On September 8, 2022 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) reported that the company will participate in the H.C. Wainwright Global Investment Conference in New York City on Wednesday, September 14, 2022 (Press release, Vanda Pharmaceuticals, SEP 8, 2022, https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-participation-in-the-hc-wainwright-global-investment-conference-301620904.html [SID1234619291]). A corporate presentation is scheduled for 8:30 a.m. Eastern Time.

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The corporate presentation given at the H.C. Wainwright Global Investment Conference may be accessed live on Vanda’s corporate website, www.vandapharma.com. Investors should click on the Investors tab and follow the link under Recent Events. Investors are advised to go to the conference website at least 15 minutes early to register, download, and install any necessary software or presentations. A link to the archived conference will be available on Vanda’s website for a period of approximately 30 days.

On September 8, 2022 The Translational Genomics Research Institute (TGen), part of City of Hope, one of the largest cancer research and treatment organizations in the United States, reported a partnership with actress, singer-songwriter and advocate Lynda Carter Altman to accelerate diagnostics and treatments, including precision medicine approaches, for a deadly and difficult-to-treat form of blood cancer (Press release, TGen, SEP 8, 2022, View Source [SID1234619290]).

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Carter Altman is providing a philanthropic gift to support this work, which honors her late husband, Robert Altman, who passed away last year after his myelofibrosis advanced into secondary acute myeloid leukemia (sAML), a rare blood cancer for which early detection is critical and there are currently limited treatment options. As a caregiver for her husband, Carter Altman experienced firsthand the unique challenges associated with treating and managing a rare cancer — and the need to better monitor and understand disease progression.

The experience led her to seek answers and national expertise in precision medicine research, eventually extending her partnership and a gift to TGen and City of Hope to advance diagnostic and treatment options for patients and their families. Carter Altman has also been appointed to the Foundation Board of Directors for TGen.

"When I lost Robert, I was left with so many questions. I wanted to understand why rare cancers are so difficult to treat, what research or treatment advances were being made to change that and, most importantly, how I could help lessen the challenges for other families facing a rare cancer diagnosis," said Carter Altman. "I have long appreciated and respected the work of TGen and now City of Hope, and I’m thrilled to be partnering with them to make advances on both the diagnostics and treatment that I believe will change the future of rare cancer diagnoses."

Carter Altman’s gift will establish The Robert & Lynda Carter Altman Family Foundation Research Fund. This fund will support TGen and City of Hope’s two-track approach to developing leading-edge diagnostic and treatment technologies for myelofibrosis and its transition into sAML. The first track will fund a diagnostic project at TGen using tools like genomic sequencing to improve early detection and pinpoint disease progression. The second track will fund accelerated therapeutic development at City of Hope with the goal of enabling a first-in-human clinical trial of an investigational new drug to mitigate disease progression. The research will help scientists and physicians better understand a patient’s risk of developing more life-threatening forms of cancer, allowing for earlier intervention with precision medicine — a tailored treatment approach that harnesses genomic insights, clinical expertise and advanced analytics to pioneer personalized treatment and prevention.

Jeffrey Trent, Ph.D., president and research director of TGen and a lifelong friend of Carter Altman, leads the collaboration with Michael Caligiuri, M.D., president of City of Hope National Medical Center and Deana and Steve Campbell Physician-in-Chief Distinguished Chair, to advance genomic research and medicine. Together, TGen and City of Hope will advance genomics diagnostics and precision medicine by leveraging TGen’s innovative development of genomic technologies that identify biomarkers in patients’ DNA to predict disease progression and City of Hope’s extensive research in blood cancers and experience implementing treatments to prevent disease progression.

"It’s an exciting time to be studying cancer diagnostics and treatment. Building on the research and innovation of our colleagues at City of Hope who are pioneers in this space, we’re able to apply the tools of genomics in new ways, reaching breakthroughs at an unprecedented pace," said Trent. "Lynda has spent decades inspiring people, first with her iconic roles on screen, and now as she joins us in the battle to end cancer. We are grateful to have her involvement with this work and are confident that we can achieve her goals of helping other families avoid some of the challenges she personally experienced in her journey with her husband and his cancer battle."

City of Hope’s deep expertise in the treatment of blood cancers will play a crucial role in helping to evolve the insights and research advances into the clinical treatment setting. "This partnership and gift from Lynda ultimately support expedited and more precise care for all cancer patients. With City of Hope’s unique bench to bedside approach, we can move at unparalleled speeds to find solutions to challenging diseases," said Caligiuri. "We are thrilled to have additional support and resources needed to further our commitment to ensuring all patients have timely access to appropriate care, genomic testing and precision medicine."

City of Hope is leading the way in the democratization of cancer care — ensuring that every person living with cancer, regardless of their background or circumstances, has access to leading-edge cancer care.

"For 100 years, City of Hope has provided quality cancer care, and we continue to turn hope into reality for our patients. With TGen’s research and discovery, and now Lynda’s generous partnership, we are at the precipice of unlocking new breakthroughs in the genetic components of complex disease and precision medicine treatment," said Robert W. Stone, City of Hope’s president and chief executive officer and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "We are incredibly grateful for the partnership of powerful advocates like Lynda who help us harness and maximize the combined power of collaboration in our fight against cancer."

On September 8, 2022 Sklip Inc reported that it has received academic hospital based institutional review board (IRB) approval to clinically test Sklip artificial intelligence (AI) skin cancer triage with patients in home settings (Press release, sklip inc, SEP 8, 2022, View Source [SID1234619289]). Sklip System AI, which previously received US Food and Drug Administration (FDA) Breakthrough Designation status, is a software as a medical device (SaMD) tool that uses proprietary artificial intelligence technology to triage skin cancers using digital dermoscopy images. Sklip makes it easy for professional and health conscious (patient) users to acquire these images on their own smartphones when using a patent pending Sklip dermatoscope attachment. The Sklip attachment does not require an adapter and when aligned with a smartphone rear facing camera, allows the user to take high-definition medical grade images of self-selected moles of concern. The use of Sklip System AI can identify early signs of skin cancer with an accuracy above 95%.

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This IRB approval marks the next step in the Sklip’s progression towards FDA Clearance review of Sklip System AI for safe, effective and regulated consumer use. Used as a home-based digital health tool, Sklip artificial intelligence triage has the potential to reduce wait times to see a dermatologist from an average of 6 months to 10 days.

Statistics show that skin cancer is an increasing public health concern with 1 in 5 Americans developing skin cancer in their lifetime and more than two people dying from skin cancer every hour. Dermoscopy use in dermatology offices is the standard of care and making Sklip System Artificial Intelligence available with in American homes can potentially improve earlier triage and detection of skin cancers. Early identification of melanoma skin cancer before it becomes invasive can increase 5-year survival rates from 24% to 99%. This IRB approval marks the next step in the Sklip’s progression towards FDA Clearance review of Sklip System AI for safe, effective and regulated consumer use. Used as a home-based digital health tool, Sklip artificial intelligence triage has the potential to reduce wait times to see a dermatologist from an average of 6 months to 10 days.

The company was founded by husband and wife, European trained dermatologists, Alexander Witkowski MD, PhD and Joanna Ludzik MD, PhD, who currently practice dermatology in the United States. They have built the Sklip team with a common belief in precision healthcare for all, through improved access and lowered costs. Their work aims to bring innovative tools and technology to the American healthcare system.

On September 8, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, reported that it will report financial results for the first quarter of fiscal year 2023 before the market open on Thursday, October 6, 2022 (Press release, AngioDynamics, SEP 8, 2022, View Source [SID1234619288]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13732702.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, October 6, 2022, until 11:59 p.m. ET on Thursday, October 13, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13732702.

On September MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2022 (Press release, MEI Pharma, SEP 8, 2022, View Source [SID1234619287]).

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"This past fiscal year was marked by progress on multiple fronts, including the first patient dosed in our Phase 3 COASTAL study, strong zandelisib data reported from the global Phase 2 TIDAL study, reporting of data from our voruciclib and ME-344 programs, and key appointments to our executive team and board of directors," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Further, we remain well capitalized with $153 million to advance our pipeline and continue operations for about two years."

Dr. Gold continued: "Despite a strong start to the fiscal year, our successes have been tempered by changes to the FDA’s approach to accelerated approvals, as now encapsulated by the FDA’s Project FrontRunner, which largely has closed the pathway to marketing authorization based on data from a single-arm study like our Phase 2 TIDAL study. However, the FDA emphasized that we and our partner, Kyowa Kirin, should continue efforts to evaluate zandelisib in our ongoing randomized Phase 3 COASTAL study. We remain confident in zandelisib’s potential to benefit patients with B-cell malignancies as we continue evaluating zandelisib’s unique profile, particularly in combination with other therapies, to provide physicians and their patients new treatment options for cancer."

Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Report complete data from the follicular lymphoma cohort in the Phase 2 TIDAL study by year-end 2022.
Dose the first patient in the Phase 2 CORAL study evaluating zandelisib plus Venclexta (venetoclax) and rituximab in patients with chronic lymphocytic leukemia by year-end 2022.
Provide an update from the Phase 1b study cohort evaluating zandelisib plus Brukinsa (zanubrutinib) at an upcoming scientific congress.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Dose the first patient cohort of voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia by year-end 2022 in the Phase 1 study.
ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 1b study evaluating ME-344 plus Avastin(bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.
Fiscal Year 2022 and Recent Select Drug Candidate Pipeline Highlights

Zandelisib

In July 2022, MEI Pharma and Kyowa Kirin announced publication in The Lancet Oncology of data from the Phase 1b clinical study of zandelisib in patients with relapsed or refractory B-cell malignancy.
In June 2022, MEI Pharma and Kyowa Kirin presented ongoing clinical data on zandelisib at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022 and European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress.
In March 2022, after meeting with the FDA, MEI Pharma and Kyowa Kirin announced they no longer plan to submit an FDA marketing application under the accelerated approval pathway using the single arm TIDAL study.
In November 2021, MEI Pharma and Kyowa Kirin first reported data from the ongoing global Phase 2 TIDAL study evaluating zandelisib as a single agent in patients with relapsed or refractory follicular lymphoma. The data demonstrate:
Overall response rate of 70.3% in the primary efficacy population; the complete response rate was 35.2%.
9.9% of patients discontinued therapy due to a drug related adverse event.
As of the data cutoff date, the data were not sufficiently mature to accurately estimate the final duration of response in the FL primary efficacy population. At that time, the median follow-up time for response was 8.4 months.
In November 2021, MEI Pharma and Kyowa Kirin announced that the U.S. Food and Drug Administration granted orphan-drug designation to zandelisib for the treatment of follicular lymphoma.
In August 2021, MEI Pharma and Kyowa Kirin announced the first patient dosed in the Phase 3 COASTAL study evaluating zandelisib plus rituximab in patients with relapsed or refractory indolent Non-Hodgkin B-cell lymphoma.
Voruciclib

In November 2021, MEI reported data from the Phase 1 dose-escalation study of voruciclib, an oral CDK9 inhibitor, in patients with relapsed or refractory B-cell malignancies or acute myeloid leukemia at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
ME-344

In April 2022, MEI reported preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) evaluating the combination of ME-344 with venetoclax in standard-of-care-resistant acute myeloid leukemia (AML) cell lines and relapsed or refractory (R/R) AML patient samples.
Fiscal Year 2022 and Recent Corporate Highlights

During fiscal year 2022, MEI announced several additions to its management team. In June 2022, MEI appointed Anne Frese as Senior Vice President, Chief People Officer. In February 2022, MEI appointed Alejandro Ricart, M.D., as Senior Vice President, Clinical Development, and Yomara Gomez-Naiden as Senior Vice President, Quality. In July 2021, MEI appointed Tina C. Beamon, J.D. as Chief Compliance Officer.
In December 2021, MEI completed a public offering of common stock resulting in net proceeds to the Company of approximately $48.7 million.
In November 2021, MEI appointed Sujay Kango to its Board of Directors.
Fiscal Year 2022 Financial Results

As of June 30, 2022, MEI had $153.3 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the year ended June 30, 2022, net cash used in operations was $48.7 million, compared to $52.4 million for 2021. The decrease primarily related to changes in working capital.
Research and development expenses were $85.6 million for the year ended June 30, 2022, compared to $69.4 million for 2021. The increase was primarily related to increased development costs associated with zandelisib, increased drug manufacturing costs, and increased consulting fees to support clinical trial activities.
General and administrative expenses were $30.5 million for the year ended June 30, 2022, compared to $24.4 million for 2021. The increase primarily related to increased personnel costs, professional services costs, and general corporate overhead expenses incurred during 2022.
MEI recognized revenues of $40.7 million for the year ended June 30, 2022, compared to $34.8 million for 2021. The increase in revenue related to increased reimbursement of expenses from Kyowa Kirin due to research and development activity related to zandelisib.
Net loss was $54.5 million, or $0.44 per share, for the year ended June 30, 2022, compared to net loss of $41.3 million, or $0.37 per share for 2021. MEI had 133,152,045 shares of common stock outstanding as of June 30, 2022, compared with 112,614,643 shares as of June 30, 2021.
The adjusted net loss for the year ended June 30, 2022, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $75.2 million, compared to an adjusted net loss of $59.4 million for 2021.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, September 8, 2022, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma earnings call.

The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.