On April 26, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (Press release, Bristol-Myers Squibb, APR 26, 2024, View Source [SID1234642390]). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in June 2024.

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"For eligible patients with unresectable or metastatic urothelial carcinoma, platinum-based chemotherapy in the first-line setting has been the standard of care for decades but the durability of response to chemotherapy alone is poor and once a patient progresses, treatment options become increasingly limited," said Dana Walker, vice president and Global Program Lead, Genitourinary Cancers, Bristol Myers Squibb. "New treatment options that may improve responses, delay disease progression, and offer survival benefit in the first-line setting are needed. With today’s CHMP positive opinion, we are one step closer to potentially providing eligible patients with unresectable or metastatic urothelial carcinoma in the European Union with a new first-line treatment option."

The positive CHMP opinion is based on results from a sub-study of the CheckMate -901 trial which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. In the sub-study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR). With a median follow up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171). Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012). The safety profile was consistent with the known safety profiles of the individual components of the regimen. No new safety concerns were identified. Please see Important Safety Information below.

CheckMate -901 is the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit compared to standard-of-care chemotherapy alone in the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

On March 7, 2024 the U.S. Food and Drug Administration (FDA) approved the use of Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, following a Priority Review. Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across multiple tumors, including urothelial carcinoma, renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, melanoma, hepatocellular carcinoma, gastric cancer, squamous cell carcinoma of the head and neck and esophageal squamous cell carcinoma.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -901 clinical trial.

About CheckMate -901

CheckMate -901 is a Phase 3, randomized, open-label trial evaluating Opdivo in combination with Yervoy (ipilimumab) or Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy compared to standard-of-care chemotherapy alone, in patients with untreated, unresectable or metastatic urothelial cancer.

In the sub-study of CheckMate -901, evaluating Opdivo with cisplatin and gemcitabine vs. standard-of-care chemotherapy alone, a total of 608 patients eligible for cisplatin-based chemotherapy were randomized to receive either Opdivo 360 mg in combination with cisplatin and gemcitabine every three weeks for up to six cycles followed by 480 mg/Q4 Opdivo monotherapy every 4 weeks until disease progression or death up to a maximum of two years, or cisplatin-gemcitabine alone every three weeks for up to six cycles. The primary endpoints of this study are overall survival (OS) and progression-free survival (PFS).

The OS and PFS outcomes for patients eligible for cisplatin-based chemotherapy are based on the final efficacy analyses of these endpoints.

The CheckMate -901 primary study, evaluating Opdivo plus Yervoy vs. standard-of-care cisplatin- or carboplatin-based chemotherapy in patients with untreated, unresectable or metastatic urothelial carcinoma remains ongoing.

About Urothelial Carcinoma

Bladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but approximately 50% of patients who undergo surgery will experience disease progression and recurrence within two-to-three years post-surgery. Approximately 20% to 25% of patients with urothelial carcinoma develop metastatic disease. The poor durability of responses seen with chemotherapy alone in the first-line setting presents a major challenge in the treatment of metastatic disease, and there are limited treatment options in the second-line setting for patients with advanced urothelial carcinoma.

On April 26, 2024, BeiGene, Ltd. (the "Company") filed its 2023 Annual Report (the "STAR Annual Report") with the Science and Technology Innovation Board (the "STAR Market") of the Shanghai Stock Exchange, which was prepared in accordance with the listing rules of the STAR Market and the applicable securities laws and regulations of the Peoples’ Republic of China (the "PRC" and the "PRC Securities Laws") (Press release, BeiGene, APR 26, 2024, View Source [SID1234642389]). The STAR Annual Report is available to the public in Chinese language only on the website maintained by the Shanghai Stock Exchange at www.sse.com.cn.

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As required by the PRC Securities Laws, the STAR Annual Report contains additional financial information of the Company’s gross profit margin ratio, research and development expenses allocated by key products and other research and development projects and production, sales and inventory stock units for the year ended December 31, 2023 (the "Reporting Period"), prepared in accordance with the China Accounting Standards for Business Enterprises – Basic Standard ("CAS") and other applicable PRC accounting rules, guidance and interpretations (together with CAS, "PRC GAAP"), including but not limited to the China Securities Regulatory Commission’s Compilation Rule for Information Disclosure by Companies Offering Securities to the Public No. 15 – General Rules for Financial Statement (2023 revised), and Compilation Rule for Information Disclosure by Companies Offering Securities to the Public No. 24-Special Provisions on Information Disclosure in Financial Statements of Pilot Innovative Red-chip Companies on the Sci-Tech Innovation Board. The key differences between such financial information prepared in accordance with PRC GAAP and those prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") for the Reporting Period, which was previously filed with the U.S. Securities and Exchange Commission, are summarized below.

Key Differences between PRC GAAP and U.S. GAAP

Share-based Compensation

Under U.S. GAAP, the Company elects to recognize share-based compensation expenses using the straight-line method for all employee equity awards granted with graded vesting based on service conditions, provided that the amount of compensation cost recognized at any date is at least equal to the portion of the grant-date value of the options that are vested as of that date.

Under PRC GAAP, the Company recognizes share-based compensation expense using the accelerated method for all employee equity awards granted with graded vesting.

Under PRC GAAP, the excess tax benefit resulting from the pre-tax deductible amount arising from U.S. employee share-based payments over the cumulative share-based payment-related expenses recognized for accounting purposes should be recorded in shareholders’ equity rather than in current income tax expenses/benefits under U.S. GAAP.

Leasing

Under U.S. GAAP, as a lessee, the Company recognizes a lease liability based on the present value of the total remaining lease payments, and a corresponding right-of-use assets. The Company subsequently recognizes operating lease expenses on a straight-line basis over the lease term.

PRC GAAP requires lessees to present interest expenses on the lease liability and depreciation on the right-of-use assets separately in the statements of operations. The combination of a straight-line depreciation of the right-of-use assets and the effective interest rate method applied to the lease liability will result in a higher total charge to profit or loss in the initial years of the leases and decreasing expenses during the latter part of the lease term.

Gross Profit Margin Ratio

As required by the PRC Securities Laws, the 2023 STAR Annual Report contained financial information regarding gross profit margin ratio by region, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below. Amounts reported herein are stated in thousands of U.S. dollars.
For the year ended December 31, 2023
For the year ended December 31, 2022
By Region
Revenue
COGS
Gross Margin ratio
Revenue
COGS
Gross Margin ratio
China
1,101,951
352,706
68.0%
840,032
276,729
67.1%
Ex-China
1,356,828
27,214
98.0%
575,889
9,746
98.3%
Total
2,458,779
379,920
–
1,415,921
286,475

Research and Development Expenses Allocated by Key Products and Other R&D Projects

As required by the PRC Securities Laws, the 2023 STAR Annual Report contains financial information regarding the research and development ("R&D") expenses allocated by key products, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below. Amounts reported herein are stated in thousands of U.S. dollars.
Pipeline Products/ Projects
For the year ended December 31, 2023
For the year ended December 31, 2022
Zanubrutinib
158,051
126,959
Tislelizumab
83,799
88,935
Pamiparib
8,963
11,606
Ociperlimab (BGB-A1217)
77,717
106,608
Bcl-2 (BGB-11417)
52,548
22,377
OX40 (BGB-A445)
15,757
11,215
CDAC (BGB-16673)
3,584
1,071
Other R&D projects
150,998
100,726
R&D collaboration projects
100,115
167,620
Subtotal of external R&D expenses
651,532
637,117
Subtotal of internal R&D expenses
1,127,062
1,003,391
Total
1,778,594
1,640,508

Production, Sales and Inventory Stock Units

As required by the PRC Securities Laws, the 2023 STAR Annual Report contained financial information regarding the production, sales and inventory stock units of key products, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below.

Item
Unit
Production or purchase quantity for the year ended December 31, 2023
Sales quantity for the year ended December 31, 2023
Stock quantity as of December 31, 2023
Key products
vials
5,004,600
3,878,000
2,666,400

On April 26, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Orion Corporation, a global pharmaceutical company based in Finland, has selected the lead bispecific antibodies from the companies’ second development program, and is exercising its option to develop these molecules under the existing 2021 research collaboration and license agreement (Press release, Alligator Bioscience, APR 26, 2024, View Source [SID1234642388]). The exercise of this development option triggers an undisclosed milestone payment to Alligator.

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"Our research collaboration with Alligator has allowed us to identify again new lead molecules with potential to be selected for clinical development. It is fantastic to see how productive this collaboration is," said Outi Vaarala, Senior Vice President, Innovative Medicines Business and R&D, Orion Corporation
"The collaboration with Orion that was initiated less than 3 years ago continues to be very productive with Alligator delivering two clinical candidates to date. With this option exercise, we believe Orion has selected considerably differentiated bispecific antibodies that could lead to highly innovative treatments." said Søren Bregenholt, CEO of Alligator Bioscience. "We look forward to continuing to work alongside Orion, helping them move these drug candidates to the clinic as quickly as possible."

Under the initial agreement signed in August 2021, Alligator employed its proprietary phage display libraries and RUBY bispecific antibody format to develop immuno-oncology product candidates based on design criteria identified by Orion. In January 2023, the agreement was expanded to include the development of a second bispecific antibody. Alligator is eligible for development, approval and sales milestone payments in addition to royalties if Orion continues developing and commercializing the resulting product candidates.

On April 26. 2024 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2024 (Press release, AbbVie, APR 26, 2024, View Source [SID1234642384]).

"We continue to demonstrate outstanding operational execution and delivered another quarter of strong results," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "I couldn’t be more proud of the organization we have built over the past 11 years. We’ve established an exemplary company culture, developed a productive R&D engine, delivered top-tier financial performance and made a remarkable impact on patients and the communities we serve."

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"I want to thank Rick for his exceptional leadership since AbbVie’s inception and I am deeply honored to serve as the company’s next CEO," said Robert A. Michael, president and chief operating officer, AbbVie. "First quarter results were well ahead of our expectations, driven by excellent performance from our ex-Humira growth platform. Based on our strong results and significant momentum, we are raising our full-year outlook."

First-Quarter Results

•Worldwide net revenues were $12.310 billion, an increase of 0.7 percent on a reported basis, or 1.6 percent on an operational basis.

•Global net revenues from the immunology portfolio were $5.371 billion, a decrease of 3.9 percent on a reported basis, or 3.1 percent on an operational basis, due to Humira biosimilar competition.
◦Global Humira net revenues of $2.270 billion decreased 35.9 percent on a reported basis, or 35.2 percent on an operational basis. U.S. Humira net revenues were $1.771 billion, a decrease of 39.9 percent. Internationally, Humira net revenues were $499 million, a decrease of 15.8 percent on a reported basis, or 11.6 percent on an operational basis.
◦Global Skyrizi net revenues were $2.008 billion, an increase of 47.6 percent on a reported basis, or 48.0 percent on an operational basis.
◦Global Rinvoq net revenues were $1.093 billion, an increase of 59.3 percent on a reported basis, or 61.9 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.543 billion, an increase of 9.0 percent on a reported basis, or 9.8 percent on an operational basis.
◦Global Imbruvica net revenues were $838 million, a decrease of 4.5 percent, with U.S. net revenues of $610 million and international profit sharing of $228 million.
◦Global Venclexta net revenues were $614 million, an increase of 14.2 percent on a reported basis, or 16.3 percent on an operational basis.
◦Global Elahere net revenues were $64 million, reflecting a partial quarter of sales based on the February 12, 2024 close date of the ImmunoGen acquisition.

•Global net revenues from the neuroscience portfolio were $1.965 billion, an increase of 15.9 percent on a reported basis, or 16.0 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $748 million, an increase of 4.1 percent on a reported basis, or 4.5 percent on an operational basis.
◦Global Vraylar net revenues were $694 million, an increase of 23.6 percent.
◦Global Ubrelvy net revenues were $203 million, an increase of 33.8 percent.
◦Global Qulipta net revenues were $131 million, an increase of 97.7 percent.

•Global net revenues from the aesthetics portfolio were $1.249 billion, a decrease of 4.0 percent on a reported basis, or 2.5 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $633 million, a decrease of 3.9 percent on a reported basis, or 2.6 percent on an operational basis.
◦Global Juvederm net revenues were $297 million, a decrease of 16.4 percent on a reported basis, or 13.7 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the first quarter was 66.7 percent. The adjusted gross margin ratio was 82.9 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 26.9 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 15.8 percent of net revenues. The adjusted R&D expense was 14.7 percent of net revenues.

•Acquired IPR&D and milestones expense was 1.3 percent of net revenues.

•On a GAAP basis, the operating margin in the first quarter was 22.7 percent. The adjusted operating margin was 42.2 percent.

•On a GAAP basis, net interest expense was $453 million. The adjusted net interest expense was $429 million.

•On a GAAP basis, the tax rate in the quarter was 21.8 percent. The adjusted tax rate was 14.8 percent.

•Diluted EPS in the first quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.31. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced that its board of directors unanimously selected Robert A. Michael, AbbVie’s current president and chief operating officer, to succeed Richard A. Gonzalez as the company’s chief executive officer (CEO). Mr. Gonzalez, who has served as CEO since AbbVie’s formation in 2013, will retire from the role of CEO and become executive chairman of the board of directors, effective July 1, 2024. Additionally, the board has appointed Mr. Michael as a member of the board of directors effective July 1, 2024.

•AbbVie announced that it completed its acquisition of ImmunoGen. This transaction added ImmunoGen’s flagship antibody-drug conjugate (ADC), Elahere (mirvetuximab soravtansine-gynx), for folate receptor-alpha (FRα)-positive platinum-resistant ovarian cancer (PROC), to AbbVie’s portfolio. Late-stage development programs for Elahere provide opportunity to expand into additional patient populations. The transaction also included a pipeline of ADCs that further build on AbbVie’s existing oncology pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies.

•AbbVie announced that the U.S. Food and Drug Administration (FDA) granted full approval for Elahere for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. The full approval of Elahere was based on the confirmatory MIRASOL Phase 3 trial in which data showed that Elahere treatment resulted in an overall survival (OS) benefit and reduced the risk of cancer progression by 35%.

•AbbVie announced that the FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for Epkinly (epcoritamab), for the treatment of adult relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy. If approved, Epkinly will be the only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy, marking its second indication following FDA and European Medicines Agency (EMA) approval of R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment. The FDA had previously granted this investigational indication Breakthrough Therapy Designation (BTD). The sBLA is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. Epkinly is being co-developed by AbbVie and Genmab.

•AbbVie announced positive top-line results from the Phase 3 SELECT-GCA study, showing Rinvoq (upadacitinib, 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remission from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving Rinvoq in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. Rinvoq’s safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified.

•AbbVie announced positive topline results from the Phase 3b/4 LEVEL UP study, that evaluated the efficacy and safety of Rinvoq (15 mg, once daily starting dose and dose-adjusted based on clinical response) versus Dupixent (dupilumab) in adults and adolescents with moderate to severe atopic dermatitis (AD) who had inadequate response to systemic therapy or when use of those therapies was inadvisable. Rinvoq demonstrated superiority versus Dupixent in the primary endpoint of simultaneous achievement of near complete skin clearance (Eczema Area and Severity Index 90) and no to little itch (Worst Pruritus Numerical Rating Scale of 0 or 1) at Week 16. Rinvoq also showed superiority versus Dupixent for all ranked secondary endpoints, including the rapid onset of achieving near complete skin clearance and no to little itch. The safety profile of Rinvoq was consistent with the profile in previous AD studies with no new safety signals identified during the 16-week period.

•At the Congress of European Crohn’s and Colitis Organisation (ECCO), AbbVie presented 17 abstracts, including nine oral presentations and eight posters, from a range of studies across its inflammatory bowel disease (IBD) portfolio. Oral presentations included new post-hoc analysis of clinical and endoscopic outcomes from the Phase 3 SEQUENCE trial comparing Skyrizi (risankizumab) versus Stelara (ustekinumab) in patients with moderate to severe Crohn’s disease (CD), results from the Phase 3 COMMAND study of Skyrizi as a maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC), and long-term safety results from the Phase 3 U-ENDURE trial of Rinvoq in adult patients with moderately to severely active CD. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•At the 2024 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented 29 abstracts including three late-breaking presentations. The presented data across AbbVie and Allergan Aesthetics’ extensive portfolios reinforce the companies’ ongoing commitment to developing transformative medical dermatology and aesthetic treatments to advance and redefine the standard of care for patients.

•Allergan Aesthetics announced the FDA approval of Juvederm Voluma XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21. Juvederm Voluma XC is the first and only hyaluronic acid (HA) dermal filler to receive FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.

•At the American Academy of Neurology (AAN) Annual Meeting, AbbVie announced an interim analysis of an ongoing 156-week extension study that supports the long-term safety, tolerability and efficacy of Qulipta (atogepant) to prevent chronic and episodic migraine. The overall long-term safety results were consistent with the known safety profile of Qulipta in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.

•AbbVie and Landos Biopharma announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist in Phase 2 for the treatment of UC.

•AbbVie and OSE Immunotherapeutics, a clinical-stage immunotherapy company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.

•AbbVie and Tentarix Biotherapeutics announced a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. The collaboration will leverage AbbVie’s therapeutic area expertise and Tentarix’s Tentacles platform.

Full-Year 2024 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.97 – $11.17 to $11.13 – $11.33, which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2024. The company’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2024, as both cannot be reliably forecasted.

On April 26, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the first quarter of 2024 (Press release, MediGene, APR 26, 2024, View Source [SID1234642362]). The full Quarterly Statement Q1 2024 can be downloaded here: View Source

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"During the first quarter of 2024, our focus remained on executing our strategic plan and advancing the development of our unique TCR-T therapies for solid tumors, such as our lead program MDG1015," said Selwyn Ho, CEO at Medigene. "While our core expertise lies in generating optimal TCRs, we are also exploring ways to broaden their application beyond TCR-T cell therapies."

"The recently announced capital increase will bolster our financial position," Selwyn Ho continued. "This will enable us to continue to advance our TCR-T therapies as well as pursue new partnerships and expand our End-to-End Platform into TCR-based therapies like T cell engagers (TCE) and TCR-Natural Killer (TCR-NK) therapies. By expanding our platform, we aim to create added value for both patients with solid tumors and our shareholders."

Financial and corporate development

The financial performance in Q1 2024 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 3.0 million during the first quarter of 2024, derived from partnerships. R&D expenses for the quarter amounted to EUR 3.2 million, demonstrating the Company’s continued dedication to advancing its pipeline. As of March 31, 2024, the Company holds cash and cash equivalents in the amount of EUR 4.4 million and time deposits of EUR 8.0 million.

The Management Board therefore maintains its guidance for fiscal year 2024 published in the annual report 2023 on March 28, 2024, in its entirety, and confirms its cash runway into April 2025.

From a partnering perspective, the Company’s ongoing global strategic collaboration with BioNTech continues to make good progress and Medigene is working on a number of undisclosed targets. In January 2024, Regeneron Pharmaceuticals Inc. (Regeneron; formerly: 2seventy bio, Inc.) commenced patient enrollment in an investigator-initiated trial (IIT) in Greater China for the program utilizing Medigene’s TCR targeting MAGE-A4. Upon reaching the contractually agreed milestone for the IIT, Medigene anticipates receiving an additional milestone payment. As previously announced, Medigene and Hongsheng Sciences have mutually agreed to terminate the remaining framework agreement of the partnership. Those assets previously under this agreement have been returned to Medigene for potential expansion of its pipeline.

Subsequent to the quarter, on April 23, 2024, the Company announced the launch of a capital raise with subscription rights as part of the Company’s near and medium-term financing strategy. Medigene intends to use the gross proceeds of up to approximately EUR 5.9 million to fund its operating activities and to progress work for the clinical development of the Company’s lead program, MDG1015.

Members of Medigene AG’s management and Supervisory Board will subscribe for new shares as part of the rights offering and the private placement. Within the framework of a backstop agreement, an investor has declared his commitment to Medigene to acquire unsubscribed new shares in an amount of up to EUR 3 million.

The parameters of the capital increase are as follows: The Company plans to increase its share capital from EUR 24,562,658.00 by up to EUR 4,912,531.00 to up to EUR 29,475,189.00 by issuing up to 4,912,531 new no-par value registered shares with a pro rata amount of the share capital of EUR 1.00 and with full dividend rights from January 1, 2023.

The new shares will be offered to all shareholders for subscription. Over-subscription is permitted. Any unsubscribed new shares will be offered for purchase in a private placement to new investors within the European Union. The subscription ratio is set at 5:1, i.e. five (5) old shares entitle the subscription to one (1) new share. Organized trading of subscription rights is arranged. The subscription price for both the exercise of subscription rights and the private placement is EUR 1.20. The subscription period for the new shares commenced on April 24, 2024 and ends on May 7, 2024 at 24:00 hours (CEST). The new shares are to be admitted to trading on the Frankfurt Stock Exchange (Prime Standard) after they are issued. The capital increase will not require a prospectus.
Details of the rights offering are published in the Federal Gazette also are available on the Company’s website View Source

Scientific and clinical development

In February 2024, Medigene announced the initial clinical indications for the first-in-human Phase 1 clinical trial for its lead program MDG1015, selecting gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma as the target cancers to be treated. Following recent positive EU and US preliminary regulatory interactions, the program remains on track for an IND/CTA approval in the second half of 2024. Subject to financing, the Company expects to initiate a Phase 1 trial for MDG1015 by the end of 2024.

In April 2024, the Company presented data for MDG1015 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which showed superior T cell functionality and tumor cell killing as well as a favorable safety profile of TCR-T cells armored and enhanced with Medigene’s PD1-41BB costimulatory switch protein. The poster data further illustrated that this costimulatory switch protein-mediated costimulatory signal is TCR-gated, indicating that costimulation only occurs when the TCR binds to the tumor antigen present on a tumor cell. As such, healthy cells that did not express the tumor antigen (NY-ESO-1) were not targeted, irrespective of their PD-L1 expression and no signs of toxicity were seen in diverse healthy tissues in vitro.