On November 12, 2020 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first nine months of 2020 (Press release, Epigenomics, NOV 12, 2020, View Source [SID1234570701]).

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Major Events after the End of the Reporting Period

On October 16, 2020, the U.S. Centers for Medicare and Medicaid Services (CMS) published a preliminary negative reimbursement proposal in connection with the National Coverage Determination (NCD) of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. Following the 30-day public comment period ending on November 15, 2020, which will be used to convince CMS of the scientifically proven benefits of the Epi proColon blood test, CMS will publish its final decision within 60 days.
Greg Hamilton, CEO of Epigenomics AG: "We still do not understand the CMS’ preliminary decision. It is unexplainable to us why our microsimulation studies from CISNET and Harvard Medical School were not taken into account in CMS’ decision making process. Both studies were published in renowned, peer-reviewed scientific journals and clearly show that Epi proColon can reduce the incidence and mortality of colorectal cancer as effectively or better than other approved methods. Ultimately, the CMS’ preliminary decision is thus at the expense of the patients and accepts avoidable deaths. We believe there is a chance that CMS will change its final decision based on these results, as it has done in the past, and we will do everything in our power to change CMS’ preliminary decision."

On October 26, 2020, the Executive Board of Epigenomics AG further announced that pursuant to Sec. 92 par. 1 German Stock Corporation Act ("Aktiengesetz"), a cumulative loss of more than half of the nominal share capital of the Company has been incurred. Thus, the Company published the invitation to an Extraordinary General Shareholders’ Meeting in due time on November 5, 2020,which will take place as a virtual event on November 27, 2020.
In addition, on November 3, 2020, the Company announced the intention to propose to the Extraordinary General Shareholders’ Meeting to reduce the share capital and to authorize the issuance of convertible bonds with a nominal value of up to EUR 5.5 million.
Greg Hamilton: "We strongly believe there is value in both our FDA approved blood test and our future product pipeline. However, our current liquidity reach of Q1 2021 limits our ability to both maximize our chances of reversing CMS’ decision for Epi proColon and identifying and executing strategic alternatives that would maximize shareholder value. The convertible bonds, which include a so-called back-stop agreement of up to EUR 4 million from our largest shareholder Deutsche Balaton Aktiengesellschaft, are an important bridge financing for the company. Each shareholder will receive a subscription right to prevent dilution of his or her shareholding. We ask all shareholders to register for the General Shareholders’ Meeting and to follow our proposals when voting in order to maximize our opportunity for success."

9M 2020 Financial results

Total revenue in the first nine months of 2020 was EUR 541 thousand compared to EUR 847 thousand for the same period of the previous year, due to the effects of the Covid-19 pandemic. This was caused by lower product revenue in the U.S., as many eligible patients postponed their medical checkups in the current pandemic situation.
Research & development costs declined from EUR 5,654 thousand in the prior year to EUR 3,412 thousand in the 9-month period mainly driven by the interruption of almost all clinical studies in the U.S.A., including the post-approval study for Epi proColon, forced by the Covid-19 pandemic.
Selling, general and administrative costs decreased by EUR 1,429 thousand to EUR 5,442 thousand (9M 2019: EUR 6,871 thousand) in the reporting period, due to the reduction in sales and marketing activities, as virtually all relevant events such as conferences and trade fairs were cancelled due to the pandemic.
Overall, operating costs fell from EUR 13.4 million to EUR 10.9 million compared to the first nine months 2019 for the reasons mentioned above.
Adjusted EBITDA (before share-based payment expenses) for the first nine months of 2020 was EUR -8.1 million (9M 2019: EUR -9.7 million).
The net loss for the period improved to EUR 9.1 million (9M 2019: EUR 10.0 million); the loss per share additionally decreased to EUR 0.20 (9M 2019: EUR 0.28) due to the increased number of shares resulting from the latest capital increases.
The cash outflow from operating activities fell significantly in the first nine months of 2020 by EUR 3.3 million to EUR 7.5 million (9M 2019: 10.8 million). This is due to the improved operating result (EBIT) compared to the previous year.
As of September 30, 2020, the Company had cash and cash equivalents (including marketable securities) of EUR 6.6 million compared to EUR 11.0 million at the end of 2019.
Outlook 2020:

Revenue / EBITDA / Cash consumption

Due to the continued uncertainty surrounding the effects of Covid-19, Epigenomics AG, like many publicly traded companies and as already explained in the H1 2020 report, has pulled its revenue guidance for 2020. Moreover, the Company has now revised its guidance for adjusted EBITDA before share-based payment expenses and cash consumption upward as the cost reduction programs initiated in spring are now showing significant results. EBITDA before share-based payment expenses is expected to be within a range of EUR -10.0 million to EUR -11.0 million (previously: EUR -10.5 million to EUR -12.5 million) and cash consumption is expected to be between EUR 10.0 million and EUR 11.0 million (previously: EUR 10.5 million to EUR 12.5 million).
Further Information

The financial report for the first nine months of 2020 is available on the Epigenomics website: View Source

Furthermore, a letter from the Executive Board to the shareholders of the Company is also available on Epigenomics’ website: View Source

On November 12, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies targeting specific pathogenic bacteria, reported financial results and a business update for the third quarter ended September 30, 2020 (Press release, BiomX, NOV 12, 2020, View Source [SID1234570681]).

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"BiomX continues to lead in the field of phage therapy by implementing proprietary processes for accelerated development," commented Jonathan Solomon, Chief Executive Officer of BiomX. "Our novel BOLT platform, which is the result of an accumulated five years of technological development, significantly reduces the time required to reach clinical proof-of-concept. The improved efficiency of this platform allows us to expand our portfolio with two significant new programs without affecting our projected cash runway."

Continued Mr. Solomon, "This expansion includes near term opportunities with phage therapy candidates. We expect clinical proof of concept results in patients for cystic fibrosis and atopic dermatitis by the end of 2021 and mid-2022, respectively. Improvements in R&D also allow for the consolidation of our inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC) programs. We now have one improved, broad host range product candidate, BX003, targeting Klebsiella pneumoniae, a potential pathogen implicated in both diseases to be developed for both indications. The consolidation of these programs results in an updated timeline for Phase 1b/2a results with BX003 expected in mid-2022. In addition, we expect data from a planned Phase 2 cosmetic clinical study in acne-prone skin in the second quarter of 2021."

About the BOLT Platform

The newly unveiled BOLT ("BacteriOphage Lead to Treatment") R&D platform enables BiomX to rapidly develop, manufacture and formulate a phage treatment targeting a given pathogenic bacteria. The platform allows BiomX to conduct an initial clinical proof of concept study in patients (Phase 2 results) within approximately 12-18 months of project initiation1. The ability to move quickly into clinical development is also driven by the strong safety profile of naturally-occurring phage, as corroborated by regulatory guidance provided to BiomX by the FDA as relating to its IBD program, allowing the Company to bypass safety studies and studies in healthy volunteers and to proceed directly to patient studies.

Recent Highlights and Key Upcoming Milestones

Acne-Prone Skin

The Company expects to initiate a Phase 2 cosmetic clinical study of phage therapy BX001 in the first quarter of 2021, with results expected in the second quarter of 2021.
Cystic Fibrosis

A new program for development of a phage therapy targeting chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with cystic fibrosis. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the fourth quarter of 2021.
Atopic Dermatitis

A new program for development of a topically administered phage therapy targeting Staphylococcus aureus, a bacterium linked to the development and exacerbation of inflammation in atopic dermatitis. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the first half of 2022.
IBD and PSC

Results of a Phase 1a study are expected in the first quarter of 2021. The study is designed to provide safety and pharmacokinetic data, including an assessment of delivery of viable phage to the gastrointestinal system as a key exploratory endpoint.
Results of the Phase 1b/2a study aimed at evaluating the efficacy of BX003, improved broad host range phage therapy, in reduction of the target bacteria Klebsiella pneumoniae are expected by mid-2022.
Tumor-Targeted Delivery in Cancer

BiomX is exploring phage mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria residing in the tumors of patients with colorectal cancer. Preclinical results from animal studies evaluating use of phage therapy in combination with checkpoint inhibitors are expected in the second quarter of 2021.
Biomarker Discovery Collaboration with Boehringer Ingelheim

In September 2020, BiomX entered into a collaboration with Boehringer Ingelheim to utilize the BiomX XMarker microbiome-based biomarker discovery platform to potentially identify biomarkers associated with patient phenotypes in IBD.
Third Quarter 2020 Financial Results

Cash balance and short-term deposits as of September 30, 2020, were $64.5 million, compared to $82.4 million as of December 31, 2019. The decrease was primarily due to net cash used in operating activities.
Research and development expenses were $6.4 million in the third quarter of 2020, compared to $2.9 million in the same period of 2019. The increase was primarily due to growth in the number of employees which resulted in an increase of salaries and related expenses and due to an increase in depreciation and amortization expenses.
General and administrative expenses were $2.4 million in the third quarter of 2020, compared to $1.8 million in the same period in 2019. The increase was primarily due to expenses associated with operating as a public company, such as directors’ and officers’ insurance, filing and legal and accounting expenses.
Net loss was $8.8 million in the third quarter of 2020, compared to $4.3 million in the same period of 2019.
Net cash used in operating activities was $17.3 million for the nine months ended September 30, 2020, compared to $10.5 million in the same period of 2019.
Financial Expectations

Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan through mid-2022.
Conference Call Details

BiomX management will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the third quarter of 2020 and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). A live and archived webcast of the call will be available in the Investors section of the company’s website at www.biomx.com.

On November 12, 2020 MaaT Pharma reported that it treated its first patient in a Phase 1 clinical trial to evaluate the safety and tolerability of MaaT033, a capsule formulation of the company’s lead biotherapeutic, MaaT013, characterized by high microbial species diversity and richness (Press release, MaaT Pharma, NOV 12, 2020, View Source [SID1234570680]). The trial named CIMON will enroll patients with acute myeloid leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) following intensive chemotherapy. MaaT033 is being developed to provide a complete approach to restoring a functional gut microbiome and re-establishing immune system homeostasis to treat life-threatening diseases. The capsule formulation provides a convenient route of administration for patients who are already undergoing intensive treatment regimens, while providing a high and consistent richness of microbial species, derived from pooling the intestinal ecosystems of healthy donors.

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John Weinberg, MD, Chief Medical Officer at MaaT Pharma commented: "As shown in our previous ODYSSEE trial, cancer treatments, in particular chemotherapy, induce a drastic reduction in microbial species networks in the gut, leading to a decline in its protective epithelial layer and disruption of immune system functionality. This in turn can result in multiple complications, some of them severe, especially for leukemia patients. The MaaT033 capsule formulation is designed to restore the microbiome of patients that receive intensive chemotherapy and adds an important treatment modality to our portfolio of microbiome restoration therapeutics. Use in an ambulatory setting will be facilitated, and we will be able to address the needs of a broader patient population."

The CIMON trial (NCT04150393) will enroll 27 patients in 4 centers. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days, that supports gut microbiome engraftment in patients with AML or high-risk MDS that are undergoing intensive chemotherapy. Overall safety, tolerability, and dose regimen will be evaluated, as will the impact on the gut microbiome, to identify a recommended Phase II dose.

"Initiating the clinical evaluation of our capsule formulation is an important milestone for MaaT Pharma, enabling us to expand our therapeutics pipeline with a complimentary product candidate to our MaaT013 biotherapeutic. MaaT033 is designed to address a number of different tumor indications where increased ease of administration is important," added Hervé Affagard, CEO and Co-founder of MaaT Pharma. "Despite the challenges of the COVID-19 pandemic, we continue to meet our development goals for our growing pipeline of microbiome biotherapeutics while ensuring the safety and quality of our product candidates."

The CIMON Phase 1b trial is expected to be completed in the fourth quarter of 2021.

About MaaT033
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality in order to improve clinical outcomes as well as control adverse events related to conventional treatments for cancer. The capsule formulation eases administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma’s products.

On November 12, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported its third quarter 2020 results today (Press release, Ultimovacs, NOV 12, 2020, View Source [SID1234570679]). A presentation by the Company’s management team will take place today on a webcast at 09:00 CEST.

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The presentation can be followed as a live webcast, accessible directly through this link or through the link displayed under Reports and Presentations in the investor section of Ultimovacs’ corporate website www.ultimovacs.com.

Highlights for the third quarter of 2020:

In the INITIUM trial, a total of twelve patients have been enrolled as per reporting date (compared to three patients reported in the previous quarterly report). INITIUM is a randomized, multi-center Phase II trial evaluating UV1 as a treatment for first-line patients with metastatic malignant melanoma.
In the NIPU trial, a total of six patients have been enrolled as per reporting date (compared to four patients reported in the previous quarterly report). NIPU is a randomized, multi-center Phase II trial in which UV1 is investigated as a second-line treatment in mesothelioma.
The Covid-19 situation has so far had fairly limited impact regarding site openings and patient inclusion in the Phase II clinical trials. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
In the fully enrolled US-based Phase I trial in malignant melanoma, positive topline results from the first cohort of 20 patients were announced in September 2020. The results confirm achievement of the primary endpoints of safety and tolerability and indicate initial signs of clinical response; the 12-month Overall Survival (OS) rate was 85% and median Progression Free Survival (mPFS) was not reached after 12 months.
Five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer was reported in October 2020. The results confirm achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit. At the five-year landmark, the OS rate was 33% and mPFS was 10.7 months. (Post-period event)
In May 2020, Ultimovacs announced a collaboration with a non-specified big pharma company and a leading European oncology clinical trial group to evaluate UV1 in a third Phase II clinical trial. As communicated in September 2020, finalization of the agreement and announcement of the collaboration is expected during the fourth quarter of 2020.
The regulatory approval is now in place to start the Phase I TENDU trial. This trial will investigate a prostate cancer specific vaccine based on the TET technology. The first patient is expected to be enrolled in the first quarter of 2021.
Total operating expenses amounted to MNOK 31.1 in Q3-20 and MNOK 98.6 YTD. Cash flow from operations was MNOK -29.6 in Q3-20. Total cash and cash equivalents were reduced by MNOK 29.2 during Q3-20, amounting to MNOK 453.5 as per 30 September 2020.
The full report and presentation are also available under Reports and Presentations in the investor section of Ultimovacs’ corporate website www.ultimovacs.com.

On November 11, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported that it will present at the Stifel Virtual Healthcare Conference on Wednesday, November 18, 2020 and the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 (Press release, Cue Biopharma, NOV 11, 2020, View Source [SID1234608290]).

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Cue Biopharma will provide an overview highlighting the Immuno-STAT (Selective Targeting and Alteration of T cells) platform, its expanding pipeline and anticipated milestones. The presentations will also include an update on the Company’s ongoing Phase 1 monotherapy dose escalation trial of CUE-101 including details pertaining to patients from cohorts 4, 5, and 6 being treated for HPV16-driven recurrent/metastatic head and neck cancer.

Additional conference details can be found below:

Stifel Virtual Healthcare Conference 2020
Date and Time: November 18, 2020 at 9:20 a.m. EST
Webcast Link: View Source
A live and archived webcast of the presentation will be available in the Investors section of the Company’s website at www.cuebiopharma.com. .

Jefferies Virtual London Healthcare Conference
Date and Time: November 19, 2020 at 9:05 a.m. EST
Webcast link: View Source
A live and archived webcast of the presentation will be available in the Investors section of the Company’s website at www.cuebiopharma.com. .