On August 10, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported its Half-Year Report 2023, presenting all material developments up to 30 June 2023 and the Company’s current outlook (Press release, 4SC, AUG 10, 2023, View Source [SID1234634104]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "Given the positive topline data from the RESMAIN study, Kinselby is extremely well placed for the next stage of its development as we look to commercialize the drug through either a sale, licensing or partnership. Kinselby remains uniquely positioned as a maintenance therapy in CTCL, where there are no alternative comparable treatments and it offers significant benefits for patients by halting disease progression. We are focused on near term registrations of Kinselby to get this important drug to patients as quickly as possible."

Key highlights in Q2 2023
Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo
Further results from the RESMAIN study evaluating resminostat in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands
The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA)
EMA has notified 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG)
4SC is actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and UK, and intends to discuss with the US Food and Drug Administration regarding requirements for a resminostat marketing application for CTCL treatment in the US
4SC’s partner for Japan, Yakult Honsha is responsible for the filing of a marketing application for Kinselby (resminostat) in Japan
Development of cash balance in H1 2023 and financial forecast
As of 30 June 2023, 4SC holds cash balance/funds of €12.158 million, compared to €14.825 million as at 31 December 2022. The monthly use of cash from operations amounted to €0.945 million on average in the first half year of 2023 (H1 2022: €1.375 million) and was in the forecast range of €0.8 million and €1.1 million forecast for 2023.

The Management Board of 4SC estimates that current funds should be sufficient to finance 4SC into Q3 2024.

2023 business outlook
4SC is fully focused on the registration and commercialization of resminostat (Kinselby) in the European Union, Switzerland and the UK and defining the requirements for marketing resminostat for CTCL in the US through discussions with the United States (US) Food and Drug Administration. In July 2023, the Company engaged a global investment banking firm serving companies in the life sciences industry to assist 4SC in evaluating the Company’s options for the commercialization of resminostat (Kinselby).

On August 9, 2023 HLB Life Science R&D, a subsidiary of HLB Life Science, is introducing next-generation targeted anticancer substances from the Lead Discovery Center (LDC), a global new drug candidate research institute in Germany, and conducting joint research (Press release, HLB Life Science, AUG 9, 2023, View Source;word=&page=1&v=386 [SID1234649276]).

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HLB Life Science R&D announced on the 9th that it signed a contract to acquire the global rights to the new anticancer substance discovered by LDC. The acquisition amount consists of a portion of the upfront payment, as well as stage-by-stage milestones and sales royalties.

LDC is a company that was spun off in 2008 from the Max Planck Society, a world-class research institute in Germany that has produced 32 Nobel Prize winners. Since its establishment, it has transferred more than 20 new drug technologies to leading global pharmaceutical companies. It is currently conducting more than 120 research projects on various diseases, including cancer, autoimmune, metabolic, cardiovascular, central nervous, and infection.

The targeted anticancer substance introduced by HLB Life Science R&D this time was also created through collaboration with the Max Planck Society Institute of Molecular Physiology. The substance, which inhibits the transcription process of a specific gene that helps cancer cells damaged by anticancer drugs to recover on their own, has confirmed a high killing effect on cancer cells through early research in the non-clinical stage.

HLB Life Science R&D plans to complete the non-clinical stage through joint research with LDC along with the new drug substance technology transfer and enter the clinical stage as quickly as possible.

Han Yong-hae, Chief Technology Officer (CTO) of HLB Group and Head of HLB Life Science R&D, said, "After a long period of in-depth discussions with LDC on discovering targeted anticancer drugs with new mechanisms, we recently agreed to begin full-scale development of next-generation targeted anticancer agents through joint research between the two companies."

He added, "As soon as we acquire LDC’s new drug substance, we will begin full-scale research and development at HLB Life Science R&D’s new drug research center."

"We are very pleased to form a strong partnership with HLB Life Science R&D," said Bert Klebble, CEO of LDC. "HLB Life Science R&D has the high capacity to stably develop anticancer compounds that are the culmination of our research results." Meanwhile, HLB Life Science R&D

is conducting research to develop an animal anticancer agent for the targeted anticancer agent ‘rivoceranib’ and to develop a medical cannabis treatment.

On August 9, 2023 Syros Pharmaceuticals, Inc. (the "Company") reported to have received notice from Incyte Corporation ("Incyte") that Incyte has elected to terminate the Target Discovery, Research Collaboration and Option Agreement dated January 8, 2018 by and between the Company and Incyte (the "Agreement") related to the discovery, development and commercialization of novel therapies for myeloproliferative neoplasms (Filing, 8-K, Syros Pharmaceuticals, AUG 9, 2023, View Source [SID1234634281]). Incyte exercised its right to terminate the Agreement for convenience. The termination will be effective within sixty days of August 9, 2023.

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Under the terms of the Agreement, the Company agreed to identify and conduct initial validation of novel therapeutic targets with a focus on myeloproliferative neoplasms, and Incyte received options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for the development and commercialization of therapeutic products directed to up to seven validated targets. The Company completed all of its allocated target identification and validation activities under the Agreement. Incyte elected not to exercise its option rights to any of the identified targets.

Incyte previously paid the Company $10.0 million in up-front consideration in connection with entering into the Agreement. The Company was also eligible to receive certain target selection milestone payments and option exercise fees if Incyte selected targets for validation and exercised its options to obtain exclusive rights to collaboration intellectual property for therapeutic products directed to validated targets, as well as other potential development, regulatory and commercial milestone payments and low single-digit royalties on net sales for any therapeutic product resulting from the collaboration. The Company will not receive any of these milestone payments or royalties.

The foregoing description of the terms of the Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Agreement filed, with confidential terms redacted, as Exhibit 10.22 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2017, and the subsequent letter agreement, dated November 18, 2019, by and between the Company and Incyte, which was filed with confidential terms redacted as Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2019.

On August 9, 2023 Epigenomics AG (FSE: ECX, the "Company") reported its financial results (IFRS, unaudited) for the second quarter and first half of 2023 (Press release, Epigenomics, AUG 9, 2023, View Source [SID1234634187]).

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Operational developments

As the Company was not able to raise additional capital to secure funding for the FDA pivotal study of the "Next-Gen" test, the restructuring of Epigenomics AG was initiated on February 15, 2023. The cost minimization thus initiated to secure the Company’s existence has, among other things, also given the Executive Board the time to conduct discussions with numerous potential partners to commercialize the assets in order to create value for the shareholders. Ultimately, an agreement was reached with New Day Diagnostics LLC on July 24, 2023, to sell substantially all of Epigenomics’ assets. This agreement is still subject to the approval of Epigenomics AG’s shareholders.
Jens Ravens, CEO of Epigenomics AG: "The Supervisory Board and I recommend that all shareholders approve the sale of significant assets to New Day Diagnostics LLC at the Company’s upcoming Extraordinary General Shareholders’ Meeting on September 11, 2023, in Berlin. We are convinced that the sale is in the best interest of Epigenomics and its shareholders in the current situation."

The agreement with New Day Diagnostics LLC provides for a purchase price of USD 12.05 million, consisting of
cash payments in the amount of USD 1.8 million to be made by the acquirer which, in addition to other measures, will secure the existence of Epigenomics AG,
further cash payments of USD 8.0 million contingent on the achievement of certain milestones related to Epi proColon and Epi proColon "Next-Gen" (in particular with regard to the further development of the "Next-Gen"" test)
a 3.0% interest in New Day Diagnostics LLC and an observing function on the Company’s Supervisory Board,
and royalties or earn-out payments (mainly in the form of royalties) linked to the commercialization of Epi proColon "Next-Gen" until the patents expire, which is expected to be in October 2043.
Dr. Helge Lubenow, Chairwoman of the Supervisory Board of Epigenomics AG, commented: "Following the discussions over the last months, the Executive Board and the Supervisory Board are convinced that the agreement with New Day Diagnostics LLC currently offers the only opportunity to further develop the "Next-Gen" test, to achieve FDA approval and thus – if the sensitivity and specificity thresholds of CMS are exceeded – to obtain Medicare reimbursement. This would, in the view of the Executive Board and Supervisory Board, maximize the potential shareholder value to be achieved."

In order to obtain an independent assessment of the agreement, the Executive Board and the Supervisory Board have furthermore engaged Mazars GmbH & Co. KG Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft – a leading international consulting firm – to perform an assessment of the transaction price of the present agreement compared to the current status quo and outlook. In this fairness opinion, Mazars concludes that the offered transaction price for the sale of the assets to be transferred can be assessed as financially reasonable ("fair") from the perspective of Epigenomics AG according to the standard "Principles for the Preparation of Fairness Opinions" („Grundsätze für die Erstellung von Fairness Opinions", IDW S 8) of the German Institute of Public Auditors (Institut der Wirtschaftsprüfer, IDW).
The complete agreement and the fairness opinion can be found on the Company’s website in the Investor Relations section at View Source
Financial key figures

Revenues in the first half of 2023 decreased slightly from EUR 241 thousand to EUR 203 thousand compared to the same period of the previous year. The reason for the decrease was the discontinuation of Epi proColon sales as part of the restructuring.
Similarly, R&D expenses decreased to EUR 1,445 thousand in the first six months of 2023 (6M 2022: EUR 3,140 thousand) due to the restructuring.
Selling and administrative expenses increased from EUR 3,582 thousand to EUR 6,925 thousand. The increase was due to costs for the implementation of the restructuring and in connection with the negotiations on the sale of significant assets.
EBITDA (before share-based payment expenses) amounted to EUR -6,483 thousand in the reporting period, compared to EUR -3,611 thousand in the same period of the previous year.
The net loss for the period increased to EUR -8,224 thousand (6M 2022: EUR -3,957 thousand); the loss per share[1] increased accordingly from EUR -0.98 to EUR -1.93 compared to the same period of the previous year.
At EUR 6,440 million, cash consumption in the first half of 2023 was roughly at the same level as in the prior-year period (6M 2022: EUR 6,283 thousand).
As of June 30, 2023, the Company had cash and cash equivalents of EUR 3,584 thousand (December 31, 2022: EUR 10,126 thousand).
Outlook 2023

The Company confirms its outlook for fiscal year 2023 and expects EBITDA (before share-based payment expenses) to be within the range of EUR -7.0 million to EUR -9.0 million.
In terms of cash consumption, Epigenomics forecasts a range of EUR 7.0 million to EUR 9.0 million for the current full year 2023.
More information

The interim statement for the first half of 2023 (unaudited) can be found on Epigenomics’ website at: View Source

On August 9, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the second quarter and six months ended June 30, 2023 (Press release, Summit Therapeutics, AUG 9, 2023, View Source [SID1234634115]).

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Operational & Corporate Updates

Our operational progress with ivonescimab (SMT112), an innovative, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:
Summit is actively engaged in development activities for SMT112. In just over six months since we closed our in-licensing transaction for ivonescimab, Summit has:
Held multiple meetings with the US Food & Drug Administration (FDA) regarding its planned Phase III clinical program and incorporated this feedback accordingly, and
Begun its clinical development in non-small cell lung cancer (NSCLC) in the following indications:
Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) ("HARMONi" trial)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients ("HARMONi-3" trial)
In May 2023, the first patient in Summit’s license territories was treated in the Phase III HARMONi clinical trial.
Summit intends to dose patients in the HARMONi-3 trial during the second half of 2023.
In June 2023, promising Phase II data from AK112-201, a study of Chinese subjects conducted and analyzed by our partners, Akeso, was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In addition to encouraging data in multiple indications within NSCLC, a portion of the updated data presented at ASCO (Free ASCO Whitepaper) supports Summit’s HARMONi-3 clinical trial in first-line metastatic squamous NSCLC: Phase II data in 63 treatment-naive, squamous NSCLC patients treated with ivonescimab plus chemotherapy with a median follow-up time of 13.3 months experienced:
Median progression-free survival (PFS) of 11.0 months (95% CI: 9.5 to 16.8 months)
Overall response rate (ORR) of 67% (95% CI: 53% to 78%) with a median duration of response of 15 months
Median overall survival (OS) was not reached; although estimated 9-month OS was 93.2%
Grade >3 treatment-related adverse events (TRAEs) was 41%; the most frequent TRAEs were anemia, decreased neutrophil counts, and alopecia
Recapping our Collaboration and License Agreement with Akeso Inc. (Akeso) for ivonescimab (SMT112):
On December 5, 2022, Summit and Akeso entered into a Collaboration and License Agreement for ivonescimab.
The Collaboration and License Agreement with Akeso closed on January 17, 2023 after going effective following customary waiting periods.
Summit received the rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso retained development and commercialization rights for the rest of the world, including China.
In exchange for these rights, Summit committed to an upfront payment of $500 million, which was paid in two installments.
The first installment worth $300 million was paid in January in conjunction with the closing of the transaction. Of the $300 million paid to Akeso by Summit, Akeso opted, in accordance with the Collaboration and License Agreement, to receive 10 million shares in lieu of a cash payment of $25.1 million; the remaining $274.9 million was paid by Summit to Akeso in cash.
The second installment of $200 million was paid on March 6, 2023 in cash.
Going forward, Akeso will be eligible to receive regulatory and commercial milestones of up to $4.5 billion. In addition, Akeso will receive low double-digit royalties on net sales in the Summit territories.
Akeso has a rich and diversified antibody drug pipeline with over 30 internally discovered drug candidates in various stages of development, including six bispecific antibodies. Akeso has taken part in over 80 clinical trials for 17 drug candidates, including 14 pivotal trials. Akeso has two drugs approved for oncology indications in China: a PD-1 inhibitor and a novel PD-1 / CTLA-4 bispecific antibody. Akeso has over 2,400 employees.
Financial Highlights

Aggregate cash, cash-equivalents, short-term investments, and receivables on June 30, 2023 totaled $220.1 million as compared to $654.7 million on December 31, 2022.
Our cash, cash-equivalents and short-term investments on June 30, 2023 was $215.0 million as compared to $648.6 million on December 31, 2022. Accounts receivable and research and development tax credits receivable on June 30, 2023 were $5.1 million as compared to $6.1 million on December 31, 2022.
Our short-term investments consist of U.S. treasury securities.
Our notes payable balance at June 30, 2023 was $100.0 million, which is due in September 2024.
Based on our current cash and investments position, we believe that we have sufficient capital resources to fund our operating costs and working capital needs, including our planned clinical trials for ivonescimab, for at least twelve months following the issuance of our Q2 financial statements filed on Form 10-Q.
Net loss for the three and six months ended June 30, 2023 was $14.7 million and $557.1 million, respectively. Net loss for the three and six months ended June 30, 2022 was $16.8 million and $38.2 million, respectively.
The net loss for the six months ended June 30, 2023 includes one-time in-process research and development expenses associated with the in-licensing of ivonescimab from Akeso of $520.9 million.
Operating cash outflow for the six months ended June 30, 2023 and 2022 was $42.4 million and $38.2 million, respectively.
Second Quarter 2023 Earnings Call

Summit will host an earnings call this morning, Wednesday, August 9, 2023, at 9:00am ET. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.