On May 14, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the first quarter ended March 31, 2021 (Press release, Compugen, MAY 14, 2021, View Source [SID1234580035]).

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"2021 will be an important year of milestones and execution for Compugen," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "During this year we expect to share data readouts for COM701 in monotherapy, dual and triple combination studies, as well as our COM902 monotherapy study. These important readouts will build upon our earlier COM701 clinical data which have shown durable responses, including a confirmed complete response, in a highly refractory patient population in indications unlikely to respond to checkpoint inhibitors. Our data shared to date reinforce our confidence that COM701 is clinically active, and that PVRIG has the potential to act as an important and untapped target in the immune-oncology space."

Dr. Cohen-Dayag continued, "Our strong execution also includes two new studies: the Phase 1b cohort expansion of COM701 with Opdivo to be initiated in the second quarter of 2021 and the Phase 1 COM701 with COM902 dual combination study to be initiated in the second half of this year. With these programs in place, we will have made tremendous strides in creating a clinical program that comprehensively evaluates the roles of DNAM axis members, PVRIG and TIGIT, with the intersecting PD-1 pathway. We will continue to push forward as leaders in the DNAM axis space, advancing our wholly owned PVRIG and TIGIT assets to potentially drive cancer immunotherapy responses in new and expanded patient populations."

Recent and First Quarter 2021 Corporate Highlights

Announced encouraging updated data from COM701 monotherapy and in combination with Opdivo (nivolumab) studies with durable responses, including a complete response, in tumor types typically unresponsive to checkpoint inhibitors
Announced expansion of clinical collaboration agreement with Bristol Myers Squibb with planned Phase 1b cohort expansion study evaluating COM701 with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers. The study is on track to be initiated in the second quarter of 2021
Announced the expansion of the Company’s ongoing research collaboration with Johns Hopkins University to explore the underlying biology and mechanism of action of a novel myeloid target for cancer immunotherapy discovered by Compugen
Published peer-reviewed preclinical data in Cancer Immunology, Immunotherapy, which demonstrate the synergistic effect of COM902 with PVRIG and PD-1 blockade. In vitro and in vivo, the reduced Fc receptor engagement of COM902 does not result in T cell depletion. In vitro COM902 enhances human T and NK cell function and enhances anti-tumor lymphocyte responses and inhibits tumor growth in vivo
Published a review on the biology and potential therapeutic relevance of the DNAM-1 axis in Cancer Immunotherapy
Announced upcoming oral presentation of updated data from COM701 Phase 1 monotherapy and combination study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting
Announced upcoming participation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Targets for Cancer Immunotherapy: A Deep Dive Seminar Series. Eran Ophir, Ph.D., Vice President Research and Drug Discovery, Compugen, will participate in a seminar titled "The TIGIT Pathway: A Deep Dive in Cancer Immunotherapy Targets".
Financial Results
R&D expenses for the first quarter ended March 31, 2021, were $7.3 million compared with $4.7 million for the comparable period in 2020. The increase is attributed mostly to drug manufacturing activities and clinical related activities.

General and administrative expenses for the first quarter ended March 31, 2021, were $2.7 million compared with $2.5 million for the comparable period in 2020. The increase is attributed mainly to increased corporate-related expenses.

Net loss for the first quarter ended March 31, 2021 was $9.9 million, or $0.12 per basic and diluted share, compared with a net loss of $7.1 million, or $0.10 per basic and diluted share, in the comparable period of 2020.

As of March 31, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $119.4 million, compared with approximately $124.4 million as of December 31, 2020. The Company has no debt.

Opdivo is a registered trademark of Bristol Myers Squibb.

Conference Call and Webcast Information
The Company will hold a conference call today, May 13, 2021, at 8:30 AM ET to review its first quarter 2021 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 14, 2021 Cardinal Health (NYSE: CAH) reported that it is sending an irrevocable notice of early redemption to the holders of all of the Company’s 3.200% notes due June 2022 that are outstanding as of the early redemption date (aggregate principal amount of $237,558,000) and $262,442,000 in aggregate principal amount of the Company’s 2.616% notes due June 2022 (Press release, Cardinal Health, MAY 14, 2021, View Source [SID1234580004]). The early redemption date is set to June 15, 2021, pursuant to the June 2, 2008 indenture and the notes.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

With respect to the 3.200% notes, in accordance with the terms and conditions set forth in the indenture and the notes, the 3.200% notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the then current adjusted treasury rate (as defined in the notes) plus 25 basis points, plus, in either case, accrued but unpaid interest on the principal amount being redeemed to the redemption date.

With respect to the 2.616% notes, in accordance with the terms and conditions set forth in the indenture and the notes, the 2.616% notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount of the notes to be redeemed or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed that would be due if the notes of such series matured on May 15, 2022 (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the then current adjusted treasury rate (as defined in the notes) plus 15 basis points, plus, in either case, accrued but unpaid interest on the principal amount being redeemed to the redemption date.

This press release shall not constitute a notice of redemption of the notes, and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On May 14, 2021 Australian pharmaceutical group Phebra (‘Company’) reported that congratulates the Australasian Leukaemia and Lymphoma Group (ALLG) on the release of their abstract EP433 at the virtual European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Conference (Press release, Phebra, MAY 14, 2021, View Source [SID1234580036]).

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The abstract builds on the initial bioequivalence data from the first phase of the trial, published at EHA (Free EHA Whitepaper) in June 2019 and reveals the final results from the ALLG APML5 bioavailability study undertaken by the ALLG at hospitals across Australia in 31 patients with previously untreated APL.

The aim of the APML5 study, was to characterise the bioavailability of Phebra’s oral arsenic trioxide (ATO) capsules and intravenous ATO in patients undergoing standard-of-care consolidation therapy by comparing the total arsenic AUC0-24 and Cmax in whole blood and plasma. Estimates of the geometric mean or oral /IV ratios for all pK parameters closely approximate unity confirming bioequivalence of the oral and IV formulations.

Phebra’s extensive knowledge of arsenic formulations and long-standing relationships with Australian healthcare providers led to a collaboration with the ALLG. Phebra provided funding and supplied the oral ATO capsules and IV ATO injection for the ALLG trial.

With its decade-long ongoing manufacture and supply of Phenasen (arsenic trioxide) Injection, from its multi-purpose sterile injectables facility in Sydney, Australia, Phebra was the first pharmaceutical company to pursue and achieve registration of arsenic trioxide injection for the treatment of newly-diagnosed APL patients. APL is a rare subtype of Acute Myeloid Leukaemia (AML), which accounts for only 10% of all AML diagnoses. AML is rare disease diagnosed at a rate of 3.7 per 100,000 of population.[1].

Phebra Chief Executive Officer (CEO) Andre Vlok, said: "We’re excited that the study’s final pK results confirm the bioequivalence of the oral and IV formulations. It demonstrates that Phebra’s novel oral ATO formulation has the real potential to be a viable, new treatment option for blood cancer patients."

Phebra Executive Director of Research, Dr Mal Eutick, added: "This innovative oral arsenic capsule will provide a beneficial treatment option for patients with APL, importantly, reducing the time they need to spend at hospitals undergoing infusions. We congratulate the ALLG and the team of researchers for their collaboration with Phebra on this breakthrough treatment."

The Chief Executive Officer of the ALLG, Delaine Smith, said: "Clinical trials are essential to understand the biology of the disease and to improve the survival and care of patients. The ALLG member network of haematologists collaborate to conduct high quality trials and research projects that create Better Treatments and Better Lives. The oral capsule formulation of ATO can provide a more convenient treatment option and improve the lives of those with APL."

On May 14, 2021 Cullinan Oncology, Inc. (Nasdaq: CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, reported its financial results for the first quarter ended March 31, 2021 and reported on recent business highlights (Press release, Cullinan Oncology, MAY 14, 2021, View Source [SID1234579975]).

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"I am pleased with the progress we have made across our portfolio and our organization thus far in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "Our recently completed Series C financing and Initial Public Offering will support continued development and expansion of our diverse pipeline. In addition, we look forward to sharing both clinical and preclinical updates throughout the year, including a poster presentation with updated clinical data for Cullinan Pearl at ASCO (Free ASCO Whitepaper) in June and updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in the third quarter."

Q1 2021 Portfolio Highlights

Cullinan Pearl: Based on pre-specified efficacy and safety criteria, we initiated Phase 2a dose expansion in the 100 mg BID cohort of our ongoing Phase 1/2a trial evaluating CLN-081 in NSCLC patients with EGFR ex20ins mutations. An abstract containing data from this trial as of November 2020 was selected for a poster presentation at ASCO (Free ASCO Whitepaper). The poster presentation will contain updated safety and efficacy data subsequent to the November 2020 cutoff and will be available during the conference, which takes place from June 4 – 8, 2021.
Cullinan MICA: Continued to advance CLN-619, a novel MICA/B-targeted antibody designed to engage innate and adaptive immune cell responses, through IND-enabling activities, including drug product manufacturing, to support an IND submission in the second quarter of 2021.
Cullinan Florentine: Based on FDA feedback, amended the proposed clinical trial protocol for CLN-049, a bispecific FLT3 x CD3 antibody, to support an IND resubmission in mid-2021.
Cullinan Amber: Expanded the preclinical data package for Cullinan Amber’s lead program, CLN-617, a fusion protein uniquely combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding domain for the treatment of solid tumors.
Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.
Q1 2021 Financial Results

Cash Position: Cash, cash equivalents and investments were $473.0 million as of March 31, 2021, compared to $210.2 million as of December 31, 2020. Net cash used in operating activities was $1.5 million. Net cash provided from financing activities was $264.6 million, which included net proceeds from the company’s IPO completed in January 2021.
R&D Expenses: Research and development expenses were $12.4 million for the quarter ended March 31, 2021, including $3.0 million of sub-licensing expense and $1.6 million of non-cash equity-based compensation expense.
G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended March 31, 2021, including $1.9 million of non-cash equity-based compensation expense.
Net Income: The Company’s net income was $1.4 million for the quarter ended March 31, 2021, which included $18.9 million of revenue from the license agreement with Zai Lab (Shanghai) Co., Ltd.

On May 14, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the company will participate and be available for 1×1 meetings at the following upcoming conference (Press release, Cellectar Biosciences, MAY 14, 2021, View Source [SID1234580005]):

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Oppenheimer Rare & Orphan Disease Summit
Date: May 21, 2021
Time: On demand presentation for registered participants
Available for 1×1 meetings
Webcast: To register, click on the link HERE
A replay of the presentation will be available on the Events page of the company website.