CohBar Reports First Quarter 2020 Financial Results and Provides Business Update

On May 14, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2020 (Press release, CohBar, MAY 14, 2020, View Source [SID1234558168]).

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"I am pleased to share with you that since my arrival at CohBar last May, we have expanded the number of programs from two to five with the newest targeting COVID-19 associated acute respiratory distress syndrome (ARDS)," said Steven Engle, CohBar’s Chief Executive Officer. "Recently, we announced that we have a new target for our CB5064 apelin agonist program, which is COVID-19 associated ARDS, an underlying disease that lacks adequate therapies. We are excited because published preclinical studies have shown that apelin can reduce the severity of acute lung injury. Also in this past quarter, we demonstrated that our recently discovered CXCR4 antagonist enhanced the effectiveness of a chemotherapeutic agent in a model of melanoma, and made additional progress with our antifibrotic program by generating new results in a therapeutic model of idiopathic pulmonary fibrosis (IPF). Finally, like many companies, we paused our Phase 1b study in NASH and obesity, which we hope to continue once the COVID-19 associated conditions impacting our study sites have improved. With this quarter’s accomplishments, CohBar continues to expand its portfolio of mitochondrial encoded peptides to maintain our leadership in mitochondrial medicine."

First Quarter 2020 R&D and Business Highlights

CB5064 Analogs for COVID-19 Associated ARDS and Type 2 Diabetes: In May, the company initiated testing of CB5064 analogs that interact with the apelin receptor in preclinical models of ARDS to assess their potential as therapeutics for COVID-19 associated ARDS. CohBar previously demonstrated the beneficial effects of this novel family of peptides on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of T2D, as presented at the American Diabetes Association in 2019.

ATS Abstract Accepted for MBT2 Analogs for Fibrotic Diseases: In April, the company’s late-breaking abstract was accepted as a poster presentation at the American Thoracic Society (ATS) 2020 International Conference. The poster will summarize the prophylactic and therapeutic activity of a novel peptide, MBT2, in preclinical models of IPF. MBT2 has demonstrated reductions in lung fibrosis, inflammation, collagen levels, and other parameters. IPF is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.

CB4211 Clinical Study Paused due to COVID-19 Pandemic: In March, the company announced delays in the completion of its CB4211 Phase 1b study for NASH and obesity due to the COVID-19 pandemic. CohBar has previously presented evidence that the novel mechanism of action of CB4211 enhances insulin effects on fat cells (adipocytes) leading to reduction of liver fat in preclinical models.

New CXCR4 Inhibitor Program Targets Cancer and Other Indications: In January, the company announced its discovery of MBT5 analogs, a novel family of potent and selective peptide inhibitors of the chemokine receptor, CXCR4. CXCR4 is overexpressed in more than 75% of cancers and high levels of the receptor are associated with poor survival prognosis.

Investment Community Outreach Continues to Expand: In this past quarter, CohBar held meetings with investors, analysts, and bankers in Boston, New York, and San Francisco. The company hosted meetings around the JP Morgan Healthcare, BIO CEO and ROTH conferences.

CohBar’s Chief Operating Officer Stepping Down from Management Role: Jon Stern, the company’s senior executive, will be stepping down from his role as COO on May 31, 2020. Since joining the company in 2012, Mr. Stern has served in various executive roles including Chief Strategic Officer and Chief Executive Officer. He will remain actively involved as a member of the company’s board of directors.
Founder’s Update

During the first quarter and subsequent period, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases.

Dr. Cohen published a paper linking MOTS-c to exercise performance in the journal Aging, titled "Increased expression of the mitochondrial derived peptide, MOTS-c, in skeletal muscle of healthy aging men is associated with myofiber composition." Dr. Barzilai delivered a keynote on "The Science and Economy of Aging" at the World Economy Forum in Davos, Switzerland in January. He also spoke on longevity and the science of aging in San Francisco, Singapore, Abu Dhabi, Tel Aviv, and Naples, Florida.

First Quarter 2020 Financial Highlights

Cash and Investments. CohBar had cash and cash equivalents of $10.2 million as of March 31, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended March 31, 2020, was approximately $2.5 million.

R&D Expenses. Research and development expenses were similar for the three months ended March 31, 2020 and the prior year quarter at $1.4 million.

G&A Expenses. General and administrative expenses were $1.8 million for the three months ended March 31, 2020, compared to $1.5 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher D&O insurance premiums, board fees and stock-based compensation costs.

Net Loss. For the three months ended March 31, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share. For the three months ended March 31, 2019, net loss, which included $0.9 million of non-cash expenses, was $2.9 million, or $0.07 per basic and diluted share.
First Quarter Investor Call and Slide Presentation:

Date: May 14, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13702385
Slide Presentation

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 923 145 161 and Password CWBR, or
Go to www.cohbar.com and click on Q1 2020 Shareholder Presentation at top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 14, 2020, through 11:59 p.m. Eastern Time on June 4, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13702385. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

First results from the ACP-001 study presented at EHA

On May 14, 2020 CellProtect Nordic Pharmaceuticals reported that results from the first-in-human study ACP-001 was made public at the 2020 EHA (Free EHA Whitepaper) meeting (Press release, CellProtect Nordic Pharmaceuticals, MAY 14, 2020, View Source [SID1234561095]).

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Key findings from the study:

Overall survival (OS) 100% after a median follow-up time of 60 months
Median progression free survival (PFS) 34 months
No serious adverse events
The present study demonstrates that autologous NK cell-based immunotherapy is feasible and demonstrates clinical applicability with efficacy responses in an upfront autologous HSCT-setting in multiple myeloma (MM). The treatment strategy opens for usage of autologous NK cells in clinical settings where patients are not readily eligible for allogeneic NK cell-based treatments, including MRD and maintenance treatment in MM and other forms of malignancies.

Aptose to Present Early CG-806 Clinical Findings at the 25th Congress of the European Hematology Association

On May 14, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new clinical data on CG-806, its oral, first-in-class FLT3/BTK cluster selective kinase inhibitor, will be presented in a poster presentation at the 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), EHA (Free EHA Whitepaper)25 Virtual Congress, taking place June 11-14, 2020 (Press release, Aptose Biosciences, MAY 14, 2020, View Source [SID1234557980]).

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CG-806 Poster Presentation Details:

EARLY CLINICAL FINDINGS FROM A PHASE 1 A/B DOSE ESCALATION TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF CG-806 IN PATIENTS WITH RELAPSED OR REFRACTORY CLL/SLL OR NON-HODGKIN’S LYMPHOMAS
Date & Time: Friday, June 12, 08:30 CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Abstract Code: EP711
Location: Virtual

The accepted abstract is available online on the EHA (Free EHA Whitepaper) conference website, ehaweb.org.

About CG-806

CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies. This small molecule, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of AML in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML and other myeloid malignancies. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent or other non-covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

Merck to Present at the UBS Virtual Global Healthcare Conference

On May 14, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Mike Nally, executive vice president and chief marketing officer, is scheduled to participate in a fireside chat at the UBS Virtual Global Healthcare Conference on May 18, 2020, at 11:40 a.m. EDT (Press release, Merck & Co, MAY 14, 2020, View Source [SID1234558004]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

MEI Pharma and Kyowa Kirin Announces ME-401 Phase 1b Study to be Highlighted in a Presentation at the Virtual Edition of the 25th European Hematology Association Annual Congress

On May 14, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that updated Phase 1b data on ME-401, its investigational oral phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor drug-candidate in clinical development for the treatment of follicular lymphoma and other B-cell malignancies, will be presented in a poster session at the Virtual Edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress to be held June 11 to June 14, 2020 (Press release, MEI Pharma, MAY 14, 2020, View Source [SID1234558033]).

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Presentation at EHA (Free EHA Whitepaper)25 Virtual Congress

Title: The PI3kδ Inhibitor ME-401 is Well-Tolerated on Intermittent Schedule and Produces a High-Rate of Durable Responses in Relapsed Refractory (R/R) Indolent B-Cell Malignancies
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Authors: John Pagel, et. al.
Abstract ID: EP1174
Session Type: Poster

The abstract is available on the EHA (Free EHA Whitepaper) Annual Congress website. Presentations and posters will be available on the EHA (Free EHA Whitepaper) website for on-demand viewing beginning on June 12, 2020 at 8:30 a.m. ET.