lesions following treatment with Namodenoson, an A3 adenosine receptor (A3AR) ligand (Press release, Can-Fite BioPharma, DEC 29, 2021, View Source [SID1234597825]). These pending patent applications are the latest in Can-Fite’s growing IP portfolio covering its platform technology, as well as its drug candidate Namodenoson and its use in a variety of advanced cancers.

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Can-Fite’s Namodenoson, a small orally bioavailable drug that binds with high affinity and selectivity to A3AR, was recently found to clear all cancer lesions in a patient treated under an Open Label Extension program of its concluded Phase II study for the treatment of HCC. In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval.

"Can-Fite’s IP portfolio includes about 200 patents and pending patent applications in 16 patent families. Given the very strong new data on Namodenoson’s efficacy in advanced HCC, these latest patent filings seek to further fortify our IP position with respect to Namodenoson in liver cancer and also expand our pending claims for advanced disease in other cancer indications", stated Can-Fite’s Chairman, Dr. Ilan Cohn, a Senior and Founding Partner at Cohn De Vries Stadler & Co., a leading IP firm.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.