On February 9, 2022 Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock (Press release, Aeglea BioTherapeutics, FEB 9, 2022, View Source [SID1234607932]). Aeglea expects to grant the underwriters a 30-day option to purchase additional shares of common stock. All of the securities are being offered by Aeglea. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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JonesTrading Institutional Services LLC and LifeSci Capital LLC are acting as joint book-running managers in the offering.

Aeglea intends to use the net proceeds from the offering, together with its existing cash resources, to fund its ongoing Biologics License Application submission activities for pegzilarginase and its potential commercialization in the United States, complete its ongoing Phase 1/2 clinical trial of AGLE-177 and prepare for a potential pivotal study in Homocystinuria, advance AGLE-325 for Cystinuria through IND-enabling studies, and the remainder to fund continued research and development, manufacturing, working capital and general corporate purposes.

The securities are being offered by Aeglea pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering will be made only by means of the written prospectus and prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying base prospectus may also be obtained, when available, from JonesTrading Institutional Services LLC at [email protected] or LifeSci Capital LLC at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Aeglea, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that Vincerx’s management team will participate in a fireside chat and one-on-one investor meetings at the SVB Leerink 11th Annual Global Healthcare Conference, to be held virtually February 14-18, 2022 (Press release, Vincerx Pharma, FEB 9, 2022, View Source [SID1234607886]).

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An archived webcast will be accessible in the Investors section of the Company’s website.

On February 9, 2022 Bristol Myers Squibb (NYSE:BMY) reported that it has entered into accelerated share repurchase (ASR) transactions under agreements with Morgan Stanley & Co. LLC, Barclays Bank PLC, Citibank, N.A. and JPMorgan Chase Bank, N.A., (collectively, the "ASR Agreements") to repurchase, in aggregate, $5 billion of Bristol Myers Squibb common stock (Press release, Bristol-Myers Squibb, FEB 9, 2022, View Source [SID1234607902]).

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Under the ASR Agreements, the ASR transactions will be completed under a previously announced $15 billion board-authorized multi-year share repurchase program, under which the company will have approximately $10.2 billion of remaining share repurchase authorization after giving effect to the ASR transactions. Bristol Myers Squibb expects to fund the repurchases with cash on-hand. Approximately 85 percent of the shares to be repurchased under the ASR transactions will be received by Bristol-Myers Squibb on February 9, 2022. The total number of shares ultimately repurchased under the ASR transactions will be determined upon final settlement and will be based on a discount to the volume-weighted average price of Bristol-Myers Squibb’s common stock during the terms of the ASR transactions. Bristol-Myers Squibb anticipates that these ASR transactions will be settled during the second and third quarters of 2022.

On February 9, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company has earned a $10 million non-dilutive milestone payment related to 2021 sales of RUXIENCE (Press release, Aptevo Therapeutics, FEB 9, 2022, View Source [SID1234607917]). Additionally, based on RUXIENCE 2021 fourth quarter and full-year sales results, the Company is optimistic about the possibility of earning additional non-dilutive milestones totaling $22.5 million over the next two years. The Company also announced that its Phase 1b trial evaluating lead drug candidate APVO436 for the treatment of acute myeloid leukemia (AML) continues to enroll new clinical trial sites and that the first complete remission patient, announced in 2021, is proceeding to transplant.

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RUXIENCE Milestones

Aptevo has earned a $10 million milestone payment related to sales of RUXIENCE under the terms of its royalty purchase agreement with HealthCare Royalty Management, LLC (HCR). The milestone will be used to pay down MidCap Financial debt, reducing outstanding principal on the debt to $5 million and strengthening the Company’s balance sheet. This, in combination with $46.3 million of cash-on-hand as of December 31, 2021, gives the Company cash runway through 1Q23, positioning Aptevo well to complete dosing in its ongoing APVO436 Phase 1b clinical trial and, in partnership with Alligator BioScience, to initiate a clinical trial for ALG.APV-527.

RUXIENCE, a Pfizer drug, is a biosimilar to RITUXAN. Pfizer reported 2021 revenue of $491 million from RUXIENCE, including $148 million in 4Q21, exceeding the $395 million threshold required for Aptevo to fully earn the 2021 $10 million milestone. Annualizing the $148 million Q4 revenue suggests 2022 full-year revenue could be approximately $592 million. Aptevo will earn $12.5 million of additional milestones in 2022 if revenue is at least $525 million. Similarly, an additional $10 million milestone can be earned in 2023 if revenue is at least $570 million. Given the above, Aptevo is optimistic about fully earning these additional future non-dilutive milestones totaling $22.5 million.

APVO436 Clinical Trial

The Company’s multi-site, multi-cohort Phase 1b clinical trial evaluating APVO436 for the treatment of acute myeloid leukemia (AML) continues to progress:

MD Anderson Cancer Center joins numerous other sites already enrolling and Aptevo plans to add additional sites this year
A patient with complete remission, announced in November 2021, is progressing to transplant
Initial data is expected mid-year 2022
"We are very pleased to announce meaningful progress in our clinical work and to reinforce the strength of our financial position, especially during such a challenging time in the market. From our inception, Aptevo has remained committed to a focused business strategy designed to deliver results that will ultimately benefit patients," said Marvin White, CEO. "On the clinical side, we are pleased to expand the number of trial sites as this increases the pool of patients potentially eligible to participate in the study. Further, we are happy to report that the patient we reported on in November, who achieved complete remission in the expansion trial, remains in remission and is proceeding to transplant. We wish them well."

"Adding to Marvin’s comments about a previously reported complete remission patient, it’s encouraging that they are proceeding to transplant after receiving a combination of chemotherapy plus APVO436. Complete remission and transplant in patients who have failed prior frontline therapy such as this one, are indicators that the patient is making positive clinical progress in fighting this difficult-to-treat disease." said Dirk Huebner, MD, Senior Medical Advisor.

On February 9, 2022 Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported with its shareholder, Grand Pharmaceutical Group Limited, that SIR-Spheres Y-90 resin microspheres have been approved by the National Medical Products Administration (NMPA) for the treatment of patients with colorectal cancer liver metastases (Press release, Sirtex Medical, FEB 9, 2022, View Source [SID1234607933]).

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The NDA approval of SIR-Spheres for the Chinese market is the first therapeutic radiopharmaceutical approved by the NMPA in 2022 and is the only radioactive microsphere product approved by the NMPA based on clinical trial data obtained outside of China. The first procedure of selective internal radiation therapy (SIRT) using SIR-Spheres in China was successfully performed for a patient in September 2021, which at that time utilized the pilot implementation policy for commercialized medical devices in Hainan.

"We are proud to expand the reach of SIR-Spheres to China, where thousands of patients will now have access to this treatment option," said Kevin R. Smith, Chief Executive Officer of Sirtex. "We express deep gratitude to our partners at Grand Pharmaceutical Group Limited, Sirtex China and our Global Regulatory, Quality Assurance, Operations and Medical teams for their incredible work and diligence that has allowed us to reach this goal."

According to GLOBOCAN 2020, there were 410,000 new cases of liver cancer with 390,000 deaths in China. Additionally, in 2020, there were over 550,000 new cases of colorectal cancer with more than 280,000 deaths in China. Those morbidity and mortality rates are about twice as high as average global rates.

"The prognosis for patients suffering from liver cancer in China is poor, with the five-year survival rate being roughly 12%," notes Dr. Tang Weikun, Chairman of the Board at Grand Pharmaceutical Group Limited. "The use of SIR-Spheres to downstage liver tumors to the point where they can be surgically removed has been well documented in other countries. Our hope is that by expanding the reach of SIR-Spheres to China, we will have a similar impact, with improved treatment outcomes and survival rates among patients diagnosed with liver tumors."