On November 15, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing how the Company’s DecisionDx-SCC test can provide objective, independent and significant risk-stratification for cutaneous squamous cell carcinoma (cSCC) tumors with uncertainty in differentiation status (Press release, Castle Biosciences, NOV 15, 2022, View Source [SID1234624109]). The data were shared in an oral presentation given at the American Society of Dermatopathology (ASDP) 59th Annual Meeting by Sarah Estrada, M.D., dermatopathologist with Affiliated Dermatology in Scottsdale, Arizona.

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Overall, these data demonstrate how DecisionDx-SCC can significantly stratify the risk of metastasis in high-risk cSCC patients with an ambiguous tumor differentiation status. Additionally, the study suggests that incorporating the test’s results into clinical cSCC risk assessments could improve risk-stratification and enhance current patient management decisions to improve patient outcomes.

Subjective pathology variability in the histologic grading of cSCC tumors is an important clinical issue, particularly when comparing moderately differentiated tumors. Poor differentiation has been shown to be an independent risk factor associated with poor patient outcomes.1–3 However, there is a lack of consistency in differentiation assessment4 which can adversely impact the value of differentiation as a prognostic factor. In fact, the two most widely used cSCC staging systems, American Joint Committee on Cancer Staging Manual Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH), vary on their inclusion of poor differentiation as a risk factor for staging; BWH includes it, while AJCC8 does not.

"A single clinicopathologic risk factor, including a cSCC tumor’s differentiation status, can affect staging and thereby escalate or deescalate patient treatment plans," commented Estrada. "Objective risk-stratification that is independent of clinicopathologic factors and staging, as provided by DecisionDx-SCC test results, can identify high-risk cSCC lesions and provide clarity in challenging staging situations."

The presentation, titled "Incorporating the 40-GEP test for poorly differentiated cutaneous squamous cell carcinoma (cSCC) tumors mitigates risk assessment uncertainty from histologic grading," describes the results of a study involving a cohort of 420 high-risk cSCC patients divided into either moderately or poorly differentiated statuses, based on their pathology report and review by an independent dermatopathologist.

A sub-cohort of 171 tumors with differentiation uncertainty was then staged using BWH criteria. The differentiation status of the tumors in this "differentiation uncertainty cohort" was then manually changed so that poorly differentiated was changed to moderately differentiated and vice versa, and changes to BWH staging were analyzed.

The study data showed that:

For 40% of patients in the sub-cohort, the BWH stage changed based upon the alteration of differentiation status, which could impact treatment decisions.
DecisionDx-SCC independently and significantly stratified the sub-cohort according to metastatic risk; patients with a low-risk (Class 1) result had a statistically significant higher three-year metastasis free survival than both moderate-risk (Class 2A) and high-risk (Class 2B) patients (90.1% vs. 78.6% and 62.5%, respectively; p=0.02).
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On November 15, 2022 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s lead product candidate, PRP, could enhance the effects of novel therapies like immune checkpoint inhibitors that can have a role in pancreatic cancer treatment (Press release, Propanc, NOV 15, 2022, View Source [SID1234624108]). Chief Scientific Officer and Co-Founder, Dr. Julian Kenyon MD, MB, ChB, predicts therapies can enhance the patient’s immune response to fight solid tumors by enabling detection of specific tumor cells within the body that were previously undetected. For example, once considered a "non-immunogenic" cancer, pancreatic ductal adenocarcinoma (PDA) has been identified with upregulated immune networks and immune checkpoint molecule expression in its tumor microenvironment and is now redefined as an immunogenic cancer, according to the World Journal of Gastroenterology, November 21, 2016.

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PDA is a highly aggressive malignancy, characterized by delayed diagnosis and treatment resistance. At the time of clinical detection, most PDA cancers are either advanced locally, or metastatic, i.e., ineligible for surgical resection and with a typical five-year survival in the single digits. One of the reasons for the poor effect of treatment is the ability of PDA to evade host immune surveillance. The tumor microenvironment of PDA is composed of a dense fibrotic stroma of extracellular (outside cell) matrix components and a variety of inflammatory cells. "This is where PRP comes in, and, as we understand, it can potentially expose the tumors and lower drug resistance, whereas before they were largely impenetrable," said Dr. Kenyon.

PRP was recently reported as having a significant impact on the tumor microenvironment by impact inhibiting, slowing, or reversing tumor development through acting as an anti-tumor agent, decreasing tumor cell proliferation, developing a non-malignant phenotype (observable characteristics) and promoting cell adhesion (sticking close to one another) and differentiation (cell specialization rather than stem cell-like). To accomplish this, PRP targets specific pathways like TGFβ, critical for tumor development and prevention of immunorecognition by the body’s own immune system. Furthermore, numerous pathways affected downstream are also impacted by altering the tumor surface, which is often resistant to immune regulators due to the impenetrability of the tumor walls.

"Immune checkpoint inhibitors have only recently been investigated for solid tumors like PDA and we are now only realizing the importance of the immune checkpoint inhibition in these cancers. PRP, which is a combination of two proenzymes, trypsinogen and chymotrysinogen, has been shown to impact the tumor microenvironment dramatically, which could have significant implications for other treatment modalities, such as chemotherapy, but also immune checkpoint inhibitors, which could result in improved effects," said Dr. Kenyon. "As we progress along the clinical development pathway, we will continue to explore combinatorial treatments that, if proven clinically beneficial, could have a marked impact on the response rates of approaches like immune checkpoint therapy and lead to improved benefits for sufferers."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On November 15, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focused on the development of differentiated, best-in-class T Cell Receptor engineered T cell (TCR-T) therapies, reported an updated corporate strategy to drive and expedite the development of novel therapies for the treatment of multiple solid tumor indications with high unmet need (Press release, MediGene, NOV 15, 2022, View Source [SID1234624107]).

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"We are excited to announce this strategy and corporate update for Medigene," said Dr. Selwyn Ho, MB BS, Chief Executive Officer at Medigene. "At the heart of our work is our extensive expertise on T cell immunology and many years of development of a proprietary, innovative "end-to-end" platform under the leadership of our Chief Scientific Officer, Prof. Dolores Schendel.

With the platform containing multiple combinable technologies that optimize the development of, as well as enhance the TCR-T products from both an activity and potential safety perspective, we believe that our emerging TCR-T therapies have the potential to address the significant challenges that solid tumors create for immunotherapies, and improve clinical outcomes. The robustness of our work has been well validated through multiple partnerships where potentially highly differentiated TCRs and novel individual technologies have been licensed from Medigene, as well as through the success of our MDG1011 phase 1 trial.

We are focused on delivering best-in-class TCR-T therapies to patients suffering from difficult to treat tumors and have accelerated and prioritized our research activities. Our lead program, MDG1015, is a 3rd generation TCR-T therapy that combines a novel TCR against NY-ESO-1, a well-characterized and validated cancer antigen expressed in multiple tumor types, with the PD1-41BB Switch Receptor that significantly improves the ability of our TCR-T cells to kill cancer cells. This program has the potential for a more targeted, safer, and potent immune response while overcoming highly immunosuppressive tumor microenvironment.

To support our efforts, we continue to strengthen our leadership team and have appointed Mr. James Cornicelli as Head of Corporate Development and Strategy. As a highly seasoned executive with over 20 years in senior business development and strategic advisory roles, Mr. Cornicelli brings multiple areas of expertise that will help guide our company on critical decisions about partnering and accelerate our growth strategy."

Strategic Actions Summary:

TCR-T Therapies Central to Medigene’s Approach
Medigene’s strategy will focus on developing best-in-class T Cell Receptor engineered T cell (TCR-T) therapies. TCR-T therapies are a novel class of cellular immunotherapy with the ability to engage both surface and intracellular antigens on target cells, unlike CAR-T cell-based therapies, allowing for solid tumor targeting in a highly specific manner. The first generation of TCR-T therapies have shown improvements in outcomes in solid tumor clinical trials; however, unmet needs remain for further improvements in efficacy, that are sustained and with a lower risk of adverse effects.

Pipeline Expansion and Acceleration of Discovery Programs MDG1015 and MDG10xx
MDG1015, the company’s lead program, consists of a novel TCR against NY-ESO-1 (New York esophageal squamous cell carcinoma 1), a well-characterized cancer testis antigen (CTA) expressed in multiple tumor types combined with our PD1-41BB Switch Receptor technology, which blocks the PD1/PD-L1 inhibitory axis between T cells and tumors and activates the 41BB co-stimulatory pathway in TCR-T cells. This co-stimulation and reduced inhibition, help mitigating the negative effects of the solid tumor microenvironment, leading to multiple improvements in the activity of MDG1015, including improved tumor cell killing, greater effector T cell function, and enhanced T cell proliferation. For MDG1015 we expect a CTA / IND filing in 2H 2024.

MDG10xx is our second newly announced TCR-T therapy program against several undisclosed targets, in combination with the PD1-41BB Switch Receptor technology. The selection of a lead candidate for MDG10xx is planned for the second half of 2023.

Advancing Broad, Proprietary "End-to-End" Platform
Medigene’s "end-to-end" platform provides multiple combinable, exclusive, and proprietary technologies to create potential best-in-class TCR-T therapies to address the unmet needs in the treatment of solid tumors. The platform includes technologies that both help optimize our development activities as well as to enhance our TCR-T therapy products, during the stages of target screening, TCR generation, TCR-Therapy optimization, manufacturing, and clinical development. These include:

EXPItope-M: Proprietary in silico tool to identify immunogenic epitopes as potential TCR target specificities.
Allo-HLA TCR priming technology: Generation of high-affinity natural TCRs, for improved sensitivity and safety, by bypassing the thymic selection
CrossTAg vector system: Technology loads antigen on both HLA Class I and Class II complexes in antigen-presenting cells (APCs), creating stronger and more sustained immune responses
JOVI-Tag: Tool allowing standardized enrichment and tracking of recombinant TCR (rTCR) -expressing T cells to enable selection of safer TCRs when using HTS
PD1-41BB Co-Stimulatory Switch Receptor: A novel, highly innovative receptor that enhances TCR-T cell functionality, enabling it to mitigate against immunosuppressive tumor microenvironment (TME) and improves efficacy and sustained immune responses
Precision Pairing: Enables the modification and tailoring of TCR constant regions to improve pre-clinical efficacy through the enhanced anti-tumor functional activity of TCR-T cells and potential for improved safety by reducing the potential for off-target effects
Inducible iM-TCR: Control mechanism to regulate TCR-T therapy efficacy & safety, to avoid T cell exhaustion, cell death, and a loss of efficacy as well as to prevent over-activation of TCR-T which can mediate inflammatory responses in off-target tissues
Medigene is also currently developing additional novel and complementary technologies to add to our platform that will further optimize the development of and continue to enhance our TCR-T therapies.

Strengthening & Expanding our Partnership Approach By Leveraging our Innovative Assets & Technologies
To date, multiple partnerships have been established that validate our "end-to-end" platform assets and technologies, including with BioNTech, 2SeventyBio, and Hongsheng Sciences. Medigene will continue to work closely with our existing partners and explore new partnership opportunities to maximize the value of our current and future assets and technologies and ultimately deliver novel and differentiated TCR-T therapies to patients.

Focus on Solid Tumors
As previously announced, we have successfully completed our phase 1 MDG1011 program in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and multiple myeloma (MM). The MDG1011 trial provides clear clinical validation of our ability to generate and manufacture TCR-T therapies and details of our manufacturing process have been shared at the Cell UK meeting in London, in November 2022 with the presentation available on Medigene’s website. The expanded clinical dataset from the trial will be available in due course.

Despite this positive trial for MDG1011, as previously disclosed, we have focused any further research and development efforts towards solid tumors. The company is accelerating our plans to identify a suitable strategic partner and will provide an update in due course.

Webcast on Updated Corporate Strategy

The company will host a live conference call and webcast on its updated strategy on Wednesday, November 16, 2022, at 3 pm CET. A Q&A session will follow management’s formal presentation. A new corporate deck providing an overview of Medigene’s technologies, pipeline, and strategic vision can now be found here: View Source

Following the call, an archived webcast will also be accessible on the Investor & Media section of the Medigene Web site View Source

On November 15, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate progress (Press release, Affimed, NOV 15, 2022, View Source;text=As%20of%20September%2030%2C%202022%2C%20cash%20and%20cash%20equivalents%20totaled,support%20operations%20into%20mid%2D2024. [SID1234624106]).

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"We are excited to have secured a partner that is able to provide a commercially viable NK cell product that enables us to start a registration directed, multicenter clinical trial in order to bring this promising treatment to patients in need as fast as possible. This collaboration builds on the foundation of the exceptional data of AFM13 in combination with NK cells that will be presented at ASH (Free ASH Whitepaper)," said Dr. Adi Hoess, CEO of Affimed. "The progress we are making across our pipeline has laid the foundation for the next steps of development. We are looking forward to sharing key clinical milestones before the end of this year, including topline data from the REDIRECT study and data from the combination of AFM13 with NK cells."

CLINICAL STAGE PROGRAM UPDATES
AFM13 (CD30/CD16A)

Affimed expects to report top-line data from the phase 2 REDIRECT study (AFM13-202) of AFM13 monotherapy in patients with relapsed / refractory (r/r) CD30-positive peripheral T-cell lymphoma (PTCL) in mid-December. REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy that has completed enrollment of more than 100 r/r PTCL patients. The focus of the topline data will be the overall response rate and preliminary assessment of response duration.

A clinical update from the ongoing phase 1/2 trial with Affimed’s lead innate cell engager (ICE) AFM13 precomplexed with cord blood-derived NK cells followed by three weekly infusions of AFM13 in patients with CD30-positive r/r Hodgkin and non-Hodgkin lymphomas will be provided at the upcoming ASH (Free ASH Whitepaper) conference in an oral presentation by Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, on Saturday, December 10, 2022 at 1:15 p.m. CST / 2:15 p.m. EST.
Since the last study update in April 2022 until July 31, 2022, an additional 11 patients were enrolled, resulting in 24 patients treated at the recommended phase 2 dose (RP2D) with up to 4 cycles; a total of 30 patients have been enrolled in the study. The combination treatment continues to show a 100% ORR at the highest dose level and a further improvement in the CR rate, from the previously reported 61.5% to 70.8%.
The safety profile for AFM13 is consistent with previously reported data of infusion related reactions being manageable, with the main treatment-related side-effect being infusion-related reactions. The side effects observed in the trial were transient and did not lead to treatment delays or discontinuations.

Affimed plans to host an in-person investor meeting and webcast in conjunction with the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Saturday, Dec. 10, 2022.

Partnership with Artiva
In November 2022, Affimed announced a strategic partnership with Artiva Biotherapeutics to jointly develop, manufacture and commercialize a combination therapy of AFM13 and Artiva’s cord blood-derived, cryopreserved/off-the-shelf, allogeneic NK cell product candidate, AB-101 in CD30-positive lymphomas. Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 co-administered combination therapy to the U.S. Food and Drug Administration (FDA) requesting feedback on the clinical trial design in r/r Hodgkin lymphoma with an exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma and potential path to registration. The FDA is expected to provide feedback by Q1 2023.

The companies expect to submit an Investigational New Drug (IND) application to the FDA in H1 2023.

AFM24 (EGFR/CD16A)

AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EFGR mutant) and colorectal cancer.

Comprehensive correlative science findings of the AFM24-101 study presented in a poster at the 37th SITC (Free SITC Whitepaper) Annual Meeting showed that starting at low doses of AFM24, NK cell activation was seen in peripheral blood. CD16A receptor occupancy leveled off at doses of 320mg and above, indicating receptor saturation. Activation of the adaptive immune system was also seen at higher doses of AFM24. When tissue biopsies were analyzed, AFM24-treated patients had an increase in NK cells and cytotoxic T cells in the tumor, suggesting that treatment with AFM24 activates both the innate and adaptive immune system in the periphery of the tumor as well as the tumor microenvironment.

AFM24-102: Enrollment continues in the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced epidermal growth factor receptor-expressing solid tumors. AFM24-102 includes patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies.
The first cohort (160 mg) was completed successfully with no reports of dose-limiting toxicities (DLTs). Enrollment is ongoing in the second dose escalation cohort treating patients with a weekly AFM24 dose of 480 mg. No DLTs were observed in the first three patients treated in this cohort and three additional patients are being enrolled at this dose level to confirm 480 mg as the RP2D.
Data from the first cohort of the phase 1 dose escalation study presented at SITC (Free SITC Whitepaper) showed that clinical activity was observed in two patients at the 160 mg dose level. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response (PR). The second patient with pancreatic adenocarcinoma showed stable disease (SD) beyond four months.

AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the first dose cohort (160 mg AFM24 weekly), with no DLTs observed. The Company is currently enrolling patients at the 480 mg dose level. AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.

Affimed expects to provide data updates from the three ongoing studies at major scientific conferences in Q2 and Q3 of 2023.
PRECLINICAL PROGRAMS
AFM28 (CD123/CD16A)

Affimed’s AFM28 ICE targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).

Pre-clinical data from a collaboration between Affimed and the Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University will be presented at the ASH (Free ASH Whitepaper) conference.

The study evaluated the efficacy of AFM28 in preclinical AML models. In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD132-positive tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was independent of leukemic cell mutational profiles and was also effective in targeting cells with low levels of CD123 surface expression.

Residual leukemic stem cells are a frequent cause for relapse and associated with poor prognosis. Patient-derived AML cell cultures incubated with AFM28 and allogeneic NK cells showed significantly reduced numbers of outgrowing colonies compared to controls. That indicates that LSCs and progenitor cells were eliminated. These results were confirmed in an AML mouse model demonstrating complete inhibition of tumor growth throughout a 42-day treatment period in comparison to untreated control mice who all developed systemic disease.

The Company anticipates initiating the phase 1 clinical study for AFM28 in H1 of 2023.

PARTNERSHIPS AND COLLABORATIONS
Partnered programs with Genentech and Roivant continue to progress.

Roivant presented a poster at SITC (Free SITC Whitepaper) that AFVT-2101/AFM32 represents a novel approach to treating folate receptor alpha (FRα) expressing tumors by engaging the innate immune response for safe and effective tumor cell killing. The company announced that it is expecting to enter phase 1 clinical trial in 2023.

Affimed is eligible for additional proceeds including pre-clinical milestones as well as milestones based on early regulatory achievements.

THIRD QUARTER 2022 FINANCIAL HIGHLIGHTS
Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of September 30, 2022, cash and cash equivalents totaled €222.9 million compared to €197.6 million on December 31, 2021. Based on the Company’s current operating plan and assumptions, cash and cash equivalents are expected to support operations into mid-2024.

Net cash used in operating activities for the quarter ended September 30, 2022, was €19.0 million compared to €25.6 million for the quarter ended September 30, 2021.

Total revenue for the quarter ended September 30, 2022, was €14.9 million compared with €8.7 million for the quarter ended September 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses for the quarter ended September 30, 2022, increased by 27% from €20.6 million to €26.1 million compared to the quarter ended September 30, 2021. Research and development expenses increased primarily due to higher expenses associated with the development of the AFM13 and AFM24 programs and included costs to produce clinical trial material, clinical patient trial costs and manufacturing, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.

General and administrative expenses increased 19% from €6.8 million in the quarter ended September 30, 2021 to €8.1 million in the quarter ended September 30, 2022. The increase predominately relates to an increase in headcount, higher share-based payment expenses, an increase in insurance premiums and higher consulting costs.

Net finance income for the quarter ended September 30, 2022 increased by 84% from €1.5 million in the quarter ended September 30, 2021, to €2.7 million. Net finance income is largely the result of foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year.

Net loss for the quarter ended September 30, 2022, was €16.5 million, or €0.11 loss per common share compared with a net loss of €17.1 million, or €0.14 loss per common share, for the quarter ended September 30, 2021.

The weighted number of common shares outstanding for the quarter ended September 30, 2022 was 149.3 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of September 30, 2022, which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

CONFERENCE CALL AND WEBCAST INFORMATION
Affimed will host a conference call and webcast November 15, 2022, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link https://register.vevent.com/register/BI62ec6e16028b424eba578af8c49e4240, and you will be provided with dial-in details and a pin number.

Notes: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

On November 15, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported a corporate and strategic update, following an in-depth evaluation of the business (Press release, Hutchison Medipharma, NOV 15, 2022, View Source [SID1234624103]).

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In response to the challenging market conditions currently affecting the global biopharmaceutical sector, HUTCHMED has taken a number of decisions aimed at accelerating HUTCHMED’s path to profitability and establishing a long-term sustainable business.

HUTCHMED is proactively making a strategic shift to focus on the most advanced assets from its internal developed pipeline, that are most likely to drive near-term value. Accordingly:

HUTCHMED will prioritize its late-stage and registrational studies, to focus on bringing these assets through regulatory approval in particular the global registration of fruquintinib.
Selected early-stage studies will not be prioritized for internal development, and others will be considered as candidates for out-licensing opportunities, enabling the company to focus resources on its later-stage assets. As some related clinical trials wind down, HUTCHMED remains committed to ethical practices and patient care will continue to be our top priority.
HUTCHMED will seek potential partnerships to commercialize its assets outside of China, to accelerate the availability of innovative medicines for patients globally.
HUTCHMED will provide updates in due course with detailed decisions regarding specific programs and progress to streamline the organization, redeploying key talent in support of registrational studies and regulatory submissions.

In light of this strategic shift in focus, Dr. Michael Shi, currently Executive Vice President, Head of Research and Development and Chief Medical Officer, China, will become responsible for clinical development globally. Under Dr. Shi’s leadership, HUTCHMED will remain highly focused on the regulatory submission and further development for fruquintinib, its lead international asset, following the successful multi-regional clinical trial results achieved in August 2022 from FRESCO-2, including its upcoming U.S. FDA New Drug Application filing. As part of this change in strategic focus, Dr. Marek Kania, Executive Vice President, Managing Director and Chief Medical Officer, International, will be transitioning out from his role with HUTCHMED.

Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said:

"We believe that these prudent actions will ensure that we accelerate our path to profitability and therefore establish a sustainable business to support our future success. The challenging market conditions affecting biopharmaceutical companies across the globe require companies to be disciplined in their approach and, like many other companies, we have decided to make adjustments now to enable us to focus on the development of the products in our late-stage pipeline.

"On behalf of the Board and management team, I would like to recognize the contributions of everyone affected by our decisions and I remain grateful to our global team for their continued work towards HUTCHMED’s success. I would also like to thank Marek for his contribution to HUTCHMED, his role in establishing our presence internationally, and building a strong leadership team to accelerate the clinical development of several major programs.

"Our vision of becoming a global biopharmaceutical company remains unchanged, but we expect to fulfill this strategy by commercialization outside China primarily through partnerships. Regardless, we will continue to invest in global development to reach our goal of bringing innovative medicines to patients worldwide."