Pulse Biosciences Announces Strategic Change of Focus in Support of Significant Additional Opportunities for medicinal related Nano-Pulse Stimulation

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.

Gilead Sciences Completes Acquisition of MiroBio

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."

InnoCare Completes Initial Public Offering on the STAR Market of the Shanghai Stock Exchange in China

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.

Alpine Immune Sciences Announces Pricing of $100 Million Public Offering

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.

Blood Cancer Discovery Publication Further Validates Exscientia’s AI Precision Medicine Platform for Improving Patient Outcomes

On September 20, 2022 Exscientia (Nasdaq: EXAI), ETH Zurich, the Medical University of Vienna, and the Center for Molecular Medicine (CeMM) reported a new publication in Blood Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), titled "Deep Morphology Learning Enhances Precision Medicine by Image-Based Ex Vivo Drug Testing" from the laboratory of Prof. Berend Snijder (Press release, Exscientia, SEP 20, 2022, View Source [SID1234619700]). This post-hoc analysis builds on the transformative work of the EXALT-1 trial, published in Cancer Discovery, by using deep learning algorithms to classify complex cell morphologies in patient cancer tissue samples into disease "morphotypes."

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EXALT-1 was the first prospective trial to demonstrate significantly improved outcomes for late-stage haematological cancer patients using an AI-supported precision medicine platform to guide personalised treatment recommendations as compared to physician’s choice of treatment. In EXALT-1, 40% of patients experienced exceptional responses lasting at least three times longer than expected for their respective disease. The post-hoc analysis published today in Blood Cancer Discovery shows that combining the technology as used in EXALT-1 with new deep learning advancements that take advantage of cell-specific features in high-content images revealed a potential to further increase these patient outcomes.

"Following results of the EXALT-1 study, these findings continue to validate that our AI-guided precision medicine platform has the ability to identify highly actionable clinical treatment recommendations for blood cancers, deepening our insights and enhancing the clinical predictive power of the platform to help patients," said Gregory Vladimer, Ph.D., VP Translational Research at Exscientia and co-inventor of the platform technology. "Cell morphology, or assessing the characteristics of cells, is fundamental to the diagnosis of cancer. Within this research, we were able to utilise deep learning within the platform to improve our ability to identify personalised cancer treatments, leading to improved clinical outcomes for patients. At Exscientia, we are excited to expand the platform’s applications in order to bring personalised medicine to broader populations."

"We believe performing drug screens directly in tumour tissues of cancer patients is a great step forward in understanding tumour complexity compared to traditional cell model systems. The fact that we can now harness the power of deep learning to turn these terabytes of images into actionable insights is very exciting indeed," added Prof. Berend Snijder, Principal Investigator at the Institute of Molecular Systems Biology of the ETH Zurich in Switzerland.

The impact of deep learning on the clinical predictive power of ex vivo drug screening was assessed in a post-hoc analysis of 66 patients over a period of three years in a combined data set of 1.3 billion patient cells across 136 ex vivo tested drugs across haematological diagnoses including acute myeloid leukaemia, T-cell lymphomas, diffuse large B-cell lymphomas, chronic lymphocytic leukaemia and multiple myeloma. Patients receiving treatments that were recommended by the platform’s immunofluorescence analysis or deep learning on cell morphologies showed an increased rate of achievement of exceptional clinical response, defined as a progression free survival period that lasted three times longer than expected for each patient’s respective disease. Post-hoc analyses confirmed that the clinical predictions became more accurate when also considering the drug toxicity on the healthy cells within the tested patient sample.

Exscientia’s precision medicine platform uses custom deep learning and computer vision techniques to extract meaningful single-cell data from high content images of individual patient tissue samples. This analysis generates clinically-relevant insights into which treatments will deliver the most benefit to an individual patient. Further evaluation of individual patient results through Exscientia’s genomics and transcriptomics capabilities may help Exscientia further understand which other patients may benefit from similar treatments. The underlying technology was developed by Dr. Gregory Vladimer and Prof. Berend Snijder while working in the laboratory of Giulio Superti-Furga at the CeMM Research Center for Molecular Medicine in Austria.