On October 20, 2022 Median Technologies (Euronext Growth – ALMDT) (Paris:ALMDT), whose Board of Directors approved on October 18, 2022 the consolidated IFRS financial statements for the first half of 2022 after a limited review, reported its half-year results as well as revenues for the third quarter of 2022 (Press release, MEDIAN Technologies, OCT 20, 2022, View Source [SID1234622244]).

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!

Fredrik Brag, CEO and Founder of Median Technologies said:

"We are very pleased that in this uncertain economic environment, Median continues to deliver double digit growth of its revenues and backlog.
We can already observe the very strong impact of the launch of Imaging Lab in May 2022, which is generating significant traction with biopharma companies. Median is positioning itself to become the strategic partner to extract insights from medical images by applying AI solutions to better understand the mechanism of action of new drugs. Therefore, we are becoming the natural provider for clinical studies. With this strong and unique differentiator, we expect to see a clear impact on our iCRO order backlog in the coming months.
Our iBiopsy activities have also been very intense during the quarter with the formation of a first class clinical advisory board and our continued interaction with the FDA for our iBiopsy LCS CADe/CADx SaMD which is following its natural course. We still expect to start our pivotal study in the coming months. Furthermore, the European Union has announced that lung cancer screening1 will become one of the main priorities for the new cancer plan "Europe’s beating cancer plan", which should substantially increase our total addressable market in the coming years."

Further growth during Q3 2022

Third quarter revenues amounted to €6.0 million, representing a 13% increase compared to Q3 2021 revenues (€5.3 million). Revenues for the first three quarters of 2022 were €18.7 million, up 21% compared to the €15.4 million for the first three quarters of 2021. Revenues are entirely generated by the iCRO2 business, which provides imaging services to the biopharmaceutical industry worldwide for oncology clinical trials.

The order backlog3 was €62.5 million on September 30, 2022 , up €8.3 million compared to September 30, 2021 (€54.2 million, +15%).

Cash and cash equivalents totaled €25.9 million on September 30, 2022, including receipt of the 2021 research and innovation tax credit for €1.6 million, and benefiting from the collection of late payments from the second quarter by the Chinese subsidiary following the lockdown in the Shanghai region.

Financial information at June 30, 2022 (IFRS consolidated financial statements)

Median Technologies continued robust growth momentum during the first half of 2022 .

The Company continued the development program of its iBiopsy Lung Cancer Screening (LCS) CADe/CADx software as medical device (SaMD), which resulted in an increase of the cash flow deficit, partially offset by the additional margins generated by the growing iCRO business.

Working capital requirements deteriorated temporarily due to the closure of Chinese administration offices during the lockdown in Shanghai, which delayed the invoicing and collection process for trade receivables. On June 30, 2022, the Group estimated late payments of €2.5 million.

The operating loss reached (€11.0) million, representing an increase of €6.5 million relative to the year-earlier period, including €4.3 million due to the accounting under IFRS of free share allocations made in October 2021 for the Group’s employees and management (with no cash impact), and also due to the investments made for research and development work for the iBiopsy platform.

The increase in revenues and the margin generated by the iCRO business helped reduce the impact of investments in iBiopsy on operating result.

Financial result reached €2.4 million, due primarily to an IFRS accounting valuation adjustment (with no cash impact) of the equity warrants issued in favor of the EIB with the drawing of the first €15 million tranche of its loan in H1 2020. This valuation has been significantly impacted by changes in the share price since the issue of these warrants. Although it is recorded in the statement of financial position under financial instruments, no reimbursement will be made that could affect the Group’s cash in the future.

On October 20, 2022 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent Genetics" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it will release its third quarter 2022 financial results after the market closes on Monday November 7, 2022 (Press release, Fulgent Genetics, OCT 20, 2022, View Source [SID1234622243]). Management will host a conference call for the investment community the same day at 4:30 PM ET (1:30 PM PT) to discuss the results and answer questions.

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 call may be accessed through a live audio webcast on the Investor Relations section of the company’s website, View Source An audio replay will be available at the same location.

On October 20, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, Nov. 3, 2022, following the release of its third quarter 2022 financial results (Press release, Puma Biotechnology, OCT 20, 2022, View Source [SID1234622242]).

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 call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On October 20, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from its prospective, multicenter DECIDE1 study in which DecisionDx-Melanoma test results influenced 85% of clinicians’ decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure, demonstrating the role of the test’s results in guiding risk-aligned patient management decisions (Press release, Castle Biosciences, OCT 20, 2022, View Source [SID1234622241]).

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!

"Melanoma is an aggressive and deadly disease, thus any decisions on whether to forego a procedure like an SLNB cannot be taken lightly," said J. Michael Guenther, M.D., surgical oncologist at St. Elizabeth Physicians in Edgewood, Kentucky. "The clinically actionable information that DecisionDx-Melanoma provides is precious to both doctors and patients. It enables me to have more productive conversations with my patients, so we can make shared, informed decisions about their overall care; this includes decisions on whether to pursue an SLNB if their risk of a positive sentinel lymph node is low."

The data was presented during the 19th International Congress of the Society for Melanoma Research (SMR), held Oct. 17-20 in Edinburgh, United Kingdom, through a poster (# P- 037) titled, "Clinical use of the 31-gene expression profile for informing sentinel lymph node biopsies: a prospective, multicenter study." The poster can be viewed here.

SLNB surgery is used to determine whether a patient’s melanoma has spread to the lymph node; the procedure has the potential for complications and returns a biopsy that is negative for metastatic spread in up to 88% of patients who undergo the procedure.2-3 DecisionDx-Melanoma is a gene expression profile risk stratification test designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. The test has been validated to identify patients who have less than a 5% risk of a positive SLN, indicating that these patients could safely forego the SLNB surgical procedure, and improve the yield of positive SLNBs by identifying patients more likely to have a positive SLNB result.4-5

Study highlights:

The prospective, multicenter study included patients with invasive cutaneous melanoma (tumors staged as T1a (and at least one high-risk feature), T1b and T2) who were considering the SLNB surgical procedure.
Clinicians received DecisionDx-Melanoma test results prior to making SLNB decisions and were asked which features influenced their decision on whether to perform the procedure. Potential influencing factors included patient preference, clinical and pathological features and DecisionDx-Melanoma results.
The data showed that DecisionDx-Melanoma test results influenced 85% of SLNB decisions, and that DecisionDx-Melanoma test results and patient preference played a significant role in influencing the decision to undergo or forego SLNB.
When DecisionDx-Melanoma test results influenced for SLNB, the procedure was performed in 92% of the cases in the study; similarly, when the test result influenced against SLNB, the decision was made to forego SLNB in 70% of cases. This data indicates that the test’s results in conjunction with current guidelines can guide risk-aligned clinical decision-making regarding the SLNB surgical procedure.
The use of DecisionDx-Melanoma test results in conjunction with current guidelines resulted in a significant reduction of SLNB procedures performed, most notably a 29% decrease in SLNBs performed for patients with a low-risk (Class 1A) test result, compared to SLNB decisions made based on a patient’s clinicopathologic risk factors alone (p<0.01).
As demonstrated in the study, DecisionDx-Melanoma test results can influence important clinical decisions regarding the SLNB surgical procedure. Additionally, the use of DecisionDx-Melanoma test results could help patients with low-risk (Class 1A) test results, whose tumor biology indicates that they can safely forego the procedure and still experience positive outcomes, and their clinicians have more informed conversations regarding clinical decisions and avoid a potentially unnecessary procedure.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On October 20, 2022 Zymeworks Inc. ("Zymeworks" or the "Company") (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the highlights from its early R&D Day reviewing the Company’s progress and plans for the development of its novel pipeline assets and applications of its proprietary next-generation technology platforms (Press release, Zymeworks, OCT 20, 2022, View Source [SID1234622240]).

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 event is an important opportunity for us to provide an update on our progress in developing the next generation of innovative therapeutics based on our proprietary engineering platforms and integrated technologies," said Kenneth Galbraith, Chair and CEO of Zymeworks. "During the program we will review recent data related to our antibody drug conjugates (ADC) and multi-specific antibody therapeutics (MSAT). Our goal at Zymeworks is to submit five Investigational Drug Applications in the next five years, and we believe today’s early R&D Day will demonstrate that we have the momentum, expertise, and resources in place to be successful in developing the next wave of potential best-in-class therapeutics."

The event will include presentations on ADC and MSAT research programs and emerging pipeline candidates that expand the Company’s focus on cancer indications with significant unmet patient needs. Similarly, the event will highlight the future development path and strategy that we believe will help drive the next advances in antibody-based therapeutics.

Presenters will include:

Paul Moore, Ph.D., Chief Scientific Officer
Stuart Barnscher, Director, Preclinical Programs, ADC Therapeutics Development
Jamie Rich, Ph.D., Director, Technology, ADC Therapeutic Development
Thomas Spreter Von Kreudenstein, Ph.D., Director, Protein Engineering
Nina Weisser, Ph.D., Director, Multispecific Antibody Therapeutics
"Our team is excited to have the opportunity to share these important updates and provide insight into the future in antibody-based therapeutics we are pursuing at Zymeworks," said Paul Moore, Ph.D., Chief Scientific Officer of Zymeworks. "The use of our advanced technology platforms and continued scientific advancements in both protein engineering and antibody conjugation brings us further towards our goal of addressing difficult to treat cancers with traditionally poor patient prognosis."

Zymeworks Early R&D Day Program Highlights

Update on the Company’s ADC programs, including:

Topoisomerase 1 inhibitor (TOPO1i) payload
ZW191– a Folate Receptor-alpha targeted topoisomerase-1 ADC
ZW251 – a Glypican-3 targeted topoisomerase-1 ADC
ZW220 – a NaPi2b targeted topoisomerase-1 ADC
Review of progress in MSAT development, including:

ZW171– a Mesothelin x CD3 targeted 2+1 format bispecific antibody
Tri-specific T-cell Engagers incorporating co-stimulation (TriTCE-costim)
Tri-specific T-cell Engagers incorporating checkpoint inhibition (TriTCE-CPI)
Early R&D Day Webcast Information

A live webcast of the Company’s Early R&D Day event will be available on the Investors & Media section of Zymeworks’ website, www.zymeworks.com. A replay of the webcast will be available following the presentation.