On May 13, 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 13, 2021, View Source [SID1234579848]).

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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 13, 2021 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company reported that IMV’s executive management team will be participating in two upcoming investor conferences (Press release, IMV, MAY 13, 2021, View Source [SID1234579885]).

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Sachs and Associates, 7th Annual Immuno-oncology Innovation Forum Panel

IMV panel participant: Fred Ors, President and CEO

Date: Wednesday, May 19, 2021

Time: 2:50 p.m. EDT

Registration: View Source

Only registered participants will be able to listen to this panel. Details to register can be found in the link above.

Family Office Investor Event – Healthcare & Biotech TSX Showcase

Date: Wednesday, May 19, 2021

Time: 10:00 a.m. EDT

On May 13, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported the closing of a $35 million Series A financing for a joint venture in China. Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the joint venture will be headquartered in Shanghai and enable the potential development and commercialization of certain Kinnate targeted oncology product candidates across Greater China (mainland China, Hong Kong, Taiwan, and Macau) (Press release, Kinnate Biopharma, MAY 13, 2021, View Source [SID1234579914]). Kinnate Biopharma will be the majority shareholder in the joint venture. The company has also announced that veteran biopharmaceutical industry executive Wenn Sun, Ph.D., has been appointed as the joint venture’s Executive Chair.

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"Establishing operations in China creates a tremendous opportunity for Kinnate to build its global footprint and further advance our mission of expanding access to innovative targeted therapies for people battling cancer," said Nima Farzan, President and CEO of Kinnate Biopharma Inc. "OrbiMed Private Investments and Foresite Capital have been important partners in the growth of Kinnate and we are pleased to now have the support of OrbiMed Asia Partners who led this financing and brings tremendous expertise and connections in China to this new joint venture. I look forward to working with this leading team of investors and Dr. Sun to make precision medicine a reality for more people in Greater China, which is one of the world’s largest healthcare markets."

The initial focus of the joint venture is on advancing the development of KIN-2787 for the Greater China market. KIN-2787 is a Rapidly Accelerated Fibrosarcoma (RAF) inhibitor candidate being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors. The joint venture will also pursue development of KIN-3248 for the Chinese market. KIN-3248 is a Fibroblast Growth Factor Receptors (FGFR) inhibitor candidate for the treatment of patients with intrahepatic cholangiocarcinoma (ICC), a cancer of the bile ducts in the liver, and urothelial carcinoma (UC), a cancer of the bladder lining. The joint venture, which will be subsequently named, has an exclusive license to one other Kinnate program and may also obtain rights to develop certain other new product candidates in Greater China from the Kinnate pipeline, as well as other third-party product candidates in China and other geographies.

"Since its founding, Kinnate has demonstrated impressive scientific discipline and exceptional execution in building a robust pipeline of targeted therapies for hard-to-treat cancers," said Steven D. Wang, Ph.D., CFA, Partner and Senior Managing Director, OrbiMed Asia Partners. "We are pleased to join them in establishing this joint venture in China and look forward to working closely with Dr. Sun and our other regional colleagues in bringing these potentially life-saving therapies to more patients."

Dr. Sun is the Founder and President of Precision Medicine Asia (PREMIA), an oncology-focused clinical genomic data company she founded in 2018. Previously, she was the Founder and Managing Partner for OxOnc Development, a venture company that, along with Pfizer Oncology, co-developed XALKORI in patients with ROS1 genetic alterations in Asia, including China. Dr. Sun also served as Head of Strategic Alliances for GSK Oncology, and helped build its alliances with various clinical research networks around the world. In 2003, in collaboration with the National Comprehensive Cancer Network (NCCN), she helped introduce the NCCN Guidelines to China. Dr. Sun was appointed Chief Business Development Officer at the Lurie Cancer Center of Northwestern University after her post-doctoral fellowship at University of Wisconsin-Madison.

"I am honored to join the Kinnate team and lead the joint venture’s efforts to help the patients in China for whom no genomically-targeted therapies exist or for which a resistance to targeted treatments has evolved," said Dr. Sun. "KIN-2787 has already demonstrated very promising results in pre-clinical studies and presents a significant opportunity to help address the tremendous demand for more effective cancer therapies across Greater China."

On May 13, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, MAY 13, 2021, View Source [SID1234579930]).

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"We continue to focus on advancing our novel pipeline and are pleased to have initiated the emricasan study for treatment of mild symptomatic COVID-19 patients and are on track to initiate the HST-003 study for knee cartilage repair in the second quarter of 2021," said Richard W. Pascoe, President and Chief Executive Officer. We also welcomed Dr. Susan Windham-Bannister and Rochelle Fuhrmann to our Board of Directors. Both Sue and Rochelle bring to our board relevant industry experience with respective expertise in strategic growth and financial management, which will serve Histogen well. Looking forward, we will continue to focus on the initiation and execution of the HST-003 study, delivering top-line results of the emricasan COVID-19 trial, and completing our evaluation of the clinical development plans for the HST 001 program."

Highlights from the First Quarter Ended March 31, 2021 and Business Updates

HST-001 – In February 2021, we announced the final results from the week 26 assessments of our study of HST-001 for the treatment of androgenic alopecia in men. These results supported that HST-001 was shown to be safe and well tolerated as compared to placebo with no reports of serious adverse events but did not achieve statistical significance at week 26 as compared to placebo. Additional observations at week 26 included that 84% of patients treated with HST-001, as compared to baseline, demonstrated a statistically significant change in total hairs (terminal and vellus) within the target area (TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography system. We are currently evaluating our clinical development plans for the HST-001 program and expect to complete our evaluation in the second quarter of 2021.

HST-003 – In March 2021, we announced that the U.S. Food and Drug Administration ("FDA") confirmed that we can proceed with the initiation of our planned Phase 1/2 clinical study of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. We anticipate enrollment to commence in the second quarter of 2021. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD.

Emricasan – In March 2021, we, in collaboration with our partner Amerimmune, announced dosing the first patient in the Phase 1 study of emricasan for the treatment of mild symptomatic COVID-19 patients. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool. We, along with our partner Amerimmune, expect top-line data to be available in the second quarter of 2021.

Appointed Dr. Susan Windham-Bannister and Rochelle Furhmann to the board of directors – In March 2021, we continued to strengthen and diversify our board with the appointment of Dr. Windham-Bannister and Rochelle Fuhrmann. Dr. Windham-Bannister is an internationally recognized expert in innovation, market access and market optimization strategies. She has been recognized by Biosphere as one of the "10 Most Prominent African American Science Leaders," the Boston Globe as one of the "10 Most Influential Women in Biotech," by Boston Magazine as one of the "50 Most Powerful Women in Boston" and is the President of the National Board of Directors of the Association for Women in Science (AWIS). Dr. Windham-Bannister currently serves as Managing Partner of Biomedical Innovation Advisors LLC, which she founded with Dr. Harvey Lodish, co-founder of Genzyme, and member of the Whitehead Institute, MIT. She also serves as the President and CEO of Biomedical Growth Strategies, LLC. Ms. Fuhrmann currently serves as the Vice President Audit and Enterprise Risk Management at Becton Dickinson (BD). In 2016, Ms. Fuhrmann helped establish the BD Foundation, and she presently serves as Treasurer and as a member of its Board of Trustees. She joined BD in July 2015 as Senior Vice President and Chief Financial Officer, BD Life Sciences. Prior to joining BD, Rochelle held various positions responsible for the management of financial functions, including accounting and financial reporting, investor relations, corporate finance, risk management and treasury, primarily in the pharmaceutical industry with companies such as Amneal Pharmaceuticals and Warner Chilcott plc. She previously served as a member of the Board of Directors of Concordia International Corp. and held the position of Audit Committee Chairperson for three years.

Financings – In January 2021, we received $14 million of gross proceeds from an S-1 offering and as of March 31, 2021, an incremental $6.8 million of gross proceeds from the exercise of warrants associated with the January 2021 public offering.
First Quarter 2021 Financial Highlights

First Quarter Ended March 31, 2021 and 2020

Product and Service Revenues in the first quarter of 2021, revenue decreased 56% to $0.4 million from $1.0 million in the first quarter of 2020. The decrease is primarily related to revenue recognized during the first quarter of 2020 associated with the Allergan License Agreement amendments offset by first quarter 2021 revenue related to the final supply of cell conditioned medium ("CCM") to Allergan under the Allergan License Agreements.

Cost of revenues for the three months ended March 31, 2021 and 2020 were $0.2 million and $0.3 million, respectively. The cost of product revenue during the first quarter of 2021 is related to the final supply of CCM sold to Allergan as compared to $0.2 million of scrapped inventory and $0.1 million of costs associated with professional services during the first quarter of 2020.

Research and development expenses for the three months ended March 31, 2021 and 2020 were $2.2 million and $1.4 million, respectively. The net increase of $0.8 million for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to increases in expanded development costs of our product candidates partially offset by $0.2 million in qualifying reimbursable expenses in connection with the Department of Defense grant and increases in personnel related expenses.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were $2.3 million and $1.2 million, respectively. The $1.1 million increase for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to incremental costs related to the transition from a private to a public exchange traded entity, such as legal, accounting and insurance fees and increases in personnel related expenses.

Cash and cash equivalents as of March 31, 2021 were $21.7 million. We believe that Histogen’s existing cash and cash equivalents and cash inflow from operations will be sufficient to meet its anticipated cash needs through the second quarter of 2022.

On May 13, 2021 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its third quarter, fiscal year 2021 operating results on Monday, May 17, 2021 before the open of the U.S. financial markets (Press release, Palatin Technologies, MAY 13, 2021, View Source [SID1234580034]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on May 17, 2021 at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.