On August 10, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 (Press release, Medtronic, AUG 10, 2022, View Source [SID1234618071]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s first quarter of fiscal year 2023, which ended on Friday, July 29, 2022.

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Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022, to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at View Source

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source

Looking ahead, Medtronic plans to report its fiscal year 2023 second, third, and fourth quarter results on Tuesday, November 22, 2022, Tuesday, February 21, 2023, and Thursday, May 25, 2023, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

On August 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) (Press release, Everest Medicines, AUG 10, 2022, View Source [SID1234618070]).

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In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin).

"The acceptance of our New Drug Application for Xerava and our agreement with TTY are key steps towards bringing this important and novel therapy to Taiwan," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "With a robust organization that includes expert functions in regulatory, medical, marketing and sales, and a successful record of commercializing other important anti-infective products in the region, TTY was a clear partner of choice as we continue our work to expand the regional reach and access of this critical therapy for patients with complicated intra-abdominal infections and other potentially life-threatening infections."

"TTY Biopharm has been dedicated in the fields of cancer and critical care for many years. It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing. Through this partnership, TTY may provide more options and better solutions to both patients and medical professionals in the near future," said Sara Hou, Chief Executive Officer of TTY Biopharm.

Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.

Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region.

About Xerava (eravacycline)

Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore and the medicine is currently under review for cIAI in Greater China. Everest is also developing Xerava for the treatment of community-acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit View Source

About Complicated Intra-Abdominal Infections

Complicated intra-abdominal infections (cIAI) is a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.

On August 10, 2022 Scientists at City of Hope reported that, one of the largest cancer research and treatment organizations in the United States, may have developed a novel blood test that can be used to detect early-onset colorectal cancer, which has been on the rise in younger adults in recent years (Press release, City of Hope, AUG 10, 2022, View Source [SID1234618069]).

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"More research is needed, but this finding could help fill a void in the cancer prevention and early detection field, which does not currently have a noninvasive and accurate way to detect the presence of nonhereditary colorectal cancer in people younger than 50 years old," said Ajay Goel, Ph.D., M.S., professor and chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope. "The study is significant because it is the first time a novel microRNA (miRNA) biomarker has been identified, developed and validated to detect early-onset colorectal cancer."

Colorectal cancer is the fourth most common cancer, according to the U.S. Centers for Disease Control and Prevention. The rate of colon or rectal cancers in people younger than 50 years old has been on the rise, an alarming trend, particularly because young people diagnosed with this nonhereditary form of colorectal cancer generally have more aggressive and advanced disease at diagnosis compared to late-onset colorectal cancer diagnosed in people 50 years or older. As a result, the recommendation to begin regular colorectal cancer screening has been moved to start five years earlier at age 45.

In the study, recently published in the journal Gastroenterology, researchers systematically conducted a genome-wide analysis to identify miRNA signatures by analyzing a large, publicly available dataset. They extrapolated the data of patients with either Stage 1 or 2 early-onset colorectal cancer (42) or patients with late-onset colorectal cancer (370). (MiRNAs regulate gene expression.) Scientists then validated the results using blood samples from 149 patients with early-onset colorectal cancer and compared the data with a control group of 110. While exciting, more research using larger patient cohorts must be performed before this novel liquid biopsy can be used in the clinic.

To enhance specificity and accuracy, the researchers eliminated all miRNA markers shared by people with early- and late-onset colorectal cancer to better identify patients with early-onset colorectal cancer. They were able to identify four miRNAs that, combined, create a signature biomarker which can be used to detect and diagnose the presence of early-onset colorectal cancer in younger adults.

"The goal would be to eventually be able to use this test as a part of an annual physical exam or every six months for people who are at high-risk for colorectal cancer due to the genes they inherited," Goel said. "Noninvasive fecal and blood tests that are currently available to people are not yet able to accurately detect early-onset colorectal cancer."

The study "A liquid biopsy signature for the detection of patients with early-onset colorectal cancer" was published in Gastroenterology. The research was supported by grants from the National Cancer Institute, National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA227602) as well as from Fundación Mapfre Guanarterme.

On August 10, 2022 DCG Giving, a 501(c)(3) nonprofit part of the Dave Cantin Group, which is one of the largest financial advisory services companies for mergers and acquisitions, aims to improve cure rate and reduce side effects for children with cancer (Press release, Children’s Oncology Group, AUG 10, 2022, View Source [SID1234618068]).

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DCG Giving reported it has entered a partnership with the Children’s Oncology Group (COG) – the world’s largest organization devoted exclusively to childhood and adolescent cancer research and treatment. The goal of DCG Giving is to offer financial and structural support to COG’s local child and adolescent cancer programs and assist patients and their families across the country.

"We are proud to partner with COG, which is trailblazing the advancement for childhood and adolescent cancer research and treatment," said Executive Director Michael Weiner, MD. "Each of COG’s local programs is at the forefront of research and clinical care. These institutions are best equipped to address patient needs, and they are a part of a worldwide network that is united in the fight to cure and eradicate childhood cancer."

"We are excited for our new partnership with DCG Giving, and its ability to channel charitable donations from the automotive industry as well as other philanthropic organizations, foundations, and individuals, that will support COG’s incredible progress," said COG Chair Douglas S. Hawkins, MD. "We remain steadfast that the clinical research done by COG today will continue changing the lives of children and young adults, leading to more effective treatments for those fighting cancer in the future."

DCG Giving continually supports local pediatric cancer charities from coast to coast. Each one is a member of COG and has a track record of providing the best care to kids and families affected by cancer. Organizations that may benefit from this partnership to include the Dana-Farber Cancer Institute, New York-Presbyterian, Memorial Sloan Kettering Cancer Center, Texas Children’s Hospital, Geisinger Medical Center, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, Children’s Healthcare of Atlanta, Children’s Hospital Los Angeles, St. Jude Children’s Research Hospital, Seattle Children’s Hospital, and Johns Hopkins Children’s Center. To donate, visit View Source

On August 10, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta CAR T cell therapies for cancer, reported financial results and operational highlights for the second quarter ended June 30, 2022 (Press release, Adicet Bio, AUG 10, 2022, View Source [SID1234618067]).

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"During the second quarter of 2022, we made significant progress, achieving a number of clinical and regulatory milestones," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We are particularly pleased with the positive clinical data from our lead product candidate ADI-001 presented at ASCO (Free ASCO Whitepaper) in June, and the Fast Track Designation by the FDA. We are excited to report that we are currently enrolling patients to dose level 4 (DL4) and are on track to potentially initiate at least one pivotal study during the first half of 2023. Our pipeline of preclinical programs is advancing, and we look forward to providing a more comprehensive update on several preclinical programs during the second half of 2022. With $304 million in cash and cash equivalents, as adjusted for the at-the-market transaction, we are capitalized into the first half of 2025 and expect to meet several meaningful milestones along the way, including during the second half of this year."

Second Quarter 2022 and Recent Operational Highlights:

Received FDA Fast Track Designation for lead candidate ADI-001. In April, Adicet announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
Presented positive preclinical data at the ISCT Annual Meeting. In May, Adicet announced data from a preclinical evaluation of ADI-001 at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting. The preclinical data showed that ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate activation pathways contributing to its anti-tumor activity. These cells demonstrated superior resilience to host versus graft targeting when compared to common gene-edited approaches.
Presented positive interim data from the Phase 1 study of ADI-001 at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. During the second quarter, Adicet presented positive data from the Phase 1 study of ADI-001 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As of the May 31, 2022 data-cut date, ADI-001 demonstrated 75% complete response (CR) and objective response rate (ORR) across all dose levels with favorable safety and tolerability profile in patients with relapsed/refractory high grade aggressive NHL.
Future development plans for ADI-001. In June, Adicet announced that given the safety profile to date, the Phase 1 study protocol was amended to include a new dose level – dose level 4 (DL4) (1E9 CAR+ cells) and a potential ADI-001 consolidation dosing at dose level 3 to finalize the recommended Phase 2 dose in the second half of 2022. The Company plans to provide at least one additional clinical update for the ADI-001 Phase 1 study in the second half of 2022. The Company also announced that it expects to discuss with the U.S. FDA and the European Medicines Agency (EMA) the design of two pivotal intent studies and a potential path to support a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for ADI-001 and initiate at least one potentially pivotal study in the first half of 2023.
Moved Research & Development (R&D) operations to Redwood City, California; Establishing in-house manufacturing capacity. Adicet completed the move of its California operations to Redwood City, California for the purpose of establishing in-house manufacturing capabilities in the Redwood City facility to enable manufacturing for early clinical development of its potential clinical candidates. The manufacturing areas of the facility are expected to be operational in the fourth quarter of 2022.
Financial Results for Second Quarter 2022:

R&D Expenses: R&D expenses were $16.2 million for the three months ended June 30, 2022, compared to $10.6 million during the same period in 2021. The $5.6 million increase is primarily driven by a $2.5 million increase in payroll and personnel expenses resulting from an increase in headcount, a $1.4 million increase in contract manufacturing organization and other externally conducted R&D expense and a $0.7 million increase in contract research organization expense related to the Company’s Phase 1 trial. Payroll and personnel expenses for the three months ended June 30, 2022, includes $1.9 million of non-cash stock-based compensation expense compared to $0.8 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the three months ended June 30, 2022, compared to $5.0 million during the same period in 2021. The $1.5 million increase is primarily driven by an increase of $1.1 million of payroll and personnel expenses, which was partially offset by a $0.2 million decrease in professional service fees and a $0.2 million decrease in lab fees. Payroll and personnel expenses for the three months ended June 30, 2022, includes $2.4 million of non-cash stock-based compensation expense compared to $1.8 million during the same period in 2021.
Net Loss: Net loss attributable to common shareholders for the three months ended June 30, 2022 was $22.5 million, or a net loss of $0.56 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million, as compared to a net loss of $10.9 million during the same period in 2021, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $2.7 million.
Cash Position: Cash and cash equivalents were $260.6 million as of June 30, 2022, compared to $277.5 million as of December 31, 2021. On August 9, 2022, the Company sold an aggregate of 2,611,723 shares of the Company’s common stock at a purchase price of $17.23 per share under its existing at-the-market agreement. This resulted in aggregate gross proceeds to the Company of approximately $45.0 million, before deducting sales agent fees and expenses payable by the Company. The Company expects that current cash and cash equivalents of $304.3 million, adjusted for sales agent fees from the at-the-market transaction, will be sufficient to fund its operating expenses into the first half of 2025.