On April 1, 2021 The Mt. Sinai Health Care Foundation—continuing Mt. Sinai Medical Center’s century-old tradition of caring for Northeast Ohio—reported that has expanded its commitment to the region through a $1 million challenge grant to the Case Western Reserve University School of Medicine (Press release, Case Western Reserve University, APR 1, 2021, View Source [SID1234577499]). With this grant, the Mt. Sinai Health Care Foundation has provided over $31 million in lifetime support for Case Western Reserve.

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The grant will benefit the Dean’s Catalytic Fund, designed to provide resources for the school’s leader to invest in new opportunities to advance medicine, such as emergency student scholarship support, bridge funding to advance promising early-stage research, and recruitment and retention of exceptional faculty.

In this instance, Interim Dean Stan Gerson will use Mt. Sinai’s support to inspire additional philanthropic commitments for recruitment of the next chair of the school’s department of pharmacology.

Within the school, the Department of Pharmacology is a core basic science department which historically and currently houses some of the schools most accomplished scientists, investigators, and educators of both graduate students and medical students. Expertise within the department ranges from basic pathway discovery of physiologic, organelle and disease processes to the discovery of interventions in diseases, from drugs to peptides to gene correction strategies, and across a wide spectrum of diseases. Technology expertise from structural biology, CRYOEM, imaging technologies, DNA and energy metabolism, cell biology and drug metabolism all reflect the wide range of capabilities that will be expanded with the recruitment of the new department chair.

"Funds generated through this new challenge will help us expand on existing strengths in pharmacology," Gerson said, "and help ensure our continued success as a leader in research, medical and graduate education. Expansion of the department will enhance coordination with our hospital affiliates, to improving the health of our community."

That dedication to improving care for the people of Cleveland and beyond is a core principle of the Mt. Sinai Health Care Foundation. It’s the same commitment to people and partnerships that earned the former medical center a national reputation.

"For 25 years, the Case Western Reserve School of Medicine has been among Mt. Sinai Health Care Foundation’s highest-performing grantee partners," said Mitchell Balk, president of The Mt. Sinai Health Care Foundation, the philanthropic legacy of the former nonprofit health care center. "We know that when we invest in the School of Medicine, our investments will increase many fold and that the dividends paid will benefit not only Case Western Reserve, not only Cleveland’s bioscience sector, but indeed, all of humankind."

Gerson is grateful to the foundation and its shared vision for bolstering Northeast Ohio’s reputation as a global biomedical leader. "On behalf of the School of Medicine," he said, "I cannot thank Mitch and the Mt. Sinai Health Care Foundation enough for their incredible support."

On April 1, 2021 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies reported that it will report its financial results for the first quarter of fiscal 2021 ended February 28, 2021 on Wednesday, April 14, 2021 (Press release, Theratechnologies, APR 1, 2021, View Source [SID1234577498]).

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A conference call will be held on April 14, 2021 at 8:30 a.m. (ET) to discuss the results. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis.

The conference call can be accessed by dialing 1-844-400-1697 (toll free) or 1-703-736-7400 (International). The conference call will also be accessible via webcast at View Source Audio replay of the conference call will be available on the same day starting at 11:30 a.m. (ET) until April 21, 2021, by dialing 1-855-859-2056 (North America) or 1-404-537-3406 (International) and by entering the access code: 7982427. The audio replay is also available until April 14, 2022 on View Source

On April 1, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported the closing of the sale of its commercial, clinical and research-stage oncology portfolio to Servier Pharmaceuticals, LLC, an independent global pharmaceutical company (Press release, Agios Pharmaceuticals, APR 1, 2021, View Source [SID1234577497]). The transaction was approved by Agios shareholders on March 25, 2021.

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In consideration for its oncology portfolio, Agios received from Servier $1.8 billion in upfront cash and is eligible to receive an additional $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO (ivosidenib tablets) from sales after the closing through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from the first commercial sale through loss of exclusivity.

"First, I want to thank each and every employee within the oncology franchise who helped create truly meaningful, differentiated therapies for patients over the past decade. With your expertise and Servier’s deep commitment to its expanding oncology portfolio, we look forward to watching these programs flourish," said Jackie Fouse, Ph.D., chief executive officer of Agios. "As we look ahead, Agios is poised for a bright and focused future as we seek to rapidly advance our genetically defined disease portfolio, delivering sustainable, long-term value to shareholders and superior outcomes for patients. In the near-term, mitapivat has the potential to be a blockbuster product with approvals in our three initial focus areas – pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease – and we have tremendous untapped potential for both the pyruvate kinase R (PKR) activation portfolio as well as our other preclinical assets."

In addition, Agios reported that it has entered into a definitive agreement with Bristol-Myers Squibb Company (BMS) to repurchase 7,121,658 shares of Agios common stock held by BMS and its affiliates for an aggregate purchase price of $344.5 million, or $48.3785 per share, using the proceeds from the sale of the oncology business. As previously disclosed, the Agios board of directors authorized the company to repurchase up to $1.2 billion of its outstanding shares, using the proceeds from the sale of the oncology business. Following completion of the repurchase of shares from BMS, Agios expects to conduct the remaining $855.5 million of share repurchases over the next 12-18 months, including executing a meaningful portion of the planned repurchases by year-end through a combination of 10b5-1 plans and open market purchases.

With a singular focus on growing the company’s genetically defined disease clinical and research pipeline, Agios anticipates significant key milestones in 2021, including filing for regulatory approval for mitapivat in adults with PK deficiency in both the U.S. and EU; initiating two Phase 3 studies of mitapivat in transfusion dependent and non-transfusion dependent thalassemia; initiating a Phase 2/3 study of mitapivat in sickle cell disease; presenting the first data from the healthy volunteer study of AG-946, the next generation PKR activator; and prioritizing new indications for PKR and pyruvate kinase M2 (PKM2) activator clinical development. In addition, Agios will explore all options to maximize the patient impact and value of mitapivat globally, including strategic transactions.

Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as financial advisors to Agios on this transaction. Wachtell, Lipton, Rosen & Katz acted as legal advisor to Agios.

On April 1, 2021 Inspyr Therapeutics, Inc. (OTC:NXPX), a pharmaceutical company focused on the research and development of novel targeted precision therapeutics for the treatment of cancer, reported its financial results and business update for the fourth quarter and full year 2020 ended December 31, 2020 (Press release, Inspyr Therapeutics, APR 1, 2021, View Source [SID1234577496]).

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Business Highlights

In October 2020, we announced that the company would strengthen its strategic collaboration with Ridgeway Therapeutics by reacquiring its novel immune-oncology precision targeting platform for the treatment of cancer through the cancellation of our prior licensing agreement.
As of March 30, 2021, we have 24 issued patents in our intellectual property portfolio for 22 jurisdictions in potential future commercial markets including the United States, Europe, the United Kingdom, Asia, and other geographies.
The company is currently preparing an investigational new drug (IND) application, for its lead asset, RT-AR001, an adenosine A2B receptor antagonist. The company plans to provide an update on RT-AR001’s clinical development in the second half of 2021 after its pre-IND meeting with the U.S. Food and Drug Administration (FDA).
Financial Highlights

Cash and restricted cash was $0.4 million and $0.02 million at December 31, 2020 and 2019, respectively. As of December 31, 2020 and 2019, there was no cash over the federally insured limit.
Operating expenses was $2.5 million and $0.06 million at December 31, 2020 and 2019, respectively. The increase was mostly due to the $2.0 million associated with the licensing cost of the adenosine portfolio.
Research and development (R&D) expenses incurred were $0.02 million and $0.04 million for the years ended December 31, 2020 and 2019, respectively.

On April 1, 2021 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the fourth quarter ended December 31, 2020, and earlier today reported preliminary topline data (Press release, Delcath Systems, APR 1, 2021, View Source [SID1234577495]). The company will host its quarterly call at 8:00am ET today, with a primary focus on discussing the preliminary top line data.

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Recent Business Highlights

During and since the fourth quarter of 2020, the company:

Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO based on an analysis of currently evaluable patients. The preliminary analysis included 87% of treated patients and final results are expected later in the year. The primary endpoint, overall response rate (ORR), as determined by an independent review committee, exceeded the prespecified threshold for success. Additionally, both prespecified ORR and Progression Free Survival comparative analyses against the best alternative care arm demonstrated a statistically significant improvement. The safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications with no new safety signals observed in this patient population.

Initiated a consulting engagement to select a portfolio of follow-on indications which will maximize the value of the HEPZATO Kit and CHEMOSAT platform.

Completed an underwritten public offering of common stock at a price of $13.25 per share yielding $22.2 million in gross proceeds.

Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer and Kevin Muir as Vice President of Commercial Operations.

"The fourth quarter marked the start of a critical transformation for Delcath," said Gerard Michel, CEO of Delcath. "Since October, we have attracted new investors, strengthened the management team and, most importantly, released preliminary results from the FOCUS trial which, as of this compilation, suggests a significant improvement in the benefit risk ratio versus an earlier generation of Delcath’s proprietary percutaneous hepatic perfusion system. We look forward to continued progress in 2021, as we prepare both to file an NDA in early 2022 and expand the development of HEPZATO into additional areas of high unmet need."

Fourth Quarter 2020 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended December 31, 2020 was approximately $379 thousand, compared to $398 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $4.5 million compared to $2.1 million in the prior year quarter. Research and development expenses for the quarter were $2.7 million compared to $2.7 million in the prior year quarter. Total operating expenses for the quarter were $7.3 million compared with $4.8 million in the prior year quarter.

We recorded a net loss for the three months ended December 31, 2020, of $7.0 million, compared to a net income of $12.5 million for the same period in 2019.

Balance Sheet Highlights.

At December 31, 2020, we had cash, cash equivalents and restricted cash totaling $28.8 million, as compared to cash, cash equivalents and restricted cash totaling $10.2 million at December 31, 2019. During the three months ended December 31, 2020 and December 31, 2019, we used $4.6 million and $5.4 million, respectively, of cash in our operating activities.

Conference Call Information

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