On March 10, 2021 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2020 financial results for the period ended December 31, 2020 (Press release, Merrimack, MAR 10, 2021, View Source [SID1234576432]).

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"We are pleased that both Ipsen Pharmaceuticals and Elevation Oncology continue to pursue separate clinical stage programs which could result in milestone payments to Merrimack." said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We have continued to see reduced operating expenses and remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen and Elevation."

Fourth Quarter and Full Year 2020 Financial Results

Merrimack reported net loss of $3.0 million for the year ended December 31, 2020, or $0.22 per basic share, compared to a net loss of $17.3 million, or $1.30 per basic share, for the same period in 2019.

Merrimack reported a gain on sale of assets for the year ended December 31, 2020 of $2.1 million compared to $4.9 million for the same period in 2019.

General and administrative expenses for the year ended December 31, 2020 were $5.0 million, compared to $16.2 million for the same period in 2019.

As of December 31, 2020, Merrimack had cash and cash equivalents and investments of $14.0 million, compared to $16.6 million as of December 31, 2019.

As of December 31, 2020, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On December 1, 2020 Ipsen held a capital markets day briefing with investors. On February 11, 2021 Ipsen released its full year 2020 financial results. In both of these updates Ipsen provided guidance to investors that it may file with the FDA for accelerated approval of ONIVYDE as a treatment of second line small cell lung cancer in 2021. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma.

Elevation Oncology

– On November 18, 2020 Elevation Oncology announced that it had raised a $65 million Series B financing. This announcement included confirmation that Elevation’s phase II CRESTONE study evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion is continuing to enroll patients.

On March 10, 2021 Schrödinger (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported that preclinical data from its CDC7 program will be presented in a virtual poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Schrodinger, MAR 10, 2021, View Source [SID1234576431]).

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CDC7 is a protein kinase that is required for DNA replication initiation and involved in DNA replication stress response. CDC7 is thought to be linked to cancer cells’ proliferative capacity and ability to bypass normal DNA damage responses. Targeting proteins that play important roles in DNA replication and replication stress is gaining momentum as a new therapeutic approach for various cancers.

Details about the presentation are as follows:

Date: Saturday, April 10, 2021
Abstract Number: 1277
Title: Discovery of novel CDC7 inhibitors that disrupt cell cycle dynamics and show anti-proliferative effects in cancer cells

The virtual abstract is available in the program section of the virtual AACR (Free AACR Whitepaper) annual meeting website: View Source

On March 10, 2021 SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that its team will present data on the next generation SQZ APCs and the broader applicability of the APC platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting being held virtually April 10-15, 2021 (Press release, SQZ Biotech, MAR 10, 2021, View Source [SID1234576430]). SQZ APC is a cell therapy platform that aims to induce powerful antigen specific CD8+ T cell responses. Two posters will highlight the additional functionality of enhanced APCs (eAPCs) and potential patient population expansion by leveraging multiple mRNA based cargos. A third poster describes SQZ APCs in development for additional tumor types targeting both G12D and G12V KRAS mutations.

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SQZ eAPCs are designed to build on the power of the SQZ APC platform to produce robust and specific CD8+ T cell activation through efficient MHC-I antigen presentation. The platform leverages the cargo flexibility of the Cell Squeeze technology to create next generation product candidates by delivering multiple mRNA to potentially further enhance T cell stimulation. SQZ eAPCs are being designed to incorporate immune-signaling that would otherwise require combinations with additional immune-oncology agents. In addition, the mRNA based antigen cargo is designed to present a broader range of tumor antigen epitopes, aiming to broaden the addressable patient population. The eAPC platform has the potential to be applicable across future oncology and infectious disease programs. Data examining these enhancement and additional information will be shared in two posters at AACR (Free AACR Whitepaper).

SQZ is also applying its flexible technology to additional tumor targets. KRAS G12D and G12V make up over half of all KRAS mutations, with approximately 100,000 patients per year having KRAS G12D or G12V mutated cancers in the United States. Leveraging the flexibility of the Cell Squeeze technology, SQZ APCs have elicited specific KRAS G12D and G12V CD8+ T cells responses preclinically in both animal models and in human cells. At AACR (Free AACR Whitepaper), we will show preclinical data for SQZ APCs activating CD8+ T cells against KRas G12D and KRas G12V when delivered individually or simultaneously.

"The flexibility of the Cell Squeeze technology enables us to rapidly pursue new tumor types, such as those with KRAS mutations, as well as to add diverse functionalities to our APCs," commented Howard Bernstein, MD, PhD, SQZ chief scientific officer. "Next generation eAPCs are building on the strength of our SQZ APC’s efficient and specific CD8 T cell activation. Further enhancing cytokine and costimulatory signalling could be an innovative way for us to provide the benefits of numerous immune-oncology mechanism combinations into a single cell therapy. "

SQZ eAPC Posters

Title: Enhancing Potency of Antigen Presenting Cells via Signal 2/3 mRNA Engineering through Cell Squeeze Technology
Abstract Number: 1525
Presenter: Emrah Ilker Ozay, PhD

Title: Cell Squeeze Delivery of Antigen-Encoding mRNA Enables Human PBMCs to Drive Antigen-Specific CD8+ T Cell Responses for Diverse Clinical Applications
Abstract Number: 2626
Presenter: Michael Maloney, PhD

SQZ APC KRAS Poster

Title: Peripheral Blood Mononuclear Cells Engineered Via Microfluidic Cell Squeeze Technology to Generate APCs that Drive Mutant-KRas-Specific CD8+ T Cell Responses
Abstract Number: 1524
Presenter: Carolyne Smith, PhD

On March 10, 2021 LAVA Therapeutics B.V., a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers (bsTCE) to transform cancer therapy, reported that a poster featuring lead clinical candidate LAVA-051 will be presented at week 1 of the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held April 10-15, 2021 (Press release, Lava Therapeutics, MAR 10, 2021, View Source [SID1234576429]).

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The following abstract is now available on the AACR (Free AACR Whitepaper) website at www.aacr.org.

Title: Potent anti-tumor activity against patient CLL, MM and AML cells by LAVA-051, a bispecific Vγ9Vδ2-T and type 1 NKT cell engager targeting CD1d
Session Type: E-Poster Session
Session Title: Therapeutic Antibodies, Including Engineered Antibodies
Abstract Number: 1855

LAVA-051 is a humanized gamma-delta bsTCE which targets CD1d and the Vδ2 domain of the T cell receptor. It is the first antibody-based compound targeting CD1d to activate both Vγ9Vδ2-T and type 1 NKT cells. LAVA-051 exerted substantial antitumor activity against patient derived acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) cells that express CD1d. In addition, improved survival was observed in in vivo AML and MM mouse xenograft models treated with LAVA-051.

LAVA-051 is planned to enter a Phase I/IIa study in hematologic malignancies in 1H 2021.

On March 10, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will release its fourth quarter and full-year 2020 financial results before U.S. financial markets open on Thursday, March 18, 2021 (Press release, Legend Biotech, MAR 10, 2021, View Source [SID1234576428]).

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Legend Biotech will conduct a conference call to discuss those results on March 18, 2021 at 8:00 am ET. To listen to the call via webcast visit Legend Biotech’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source To listen to the call via telephone dial (833) 665-0666 from locations in the United States or (914) 987-7318 from outside the United States. Please refer to conference ID number 2677312.

A replay of the webcast will be available on the "Events and Presentations" page within the Investors section of the website at View Source for 90 days following the conference call.