On July 11, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported that researchers will present new data from 14 medical physics investigations validating the efficacy and feasibility of the RefleXion X1 radiotherapy platform with and without BgRT at the 2022 American Association of Physicists in Medicine (AAPM) Annual Meeting in Washington, D.C., July 10-14 (Press release, RefleXion Medical, JUL 11, 2022, View Source [SID1234616590]).

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Two of the 14 abstracts are oral presentations, one of which was selected as "Best in Physics," a distinction granted to only 15 abstracts by the AAPM. The company is showcasing the X1 radiotherapy platform and future BgRT capabilities in booth #5093.

RefleXion is also hosting an industry lunch symposium during the AAPM annual meeting at 12:45 pm EDT today. Titled "Preparing for Biology-guided Radiotherapy in the Clinic," the symposium features a presentation on BgRT and advantages for eliminating challenges with motion management by Murat Surucu, Ph.D., as well as a presentation on BgRT commissioning and workflow by Nataliya Kovalchuk, Ph.D., based on their facility’s experience participating in RefleXion’s Investigational Device Exemption (IDE) clinical study.

"We are extremely encouraged by the growing body of scientific evidence validating the RefleXion X1 platform, the future potential of BgRT, and its impact on workflow and treatment planning," said Sean Shirvani, M.D., chief medical officer of RefleXion. "To have 14 medical physics investigations presented at AAPM, including an oral presentation that earned the distinction ‘Best in Physics,’ further underscores our commitment to achieving and surpassing industry standards of quality radiotherapy treatments for patients."

The following two oral presentations and two poster presentations highlight some of the new research being shared regarding the use of BgRT for treatment planning for various anatomic sites, time savings, and simplification in workflow:

Oral Presentations:

"Investigation of computation time and storage savings using Generative Adversarial Network (GAN) source models for dose simulation of a binary MLC Lina," presented by Bin Han, Ph.D., Sunday, July 10 from 4:00 pm – 5:00 pm EDT. This study investigated the feasibility of Generative Adversarial Network (GAN) in modeling the RefleXion X1 Linac by replacing each collimated beam with a GAN generator for Monte Carlo simulation.
"Evaluation of 89Zr immune-PET for Biology Guided Radiation Therapy," selected "Best in Physics," and presented by Guillem Pratx, Ph.D., Thursday, July 14, from 7:30 am – 8:30 am EDT. This study investigated whether a long-lived PET isotope tagged with antibody (immune-PET) could simplify the BgRT workflow by reducing the multiple tracer injections while improving tumor-specific uptake and guidance.
Poster Presentations:

"One-year quality assurance experience of the first RefleXion system," presented by Murat Surucu, Ph.D., Tuesday, July 12, from 1:15 pm – 1:45 pm EDT. This study reports on the daily, monthly, and annual quality assurance (QA) measurement results of the first clinical BgRT capable machine following the AAPM TG-148 protocol.
"Biology Guided Radiotherapy (BgRT) treatment planning feasibility study for head-and-neck, abdomen, and pelvis," presented by Nataliya Kovalchuk, Ph.D., Tuesday, July 12 from 3:45 pm – 4:15 pm EDT. The purpose of this study was to evaluate the feasibility of BgRT treatment planning for various treatment sites in five cancer patients.

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]).

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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]).

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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!

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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]).

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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.