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.

On August 9, 2023 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics to improve patient care, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Immunome, AUG 9, 2023, View Source [SID1234634114]).

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"We believe combining Immunome and Morphimmune’s technologies represents a major step in our long-term strategy of creating a preeminent oncology therapeutics company," stated Purnanand Sarma, PhD, President and CEO of Immunome. "Targeted cancer therapies have made great strides in recent years, and the possible synergy between Morphimmune’s Targeted Effector Platform and Immunome’s proprietary Discovery Engine presents an opportunity to discover and develop truly novel therapies that can help cancer patients. We look forward to completing the merger by the end the year."

Highlights

Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies. In June 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies entered into a definitive merger agreement. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by Immunome, and the receipt of required stockholder approvals from Immunome and Morphimmune stockholders.
The combined company, which will operate as Immunome, will feature a synergistic platform expected to enable the development of best-in-class targeted cancer therapies across multiple modalities
Clay B. Siegall, Ph.D., current Morphimmune President & CEO and former co-founder & CEO of Seagen, Inc., to serve as Chairman and CEO of combined company
A concurrent $125 million private placement investment with leading institutional investors will support development of a combined pipeline expected to submit three investigational new drug applications (INDs) within 18 months of closing
Immunome Published Preclinical Research Demonstrating that Inhibition of IL-38 Using an Antibody Leads to Anti-Tumor Activity. In May 2023, Immunome announced the publication of data highlighting efficacy of its preclinical IL-38 blocking antibody, titled "IL-38 blockade induces anti-tumor immunity by abrogating tumor-mediated suppression of early immune activation," in the peer-reviewed journal mAbs. The data in the article demonstrates that antibody-based targeting of IL-38 leads to activation of the immunostimulatory anti-tumor mechanisms within the tumor microenvironment in preclinical testing.
Financial Highlights

Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended June 30, 2023 was $4.3 million.
Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2023 were $5.7 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2023 were $4.2 million.
Net loss: Net loss for the three months ended June 30, 2023 was $5.6 million, or $0.46 per share.
Cash and cash equivalents: As of June 30, 2023, cash and cash equivalents totaled $38.4 million.

On August 9, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the second quarter ended June 30, 2023 (Press release, Adicet Bio, AUG 9, 2023, View Source [SID1234634113]).

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"We are initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on our Phase 1 GLEAN study, and will continue to enroll mantle cell lymphoma patients, as we progress towards initiating our potentially pivotal program in 2024."

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"Throughout the first half of 2023, Adicet has achieved several clinical, regulatory and scientific milestones. Specifically, we are encouraged by the clinical results observed in our ongoing Phase 1 study of ADI-001 in patients heavily pretreated with a median of 4 prior lines therapy. The results were particularly meaningful given that 50% of patients enrolled in our study had previously progressed following autologous CAR T therapy," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We are initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on our Phase 1 GLEAN study, and will continue to enroll mantle cell lymphoma patients, as we progress towards initiating our potentially pivotal program in 2024."

Mr. Schor added, "We declared our third clinical candidate, ADI-270, which serves as our first foray to solid tumors, starting with renal cell carcinoma. ADI-270 leverages our gamma delta1 T cells, which are designed to home to solid tumors as a key differentiated property, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta to address immunosuppressive factors in the tumor microenvironment. We expect to file an IND for ADI-270 in the first half of 2024, following our IND for ADI-925 in the second half of 2023."

Second Quarter 2023 and Recent Operational Highlights:

Announced additional safety and efficacy data from ongoing Phase 1 study of ADI-001. In June, Adicet reported safety and efficacy data from the Company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell NHL. As of the May 4, 2023 data-cut date, ADI-001 demonstrated 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels in patients with median 4 prior lines of therapy. ADI-001 was generally well-tolerated in the study and there were no occurrences of dose-limiting toxicities or graft vs host disease.

In May, the Company completed a Type B meeting with the U.S. Food and Drug Administration and plans to transition the ADI-001 program into a potentially pivotal single arm Phase 2 study in post-CAR T LBCL under an accelerated approval pathway in 2024. Adicet is initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on the Phase 1 study, and will continue to enroll mantle cell lymphoma patients as the Company progresses towards initiating its potentially pivotal program in 2024. Adicet expects to provide a clinical update in the second half of 2024.

Continuing to advance broad pipeline of CAR and chimeric antigen adaptor (CAd) gamma delta T cell product candidates. The Company continues to advance its pipeline of first-in-class CAR and CAd gamma delta T cell product candidates targeting hematologic and solid malignancies. Adicet expects to submit an IND for ADI-925 in the second half of 2023.

In May, Adicet presented encouraging preclinical data at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating proof-of-concept for ADI-270, an armored CD70-targeted allogeneic gamma delta CAR T cell development candidate. Adicet expects to submit an IND Application for ADI-270 in the first half of 2024.
Appointed Katie Peng to Board of Directors. In July, Adicet announced the appointment of Katie Peng to the Company’s Board of Directors. Ms. Peng brings extensive industry and commercial expertise to the Board. She currently serves as Chief Commercial Officer at Denali Therapeutics Inc., where she is leading the global commercialization efforts of Denali’s pipeline.

Financial Results for Second Quarter 2023:

Research and Development (R&D) Expenses: R&D expenses were $28.4 million for the three months ended June 30, 2023, compared to $16.2 million during the same period in 2022. The $12.2 million increase is primarily driven by a $3.7 million increase in payroll and personnel expenses resulting from an increase in overall headcount and a $3.4 million increase in expenses related to contract drug manufacturing organizations and other externally conducted research and development. There was also a $2.7 million increase in allocated facility expenses and a $2.1 million increase in laboratory expenses. Payroll and personnel expenses for the three months ended June 30, 2023 includes $2.4 million of non-cash stock-based compensation expense compared to $1.9 million during the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the three months ended June 30, 2023, compared to $6.5 million during the same period in 2022. Payroll and personnel expenses for the three months ended June 30, 2023 includes $2.6 million of non-cash stock-based compensation expense compared to $2.4 million during the same period in 2022.

Net Loss: Net loss for the three months ended June 30, 2023 was $32.4 million, or a net loss of $0.75 per basic and diluted share, including non-cash stock-based compensation expense of $5.0 million, as compared to a net loss of $22.5 million during the same period in 2022, or a net loss of $0.56 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million.
Cash Position: Cash and cash equivalents were $205.5 million as of June 30, 2023, compared to $257.7 million as of December 31, 2023. The Company expects that current cash and cash equivalents as of June 30, 2023, will be sufficient to fund its operating expenses into the first half of 2025.

On August 9, 2023 GenScript Biotech, the world’s leading life-science research tools and services provider, and T-MAXIMUM Biotech, a biotechnology company pioneering universal cell therapies, reported to have formed a strategic collaboration agreement to enable the development of T-MAXIMUM’s development CAR-T cell therapy using GenScript’s CRISPR nucleic acid reagents (Press release, GenScript, AUG 9, 2023, View Source [SID1234634112]).

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GenScript will provide T-MAXIMUM Biotech with various CRISPR reagents to support the development of its universal CAR-T products from discovery to commercialization. The partnership with GenScript will support T-MAXIMUM Biotech’s strategic development plan to progress multiple products to the Phase II clinical research stage and deliver products to market within the next five years.

Dr. Shang Xiaoyun, CEO of T-MAXIMUM, said: "We are delighted to establish a strategic cooperation with GenScript. T-MAXIMUM focuses on recurrent high-grade gliomas without effective standard therapies and is committed to the development of universal CAR-T cell therapies. Gene editing reagents are crucial raw materials for the quality and efficacy of our products. We are confident that this collaboration will accelerate the regulatory processes in China and the United States, expediting T-MAXIMUM’s first product pipeline to benefit patients in need as soon as possible."

"We are honored to collaborate with T-MAXIMUM Biotech," said Dr. Li Hong, VP of R&D and manufacturing at GenScript. "Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumors. While CAR-T cell therapies have made remarkable strides in hematological tumors, addressing the unmet need for solid tumors remains crucial. We look forward to the further achievements of T-MAXIMUM Biotech’s cell therapy products—and to bringing good news to more patients."

T-MAXIMUM Biotech targets solid tumors with universal cell therapy

T-MAXIMUM Biotech is a clinical-stage cell therapy development company with core technology published in top journals such as Nature, Nature Biotechnology, Nature Methods, and Cell. Its universal CAR-T cell therapy product, MT027, is being developed for the treatment of recurrent high-grade gliomas. T-MAXIMUM Biotech uses the CRISPR system and electroporation RNP technology to knock out the TRAC and HLA genes, eliminating GVHD and TCR receptor signal interference, reducing rejection reactions, and prolonging the survival time of CAR-T cells in the body.

In February of this year, based on comprehensive preclinical research and positive results from investigator-initiated clinical studies (IIT), T-MAXIMUM Biotech’s MT027 obtained FDA ODD certification — a breakthrough milestone in T-MAXIMUM’s mission to "solve the treatment of diseases with no available drugs."

FDA’s certification of orphan drug designation (ODD) to T-MAXIMUM Biotech

In June of this year, the latest clinical research data of MT027 was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), further validating the feasibility of the product:

Safety: no severe CRS or ICANS occurred, no GvHD was observed, and all adverse events were grade 1-2.
Efficacy: disease control rate (DCR) was 100%, objective response rate (ORR) was 42.9%, and the 12-month survival rate after relapse was 85.7% — significantly higher than historical data of 14%.
GenScript’s GMP sgRNA service supports ODD

With 20 years of expertise in nucleic acid synthesis, GenScript has developed optimized processes, strict quality control, and extensive expertise in establishing a complete research-to-cGMP level CRISPR nucleic acid reagent product line. GenScript has supported seven successful IND approvals for gene and cell therapy (GCT) projects worldwide based on CRISPR technology and is committed to accelerating the development and commercialization process of GCT companies to the benefit of more patients.

GenScript offers one-stop chemical synthesized sgRNA and non-viral HDR knock-in templates, including GenExact linear ssDNA, GenWand linear closed-end dsDNA, and GenCircle circular miniature dsDNA, enabling high editing efficiency, low cytotoxicity, and low off-targets. From research use only to cGMP-quality products, GenScript aims to provide fast and quality services to meet the needs of cell- and gene-therapy researchers at different stages and to accelerate development of this area of fast-growing sector.