On March 5, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $1.2 million and a loss per diluted share of $0.08 for the fiscal quarter ended January 31, 2020 (Press release, Rafael Holdings, MAR 5, 2020, View Source [SID1234555241]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Rafael Holdings Highlights

Subsequent to the quarter close, Rafael Holdings and other shareholders in Rafael Pharmaceuticals, a leader in cancer metabolism-based therapeutics, entered into an agreement to provide up to $50 million to finance Rafael Pharmaceuticals’ operations and clinical development program. Please see Rafael Holdings’ Form 8-K filed with the U.S. Securities and Exchange Commission on February 3, 2020 for additional information.
On November 21, 2019, Rafael Holdings up-listed its Class B common stock to the New York Stock Exchange from the NYSE American exchange. The Company retained its ticker symbol, ‘RFL’.
The Barer Institute successfully synthesized novel chemical entities that have shown efficacy at inhibiting cancer metabolism, with ongoing studies in syngeneic animal models.
Revenue of $1.2 million in Q2 FY2020, generated through Rafael Holdings’ real estate portfolio, increased from $1.0 million in the year-ago quarter. The loss per share of $0.08 was unchanged from Q2 FY2019.
Rafael Pharmaceuticals

Following the equity issued in connection with the financing arrangement referenced above, Rafael Holdings and its subsidiaries held 50.7% (38.7% exclusive of minority interests) of the capital stock of Rafael Pharmaceuticals.

On March 3, 2020, Rafael Pharmaceuticals announced the appointment of Sanjay Sehgal, Ph.D., to Chief Regulatory Affairs and Quality Assurance Officer. Dr. Sehgal formerly served as the Senior Vice President of Regulatory Affairs and Conformance at Celularity, Inc. and was Chair of Regulatory Sciences for the American Association of Pharmaceutical Scientists (AAPS) from 2007-2008.
On January 21, 2020, Rafael Pharmaceuticals announced a collaboration with Michigan Medicine on a Phase 1b/2 clinical trial of CPI-613 (devimistat) in combination with gemcitabine and cisplatin for patients with biliary tract cancer.
On January 14, 2020, Rafael Pharmaceuticals announced that it had enrolled 250 patients – half of its enrollment goal – in its Phase 3 clinical trial (AVENGER 500) of CPI-613 for patients with metastatic pancreatic cancer. The study is being conducted at multiple sites in the United States, France, Israel and South Korea.
LipoMedix

Rafael Holdings owns 57.9% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.

On January 23, 2020, LipoMedix announced that a Phase 1 study of Promitil (PL-MLP) in 53 patients with advanced, treatment-refractory colorectal cancer treated with Promitil either as a single agent or in combination with capecitabine and/or bevacizumab was well tolerated and resulted in a substantial rate of disease stabilization. Prolonged survival of stable disease patients was also observed.
Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings

"Rafael Holdings’ key pharmaceutical investments, Rafael Pharmaceuticals and LipoMedix, both achieved important milestones in their respective clinical development programs this quarter. We also entered into an agreement to finance Rafael Pharmaceuticals’ expanding clinical development program and put in place key Barer Institute research programs. Finally, we continue to work to monetize some of our real estate portfolio including our office building in Newark, New Jersey."

On March 5, 2020 McKesson Corporation (NYSE:MCK) reported the final exchange ratio of 11.4086-for-one in connection with its previously announced offer to its stockholders to exchange their shares of McKesson common stock for shares of PF2 SpinCo, Inc. ("SpinCo") common stock (Press release, McKesson, MAR 5, 2020, View Source [SID1234555239]). The exchange offer to split-off SpinCo, which holds McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), is part of McKesson’s agreement with Change Healthcare Inc. (NASDAQ:CHNG) ("Change") to merge SpinCo with and into Change.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

McKesson also announced that the upper limit on the number of SpinCo shares that can be received for each share of McKesson Common Stock tendered has been reached.

For each share of McKesson common stock that is validly tendered and accepted for exchange McKesson will deliver approximately 11.4086 shares of SpinCo common stock, which will be immediately converted into an equal number of shares of Change common stock upon completion of the proposed merger (subject to receipt of cash in lieu of fractional shares). The exchange offer and merger are generally expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock. The transaction is subject to customary closing conditions.

McKesson will accept 15,426,537 shares of its common stock for exchange if the exchange offer is fully subscribed, based on the final exchange ratio. The exchange offer will be subject to proration if it is oversubscribed, and the number of shares accepted in the exchange offer may be fewer than the number of shares tendered.

The exchange offer is scheduled to expire at 11:59 p.m., New York City time, on March 9, 2020, unless it is extended or terminated. Holders of McKesson common stock may withdraw their tendered shares at any time before the expiration date of the exchange offer.

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.

For more information about the exchange offer, please visit www.dfking.com/McKesson or contact the information agent, D.F. King & Co., at 1-866-304-5477 (toll-free in the United States) or 1-212-269-5550 (outside of the United States), or by email at [email protected].

On March 5, 2020 DermTech, Inc. (NASDAQ:DMTK) ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that the Journal of Drugs and Dermatology has published the results of a large registry study confirming the clinical utility of the DermTech Pigmented Lesion Assay (the "DermTech PLA") (Press release, DermTech International, MAR 5, 2020, View Source [SID1234555238]). The study also confirmed the value of DermTech’s adhesive patch by demonstrating that community-based clinicians using the DermTech PLA were able to reduce unnecessary biopsies by up to 90%, lower healthcare costs and rule out melanoma via a genomics approach that elevates pigmented lesion management beyond what the eye can see.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The DermTech PLA helps clinicians employ precision dermatology and harness genomics technology to detect malignant changes that are otherwise unable to be identified visually or with histopathology, reducing the probability of missing melanoma to <1%," said Ronald Moy, M.D., member of the DermTech Scientific Advisory Board and former president of the American Academy of Dermatology. "DermTech’s PLA test has the potential to elevate patient care by bringing precision genomics detection to a field that has been relying on highly subjective measures to inform biopsy decisions."

This large, yearlong utility study, conducted in the United States, included 90 providers across 53 dermatology offices and assessed 3,418 pigmented lesions clinically suspicious for melanoma with the DermTech PLA. The results of the study demonstrate that:

Clinicians use the DermTech PLA test results to guide how they practice medicine (97.53% of PLA positive lesions are surgically biopsied and 99.94% of PLA negative lesions are followed clinically and not biopsied).
90.52% (n = 3, 094) of DermTech PLA registry study test results were negative for melanoma and 9.49% (n = 324) were positive.
There is no difference in how board certified dermatologists and other licensed clinicians follow DermTech PLA results to guide biopsy decisions—potentially expanding access to care for underserved populations who often delay treatment for a disease in which early detection is critical.
The DermTech PLA identifies the gene expression associated with early melanoma by catching malignant changes a pathologist cannot see and reduces the risk of missing melanoma from 17% to less than 1%.
"Having used the DermTech PLA more than 600 times, I have seen it bring relief to people who were facing hundreds of biopsies, people concerned with facial scars and people who have experienced painful wound healing," said Brook Brouha, M.D., Ph.D., lead author on the study. "Using the PLA as a pain-free option allows providers to detect cancer before it spreads."

Up to 90% of all biopsies for suspected skin cancer are performed unnecessarily because the current standard to assess pigmented lesions remains ambiguous. These avoidable surgeries often result in multiple scars and research has shown that about 27% of older people biopsied experience poor wound healing, bleeding, or infection.

The study, "Real-world Utility of a Non-invasive Gene Expression Test to Rule out Primary Cutaneous Melanoma – A Large US Registry," is the 15th peer-reviewed publication validating the benefits of the DermTech PLA.

"This is our largest utility study to-date and these data further support the high utility of DermTech’s PLA and the high negative predictive value of this precision dermatology technology," said John Dobak, MD, Chief Executive Officer of DermTech. "The DermTech PLA can detect malignant changes in gene expression at earlier stages which can help avoid unnecessary biopsies and reduce costs."

DermTech’s PLA, which is covered by Medicare, uses RT-PCR (reverse transcriptase–polymerase chain reaction) to measure the gene expression of two genes, LINC00518 (long-intergenic non-coding RNA 00518) and PRAME (preferentially expressed antigen in melanoma) to identify the malignant changes of melanoma on the genomic level. A DermTech PLA test is positive if LINC, PRAME, or both target genes are detected as these molecular pathology findings are known to correspond with histopathology findings of in situ or invasive primary melanoma in 7%, 50% and 93% of cases, respectively.

On March 5, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, March 12, 2020, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, MAR 5, 2020, View Source [SID1234555237]). Lineage management will also host a conference call and webcast on Thursday, March 12, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2019 financial and operating results and to provide a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 20, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 3827019.

On March 5, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended December 31, 2019, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAR 5, 2020, View Source [SID1234555236]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are entering 2020 in a position of strength," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Following the recent initiation of our Phase 1 trial of SY-5609, we are advancing two oral investigational medicines through development in multiple cancer patient populations that we believe are most likely to respond to these targeted agents, both with meaningful data readouts expected in the fourth quarter. Meanwhile, our gene control platform continues to fuel a robust preclinical and discovery pipeline in oncology and monogenic diseases. We are committed to executing with excellence on our ongoing efforts and, longer term, to leveraging our deep understanding of the regulatory genome to deliver much-needed medicines that provide profound benefits for patients."

Upcoming Milestones:

SY-1425

Report potential proof-of-concept data in the fourth quarter of 2020 from ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in the fourth quarter of 2020 from fully enrolled Phase 2 trial cohorts evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609

Report initial safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in fourth quarter of 2020 from dose-escalation portion of Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology that harbor Rb pathway alterations.
Report additional dose-escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Nominate next development candidate by the end of 2021.
Recent Pipeline Highlights:

In January 2020, Syros presented preclinical data showing that inhibiting cyclin-dependent kinase (CDK) 7 and CDK12 result in different transcriptional effects at the 2020 Keystone Symposia Cancer Epigenetics: New Mechanisms and Therapeutic Opportunities. The data showed that CDK12 inhibition preferentially decreases expression of genes with longer transcripts, a phenomenon not observed with CDK7 inhibition, pointing to distinct therapeutic opportunities for these two novel approaches to benefit patients with difficult-to-treat cancers. Also at Keystone, Syros presented on two new methods for identifying genes and transcriptional targets upon which specific cancers are particularly dependent for their survival.
In January 2020, Syros dosed the first patient in its Phase 1 clinical trial of SY-5609. The multi-center, open-label, dose-escalation trial is expected to enroll approximately 60 patients with breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations. The primary objectives of the trial are to assess the safety and tolerability of escalating doses of SY-5609, with the goal of establishing a maximum tolerated dose. Additional objectives include assessments of anti-tumor activity, PK, PD and predictive biomarkers of response. In a future expansion portion of the trial, multiple cohorts are planned to further evaluate the safety and anti-tumor activity of SY-5609 as both a single agent and in combination with other therapies.
In December 2019, Syros presented preclinical data demonstrating its discovery and validation of a novel fetal hemoglobin repressor, Nuclear Factor I X (NFIX) at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data showed that, when knocked down in primary cells and an erythroid cell line expressing adult hemoglobin, NFIX induced fetal hemoglobin in nearly 100% of cells and increased total fetal hemoglobin levels to 40%, exceeding levels that are associated with a functional cure in a subset of sickle cell disease (SCD) patients.
In November 2019, Syros and its collaborators from the Whitehead Institute for Biomedical Research presented on the identification of core drivers of metastasis in triple-negative breast cancer at the 2019 San Antonio Breast Cancer Symposium.
Recent Corporate Highlights:

In February 2020, Syros announced the closing of a $60 million senior secured loan facility with Oxford Finance, LLC. Under the terms of the financing, $20 million was drawn down at closing, and $40 million will be available across two tranches, subject to certain conditions and achievement of milestones.
In December 2019, Syros appointed Mark Alles, the former Chairman and Chief Executive Officer of Celgene Corporation, to its Board of Directors. Mr. Alles is a recognized biopharmaceutical executive with a proven record of building successful global oncology organizations and commercializing innovative therapies.
In December 2019, Syros entered into a collaboration with Global Blood Therapeutics (GBT) to discover, develop and commercialize novel oral medicines for SCD and beta thalassemia. Under the agreement, Syros will use its gene control platform to identify therapeutic targets and discover drugs that induce fetal hemoglobin, and GBT will receive an option to obtain an exclusive worldwide license to develop, manufacture and commercialize products resulting from the collaboration. Under the terms of the agreement, Syros received a $20 million upfront payment. GBT is also obligated to fund up to approximately $40 million in research expenses for at least three years. Should GBT exercise its option under the agreement, Syros could receive up to $315 million in option exercise, development, regulatory, commercialization and sales-based milestones per product candidate and product resulting from the collaboration, in addition to mid- to high-single digit royalties on sales of products resulting from the collaboration.
Fourth Quarter 2019 Financial Results:

Cash, cash equivalents and marketable securities as of December 31, 2019 were $91.4 million, compared with $99.7 million on December 31, 2018. This reflects aggregate net proceeds of approximately $65 million from Syros’ two concurrent underwritten public offerings, which closed in April 2019 but does not include the $20 million upfront payment received in connection with entry into collaboration with GBT or the $20 million from the initial tranche of the Oxford loan facility.

For the fourth quarter of 2019, Syros reported a net loss of $19.7 million, or $0.46 per share, compared to a net loss of $18.0 million, or $0.54 per share, for the same period in 2018.

Revenues were $0.5 million for the fourth quarter of 2019, as compared to $0.9 million for the fourth quarter of 2018. Revenues in both the fourth quarter of 2019 and the fourth quarter of 2018 were earned under Syros’ collaboration with Incyte Corporation.
Research and development (R&D) expenses were $14.3 million for the fourth quarter of 2019, as compared to $15.1 million for the same period in 2018. This decrease was primarily attributable to the portfolio prioritization decision made during the quarter to discontinue the SY-1365 program.
General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2019, as compared to $4.4 million for the same period in 2018. This increase was primarily attributable to an increase in employee related expenses due to increased headcount, as well as stock-based compensation expense related to the accelerated vesting of certain performance-based stock options following the execution of the Global Blood Therapeutics collaboration in December 2019.
Full Year 2019 Financial Results:

For the full year ended December 31, 2019, Syros reported a net loss of $75.4 million, or $1.88 per share, compared to a net loss of $62.3 million, or $1.91 per share, for the same period in 2018.

Revenues were $2.0 million for the year ended December 31, 2019, as compared to $2.1 million for the same period in 2018. Revenues in both 2019 and 2018 related entirely to the Incyte collaboration.
R&D expenses were $58.2 million for the year ended December 31, 2019, as compared to $50.2 million for the same period in 2018. This increase was primarily attributable to the continued advancement of the Company’s existing clinical trials and advancement of its preclinical programs, including completing SY-5609 IND-enabling studies.
G&A expenses were $21.5 million for the year ended December 31, 2019, as compared to $16.2 million for the same period in 2018. This increase was primarily attributable to an increase in employee related expenses due to increased headcount.
Financial Guidance:

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities, including the upfront payment received in connection with the GBT collaboration and the initial tranche of the Oxford loan facility, will be sufficient to fund its planned operating expenses and capital expenditures requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 2019 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 2764269. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.