On May 18, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY, the "Company") reported that it has fully placed the new shares from the capital increase resolved on April 27, 2021 (Press release, Epigenomics, MAY 18, 2021, View Source [SID1234580181]). The offer was oversubscribed multiple times. Accordingly, the Company’s share capital will be increased from currently EUR 9,852,690.00 by EUR 1,970,537.00 to EUR 11,823,227.00 by 1,970,537 new registered shares of the Company against cash contributions.

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The gross proceeds from the capital increase amount to approximately EUR 2.2 million.

The capital increase needs to be registered in the commercial register, which the Executive Board will apply for shortly. The inclusion of the new shares under the Company’s existing listing (ISIN DE000A3H2184) of the remaining shares is currently expected to take place at or around May 26, 2021.

On May 18, 2021 Calliditas Therapeutics reported that Summary of Q1 2021 January 1 – March 31, 2021 (Press release, Calliditas Therapeutics, MAY 18, 2021, View Source [SID1234580180])

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No net sales for the three months ended March 31, 2021 were recognized. For the three months ended March 31, 2020 net sales amounted to SEK 0.5 million.
Operating loss amounted to SEK 150.8 million and SEK 72.3 million for the three months ended March 31, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 136.2 million and SEK 63.7 million for the three months ended March 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively.
Cash amounted to SEK 867.3 million and SEK 728.6 million as of March 31, 2021 and 2020, respectively.
Significant events during Q1 2021, in summary
In January 2021, Calliditas announced a positive readout of the Phase 1 study with setanaxib, which enables clinical trials with higher dosing levels.
In January 2021, Calliditas shared the clinical development plan for setanaxib, including planned trials in Primary biliary cholangitis (PBC) and head and neck cancer, and additional data from Part A of NeflgArd study at its R&D Day.
In March 2021, Calliditas announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon in patients with primary IgA Nephropathy (IgAN).
Significant events after the end of reporting period, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
Investor presentation May 18, 14:30 CET
Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)

Webcast: View Source

Teleconference: SE: +46850558366 UK: + 443333009271 US: 18335268381

Financial calendar
Interim Report for the period January 1 – June 30, 2021 August 19, 2021

Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

On May 18, 2021 Almac Discovery, the independent research driven drug discovery company dedicated to the development of novel and innovative therapeutics, reported that it is delighted to share ground-breaking new research which has identified nearly thousands of gene pairs that represent ‘Achilles Heels’ or cancer vulnerabilities in analysis of more than 700 different cancer models (Press release, Almac, MAY 18, 2021, View Source [SID1234580179]). In the future, this could lead to new ways to stop cancer cells in their tracks by using existing drugs, as well as proposing new targets for drug development. These drugs could even be used to combat cancers that do not respond to the current standard treatments.

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The research was led by Mark Wappett, Head of Bioinformatics at Almac Discovery and Honorary Lecturer at Queen’s University Belfast, in collaboration with the Overton and McDade groups in the Patrick G Johnston Centre for Cancer Research (PGJCCR) at Queen’s University Belfast and the Department of Biochemistry at Vanderbilt University, USA.

Pivotal to the research is a completely new computational method for discovering cancer synthetic lethality from clustered regularly interspaced short palindromic repeats (CRISPR) and gene expression data using a website called ‘SynLeGG’. This site analyses large and complex datasets to identify changes in genes that occur in certain cancers that may make them more addicted to other similar genes and therefore susceptible to treatments targeting these partners. It was published today (17 May) in the journal Nucleic Acids Research and can be accessed here.

Study lead Mark Wappett, Almac Discovery, commented "Synthetic Lethality with Genetics and Genomics, or SynLeGG for short, provides the wider scientific community access to key datasets generated by cutting edge molecular biology technologies, such as CRISPR, and a toolkit with which to analyse this data. Ultimately we hope that by increasing the reach of this data we can expedite more targeted and effective cancer treatments."

Dr Ian Overton, Senior Lecturer at the PGJCCR explains: "Understanding the molecular fingerprints of cancer can pinpoint ways to target drugs precisely to those patients where they will be most effective. Our work makes a step towards more effective and personalised cancer treatments, ultimately saving lives.

"We make our results available on the SynLeGG web server, opening a window to share these rich resources with researchers across the scientific community – in order to accelerate progress in cancer research."

Dr Simon McDade, Senior Lecturer from the PGJCCR said: "We anticipate that this resource will seed detailed investigation of a number of specific vulnerabilities we have identified, ultimately identifying novel treatment strategies that will translate into significant benefits for cancer patients in the long term."

On May 17, 2021 Panolos Bioscience, a protein structure-based new drug development company, reported on the 17th that it has attracted 20 billion won in Series A investment (Press release, Panolos Bioscience, MAY 17, 2021, View Source [SID1234633687]).

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A total of five companies participated in the investment, including strategic investor OCI, Cloud Ivy Investment, UTC Investment, K-Clavis Investment, and JL Partners, and attracted a cumulative investment of 31.5 billion won in 19 months since its establishment in September 2019. .

Using this investment as a stepping stone, Panolos plans to enter phase 1 clinical trials in the first half of 2022 for PB101, a core pipeline that has completed the development of mass production processes with Samsung Biologics, develop additional pipelines, and expand manpower and facilities.

Panolos is developing new biotherapeutics by utilizing αART (Anti-angiogenesis-based Artifact Re-targeting Tri-specifics platform), a proprietary multi-specific drug generation platform. It can reduce the side effects of single-target protein therapeutics and is a platform with excellent potential for expanding new drug pipelines through multiple targeting.

‘PB101’, a next-generation anti-cancer drug candidate based on the αART platform, is an all-family of Vascular Endothelial Growth Factor (VEGF) (VEGF-A, VEGF-B, Placental Growth Factor) that is excessively produced around cancer cells. targets and inhibits the growth of cancer cells. Unlike conventional VEGF-inhibiting therapeutics that target only a portion of VEGF, it blocks all delivery pathways to reduce drug resistance and increase efficacy.

The αART platform has excellent productivity and stability, so it can be used as a multi-target protein platform to attach several verified active targets, which can be expanded to various therapeutic areas.

Panolos is actively expanding joint research and development using the αART platform. The company is conducting joint research with NeoImmuneTech, which develops next-generation immunotherapeutic drugs, TerraImmune, which develops autoimmune disease treatments, and Scripps Korea Antibody Research Institute.

Hyeseong Lim, CEO of Panolos, said, "Based on our expertise in protein structure analysis, we have conducted R&D with a focus on minimizing the probability of failure with a design that considers effectiveness, stability, and productivity from the candidate material development stage, and is exceptionally fast as a bio venture. "Through the development of PB101, we plan to prove the potential of the αART platform technology and expedite the expansion of the multi-target pipeline by expanding collaboration with our partners," he said.

Panolos was founded in September 2019 by CEO Lim, who has extensive experience in engineering and process development of protein therapeutics. Former Vice President of OCI Choi Soo-jin, who recently served as MD of the Ministry of Trade, Industry and Energy, joined as CEO, and Lim and CEO Lim switched to their own representative system. With the joining of CEO Choi, who has been active in the pharmaceutical industry and the government, it is expected that the company’s operations, including new drug development, will be on a growth track.

On May 17, 2021 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 a business and clinical progress update for the first quarter 2021 (Press release, Cue Biopharma, MAY 17, 2021, View Source [SID1234608279]).

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"During the first quarter of 2021 and early second quarter, we continued to make significant progress advancing the Phase 1a/1b monotherapy trial of CUE-101 and continued development of our expanding pipeline and technology platforms, as well as enhancing our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details as well as describing the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform, during the quarterly update call."

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We finished the first quarter of 2021 in a solid financial position which was further strengthened by the deployment of our at-the-market (ATM) common stock facility in April that enabled us to boost our cash position by an additional $10.4 million giving us operational runway into the fourth quarter of 2022."

Recent News & Business Updates

Reported PR in one patient and stable disease (SD) in five patients, confirmed by RECIST criteria, providing evidence of single-agent clinical activity of CUE-101 in the ongoing Phase 1 monotherapy dose escalation trial in late stage second-line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, as well as evidence of both tumor-specific CD8+ T cell expansion and dose-dependent increases in NK cells.
Extended cash runway with sales in April of an aggregate of $10.4 million shares of our common stock pursuant to our ATM equity offering sales agreement with Stifel. As of April 30, 2021, we sold a cumulative total of 2,099,700 shares of common stock for aggregate net proceeds of $32.7M, net of commissions paid, under the sales agreement.
Initiated Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as first-line therapy in patients with advanced HPV16+ head and neck cancer.
Appointed renowned experts Abul K. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF) and Michael Kalos, Ph.D., managing director of Next Pillar Consulting, LLC and former executive vice president and head of research and development at ArsenalBio, to our Scientific Advisory Board (SAB).
First-Quarter 2021 Financial Results

The Company reported collaboration revenue of approximately $1.6 million and $0.9 million for the three months ended March 31, 2021 and 2020, respectively.

Research and development expenses were $9.8 million and $9.9 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $0.9 million was primarily due to a decrease in laboratory and drug substance manufacturing costs as the clinical supply for our lead drug candidate, CUE-101, was produced during 2020, as well as a reduction in clinical and travel related expenses.

General and administrative expenses were $4.3 million and $4.0 million for the three months ended March 31, 2021 and 2020, respectively. The increase in general and administrative expense of $0.3 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the first quarter of 2021 as compared to the same period in 2020.