On May 12, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first three months of 2021 (Press release, Epigenomics, MAY 12, 2021, View Source [SID1234579751]).

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Financial key figures

Product revenue in the first quarter 2021 decreased from EUR 239 thousand to EUR 106 thousand compared to the prior-year period due to lower product revenues in the United States and Europe. In the current pandemic situation, many patients eligible for screening continue to postpone their screenings.
Research and development costs decreased from EUR 1,603 thousand to EUR 737 thousand.
Selling, general and administrative costs diminished from EUR 1,992 thousand to EUR 1,601 thousand.
EBITDA before share-based payment expenses improved to EUR -985 thousand in the reporting period vs. EUR -2,641 thousand in the same period as the previous year
The net loss for the period was EUR -1,201 thousand (Q1 2020: EUR -2,982 thousand); the net loss per share decreased significantly from EUR 0.55 to EUR 0.20 compared to the same period of the previous year.
Cash consumption decreased to EUR 1,401 thousand in Q1 2021 (Q1 2020: EUR 3,284 thousand).
As of March 31, 2021, the Company had cash and cash equivalents (including marketable securities) of EUR 7,446 thousand (December 31, 2020: EUR 4,527 thousand).
Strategic options

Following the negative reimbursement decision by the CMS in January 2021, the management is considering various strategic options. As announced at the end of March, the Company is evaluating, among other things, a potential sale of the Company by way of a share deal (public takeover) or asset deal to one or more investors as part of an M&A transaction. For this purpose, a corresponding sales process has been set up and the Company is in discussions with several potential parties. The Company has mandated a leading international investment bank as advisor in connection with the sale process.

Major events after the end of the reporting period

The first conversion period for the mandatory convertible bond issued in January 2021, ran from April 1 to April 14, 2021. Bonds with a nominal value of EUR 4,357,606.00 have been converted into 3,961,460 new shares (ISIN DE000A3H2184). Accordingly, the number of issued shares increased from 5,891,230 to 9,852,690 no-par value registered shares of the Company. The Company’s share capital increased correspondingly to EUR 9,852,690.00. The outstanding portion of the mandatory convertible bond 2021/2024 therefore has a nominal value of EUR 1,142,394.00.
In addition, on April 27, 2021, the Executive Board of Epigenomics AG resolved, with approval of the Supervisory Board, to increase the company’s share capital through a rights issue using the Authorized Capital 2020/II. The share capital shall be increased from currently EUR 9,852,690.00 by up to EUR 1,970,537.00 to up to EUR 11,823,227.00 by issuing up to 1,970,537 new registered no par value shares of the Company against cash contributions. The subscription price for the new shares was set at EUR 1.10. The subscription ratio is 5:1. This means for each five existing shares of the Company, a subscription right for one new share will be allocated. Deutsche Balaton Aktiengesellschaft, with 22.59% the largest shareholder of Epigenomics AG, has already announced that it will participate in the capital increase. The capital increase serves the purpose of improving the Company’s liquidity position ahead of upcoming important strategic decisions.
Outlook 2021

Revenue

The Company confirms its outlook for fiscal year 2021 and continues to expect revenue within the range of EUR 0.4 million to EUR 1.0 million. If the NCD decision made by CMS is successfully appealed or reversed in 2021, a change in the revenue guidance would be made.
EBITDA / Cash consumption

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -7.0 million to EUR -9.0 million. Based on the Company’s 2021 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based payment expenses).
Further Information

The 2020 Q1 interim statement (unaudited) is available on the Epigenomics’ website: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 5.00 pm (CET) / 11.00 am (EDT). The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:

Participants are asked to dial in 10 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 Epigenomics’ website subsequently.

On May 11, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will present at the 2021 RBC Capital Markets Global Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, MAY 11, 2021, View Source [SID1234584741]):

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The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors Section.

On May 11, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the first quarter ended March 31, 2021 and recent business highlights(Press release, Achilles Therapeutics, MAY 11, 2021, View Source [SID1234584048]).

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"Achilles made significant progress in the first quarter of 2021. We reported the first clinical data from our ongoing CHIRON and THETIS trials evaluating our precision TIL cNeT therapy in patients with non-small cell lung cancer and melanoma, respectively, and priced our successful US initial public offering on Nasdaq, which closed just after quarter-end," said Dr Iraj Ali, Chief Executive Officer of Achilles. "We continue to enroll and dose patients and have opened our first clinical sites in the US and EU. This year, we expect to report interim data from a total of ten patients that have received cNeT monotherapy across the CHIRON and THETIS trials and will also begin enrolling patients to receive higher dose cNeT. In addition, we will open Cohort B in the THETIS study to evaluate the addition of a PD-1 inhibitor to our cNeT therapy."

Business Highlights

Received a recommendation from the Independent Data Safety Monitoring Committee to continue the ongoing Phase I/IIa CHIRON and THETIS trials as planned

Announced initial clinical data from the first six patients dosed with the Company’s cNeT therapy showing encouraging evidence of cNeT engraftment, an overall tolerability profile similar to that of standard TIL products, stable disease in four out of the six patients, and one patient with tumor lesion reduction

Presented data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting detailing the Company’s comprehensive translational research program and insights into the in vivo dynamics of cNeT post-dosing, and the potential to develop a potency-based release assay

Strengthened the Board of Directors and Scientific Advisory Board with the additions of Julie O’Neill and Markwin Velders, Ph.D., respectively, and continued to build the team in the UK & US, including key appointments across manufacturing, supply chain and clinical operations, bio-processing and intellectual property

Received a Horizon 2020 grant as part of the Neoantigen Consortium, with the aim of developing a tool to predict neoantigen immunogenicity.

Financial Highlights

IPO: Priced an initial public offering of 9,750,000 ADRs at a public offering price of $18.00 per share for gross proceeds of $175.5 million. The IPO closed on April 6, 2021, after the quarter end.

Cash and cash equivalents: Cash and cash equivalents were $159.3 million as of March 31, 2021 as compared to $177.8 million as of December 31, 2020, not including $160.6 million in net proceeds from the IPO which closed on April 6, 2021. The Company anticipates that its existing cash and cash equivalents plus the IPO proceeds are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.

Operating Expenses: Operating Expenses were $13.7 million for the quarter ended March 31, 2021, which included $8.9 million in Research & Development, and General and Administrative expenses of $4.8 million.

Net loss: Net loss attributable to ordinary shareholders was $13.8 million for the quarter ended March 31, 2021 and the basic and diluted net loss per ordinary share was $8.38 for the quarter ended March 31, 2021.

Upcoming Events

Iraj Ali, Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2021 Virtual Healthcare Conference at on Thursday, May 13, 2021, at 9:30 a.m. ET / 2:30 p.m. BST.

A poster detailing abstract TPS9138 entitled, An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Clonal Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON), will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting taking place virtually from June 4-9, 2021. Full abstracts will be released on May 19, 2021 at ASCO (Free ASCO Whitepaper).org.

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On May 11, 2021 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the completion of a $135 million Series B financing (Press release, Nuvalent, MAY 11, 2021, https://www.nuvalent.com/nuvalent-completes-135-million-series-b-financing-to-advance-portfolio-of-novel-precisely-targeted-kinase-inhibitors-for-treatment-resistant-cancers/ [SID1234580619]). The round was led by Bain Capital Life Sciences with participation from sole founding investor, Deerfield Management, and additional new investors Fidelity Management and Research Company LLC, Wellington Management Company, Viking Global Investors, Janus Henderson Investors, Avoro Capital Advisors, Boxer Capital of Tavistock Group, Venrock Healthcare Capital Partners, Fairmount Funds Management LLC, Driehaus Capital Management LLC, and Logos Capital. Andrew Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, will join the Nuvalent Board of Directors.

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"We are encouraged by the support of this exceptional group of investors and their shared belief in our mission to develop precisely targeted therapies for patients with cancer," said Alex Balcom, Chief Financial Officer at Nuvalent. "With this financing, we are well positioned to efficiently advance our parallel lead programs into clinical development and to accelerate the discovery of additional novel, selective compounds to meet medical needs in treatment-resistant cancers."

Proceeds from the Series B financing will support the clinical advancement of Nuvalent’s parallel lead programs, NVL-520 (previously NUV-520), a potential best-in-class ROS1-selective kinase inhibitor, and NVL-655 (previously NUV-655), a potential best-in-class ALK-selective kinase inhibitor. The financing is also expected to support further expansion and accelerated development of Nuvalent’s discovery research pipeline of novel, selective small molecule kinase inhibitors.

New preclinical data leading to the selection of NVL-520 and NVL-655 for clinical advancement were recently presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting. These parallel lead compounds have been designed to address the identified clinical needs of kinase selectivity, brain penetrance, and activity against drug-resistance mutations in ROS1- and ALK-driven tumors, respectively. The preclinical data support the potential for NVL-520 and NVL-655 to remain active in tumors that have developed resistance mutations and to minimize off-target adverse events, including TRK-related adverse events affecting the central nervous system (CNS), in order to drive more durable responses for patients.

"Nuvalent’s focused approach to drug development has led to a promising pipeline of novel drug candidates with specific, rational designs and opportunity for meaningful clinical impact," said Dr. Hack. "I am pleased to join the company’s Board of Directors and look forward to working with this talented team as they continue to apply their internal expertise in chemistry and structure-based drug design towards addressing real-world medical needs identified in close collaboration with leading clinical advisors."

Nuvalent also recently announced several additions to its leadership and advisory team, including precision oncology expert Christopher Turner, M.D., as Chief Medical Officer, and leading scientific advisors with deep expertise in targeted therapies for oncology.

"We welcome Andrew to our Board of Directors, who draws from a breadth of experience across early- to late-stage companies in the biotechnology and life sciences sectors to bring a valuable, multi-faceted perspective to our growing team of distinguished leaders and advisors," said James Porter, Ph.D., Nuvalent Chief Executive Officer. "The milestones that we announced today support our significant achievements since our public launch in January 2021, and the tremendous potential that we believe Nuvalent has. With the support of this investor syndicate, we confidently move forward to develop therapies that drive deep, durable responses for patients with cancer."