Biocept to Release First Quarter 2020 Financial Results and Host Investor Conference Call on May 13, 2020

On April 29, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported Wednesday, May 13, 2020 (Press release, Biocept, APR 29, 2020, View Source [SID1234556792]). The Company will host a conference call for the investment community to discuss the results and answer questions at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

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Individuals interested in participating on the conference call may do so by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4109 for other international callers. Those interested in listening to a webcast of the live conference call may do so by visiting View Source

A replay of the conference call will be available for 48 hours following the conclusion of the call by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers, or (412) 317-0088 for other international callers, and entering the replay access code 10143445. A webcast replay will be available for 90 days at http://ir.biocept.com/events.cfm.

resTORbio and Adicet Bio Announce Merger Agreement to Advance Allogeneic Gamma Delta CAR-T Cell Therapy Technology

On April 29, 2020 resTORbio, Inc. (Nasdaq: TORC) and Adicet Bio, Inc., a privately-held biopharmaceutical company, reported that they have entered into a definitive merger agreement to create a combined publicly-traded biotechnology company focused on the development of Adicet’s off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications (Press release, ResTORbio, APR 29, 2020, View Source [SID1234556818]). Adicet’s lead candidate, ADI-001, is a gamma delta CAR-T cell therapy targeting CD20 being developed for non-Hodgkin’s lymphoma. Adicet has a pipeline of differentiated pre-clinical and discovery programs leveraging its universal, off-the-shelf gamma delta CAR-T cell platform.

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Under the terms of the agreement, Adicet would merge with a wholly-owned subsidiary of resTORbio in an all-stock transaction, and the equityholders of Adicet will become the majority owners (75%) of resTORbio’s outstanding common stock upon the close of the merger.

"After a thorough evaluation of strategic alternatives, the Board of Directors of resTORbio believes that this merger represents the highest-potential value creation opportunity for resTORbio stockholders," commented Chen Schor, Co-Founder, President and Chief Executive Officer of resTORbio, Inc. "The combined company will leverage Adicet’s scientific and product development expertise and pipeline of engineered immune cell therapeutics for cancer based on its proprietary gamma delta T cell therapy platform. We believe this transformative transaction will provide the resources for the combined company to advance multiple programs into the clinic, including Adicet’s lead candidate, ADI-001, a gamma delta CAR-T cell therapy targeting CD20, and expand the pipeline in oncology and other indications."

"Adicet believes that its novel and highly productive efforts to date have generated a compelling allogeneic cell therapy platform that overcomes key challenges faced by existing CAR-T therapy," said Anil Singhal, Ph.D. President and Chief Executive Officer of Adicet Bio, Inc. "The proposed merger with resTORbio is the right next step in our trajectory, and we expect that it will provide Adicet with the resources to rapidly accelerate the development of its unique product candidates based on this platform and leverage our cGMP manufacturing process to create best-in-class therapies for patients in need."

Adicet completed an $80 million Series B financing in October 2019 and was backed by OrbiMed Advisors, aMoon2 Fund, Novartis Venture Fund, Regeneron Pharmaceuticals, Inc., Johnson & Johnson Innovation – JJDC, Inc. (JJDC), OCI Enterprises, Inc, KB Investment Co., Ltd., Consensus Business Group, SBI JI Innovation Fund, Samsung Venture Investment Corporation, Handok, Inc., DSC Investment, Inc. and Pontifax.

In August 2016, Adicet entered into a strategic collaboration with Regeneron focused on developing next-generation engineered immune cell therapeutics using Adicet’s gamma delta T cell allogeneic platform technology.

In addition to its gamma delta T cell therapy platform, Adicet also identifies and validates cancer specific targets derived from the intracellular proteome and then generates T cell receptor-like monoclonal antibodies (TCRLs) directed to these cancer-specific peptide targets presented by major histocompatibility complex (MHC) Class I complexes. These TCRLs are designed to arm CAR-modified T cells or as T cell engaging antibodies that target solid tumors.

About the Proposed Merger
Under the terms of the merger agreement, stockholders of Adicet will receive shares of newly issued resTORbio common stock. On a pro forma basis, Adicet equityholders are expected to own approximately 75% of the combined company and current resTORbio equityholders are expected to own approximately 25% of the combined company. The parties anticipate that the combined company’s primary focus will be to advance Adicet’s unique cell therapy platform. The parties anticipate that the combined company will continue the development of RTB101, resTORbio’s small molecule product candidate that is a potent inhibitor of target of rapamycin complex 1 (TORC1), for a COVID-19 related indication, with clinical data expected by Q1 2021. The terms of the merger agreement contemplate that a contingent value right (a "CVR") will be distributed to resTORbio stockholders as of immediately prior to the effective time of the merger, entitling CVR holders to receive net proceeds from the commercialization, if any, received from a third party commercial partner of the product candidate RTB101. The terms and conditions of the CVRs will be pursuant to a CVR Agreement resTORbio will enter into prior to the closing of the merger (the "CVR Agreement").

Following the merger, the combined company will leverage expertise from both companies with Chen Schor to serve as President and Chief Executive Officer, Stewart Abbot, Ph.D., as Senior Vice President and Chief Operating and Scientific Officer, Francesco Galimi, M.D., Ph.D., as Senior Vice President and Chief Medical Officer, Lloyd Klickstein, M.D., Ph.D., as Chief Innovation Officer, Carrie Krehlik, as Senior Vice President and Chief Human Resource Officer and Joan Mannick, M.D., as Head of Infectious Diseases to oversee the clinical program conducted under the CVR. At closing, the combined board of directors is anticipated to consist of seven members, which will include five designated from Adicet, one designated from resTORbio and Chen Schor, President and Chief Executive Officer. Anil Singhal will serve as an advisor to the board of directors. The company will maintain offices in Menlo Park, CA and Boston, MA.

"On behalf of the Adicet Board, we thank Anil for his service to Adicet and welcome his contributions as an advisor to the Board of Directors," said Carl Gordon, Ph.D., member of Adicet’s Board of Directors.

The transaction is expected to close in the second half of 2020, subject to approvals of each company’s stockholders and other customary closing conditions. Upon completion of the merger, the combined company will operate under the name Adicet Bio and is expected to trade on the Nasdaq Global Market under a new ticker symbol to be determined.

JMP Securities LLC is acting as financial advisor to resTORbio and Goodwin Procter LLP is serving as legal counsel to resTORbio. Morrison & Foerster LLP is serving as legal counsel to Adicet Bio.

Epigenomics AG Reports Financial Results for Fiscal Year 2019 and Preliminary Unaudited Financial Results for the First Quarter of 2020

On April 29, 2020 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (according to IFRS) for the fiscal year 2019 (Press release, Epigenomics, APR 29, 2020, View Source [SID1234556714]). In addition, the Company announces preliminary unaudited financial results for the first quarter of 2020.

HIGHLIGHTS

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At the end of November 2019, a microsimulation model developed by scientists at Harvard Medical School was published in the journal Cancer Medicine. The results show that patient adherence and screening intervals are decisive factors in a successful colorectal cancer (CRC) screening strategy. When these factors are incorporated into the evaluation of various CRC screening measures, blood tests can play a significant role in reducing the incidence and mortality of colorectal cancer.
On February 28, 2020, the Centers for Medicare and Medicaid Services (CMS) opened the National Coverage Determination (NCD) review of Epi proColon, a further significant milestone for Epigenomics AG on its way to U.S. reimbursement by CMS. With the NCD opening, CMS is required by legal statute to publish a decision on the reimbursement of Epi proColon within a maximum period of nine months, i.e. no later than November 28, 2020. A positive reimbursement decision would be a major breakthrough for the marketing of the blood test in the U.S. market.
To finance its ongoing operations, Epigenomics successfully completed a capital increase by way of a private placement on March 31, 2020. The new shares were fully subscribed by institutional investors from Germany and the U.S.A. The gross proceeds of the capital increase amount to approximately EUR 4.0 million and, together with cost reduction measures initiated in connection with the Covid-19 pandemic, will ensure that the Company will have sufficient liquid funds well into Q1 2021.
The US-American National Comprehensive Cancer Network (NCCN) announced on April 23, 2020 that it has included Epi proColon in its updated 2020 NCCN CRC guidelines. Inclusion in the guidelines underscores the potential of Epi proColon to significantly increase screening rates and thereby reach the over 30 million Americans who are at risk for colorectal cancer but do not participate in screening.
Greg Hamilton, CEO of Epigenomics AG: "We have made tremendous progress in the last six months towards Medicare reimbursement, the key prerequisite for full commercialization of Epi proColon. In November, a pivotal microsimulation model was published demonstrating the effectiveness of Epi proColon and in February, CMS initiated its national coverage determination process for the test. In addition, the NCCN CRC screening guidelines were updated to include Epi proColon in a manner consistent with our FDA indications for use as an option for patients who refuse other screening modalities. We believe this positive momentum will culminate in a positive coverage decision later this year."

Financial results 2019

Total revenue decreased to EUR 1.1 million (2018: EUR 1.5 million), mainly due to the decrease in licensing revenue from China. Product revenue increased to EUR 1.0 million from EUR 0.8 million in 2018.
Selling, general and administrative costs increased from EUR 8.7 million (2018) to EUR 8.9 million, mainly due to greater expenses for sales and marketing. Research and development costs rose from EUR 6.4 million (2018) to EUR 7.3 million, largely because of external costs that arose in connection with carrying out the post-approval study for Epi proColon and the HCC cross-section study in the U.S.A.
The decline in EBITDA (before share-based payment expenses) to EUR -13.3 million (2018: EUR -11.4 million) was mainly caused by temporary cost increases in connection with the clinical studies and non-cash expenses.
The net loss for the year increased to approximately EUR -17.0 million (2018: EUR -12.7 million) and was impacted by a one-off non-cash expense of EUR 2.5 million; the loss per share decreased slightly to EUR -0.46 (2018: EUR -0.47).
Cash consumption rose to EUR -13.5 million in fiscal year 2019 (2018: EUR -9.6 million) due to higher operating cash outflows. Furthermore, the prior-year figure was buoyed by a stronger effect from working capital that no longer applied in the reporting period.

Preliminary financial results Q1 2020

Based on preliminary unaudited figures, Epigenomics AG generated revenues of EUR 0.2 million in the first quarter of 2020 (Q1 2019: EUR 0.3 million).
EBITDA (before share-based payment expenses) improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.6 million.
The net loss for the period also improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.9 million.
Cash consumption decreased by EUR 1.0 million to EUR -3.3 million (Q1 2019: EUR -4.3 million).

Outlook 2020

Revenue

The Company expects revenue for the fiscal year 2020 within the range of EUR 1.0 million to EUR 2.0 million.
EBITDA / Cash consumption

Epigenomics’ EBITDA (before share-based payment expenses) is expected to range from EUR -10.5 million to EUR -12.5 million. Based on the Company’s business plan 2020, cash burn is expected to be in line with EBITDA guidance (before share-based payment expenses).

Further Information

The Annual Report 2019 is available on the Epigenomics website:
View Source." target="_blank" title="View Source." rel="nofollow">View Source The Interim Statement for the first quarter 2020 will be published on May 7, 2020 on the Company’s website.

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 3.00 pm (CET) / 9.00 am (EDT). The webcast can be accessed on the Company’s website: View Source

Genmab Announces Data to be Presented at ASCO20 Virtual Scientific Program

On April 29, 2020 Genmab A/S (Nasdaq: GMAB) reported that six industry sponsored abstracts regarding Genmab and Genmab partnered programs were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, taking place from May 29 to 31, 2020 (Press release, Genmab, APR 29, 2020, View Source [SID1234556758]). The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) Meeting Library, with the full abstracts scheduled to be published on May 13, 2020. A list of the abstracts is provided below, and includes one on epcoritamab, one on tisotumab vedotin (Trial in Progress) and four on daratumumab. Beginning Friday, May 29, 2020 at 8:00 AM EDT, poster sessions will be available on demand.

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"Although this year’s ASCO (Free ASCO Whitepaper) will be a virtual conference due to the difficult and unprecedented circumstances, we are pleased that data on our proprietary pipeline and partnered programs has been accepted for presentation at this prestigious conference. We are particularly looking forward to the data presentation that will demonstrate continued solid progress in our development of epcoritamab (DuoBody-CD3xCD20)," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Epcoritamab:
Epcoritamab (GEN3013; DuoBody-CD3×CD20) to induce complete response in patients with relapsed/ refractory B-NHL: Complete dose escalation data and efficacy results from a phase I/II trial – Virtual poster presentation

Tisotumab Vedotin:
Phase Ib/II trial of tisotumab vedotin ± bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024) – Virtual poster presentation

Daratumumab (Submitted by Janssen Biotech, Inc.):
Corticosteroid Tapering in Patients with Relapsed or Refractory Multiple Myeloma Receiving Subcutaneous Daratumumab: Part 3 of the Open-label, Multicenter, Phase 1b PAVO Study – Virtual poster presentation

Daratumumab + Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Baseline slimCRAB-based Subgroup Analysis of CASSIOPEIA – Virtual poster presentation

Efficacy and Safety of Carfilzomib, Dexamethasone, Daratumumab Twice-Weekly at 56 mg/m2 and Once-Weekly at 70 mg/m2 in Relapsed or Refractory Multiple Myeloma: Cross-study Comparison of CANDOR and MY1001 – Virtual poster presentation

Subcutaneous Daratumumab in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab: A Multicenter, Randomized, Phase 2 Study (LYNX) – Virtual poster presentation

Blueprint Medicines to Report First Quarter 2020 Financial Results on Wednesday, May 6, 2020

On April 29, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, May 6, 2020 to report its first quarter 2020 financial results and provide a corporate update (Press release, Blueprint Medicines, APR 29, 2020, View Source [SID1234556778]).

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 7980947. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.