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]).

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!

"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.

On May 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.1 (Press release, Janssen Pharmaceuticals, MAY 14, 2020, View Source [SID1234558161])

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!

Findings from the study showed that apalutamide in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent.1 Median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [HR=0.78; p=0.0161 (to reach statistical significance, a p-value of p<0.046 needed to be observed)].1 After the study met its primary endpoint of metastasis-free survival (MFS), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to apalutamide. The OS results were achieved despite a crossover of 76 randomised placebo patients (19 percent) to apalutamide treatment.1 After adjusting for the cross-over of patients in the placebo arm, the treatment effect of apalutamide plus ADT exceeded median OS compared to placebo plus ADT with a difference of 21 months between the two arms (73.9 months vs 52.8 months, respectively, HR=0.69, p=0.0002). Additionally, treatment with apalutamide in combination with ADT significantly delayed patients’ time to cytotoxic chemotherapy compared to placebo in combination with ADT (HR=0.63; p=0.0002).1

"Treatment for patients with non-metastatic castration-resistant prostate cancer is primarily focused on delay of metastases and improvement of overall survival," said Eric Small, M.D., FASCO, Professor of Medicine, and Chief Scientific Officer at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, and lead SPARTAN study investigator. "The final analysis of SPARTAN includes long-term data for each of these treatment parameters and helps to support the earlier use of apalutamide versus ADT alone."

Together with data from the primary analysis, the SPARTAN study has met all primary, secondary and exploratory endpoints. The primary endpoint of the study was MFS; the secondary endpoints were time to metastasis, progression-free survival (PFS), time to symptomatic progression, OS and time to initiation of cytotoxic chemotherapy; and the exploratory endpoints were second progression-free survival (PFS2), PSA responses and risk of PSA progression.1,2

"Our driving commitment to delay the onset of metastases and add years to life for prostate cancer patients has taken a significant step forward with today’s data," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The SPARTAN trial has successfully demonstrated that apalutamide improved overall survival by an average of 14 months, reinforcing the need to treat earlier in prostate cancer for the benefit of patients and their families. At Janssen, our vision is to pioneer new approaches to treating cancer by thinking differently about diagnosis and looking towards intercepting the disease before it can even take a hold."

Median treatment duration was nearly three times longer for patients treated with apalutamide plus ADT (33 months) compared with those treated with placebo plus ADT (12 months).1 Grade 3/4 treatment-emergent adverse events of special interest were rash (5.2 percent), fractures (4.9 percent), falls (2.7 percent), ischemic heart disease (2.6 percent), hypothyroidism (0 percent) and seizures (0 percent). Safety and tolerability of apalutamide is consistent and as reported previously.1,3

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine.2,4 The study met its primary endpoint of MFS demonstrating a median MFS of more than two years (difference of 24.31 months) and a 72 percent reduction in risk of distant metastasis in patients with nmCRPC.4 OS data were not mature at the time of the final MFS analysis (24 percent of the required number of events). Updated results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in 2019 and were simultaneously published in Annals of Oncology.5,6

#ENDS#

About the SPARTAN Study
SPARTAN (NCT01946204) is a Phase 3, randomised, registrational, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in men with nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).2,7 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage in which the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and/or CT/MRI scan.8 Features include: lack of detectable metastatic disease using conventional radiographic imaging and rapidly rising PSA while on ADT with serum testosterone level below 50 ng/dL.9,10 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.11 The relative five-year survival rate for patients diagnosed with a distant-stage prostate cancer is 31 percent.12 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).7 In the U.S. apalutamide is indicated for the treatment of nmCRPC and mHSPC.13

Warnings and Precautions include ischemic heart disease, fractures, falls and seizure.2,3 In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhoea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.1,4

On May 14, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported the pricing of the initial public offering of 12,245,631 shares of its common shares at a price of $19.00 per share (Press release, ADC Therapeutics, MAY 14, 2020, View Source [SID1234558148]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by ADC Therapeutics, are expected to be approximately $232.7 million. The shares are expected to begin trading on the New York Stock Exchange on May 15, 2020 under the ticker symbol "ADCT." The offering is expected to close on May 19, 2020, subject to customary closing conditions. In addition, ADC Therapeutics has granted the underwriters a 30-day option to purchase up to 1,836,844 additional common shares.

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!

Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

On May 14, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that it has commenced its previously-announced rights offering of up to 4,279,600 of units (the "Units," and each, a "Unit") at the Initial Price (as defined below) with an aggregate offering value of up to $30,000,000 (Press release, Pulse Biosciences, MAY 14, 2020, View Source [SID1234558109]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date").

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!

Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase the Units. Each Unit shall consist of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. The subscription price per Unit shall be equal to the lesser of (i) $7.01 per Unit (the "Initial Price") or (ii) the volume weighted average price of the Company’s common stock for the five trading day period through and including the Expiration Date (the "Alternate Price"). The subscription price will determine the final number of Units issuable, and subsequently the pro rata number of Units to which stockholders can subscribe. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to the subscription price for the Units.

Stockholders wishing to exercise subscription rights must timely pay $7.01 per Unit, the Initial Price, for the number of Units they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information, subscription and warrant agent for the rights offering, at the address and phone number provided at the end of this release.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these 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. Any offer will be made only by means of the prospectus forming a part of the effective registration statement.

On May 14, 2020 Moffitt Cancer Ctr reported that Chimeric antigen receptor T-cell therapy, or CAR T, has become a game changer for lymphoma and leukemia patients who have relapsed or become resistant to previous treatments (Press release, Moffitt Cancer Ctr, MAY 14, 2020, View Source [SID1234558108]). The therapy uses a patient’s own immune cells that are re-engineered in the lab to seek out and kill cancer cells when infused back into the patient. Yescarta (axicabtagene ciloleucel) was the first CAR T-cell therapy approved for the treatment of adults with large B cell lymphoma. The pivotal ZUMA-1 clinical trial that led to its approval showed that 83% of patients responded to the therapy, with 58% having a complete response. But clinical trials often have stringent eligibility criteria and the outcomes observed may not match what physicians see in a real-world clinical setting.

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!

Moffitt Cancer Center organized a consortium of 16 cancer treatment facilities across the U.S. that offer Yescarta as a standard-of-care therapy for patients with relapsed/refractory large B cell lymphoma. They wanted to determine if the safety and effectiveness seen in the ZUMA-1 clinical trial were similar for patients treated with the now commercially available CAR T therapy. Their findings were published in the Journal of Clinical Oncology.

The consortium pooled retrospective data on 298 patients who completed apheresis, the process to remove a patient’s T cells, with the intent of having Yescarta manufactured and administered. It is important to point out that of this group, 129 patients (43%) would not have qualified for CAR T-cell therapy based on the ZUMA-1 comorbidity eligibility criteria. Overall, 275 patients (92%) received a Yescarta infusion. In the ZUMA-1 trial, 108 patients received Yescarta.

"Our analysis found that the overall response rate of 82%, and estimated 12 month durable response rate of 47%, for our group of patients compared favorably to the ZUMA-1 trial results," said Frederick Locke, M.D., corresponding author of the study and vice chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy and co-leader of the Immunology Program at Moffitt. "Durable response rates were encouraging even in patients with significant comorbidities, suggesting that patients need not meet ZUMA-1 eligibility criteria to benefit from axicabtagene ciloleucel."

One adverse reaction that can occur following CAR T therapy is cytokine release syndrome (CRS). This occurs when a large number of cytokines, which are small proteins released by immune cells, are rapidly released into the blood. This can cause a patient to have a fever, increased heart rate, difficulty breathing and low blood pressure. In the ZUMA-1 trial, 11% of patients treated with Yescarta experienced severe CRS. However, in the commercial setting, that number was lower at 7%.

"We believe this observation is due to the greater use of tocilizumab and corticosteroids compared to ZUMA-1, in line with evolving practice patterns for toxicity management," said Michael Jain, M.D., Ph.D., co-first author and assistant member of the Blood and Marrow Transplant and Cellular Immunotherapy Department at Moffitt.

The authors believe this study suggests that patients do not need to meet the ZUMA-1 eligibility criteria to benefit from Yescarta, including upper age limits and those with underlying conditions.

This study was funded by the National Cancer Institute through grants to Locke (K23CA201594) and Moffitt (P30CA076292).