On April 21, 2022 Median Technologies (Euronext Growth – ALMDT) (Paris:ALMDT) whose Board of Directors met on April 20, 2022 to close the consolidated financial statements for the year ending December 31, 2021, reported its full-year results for 2021 and business indicators for the first quarter of 2022 (Press release, MEDIAN Technologies, APR 21, 2022, View Source [SID1234612874]).

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First quarter 2022: initiation of regulatory interactions with the FDA for the iBiopsy LCS CADe/CADx1 software as medical device (SaMD) and growth in the iCRO order backlog2

During the first quarter of 2022, Median Technologies announced it had completed the CADe/CADx integration for its iBiopsy Lung Cancer Screening (LCS) software as medical device (SaMD), which has delivered outstanding sensitivity and specificity performances (see press release of March 22). On March 3, Median also announced it had submitted a 513(g) filing to the FDA. This structuring stage is the first step in Median’s interactions with the FDA, which are set to run until the iBiopsy LCS CADe/CADx SaMD obtains marketing approval.

As of March 31, 2022, Median’s first quarter revenue stood at €5.7 million, up 9.2% relative to revenue in the year-earlier period. Revenue was generated by the iCRO3 business, which provides services to the global biopharmaceutical industry for image management in oncology trials.

The order backlog stood at €62.3 million on March 31, 2022, up 18.4% relative to March 31, 2021 (€52.6 million).

On March 31, 2022, cash and cash equivalents totaled €33.1 million.

"2021 was a record year for Median with revenue of €20.5 million. Order intake was excellent during the fourth quarter after a fairly stable level for the backlog over the first three quarters. The first quarter of 2022 confirmed this momentum with the order backlog rising 18.4% relative to March 31, 2021. At the same time, revenue on March 31, 2022 was up 9.2% compared to the year-earlier period, and was the best quarterly level ever recorded by the Group," stated Fredrik Brag, CEO and founder of Median Technologies. "During the first quarter of 2022, we communicated the outstanding detection/characterization performances of our iBiopsy LCS CADe/CADx software as medical device, which could help save many lives through the early detection of lung cancer in clinical care. iBiopsy is also generating major interest from our pharma partners. The first regulatory exchanges with the FDA have now been initiated and we plan to start our pivotal trials late 2022".

2021 results: continued growth for Median and investments in the iBiopsy software as medical device (SaMD)

On January 17, 2022, Median reported business indicators for 2021 and now confirms:

Revenue as of December 31, 2021 of €20.5 million, up 52.4% relative to December 31, 2020,
An order backlog as of December 31, 2021 of €58 million,
Cash and cash equivalents of €39 million as of December 31, 2021.
As regards iBiopsy, 2021 was highlighted by progress in the development of iBiopsy LCS CADe/CADx SaMD. CADx results were presented at the Annual Meeting of the RSNA (Radiological Society of North America) at the end of November 2021 in Chicago.

Financial information as of December 31, 2021 (consolidated financial statements under IFRS accounting rules)

In 2021, Median’s cash was strengthened following the capital increase undertaken on March 25, 2021 for an amount of €26.6 million net of fees and expenses, and additional financing of over €6 million related to the exercise of equity warrants maturing on September 29, 2021.

Net cash flows from operating activities went from (€5.5) million in 2020 to (€10.1) million in 2021, primarily due to the sharp increase in working capital requirements related to growth in the business and the acceleration in investments for the development of the iBiopsy software as medical devices. Operating cash flow remained stable in 2021 relative to 2020.

The operating loss stood at €11.6 million, representing a €2.8 million increase over the year, of which €1.6 million for the IFRS accounting of free shares for Median’s employees and top management in October 2021 (with no impact on cash), and also in view of the investments made in R&D works for the iBiopsy platform.

Robust revenue and margin growth generated by the iCRO business nevertheless helped reduce the impact of investments related to iBiopsy at the operating level.

The financial loss totaled €7.3 million and stemmed primarily from an adjustment under IFRS accounting, with no impact on Median Technologies’ cash, consisting of valuing the equity warrants issued in favor of the EIB when the first €15 million tranche of the loan was drawn in H1 2020. This valuation was impacted by the increase in the Median’s share price since the equity warrant issue. It was accounted for in the balance sheet under financial instruments, and will not impact Median’s cash position.

Median Technologies informs its shareholders and the financial community that its annual financial report on the accounts for the year ending December 31, 2021 has been made available and filed with the French financial markets authority (Autorité des Marchés Financiers).
The annual financial report is available on the Company’s website: View Source

Forward-looking statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and similar expressions. Although Median’s management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, the uncertainties inherent in research and development, future clinical data and analysis, and decisions by regulatory authorities. Median Technologies’ ability to take advantage of external growth opportunities and to complete related transactions and/or obtain regulatory approvals, risks associated with intellectual property, changes in foreign exchange rates and interest rates, volatility in economic conditions the impact of cost containment initiatives and their evolution, the average number of shares outstanding, as well as those developed or identified in Median Technologies’ public filings with the AMF, including those listed under "Risk Factors" and "Forward-Looking Statements" in Median Technologies’ 2018 Reference Document. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the Autorité des Marchés Financiers.

On April 21, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that the company will release full year 2021 financial results on Tuesday April 26, 2022 after the close of market (Press release, Ambrx, APR 21, 2022, View Source [SID1234612873]). Ambrx will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.

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Individuals interested in listening to the conference call may do so by dialing (844) 200-6205 for domestic callers, or (929) 526-1599 for international callers and reference access code: 9264119; or from the webcast link in the investor relations section of the company’s website at: www.ambrx.com.

A webcast replay of the call will be available beginning April 26, 2022 at 4:30 p.m. PT / 7:30 p.m. ET. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

On April 21, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from a recent study in which patients tested with DecisionDx-Melanoma in addition to traditional clinicopathologic factors had improved survival compared to patients with only traditional clinicopathologic factors available to determine their treatment and follow-up plan (Press release, Castle Biosciences, APR 21, 2022, View Source [SID1234612872]). The study is part of the Company’s ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases. The data will be shared in a poster presentation at the 18th European Association of Dermato Oncology (EADO) Congress, being held virtually and in Seville, Spain, April 21-23, 2022.

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"Once again, the real-world data analyzed as part of our collaboration with NCI has shown the potential for a strong survival benefit in patients whose melanoma management plans included personalized test results provided by DecisionDx-Melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are committed to improving health through innovative tests that guide patient care. This study data demonstrated the ability of our test to help patients and clinicians in informing disease management and treatment plans that have the potential to improve patient survival."

The poster, titled "Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program collaboration," discusses the full cohort of data obtained thus far through the collaboration. The poster examines the impact of testing with DecisionDx-Melanoma on a patient’s survival and the ability of DecisionDx-Melanoma to accurately risk-stratify a group of real-world, unselected, prospectively tested patients with CM. The poster can be viewed here.

As part of Castle’s collaboration with NCI, patient data, including melanoma-specific survival (MSS), overall survival (OS) and additional clinicopathologic information provided by the SEER registries, was linked to data for patients with Stage I-III CM who had been tested with DecisionDx-Melanoma.

To assess if patients tested with DecisionDx-Melanoma had higher survival rates than patients who were not tested with DecisionDx-Melanoma, a group of tested patients (n=3,261) was matched to a group of patients who did not receive DecisionDx-Melanoma test results as part of their clinical care (n=10,863); the matching was based on 11 clinicopathologic and socioeconomic variables using a 1:3 ratio. The untested patients and their clinicians had only the traditional clinicopathologic features upon which to develop a melanoma treatment plan. Matching cases were limited to diagnoses in 2016 and forward to account for potential access to adjuvant therapy. In the study, patients tested with DecisionDx-Melanoma had improved survival compared to untested patients, with a 27% (hazard ratio (HR)=0.73, p=0.028) and 21% (HR=0.79, p=0.006) MSS and OS survival benefit, respectively. This suggests that DecisionDx-Melanoma test results can aid in providing more risk-aligned treatment plans for improved patient outcomes.

Additionally, similar to previously published retrospective and prospective studies, DecisionDx-Melanoma was able to accurately and independently risk-stratify patients for MSS and OS. Moreover, the data indicated that a DecisionDx-Melanoma Class 2B result was a significant and independent predictor of MSS (HR= 8.51, p<0.001) and OS (HR= 2.48, p<0.001), and conferred the highest risk of all clinicopathologic factors included in multivariable analyses that included age, ulceration status, Breslow thickness and sentinel lymph node status.

Overall, the study data showed that the precise, personalized test results provided by DecisionDx-Melanoma have the potential to improve patient survival when used as part of a melanoma management plan. In the study, patients tested with DecisionDx-Melanoma, whose clinicians also had the benefit of the patient’s clinicopathologic factors traditionally used to assess metastatic risk, had improved survival compared to patients with only traditional clinicopathologic factors available to determine their treatment and follow-up plan.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 clinically tested samples thus far (as of April 21, 2022) in a study to evaluate risk of recurrence; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result.

Through Dec. 31, 2021, DecisionDx-Melanoma has been ordered 90,154 times for patients with cutaneous melanoma.

On April 21, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, and Crossroads4Hope, A Network of Cancer Support, a 501(c)(3) organization committed to transforming the cancer experience for patients and their families across New Jersey, reported a grant from BeiGene that will enable Crossroads4Hope to expand the reach of its psychosocial support programs to more vulnerable patients and communities (Press release, BeiGene, APR 21, 2022, View Source [SID1234612871]).

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"We are proud to be a part of this important moment in their corporate history and look forward to a partnership that highlights our mutual commitment to transforming the cancer experience for patients and families."

"As BeiGene expands its presence in the New Jersey business community with our new site to be built in Hopewell, we are committed to joining with organizations that are deeply engaged in the New Jersey cancer community, as is Crossroads4Hope," said Shreya Jani, Vice President of Corporate Affairs at BeiGene. "Crossroads4Hope’s founding belief that all those affected by cancer should have a safe place to turn for emotional and social support, and their commitment to reaching the most vulnerable communities, align well with BeiGene’s vision to change how cancer is treated by developing impactful medicines that will be affordable and accessible to far more cancer patients."

Crossroads4Hope provides social and emotional support to those impacted by cancer across communities in New Jersey, including people with cancer, survivors, loved ones, caregivers, and bereaved families. Programs and services are offered at no charge for individuals and families impacted by a cancer diagnosis either directly or indirectly through a loved one. The grant from BeiGene will enable Crossroads4Hope to expand the reach of its services to additional vulnerable communities in New Jersey.

"Crossroads4Hope welcomes BeiGene to New Jersey," said Amy J. Sutton, CEO at Crossroads4Hope. "We are proud to be a part of this important moment in their corporate history and look forward to a partnership that highlights our mutual commitment to transforming the cancer experience for patients and families."

BeiGene is expanding its U.S. presence to include a flagship clinical R&D and manufacturing site at the Princeton West Innovation Campus in Hopewell, N.J. This innovation center will support BeiGene’s commitment to advancing life-changing medicines for people living with cancer around the world through state-of-the-art commercial-stage biologic pharmaceutical manufacturing, late-stage research, and clinical development capabilities.

On April 21, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported the achievement of a $50 million milestone under its collaboration agreement with Janssen Biotech, Inc. (Janssen) for ciltacabtagene autoleucel (cilta-cel), now marketed in the United States under the brand name CARVYKTI (Press release, Legend Biotech, APR 21, 2022, View Source [SID1234612870]). Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.

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Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.

The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the $50 million payment announced above, Legend has achieved $300 million in milestone payments during the collaboration.

About CARVYKTI (Ciltacabtagene autoleucel; cilta-cel)

CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

In December 2017, Legend Biotech Corporation entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

CARVYKTI received U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma in February 2022. In March 2022, CARVYKTI received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). In addition to U.S. Breakthrough Therapy Designation granted in December 2019, cilta-cel received a Breakthrough Therapy Designation in China in August 2020. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019 and from the European Commission in February 2020.