On July 12, 2022 Worldwide Clinical Trials, Inc. (Worldwide), the industry’s leading global, midsize, full-service contract research organization (CRO), reported its strategic partnership with Invitae, a leading medical genetics company (Press release, Invitae, JUL 12, 2022, View Source [SID1234616623]). The partnership makes Worldwide the first CRO to use Invitae’s Explorer tool – part of its real-world data platform that enables access to aggregated genetic testing results.

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Around the world, 300 million people have a rare disease, and 72 percent of those diseases have genetic origins (source). This partnership underscores Worldwide’s global leadership in rare disease research – one of its five major therapeutic areas of focus. A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States or 5 in 10,000 people in the European Union at any given time. Patient populations for these diseases are small and geographically widespread – a challenge for achieving access to conduct patient education and rare disease clinical research.

Through this partnership, Worldwide has access to data insights based on prevalence, incidence, demographics, geography, and epidemiology for rare disease patients. This aggregated data enables Worldwide to recruit patients faster and pinpoint optimal study locations to help its sponsors uncover new and potentially lifesaving treatments for people suffering from rare diseases.

"This is a game-changer for both our sponsors and patients enrolled in clinical trials," said Peter Benton, President and Co-CEO, Worldwide. "Our unique access to Invitae’s database provides us with superior visibility to an aggregate-level view of patients we otherwise wouldn’t be aware of and enables us to offer advanced clinical trial strategies to our sponsors. This also helps us boost much-needed patient recruitment efforts, expanding our reach and ability to connect the right patients with the right clinical trial opportunities."

"Our strategic collaboration enables Worldwide to gain valuable insight into the genetic etiology of rare disease to help shape and improve the future of clinical trials," said Sean George, Ph.D., Co-Founder and CEO of Invitae. "Our cutting-edge tools empower Worldwide with the opportunity to set clinical trial strategies based on specific disease and geographic prevalence to yield the data needed to treat genetic disorders globally."

With access to Invitae’s aggregated genetic testing data, Worldwide has enhanced its capability to combat the complexities of rare disease trials through quicker visibility of where patients are – with the ultimate goal of providing much-needed and meaningful treatments.

Aligned with their commitment to excellence in rare disease clinical trial design, Worldwide team members are attending and contributing to the World Orphan Drug Congress at the Hynes Center in Boston. Speakers include Dr. Michael Murphy, Chief Medical and Scientific Officer, Worldwide, on the topic of "Endpoints – Where Are We Now and How Does the Development Process Need to Evolve?" on 12 July at 12:15 p.m. ET; and Derek Ansel, Senior Director, Therapeutic Strategy Lead, Rare Diseases, Worldwide, on the topic of "Trends & Challenges: Patient-Focused Rare Disease Research in 2022" on 12 July at 2:00 p.m. ET.

On July 12, 2022 Mercy and GRAIL, LLC, a health care company whose mission is to detect cancer early when it can be cured, reported plans to offer a multi-cancer early detection (MCED) blood test (Press release, Grail, JUL 12, 2022, View Source [SID1234616622]). GRAIL’s Galleri test uses advanced testing capabilities to detect early cancer signals of more than 50 types of cancer. Mercy is early among health systems to offer this first-of-its-kind test.

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"Recommended cancer screenings in the U.S. currently cover only five types of cancer – breast, cervical, colon, lung and prostate – and can screen just one at a time," said Dr. Jay Carlson, clinical chair of Mercy Research, gynecologic oncologist and head of Mercy’s cancer specialty council. "This innovative test has shown the ability to screen for hard-to-detect, aggressive and often deadly types of cancer like pancreatic, ovarian and esophageal, which oftentimes have no warning signs and are caught too late."

The MCED test, which is intended to complement U.S. guideline-recommended cancer screenings, looks for a shared signal present in the bloodstream that has been associated with many cancers.

"Early detection can play a critical role in cancer treatment, allowing cancers to be caught when treatment is more likely to be successful," said Bob Ragusa, chief executive officer at GRAIL. "We believe new approaches, including multi-cancer early detection tests, are the new front in the war on cancer and one of our best chances to bend the cancer mortality curve. We’re excited to work with Mercy to offer Galleri to their patients."

The MCED test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. Galleri is available by prescription only and use of the test is not recommended for those who are pregnant, 21 years or younger, or undergoing active cancer treatment. Patients interested in the test can visit mercy.net/EarlyCancerDetection to fill out a form and, if eligible, be contacted by a Mercy care navigator to walk them through the ordering and testing process. Results will be delivered through care navigators approximately two weeks after blood is drawn and, if a positive signal is detected, they will coordinate additional testing and care.

One of the first Mercy patients to schedule the test was Nancy Dixon, a Mercy co-worker in Oklahoma City.

"My dad died when he was 51 from pancreatic cancer, one of the worst cancers because once you know you have it, the cancer is too far gone," Dixon said. "It’s always been a lingering fear. I was 16 then; I’m now 55. This test gives me some peace of mind rather than not knowing and just waiting. I wish my dad had been able to have access to this blood test. He might be alive today and know my daughter, his grandchild."

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, over 45 of which lack recommended screen tests today. Because the blood test is not currently covered by insurance, patients will pay out of pocket. Mercy will work with patients who qualify for but are unable to pay the total cost of the test.

"Technology continues to push the boundaries on what we are able to do in medicine, making it more predictive, proactive and personalized for patients," said Dr. John Mohart, Mercy chief clinical officer and communities president, who leads operations for all Mercy hospitals. "Early detection has the potential to give us more years with our loved ones, and that’s invaluable."

On July 12, 2022 Fresenius Kabi reported the immediate availability in the United States of Romidepsin for Injection, the newest addition to the company’s broad portfolio of injectable oncology medicines (Press release, Fresenius Kabi Oncology, JUL 12, 2022, View Source [SID1234616621]).

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Fresenius Kabi Romidepsin for Injection is the first approved generic equivalent for ISTODAX, providing clinicians and patients with a more affordable treatment option. Fresenius Kabi Romidepsin is supplied as a kit including one 10 mg single-dose vial of Romidepsin and one 2.2 mL vial of diluent.

"Generic oncology medicines continue to be vitally important to the protocols used in treating many forms of cancer," said John Ducker, president and CEO of Fresenius Kabi USA. "As a leading U.S. developer and supplier of oncology injectable medicines, Fresenius Kabi remains committed to continuing to expand access to affordable oncology therapies."

Fresenius Kabi Romidepsin is formulated, filled and finished in the United States. The company has invested nearly a billion dollars in U.S. manufacturing and distribution to further strengthen the domestic supply of essential medicines and technologies. To learn more, visit www.moreinamerica.com.

About Romidepsin for Injection

Romidepsin for Injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.

Important Safety Information

Myelosuppression: romidepsin can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with romidepsin; interrupt and/or modify the dose as necessary.

Infections: Fatal and serious infections. Reactivation of DNA viruses (Epstein Barr and hepatitis B). Consider monitoring and prophylaxis in patients with evidence of prior hepatitis B.

Electrocardiographic (ECG) changes: Consider cardiovascular monitoring in patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking medicinal products that lead to significant QT prolongation. Ensure that potassium and magnesium are within the normal range before administration of romidepsin.

Tumor lysis syndrome: Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and appropriate precautions taken.

Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception.

The most common adverse reactions (≥ 30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis. Grade 3-4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800‐551‐7176, option 5, or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered romidepsin and warfarin or coumarin derivatives.

Monitor for toxicities related to increased romidepsin exposure when co-administering romidepsin with strong CYP3A4 inhibitors.

Avoid use with rifampin and strong CYP3A4 inducers.

On July 12, 2022 Akanda Corp. ("Akanda") (NASDAQ: AKAN) and Tetra Bio-Pharma ("Tetra") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), reported that Akanda will supply Tetra with pharmaceutical grade cannabis flower in a microdose cap form, for use in a Storz & Bickel Mighty Medic Vaporizer for global commercialization of Tetra’s QIXLEEFTM and related products (Press release, Tetra Bio Pharma, JUL 12, 2022, View Source [SID1234616620]). In addition, Akanda will act as a Contract Development and Manufacturing Organization (CDMO) for Tetra’s clinical drug and commercial supply programs. With this project, Akanda becomes a CDMO in addition to being an EU GMP cannabis manufacturer, marking Akanda’s first entry into cannabinoid drug development, which is a new and growing market opportunity for the company, while Tetra secures a stable supply of high-quality ingredients and regulatory-approved services to satisfy clinical trials and commercialization.

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QIXLEEF is a proprietary botanical inhaled investigational new drug currently being studied in two U.S. Food and Drug Administration (FDA) authorized clinical trials: 1) REBORN©1, a Phase 2 study authorized by the FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain, and 2) PLENITUDE©, a Phase 2 multicenter clinical trial authorized by the FDA to evaluate the safety and efficacy of inhaled cannabinoids to relieve uncontrolled pain in patients with advanced cancer. The companies estimate the total addressable market (TAM) for QIXLEEF to be nearly $1.7 billion by 20281.

Under the multi-year agreement, Akanda will supply Tetra with high-quality, premium THC and CBD flower, and will provide regulatory, quality and pharmaceutical manufacturing services for the QIXLEEFTM clinical drug development and marketing authorization from its Portugal operations. The supply of the active pharmaceutical ingredient starts in [the third quarter of] 2022 and is anticipated to increase incrementally over the succeeding years based on growing demand and commercializing of Tetra’s cannabinoid-derived medicines.

Akanda will provide Tetra with a range of services, including regulatory affairs, quality control and stability testing through Akanda’s internal lab, as well as manufacturing capabilities. Upon FDA approval, the anticipated supply commitments could reach [over 10 metric tonnes] per year.

Tetra, a leader in drug discovery and development for cannabinoid-based medicines, is focusing on therapeutic areas of inflammation, pain, ophthalmology and oncology through a robust pipeline using multiple delivery systems.

"This supply agreement with Tetra is a major milestone in Akanda’s journey in becoming a cannabis platform company serving all regulated markets in the EMEA region," commented Tej Virk, CEO of Akanda. "In supporting a terrific partner with a mission to improve patient health and quality of life though cannabinoid-derived medicine, we are demonstrating that cannabis can fit into the traditional public sector model, with the expectation of reimbursement. Simultaneously, we are productively utilizing our diverse capabilities to support clinical trials for pharma grade cannabinoids. If approved, we expect to provide flower for the authorized compound, potentially creating a significant, incremental revenue stream for Akanda. This opportunity could only have been possible with our state-of-the-art facilities that we gained through the acquisition of Holigen in May."

"This collaboration transitions our Sintra facility into a global CDMO for cannabinoid-based pharmaceuticals as we build up our internal laboratory capacity and manufacturing under EU GMP," commented Dr. Akkar-Schenkl, President of Akanda. "Together with Tetra we are aiming to become the ambassadors for cancer pain treatment. The pharmaceutical grade flower and the level of pharmaceutical excellence in manufacturing, quality operations and regulatory affairs we will be providing into these projects is our fundamental commitment to worldwide palliative care in pain treatment in the field of oncology. The bioburden quality of the flower we will be providing for this delicate patient population can only be managed under stringent manufacturing conditions, special regulatory and pharmaceutical know-how."

"Tetra has been looking for quite a while to find a Global strategic CDMO partner, and we believe that Akanda is a perfect fit from a vision standpoint. This partnership will allow Tetra to secure a robust and trustable source for its clinical drug supply and for QIXLEEF commercialization plans. Aside from quality, Akanda will rapidly automate our process and increase our capacity, resulting in a 67% reduction of our cost of goods sold (COGS)," commented Guy Chamberland, M.Sc., Ph.D., Chief Executive Officer and Chief Regulatory Officer at Tetra. "Establishing a defined source of high-quality ingredients is important for Tetra, and we are excited to advance a productive collaboration with Akanda as we advance target drugs through the regulatory process."

On July 12, 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 financial results for the fourth quarter and fiscal year 2022, which ended May 31, 2022 (Press release, AngioDynamics, JUL 12, 2022, View Source [SID1234616619]).

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"Our strong performance during the quarter, driven by our Med Tech portfolio, is a direct result of the continued hard work and commitment of our AngioDynamics team," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We delivered on the strategic objectives for fiscal year 2022 that we laid out a year ago during our Investor and Technology Day while managing through a number of macro-related headwinds, including supply chain disruptions and ongoing inflationary pressures. During our fourth quarter, we reduced our backlog as our manufacturing capacity improved, exiting the quarter more than 40% above the lows we experienced in December. In addition, we launched two new AlphaVac products and initiated two important clinical trials — our PRESERVE Study for the use of NanoKnife in prostate cancer and our APEX study for the use of AlphaVac F18 in the treatment of pulmonary embolism. We remain committed to balancing and prioritizing investments in our business and enhancing our growth platforms while managing through ongoing inflationary pressures and other macroeconomic challenges. I am excited about the product launches and clinical milestones we expect to achieve in fiscal year 2023, and I look forward to the team’s continued transformation of AngioDynamics."

Fourth Quarter 2022 Financial Results

Net sales for the fourth quarter of fiscal year 2022 were $87.0 million, an increase of 13.2% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company’s net sales in the quarter.

Med Tech net sales were $22.6 million, a 40.0% increase from $16.2 million in the prior- year period, while Med Device net sales were $64.4 million, an increase of 6.1% compared to $60.7 million in the prior-year period. Med Tech includes the Auryon Peripheral Atherectomy platform, the thrombectomy platform and the NanoKnife irreversible electroporation platform.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $45.1 million, an increase of 18.5%, compared to $38.1 million a year ago. Growth was driven by Auryon sales during the quarter of $9.6 million, continuing the sequential growth trend in the business as well as strength in the Company’s thrombectomy portfolio as compared to the prior year.

Oncology net sales were $15.1 million, an increase of 5.8%, compared to $14.3 million in the prior-year period. The year-over-year growth was largely due to increased net sales of disposables of NanoKnife and Microwave.

Vascular Access net sales were $26.7 million, an increase of 9.3%, compared to $24.5 million a year ago.

U.S. net sales in the fourth quarter of fiscal 2022 were $73.7 million, an increase of 15.9% from $63.6 million a year ago. International net sales were $13.3 million, an increase of 0.4%, compared to $13.2 million a year ago.

Gross margin for the fourth quarter of fiscal 2022 was 53.4%, a decrease of 170 basis points compared to the fourth quarter of fiscal 2021, but up sequentially from 52.2% in the third quarter. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials, and freight.

The Company recorded a net loss of $6.3 million, or a loss per share of $0.16, in the fourth quarter of fiscal 2022. This compares to a net loss of $19.5 million, or a loss per share of $0.51, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the fourth quarter of fiscal 2022 was $0.3 million, and adjusted earnings per share was $0.01, compared to adjusted net loss in the prior-year period of $0.1 million and adjusted earnings per share of $0.00.

Adjusted EBITDA in the fourth quarter of fiscal 2022, excluding the items shown in the reconciliation table below, was $6.2 million, compared to $4.5 million in the fourth quarter of fiscal 2021.

In the fourth quarter of fiscal 2022, the Company generated $8.6 million in operating cash, had capital expenditures of $1.0 million and additions to Auryon placement and evaluation units of $2.7 million. At May 31, 2022, the Company had $28.8 million in cash and cash equivalents compared to $23.9 million in cash and cash equivalents at February 28, 2022. The Company had $25.0 million outstanding under its revolving credit facility at May 31, 2022 which was in line with February 28, 2022.

Full-Year 2022 Financial Results

For the twelve months ended May 31, 2022:

Net sales were $316.2 million, an increase of 8.7%, compared to $291.0 million for the same period a year ago.

Med Tech net sales were $78.7 million, a 41.2% increase from the prior year period. Med Device net sales were $237.5 million, an increase of 0.9% from the prior year period.

Gross margin declined 150 basis points to 52.4% from 53.9% a year ago due to elevated labor, material, and freight costs, as well as Auryon start-up costs.

The Company’s net loss from continuing operations was $26.5 million, or a loss per share of $0.68, compared to a net loss of $31.5 million, or a loss of $0.82 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss was $0.2 million, with adjusted earnings per share of $0.00, compared to adjusted net income and adjusted earnings per share of $1.9 million, or $0.05 per share, a year ago. Adjusted net income and adjusted earnings per share in fiscal 2022 includes a $4.2 million, and $0.08 per share benefit, respectively, related to the reimbursement of certain expenses under the employee retention credit as part of the CARES Act. A similar reimbursement benefit of $1.9 million was included in the prior year period.

Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $20.9 million, compared to $19.5 million for the same period a year ago.

Fiscal Year 2023 Financial Guidance

The Company expects its fiscal year 2023 net sales to be in the range of $342 to $348 million, gross margin to be approximately 52.5% to 54.5% and adjusted earnings per share in the range of $0.01 to $0.06 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fourth quarter and fiscal year 2022 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13730672.

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 Tuesday, July 12, 2022, until 11:59 p.m. ET on Tuesday, July 19, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13730672.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income and adjusted earnings per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.