On November 9, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first nine months of 2022 (Press release, Epigenomics, NOV 9, 2022, View Source [SID1234623518]).

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Key figures

Total revenue decreased to EUR 386 thousand in 9M 2022, compared to EUR 6,022 thousand in 9M 2021 due the sale of samples from the Company’s sample bank (the "Biobank") in the amount of EUR 5,675 thousand in 2021. On a comparable basis without the Biobank sale total revenue increased from EUR 347 thousand to EUR 386 thousands.
Research and development costs rose from EUR 2,226 thousand in the previous year to EUR 4,970 thousand in the first nine months of 2022, because of costs related to the "Next-Gen" clinical trial including additional personnel in the U.S. In addition, patient enrollment in the studies increased again after almost all clinical trials came to a standstill in the previous year due to Covid-19.
Sales, general and administrative expenses decreased from EUR 5,809 thousand in the previous year to EUR 5,315 thousand in the first nine months of 2022.
Other income of EUR 5,451 thousand in 9M 2022 (9M 2021: EUR 2,229 thousand) was mainly due to foreign currency translation gains and is related to the appreciation of the U.S. dollar against the euro.
EBITDA (before share-based payment expenses) was EUR -4,918 thousand in the reporting period compared to EUR -209 thousand in the same period of the previous year. As with revenues, the significant difference is attributable to the sale of the Biobank samples in the previous year.
Accordingly, the net loss for the period also increased to EUR -5,518 thousand (9M 2021: EUR -691 thousand); the loss per share increased from EUR 0.07 to EUR 0.34 compared to the prior-year period.
Cash consumption increased to EUR 8,918 thousand in the first nine months of 2022, compared with EUR 3,598 thousand in the same period of the previous year.
As of September 30, 2022, the Company had cash and cash equivalents of EUR 15,773 thousand (December 31, 2021: EUR 23,049 thousand).
Operational developments

The Executive Board of Epigenomics AG remains confident that Epi proColon "Next-Gen" will meet the reimbursement requirements (sensitivity of 74% and specificity of 90%) of the Centers for Medicare and Medicaid Services (CMS), which is why a pre-application for a clinical study was submitted to the FDA in spring. Following extensive study preparations, the first patients were enrolled at selected study sites in September. The Board expects to be able to publish official preliminary trial data shortly.
In order to achieve the goal of FDA approval and reimbursement of the "Next-Gen" test, the Company needs to raise additional capital to complete the trial and all supporting activities. The Company is therefore actively exploring all options to raise necessary capital to achieve its goals, including a possible listing on an alternative exchange.
Furthermore, the Extraordinary General Shareholders’ Meeting of Epigenomics AG took place on October 21, 2022, as a virtual event without physical presence of the shareholders in Munich. In addition to the notice of loss pursuant to Section 92 (1) of the German Stock Corporation Act (AktG), the reduction of the share capital to one quarter of the share capital existing at the time of the AGM was resolved. Thus, after the implementation – which is expected for the beginning of December – the Company is in principle able to perform capital increases again.
Greg Hamilton, CEO of Epigenomics AG, commented: "We are extremely excited about the progress we have made on our "Next-Gen" blood-based CRC test and the corresponding clinical trial and we expect to provide a formal preliminary data set of "Next-Gen" shortly. We initiated the clinical trial with the enrollment of the first patients in September. Furthermore, we have met with the FDA via a pre-submission meeting and feel we have a clear path forward to success."

Outlook 2022

Sales

The Company confirms its outlook for fiscal year 2022 and expects revenue within the range of EUR 0.3 million to EUR 0.8 million.
EBITDA / cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -10.5 million to EUR -11.5 million for the current full year 2022 (previously: EUR -15.0 million to EUR -17.0 million). Based on the Company’s 2022 business plan, cash consumption is expected to be between EUR 14.5 million and EUR 15.5 million (previously: EUR 15.0 million to EUR 17.0 million).
Further information

The financial report for the first nine months of 2022 can be found on Epigenomics’ website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

Participants are asked to dial in 15 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.

On November 9, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the Company will release third quarter 2022 financial results after the market closes on Wednesday, November 9, 2022 (Press release, Precigen, NOV 9, 2022, View Source [SID1234622834]). The Company will host a conference call that day at 4:30 PM ET to discuss financial results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061 (International) and providing the participant access code 3010378. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call.

Event details can be found on Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.

On November 9, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the Company will release third quarter 2022 financial results after the market closes on Wednesday, November 9, 2022 (Press release, Precigen, NOV 9, 2022, View Source [SID1234622834]). The Company will host a conference call that day at 4:30 PM ET to discuss financial results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061 (International) and providing the participant access code 3010378. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call.

Event details can be found on Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.

On November 08, 2022 OSE Immunotherapeutics reported scientific updates in oral and poster presentations selected for international conferences: the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA, November 8 – 12 and the Protein & Antibody Engineering Summit (PEGS) Europe 14th Annual Meeting in Barcelona, Spain, November 14 – 16 (Press release, OSE Immunotherapeutics, NOV 8, 2022, View Source [SID1234646950]). The communications feature the latest research on pre-IND programs from the pioneering Myeloid and BiCKI platforms, namely presentations on OSE-230 (first pro-resolutive monoclonal antibody) in chronic inflammation, CLEC-1 (new myeloid immune checkpoint) and BiCKI-IL-7 (new bifunctional therapy targeting PD-1 and IL-7) in immuno-oncology.

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very proud to share our latest scientific advances with the international scientific community on our innovative research platforms delivering next-generation first-in-class immunotherapies".

Dr Aurore Morello, Head of Research of OSE Immunotherapeutics, explains: "The communications highlight the potential therapeutic value of our 3 pre-IND assets. BiCKI-IL-7, our bispecific anti-PD1/IL-7 program, presents an innovative cytokine approach, selectively targeting tumor-specific T-cells to improve the quality and durability of memory T-lymphocyte responses. CLEC-1 is our novel myeloid checkpoint beyond the SIRPα/CD47 axis. OSE-230 stands as the first pro-resolutive agonist monoclonal antibody, capable to clear chronic neutrophil infiltrates and to inhibit the pathogenic NETosis* process and fibrosis".

Myeloid Platform

OSE-230 program in the Resolution of Inflammation (PEGS Europe 2022)

Resolution of inflammation is triggered by pro-resolving lipids activating GPCRs (G-Protein Coupled Receptor) targets. The ChemR23 GPCR is expressed on inflammatory myeloid immune cells, such as macrophages and neutrophils, and is over-expressed in tissues affected by chronic inflammatory diseases, such as lung inflammatory diseases or severe IBD (Inflammatory Bowel Disease) unresponsive to anti-TNF or anti-integrin therapies. ChemR23’s over-expression is associated with chronic neutrophil accumulation in damaged tissues. OSE-230 is the first monoclonal antibody (mAb) to activate a pro-resolutive GPCR target (ChemR23). Its innovative mechanism of action drives inflammatory neutrophil tissue clearance through apoptosis and inhibition of the pathogenic NETosis* process. This mAb triggered resolution demonstrated positive preclinical efficacy in chronic colitis or chronic arthritis models with significant decrease in tissue fibrosis and restoration of tissue healing.

CLEC-1 program in Immuno-Oncology (SITC 2022)

CLEC-1 is a novel myeloid immune checkpoint beyond the SIRPα/CD47 axis inhibiting key functions of myeloid cells and hence limiting anti-tumor responsiveness of T-lymphocytes. Myeloid cells can accumulate in the tumor microenvironment and deregulate the immune activation of T-lymphocytes. The academic collaboration with Dr Elise Chiffoleau’s team** highlights that CLEC-1 inhibition represents a novel target for cancer immunotherapy. The latest data presented at the SITC (Free SITC Whitepaper) 2022 show the ability of CLEC-1 to sense dead or stress tumor cells through the identification of a CLEC-1 protein ligand (CLEC-1 ligand) over-expressed in cancer cells. Mechanistically, CLEC-1’s expression by dendritic cells controls the cross-presentation of dead-cell tumor associated antigens and hence CD8+ T-cell cross-priming. Reversely, the absence of CLEC-1 increases the phagocytosis of tumor cells by macrophages in vivo. Proprietary anti-CLEC-1 mAbs increase survival in monotherapy in orthotopic model of hepatocellular carcinoma while combination with chemotherapy increases preclinical tumor eradication in colon carcinoma model.

BiCKI Platform

BiCKI-IL-7 program in Immuno-Oncology (SITC 2022)

BiCKI-IL-7, the most advanced candidate from the BiCKI platform, is a bifunctional therapy which targets PD-1 and at the same time provides selectively the IL-7 pro-survival cytokine to PD1-expressing T-cells. BiCKI-IL-7 restores exhausted T-cell function, disarms Treg suppressive activity and extends stem-like memory T-cells, the key T-cell subpopulation associated with anti-PD(L)1 clinical responses. This bifunctional immunotherapy preferentially delivers the IL-7 pro-survival cytokine to the right

T-cells (tumor-specific T-cells expressing high level of PD1) and at the right place (PD1-expressing

T-cells located in the tumor microenvironment and in the draining lymph nodes where the anti-tumor response is initiated and amplified). The latest data presented at the SITC (Free SITC Whitepaper) 2022 show high IL-7 receptor (IL-7R) pathway expression in TILs (Tumor-Infiltrating Lymphocytes) and tumor-specific T-cell clonotypes, predictive of long-term ICI (Immune Checkpoint Inhibitor) clinical responses. Reversely, decreased IL-7R pathway expression is associated with metabolic stress and apoptosis of tumor-specific T-cells. Redirecting IL-7 selectively on PD1 + T-cells provides stemness, proliferative and survival signals to tumor-specific T-cells inducing durable responses. Additional data presented provides a strong rationale for selective delivery of IL-7 to tumor-specific T-cells to sustain long-lasting preclinical response, as well as selective proliferation and survival of stem-like memory T-cells in vivo.

SITC 2022 communications

– Title: "IL7R TME expression correlates with immunotherapy response and is associated with T-cell stemness with decreased apoptosis" (abstract #826), poster presentation by I. Girault et al.

– Title: "Anti-PD-1/IL-7v bispecific antibody promotes TCF1+ stem like T-cells expansion and long-lasting in-vivo efficacy" (abstract #1366), poster presentation by A. Morello et al.

– Title: "Blockade of the myeloid CLEC-1 checkpoint enhances antitumor responses and tumor antigen cross-presentation" (abstract #484), poster presentation by V. Gauttier, I. Baccelli et al.

PEGS 2022 communication

– Title: "Agonist Anti-ChemR23 Antibody for Inflammatory Diseases", oral presentation in the session "Biotherapeutics for GPCR Targets" on November 16th at 5:30pm by N. Poirier.

* NETosis is a program for formation of neutrophil extracellular traps (NETs), which consists of modified chromatin decorated with bactericidal proteins from granules and cytoplasm. Recent research has highlighted that neutrophils, and in particular NETs that can be released upon activation, have central roles in the initiation and perpetuation of systemic autoimmune disorders and trigger complex and chronic inflammatory responses that lead to organ damage and fibrosis.

** Collaborative academic program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital, View Source).

ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation.
The Company’s current well-balanced first-in-class clinical pipeline includes:

Tedopi (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi in combination are ongoing in solid tumors.
OSE-279 (anti-PD1): advanced preclinical stage.
OSE-127/S95011 (humanized monoclonal antibody antagonist of IL-7 receptor) developed in partnership with Servier; ongoing Phase 2 in ulcerative colitis (sponsor OSE Immunotherapeutics) and ongoing Phase 2a in Sjögren’s syndrome (sponsor Servier); ongoing pre-clinical research in leukemia (OSE Immunotherapeutics).
VEL-101/FR104 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.).
BI 765063 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; BI sponsored international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).
OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics:

BiCKI platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI candidate targeting anti-PD1xIL-7.
Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com

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On November 8, 2022 MGFB, a subsidiary of FairWinds Bio (FWB), reported that it has entered into a patent license agreement with Mayo Clinic to advance experimental cancer vaccine therapeutics based on a novel platform developed over the past 20 years by Richard Vile, Ph.D., Mayo Clinic Professor of Immunology as well as several colleagues (Press release, Greenfire, NOV 8, 2022, View Source [SID1234625113]). Founding equity ownership in MGFB includes FWB, University of Leeds and Mayo Clinic.

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The platform is designed to address mutational burden, immune escape, and tumor resistance, commonly seen in many solid tumor patients. By delivering a broad repertoire of tumor associated antigens, ASEL and neoantigens enhanced by APOBEC mutagenesis, strong T-cell responses have been demonstrated pre-clinically without the need for identification of patient specific tumor associated antigens. Preclinical studies have demonstrated durable responses in a melanoma study in mice. Additional pre-clinical data in models of glioma and hepatocellular carcinoma confirm the utility of this approach. MGFB intends to advance multiple programs into the clinic to address indications where current therapeutic options are limited.

"I look forward to working with the MGFB team to advance these therapeutic vaccines to help the many patients who need better treatment options than are currently available," said Dr. Vile.

"We are very excited to collaborate with Mayo Clinic on this approach to treating solid tumors. Our objective is to develop the most therapeutically effective constructs with the hope of providing patients better therapeutic alternatives," said Ajit Gill, CEO of MGFB.

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.