On September 20, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported an agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A (Press release, Puma Biotechnology, SEP 20, 2022, View Source [SID1234619705]). Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia.

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Under the terms of the agreement, Puma will assume sole responsibility for the global development and commercialization of alisertib. Takeda will receive an upfront license fee of $7 million and is eligible to receive potential future milestone payments of up to $287.3 million upon Puma’s achievement of certain regulatory and commercial milestones over the course of the agreement, as well as tiered royalty payments for any net sales of alisertib.

Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. In ER-positive HER2-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015), in a Phase II randomized clinical trial as a single agent compared to a combination with fulvestrant (SABCS 2020) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). In triple-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). Alisertib has demonstrated meaningful clinical activity in these populations and most notably in ER-positive breast cancer patients who have been previously treated with a CDK4/6 inhibitor (JAMA Network Open 2021). Alisertib has also been previously tested in small cell lung cancer in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (Journal of Thoracic Oncology 2020).

"There continues to be a need for new drugs for the treatment of metastatic ER- positive, HER2-negative breast cancer and triple negative breast cancer," said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. "The results from the clinical trials of alisertib in these two indications are encouraging and suggest that the drug may be able to provide a clinical benefit to these patient populations, and, due to its novel mechanism, alisertib may be able to provide a benefit in patients who have developed resistance to other treatments modalities," said Dr. O’Shaughnessy.

"Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population," said Taofeek K. Owonikoko, MD, PhD, Chief of the Division of Hematology/Oncology and Associate Director for Translational Research and Co-Leader of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center. "The results from the clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and more specifically for patients with molecularly defined tumors that are likely to respond to an aurora kinase A inhibitor such as alisertib," said Dr. Owonikoko.

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma stated, "We are pleased to be able to complete this licensing agreement with Takeda for alisertib. To date, alisertib has demonstrated strong evidence of antitumor activity, both as a single agent and in combination with other anticancer drugs, in patients with metastatic ER-positive and triple negative breast cancer, as well as in small cell lung cancer. We look forward to the continued development of alisertib."

Puma will host a conference call today at 2:00 p.m. PDT/5:00 p.m. EDT to discuss the alisertib licensing agreement. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On September 20, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported a shift in focus to advance its core technology. Pulse Biosciences is expanding strategic opportunities within healthcare, and anticipates a concentrated focus on cardiovascular applications, with potential expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence (Press release, Pulse Biosciences, SEP 20, 2022, View Source [SID1234619704]).

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To support the realignment, Pulse Biosciences has made several executive team changes. Kevin Danahy, who served as Chief Commercial Officer since February, is succeeding Darrin Uecker as President and Chief Executive Officer. The Company is very pleased to announce that Mr. Uecker will devote his full time to the newly created role of Chief Technology Officer where he will be responsible for technology advancement and product development. Joe Talarico, who currently serves as Vice-President of North American Sales, will become Vice-President of Business Development where he will leverage his significant experience in the commercial introduction of new disruptive technologies. Board Chairman, Robert Duggan, will assume a newly created leadership role as the Company’s Executive Chairman.

"During his time at Pulse, Kevin has demonstrated strong leadership and operational skills. The Board of Directors believes he is the right person to lead Pulse during this next pivotal phase. I am confident in NPS technology and its potential," said Robert Duggan, Executive Chairman of Pulse Biosciences. "We have positioned the Company to now focus on high opportunity application areas."

Implementing the present time strategic opportunities does not require the significant sales, marketing and related administrative support team that has been in place. Accordingly, headcount now stands at 66 employees principally focused on engineering, business development and related new product support personnel. In June of 2022, Pulse Biosciences employed 121 employees. The vast majority of present time reduction in personnel mainly impacts dermatological sales, marketing and related support activities. Along with minimizing commercial activities, the Company plans to evaluate potential partners in the dermatology space. Additionally, the Company plans to hold an Investors Day in the next 60 days to show progress and highlight the promising opportunities in other health care verticals.

In support of the change in strategy, Mr. Duggan, the majority shareholder and Executive Chairman, and the Company have entered into a loan agreement in which Mr. Duggan has agreed to loan the Company $65 million to fund its product development operations.

"With the full backing of our board to make the shift in strategy at this time, I look forward to expanding into other areas of healthcare that can leverage our unique NPS technology," said Kevin Danahy, Pulse Biosciences President and Chief Executive Officer. "Shifting our strategy aligns with our ability to demonstrate our proven mechanism of action and the safety and efficacy of our technology as it relates to other markets. I am excited to have the opportunity to collaborate with this top-quality executive team through our next phase of growth."

Mr. Danahy has more than 20 years of senior management experience at medical technology companies. Most recently, Mr. Danahy served as President of Solmetex, driving revenue growth for the company through the implementation of innovative and scalable solutions, while overseeing strategy, sales, marketing, operations, engineering, and service efforts. Previously, at Zimmer Biomet, Mr. Danahy held roles of increasing responsibility, most recently as Vice President of Global Emerging Technologies and Specialty Sales. Before his time at Zimmer, Mr. Danahy served as Sr. Director at Intuitive Surgical, where he successfully transformed the sales leadership training program. Early in his career, he served in commercial leadership roles at both Medtronic and Johnson & Johnson. Mr. Danahy received a Master of Science from Tufts University.

"In conclusion, you can expect Team Pulse Biosciences to stiffen execution, measure what matters, economize wherever possible and do what it takes to achieve a dynamic, expanding and viable organization that delivers patients, physicians and caregivers products and services that significantly improve quality of life," said Robert Duggan, Executive Chairman of Pulse Biosciences.

On September 20, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash (Press release, Gilead Sciences, SEP 20, 2022, View Source [SID1234619703]). The acquisition provides Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

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"Inflammation is a key area of focus for Gilead, and MiroBio’s novel discovery platform technology and pipeline provides the opportunity to develop potentially best-in-class large molecule therapeutics to help patients with currently unmet medical needs," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "This novel approach to inflammatory diseases has the potential to be an important part of providing durable remission for patients living with complex and chronic immune-mediated conditions."

On September 20, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that the Company has successfully got listed on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE), making InnoCare the double-listed biotechnology company on the Hong Kong Stock Exchange (HKEx) and the STAR Market (Press release, InnoCare Pharma, SEP 20, 2022, View Source [SID1234619702]).

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InnoCare will use the net proceeds from the STAR Offering to fund its drug research and development, drug R&D platform upgrade, marketing network upgrade, information technology upgrade and working capital projects. China International Capital Corporation Limited acted as a sponsor and a joint bookrunner for the STAR Offering. Goldman Sachs Gao Hua Securities Company Limited, J.P. Morgan Securities (China) Company Limited and Yuekai Securities Corporation Limited acted as joint bookrunners for the STAR Offering.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "It is another key milestone in InnoCare’s development to get listed on the STAR market. Under the core value of ‘Science drives innovation for the benefit of patients’, we have established an experienced drug R&D team, built an efficient and complete platform ranging from original innovation, clinical development, manufacturing to commercialization, and developed a robust product pipeline. After the listing, we will work harder to deliver better performance, and continue to make unremitting efforts to improve public health.

InnoCare was jointly founded in 2015 by Dr. Jasmine Cui and Professor Yigong Shi. After seven years of solid development, InnoCare has established a fully integrated biotech innovation platform, and developed a robust product pipeline focusing on hematologic cancer, solid tumors and autoimmune diseases, with orelabrutinib at the commercial stage, tafasitamab in combination with lenalidomide approved for early access program in Boao, 13 clinical stage assets and three other IND enabling stage candidates.

On September 20, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported the pricing of its underwritten public offering of 13,606,000 shares of its common stock pursuant to its existing shelf registration statement (Press release, Alpine Immune Sciences, SEP 20, 2022, View Source [SID1234619701]). The shares of common stock are being offered at a public offering price of $7.35 per share. The gross proceeds to Alpine from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Alpine, are expected to be approximately $100.0 million. In addition, Alpine has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 2,040,900 shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares of common stock to be sold in the offering are being sold by Alpine. The offering is expected to close on or about September 23, 2022, subject to customary closing conditions.

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Morgan Stanley, SVB Securities and Cowen are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

A shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on May 14, 2021 and declared effective by the SEC on May 20, 2021. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone: 1-866-718-1649, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected].

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