On July 11, 2022 Median Technologies (ALMDT:PA) (Paris:ALMDT) reported its business indicators for the first half of 2022 (Press release, MEDIAN Technologies, JUL 11, 2022, View Source [SID1234616589]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Steady growth of revenue

Following record revenues in Q1 2022 of €5.7 million, Median Technologies continued its strong growth with Q2 2022 revenues of €7.0 million, which is a 43% increase versus Q2 2021 (€4.9 million). First half revenue stood at €12.7 million on June 30, 2022, up 25% versus the same period year ago (€10.1 million). Revenues are generated entirely from the iCRO1 business, which provides services for image management in oncology trials to the biopharmaceutical industry worldwide.

The order backlog totaled €60 million on June 30, 2022, up 14.3% relative to June 30, 2021 (€52.5 million). Median has overcome operational challenges caused by the lockdown in Shanghai region, especially with regards to handling tenders, which translated in a limited and temporary decrease of €2.2 million of the order backlog versus March 30th, 2022. The growth of our business in China remains solid.

On June 30, 2022, cash and cash equivalents amounted to €28.2 million. The temporary closure of official administrative services in Shanghai delayed the invoicing process and the collection of customer receivables. The group estimates current delayed payments at €2.5 million. Since the end of the Shanghai lockdown, relations between Median Technologies and official administrative services are gradually recovering their normal course and the company expects the payment delays to be caught up during Q3 2022.

"The growth momentum of our business continued during the second quarter of 2022, with record quarterly revenues, up 43% versus the same period year ago. Our affiliate in China overcame the challenge of the lockdown in Shanghai region and expectations for the year remain unchanged", indicated Fredrik Brag, CEO and founder of Median Technologies.

Median confirms its objective to obtain marketing approval in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx

In March 2022, the company announced outstanding performances for the combined malignant/benign detection and characterization capabilities of its iBiopsy LCS CADe/CADx2 software as medical device based on Artificial Intelligence and Machine Learning technologies (press release of March 22). The excellent performance of iBiopsy LCS CADe/CADx in terms of sensitivity and specificity could open new perspectives for the early diagnosis of lung cancer and the implementation of massive screening programs for this cancer, which is currently the most deadly in the world. Moreover, these results come at a time when the pharmaceutical industry is heavily investing to position new drug candidates on early stages of the disease.

Simultaneously, Median Technologies has initiated discussions with the FDA in preparation for the launch of the iBiopsy LCS CADe/CADx pivotal study at the end of 2022: following the FDA’s response to its 513(g) filing, Median will proceed with a 510k submission to file for marketing approval with the FDA for its iBiopsy LCS CADe/CADx software as medical device. Median Technologies also initiated a Q-submission process on May 2, with the aim of obtaining the FDA’s opinion on several elements including the pivotal trial protocols and potential predicates. This process will continue through the third quarter of 2022.

The significant advancements of the second quarter, allow Median to confirm its objective of obtaining marketing authorization on the US market in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx.

New synergies between the iCRO and iBiopsy activities

During ASCO (Free ASCO Whitepaper) annual conference, Median Technologies announced the creation of Imaging Lab, a new and highly differentiated iCRO entity focused on leveraging AI, data mining and radiomics technologies to exploit imaging data for oncology clinical trials. This creation expands the portfolio of services provided by the company to the biopharmaceutical industry and materializes the convergence between the iCRO division activities and those of iBiopsy.

On July 11, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported that it will take part in a fireside chat at the Guggenheim I&I Spotlight Series – Treg-based Therapies being held July 12–13, 2022 (Press release, Cue Biopharma, JUL 11, 2022, View Source [SID1234616588]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live and archived webcast of the presentation will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com.

On July 11, 2022 Symeres reported that The impact of the LIFE Cooperative on the life sciences & health sector in the Northern Netherlands (and beyond) is significant (Press release, Symeres, JUL 11, 2022, View Source [SID1234616587]). To make this visible, the Life Science Conference will be organized, including the ceremony of the Innovation Award!

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Life Science Conference from the LIFE Cooperative takes place on the 27th of September 2022 at the Forum in Groningen. During this conference, there will be panel talks, network opportunities, pitches, and the LIFE Science Innovation Award ceremony will take place.

Our Head of Innovation and Technology Ton Vries, and our Director of Medicinal Chemistry Bernard van Vliet will be present at this event.

On July 11, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported its preliminary unaudited financial results for fiscal year ended April 30, 2022 (Press release, PharmaCyte Biotech, JUL 11, 2022, View Source [SID1234616586]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Cash Position

PharmaCyte had $85.4 million in cash and cash equivalents as of April 30, 2022.

Preliminary (Unaudited) 2022 Fiscal Year End Financial Results

PharmaCyte expects to report operating expenses of approximately $4.4 million, compared to $3.6 million in the prior fiscal year. This increase is primarily due to expenses associated with PharmaCyte listing on Nasdaq and two capital raises totaling approximately $90 million.

Net loss for fiscal year 2022 is expected to be approximately $4.2 million or approximately $0.27 per share, compared with a net loss of $3.6 million, or $2.45 per share, for the prior fiscal year.

Management Commentary

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "During fiscal year 2022, our team focused on fulfilling the long list of requests from the FDA in order to have the clinical hold lifted on our planned phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). To date, we have completed almost two dozen studies with only a few remaining. Shortly, we expect to begin our two-phase pig study. This is the last major study required by the FDA.

"Our team has made considerable progress during the year, while controlling costs despite the worldwide supply chain challenges. Our progress through a challenging year demonstrates the value of our experienced and proven team of scientific and medical professionals who have played key roles in helping to get some of the world’s most successful drugs through the clinic.

"We believe the market opportunity to develop cellular therapies for cancer, diabetes and malignant ascites using our signature live-cell encapsulation technology, Cell-in-a-Box, is significant. With our enhanced cash position and recent uplisting to Nasdaq, we are positioned to methodically scale the business and further enhance our already strong scientific team as well as adding complementary capital markets experience to our Board of Directors. We are in the process of thoroughly vetting candidates to ensure that the best people are in place to help us seize the opportunities presented by the strength of our technology, therapies, and cash position.

"We are motivated not just by the market opportunity for our Company, but by the groundbreaking implications for patients. We are frustrated by the value of our stock, which like many biotech companies today, is trading below cash value. That said, we remain intent on continuing to drive our clinical progress toward a solution that we believe can revolutionize our treatment for cancer, diabetes, and malignant ascites and, in turn, create long-term shareholder value."

Recent Highlights

On July 5, 2022, the Company announced it has fulfilled another item from the list of required FDA tasks for its pancreatic cancer product candidate. This was done through the completion of a study that confirmed the qRT-PCR can be successfully implemented for testing. It also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps both before and after encapsulation in the cGMP batches.
On June 2, 2022, PharmaCyte’s Board of Directors authorized a share repurchase program to repurchase up to $10 million of PharmaCyte’s outstanding shares of common stock. The share repurchase will begin shortly after issuance of our preliminary year-end financial results in this press release.
On May 23, 2022, PharmaCyte announced that it has initiated the first in a new series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites. This is the eighth and final preclinical study that may lead to a Phase 1 clinical trial. Such a clinical trial may allow us to validate the technology much faster than PharmaCyte’s planned Phase 2b clinical trial in LAPC.
On April 19, 2022, PharmaCyte reported positive results to satisfy FDA requirements related to the empty capsule material that comprises its pancreatic cancer clinical trial product candidate.
On April 13, 2022, the Company announced that it would accelerate preparations for the start of its Phase 2b clinical trial in LAPC by working parallel paths to have the clinical hold lifted and enroll the first patient in the clinical trial for LAPC.
On April 5, 2022, PharmaCyte announced the appointment of Dr. Matthias Löhr to its Board of Directors. Dr. Löhr is Professor of Gastroenterology and Hepatology at the famed Karolinska Institute in Stockholm, Sweden, and leads the Pancreatic Team at Karolinska University Hospital. He has held dozens of leadership roles in learned societies, cancer research centers, universities and governmental agencies.
On March 22, 2022, PharmaCyte announced it had successfully completed a 24-month product stability study required by the FDA for its pancreatic cancer clinical trial product candidate. This demonstrates that CypCaps has now proven it has a shelf life of at least 24 months when stored at -80 degrees Celsius.
Cautionary Statement

The financial data contained in this press release are preliminary and unaudited, based upon PharmaCyte’s good faith estimates and subject to completion of PharmaCyte’s financial closing procedures. While PharmaCyte expects that its final financial results for its fiscal year and quarter ended April 30, 2022, following the completion of its financial closing procedures, will generally be consistent with the amounts provided in this press release. PharmaCyte’s actual results may differ materially from these estimates as a result of the completion of its financial closing procedures, as well as final adjustments and other developments that may arise between now and the time that its financial results for the fiscal year and quarter ended April 30, 2022, are finalized.

The results provided in this press release are preliminary and subject to completion and audit of PharmaCyte’s financial statements.

On July 11, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported it has formed a strategic partnership with MD Anderson Cancer Center Foundation Spain, a non-profit organization whose objectives are to beat cancer and to increase accessibility of early phase oncology clinical trials (Press release, LabCorp, JUL 11, 2022, View Source [SID1234616585]). Through this collaboration, oncology clinical trials managed by Labcorp Drug Development will be prioritized and conducted at MD Anderson Cancer Center Foundation Spain, representing a new model for future trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This collaboration will help accelerate the discovery and development of cancer therapies worldwide," said Prasanth Reddy, M.D., MPH, FACP, senior vice president and oncology head at Labcorp. "Early phase clinical research in people with cancer is the first step in the regulatory approval process for new therapies, and this collaboration meets the growing demand for oncology clinical trials throughout Spain."

Early phase clinical trials of experimental oncology drugs, often referred to as Phase I or Phase Ib trials, are designed to identify the safety profile, recommended dose, schedule of administration and pharmacologic behavior of new agents or new combinations of agents.

"Having access to drugs in early development is an opportunity for patients with cancer that has metastasized to be able to benefit from the most innovative mechanisms of action in oncology, said Dr. Enrique Grande, head of MD Anderson Madrid Medical Oncology Service and head of clinical research at MD Anderson Foundation Spain. "The agreement with Labcorp allows studies of high scientific value to be concentrated at our center, thus contributing to the consolidation of the MD Anderson Cancer Center Foundation Spain and MD Anderson Madrid hospital as a European reference in the treatment of cancer patients."

The research team at MD Anderson Cancer Center Foundation Spain designs and develops clinical trials to find the best ways to prevent, diagnose and treat cancer. The Phase I Clinical Trials Unit in Madrid was established in October 2021 as a subsidiary of the prestigious MD Anderson Cancer Center in Houston, Texas. Cancer centers running these types of clinical trials can provide more potential treatment options to patients, an indicator of the quality of care available. The new unit, the largest research unit dedicated to Phase I in Spain, is staffed with highly qualified personnel to be able to offer innovative treatments in a unified, multidisciplinary facility enabling enhanced quality services and patient care.

Labcorp Drug Development offers end-to-end capabilities in oncology from research and discovery through commercialization. During the past five years, the company has been involved in 1,035 oncology studies globally involving 125,500 patients in 83 countries. This includes 444 early phase oncology clinical trials with more than 25,000 patients. Spain is the third leading country for early phase oncology trials behind the United States and the United Kingdom.