On August 15, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported its financial results for the quarter ended June 30, 2018 (Press release, Delcath Systems, AUG 15, 2018, View Source;p=RssLanding&cat=news&id=2363736 [SID1234528978]).

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Highlights from the second quarter of 2018 and recent weeks include:

Amendment of the Company’s ongoing Phase 3 clinical trial in ocular melanoma liver metastases to a non-randomized, single-arm trial
Initiation of a $50 million rights offering
Revenue from European sales for the quarter of approximately $0.9 million;
100th CHEMOSAT treatment performed at Leiden University Medical Center;
Inclusion of CHEMOSAT in the German national treatment guidelines for liver metastases from melanoma.
Announcement that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial has again recommended that the study continue without modification;
Initiation of the ALIGN registration trial for the treatment of Intrahepatic Cholangiocarcinoma (ICC);
CHEMOSAT featured in main stage training presentation at European Conference on Interventional Oncology;
Management Commentary

"During our second quarter we continued to advance the major elements of our Clinical Development Program while taking steps to resolve the cash constraints and other restrictions that have impeded our ability to operate in recent weeks," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "These efforts culminated with the announcements we made in July of the protocol amendment to our ongoing FOCUS Phase 3 trial in ocular melanoma liver metastases to permit a non-randomized single-arm study, and our $50 million rights offering. These are highly significant developments for Delcath, and together provide both a path toward an application for FDA approval and the necessary financing to achieve it."

"Revenues for the second quarter of 2018 were approximately $0.9 million, an increase of nearly 50% over approximately $0.6 million in the prior year quarter. During the quarter, we announced CHEMOSAT was included in the German national treatment guidelines for ocular melanoma liver metastases, and that our third European commercial treatment center achieved the 100-treatment milestone. To date centers in Europe have completed over 600 CHEMOSAT treatments. CHEMOSAT was also featured in a main state presentation at the ECIO annual meeting, demonstrating the continued interest in the European research community in PHP therapy’s potential.

"Regarding our FOCUS Phase 3 Trial, in addition to the protocol amendment we announced in May that the independent Data Safety Monitoring Board (DSMB) has completed another review of safety data for treated patients in the trial and again recommended that the study continue without safety related modification. Safety data for the amended trial will be pooled with all patients treated with Melphalan/HDS under the prior protocol.

"During the second quarter, we announced the initiation of our registration trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). Called The ALIGN Trial, this trial will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe. We are leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible and have 3 centers open for patient enrollment to date. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company.

"Though the recent months have been difficult we have taken significant steps to reduce our time to NDA submission, advance our clinical and commercial programs, and obtain the financial resources required to realize PHP therapy’s potential and return value to our shareholders," concluded Dr. Simpson.

Second Quarter 2018 Financial Results

Revenue for the three months ended June 30, 2018 was $0.9 million, up from $0.6 million for the prior year period driven by the establishment of reimbursement coverage of CHEMOSAT procedures in Germany. Selling, general and administrative expenses were approximately $2.6 million compared to $2.5 million in the prior year quarter, a slight increase related to decreased production and adjustments to overhead allocations. Research and development expenses for the current quarter increased to $4.1 million from $2.5 million in the prior year quarter, driven by increased costs associated primarily due to the ongoing accrual of the Company’s Phase 3 FOCUS trial. Total operating expenses for the current quarter were $6.7 million compared with $5.1 million in the prior year quarter.

The Company recorded net loss for the three months ended June 30, 2018, of $6.7 million, an increase of $4.7 million, or 242.6%, compared to a net loss of $1.9 million for the same period in 2017. This increase in net loss is primarily due to a $6.7 million decrease in interest expense primarily related to the amortization of debt discounts related to convertible notes that were fully satisfied in 2017, and a $2.6 million increase in the change in the fair value of the warrant liability, both non-cash items. Additionally, there was a $1.7 million increase in operating expenses primarily related to increased investment in our clinical trial initiatives.

Balance Sheet Highlights
At June 30, 2018, the Company had cash and cash equivalents totaling $1.3 million, as compared to cash and cash equivalents totaling $4.0 million at December 31, 2017 and $1.8 million at June 30, 2017. During the six months ended June 30, 2018 and June 30, 2017, the Company used $9.3 million and $8.1 million respectively, of cash in its operating activities. The Company believes that its capital resources are adequate to fund its operating activities through August 2018.

On June 4, 2018, the Company entered into a Securities Purchase Agreement (the "SPA") with an institutional investor pursuant to which the Company issued $3.3 million in principal face amount of senior secured convertible notes of the Company (the "Notes") and related Series D Warrants (the "Series D Warrants") to purchase additional shares of the Company’s common stock ("Common Stock"). $3.3 million of the Notes were issued for cash proceeds of $2.4 million with an original issue discount in the amount of $1.1 million.

On July 20, 2018, the Company entered into a Securities Purchase Agreement with another institutional investor for the remaining Notes and Warrants in proportionate amounts to those issued in the June 4, 2018 transaction which is discussed in Note 7, in a transaction exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder, and received gross proceeds of $1,600,000.

Rights Offering & Bridge Financing

On July 16, 2018 the Company filed a registration statement on Form S-1 with the SEC for a rights offering for up to 28,571,429 shares of common stock at the subscription price of $1.75 per share. The subscription period this rights offering began on Tuesday, August 7, 2018 upon declaration of effectiveness of its registration statement on Form S-1 by the SEC.

On August 14, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported financial and operating results for the second quarter ended June 30, 2018 (Press release, Oncocyte, AUG 14, 2018, View Source [SID1234528870]). The Company ended the second quarter with $10.3 million in cash and cash equivalents and marketable securities valued at $0.7 million. On July 31, the Company closed a $3.59 million at-market registered direct offering of common stock and warrants, before financing expenses, led by the Company’s senior management team and Board of Directors, further bolstering its balance sheet. The Company projects that its cash position, coupled with prudent expense management, will be sufficient to execute its near-term strategy and the continued development of DetermaVu, the Company’s liquid biopsy lung cancer diagnostic test.

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"We achieved our primary goal during the first half of 2018 – putting our DetermaVu development program back on track," said William Annett, President and Chief Executive Officer. "We are now beginning to take the next steps in the development plan and remain encouraged that DetermaVu could address an estimated $4.7 billion annual U.S. market for a confirmatory lung cancer liquid biopsy test. The recent financing, which included investments by senior management and certain members of our Board of Directors, provided us with additional resources to advance the development of DetermaVu and demonstrates our management’s confidence in our ability to execute our plans."

Highlights

Appointed Albert P. Parker to the newly created position of Chief Operating Officer. Mr. Parker has had a distinguished career in the Life Sciences industry, including senior roles at companies such as Wyeth and Sunovian. He also has an extensive background in business development and creating partnerships with key industry players.

Generated encouraging study results for DetermaVu, OncoCyte’s lung cancer blood test, and selected a new, Next Generation Sequencing (NGS) clinical diagnostic testing platform. The platform has demonstrated consistent data and increased test performance.
Discovered, filed patent applications on, and tested a new set of 190 biomarkers which could help to distinguish malignant from benign lung nodules. OncoCyte’s most recent development work incorporated these newly discovered biomarkers into a new, next-generation version of DetermaVu. These biomarkers appear to be more robust than those used in the earlier biomarker panel and may enhance the utility and accuracy of DetermaVu. The use of the new biomarkers in combination with the existing biomarkers achieved encouraging results even without the inclusion of clinical data such as nodule size, while the original DetermaVu algorithm included nodule size as a contributing factor.
OncoCyte is planning to initiate a series of studies which if successful will lead to a prospective, blinded R&D Validation Study on approximately 250 patient samples to assess the performance of the second-generation algorithm on the new diagnostic testing platform. All the samples required for the R&D Validation Study are in-house and available for testing.
Completion of the R&D Validation Study is targeted for late 2018, and if the study is successful the Company will follow with an Analytical Validation Study and a CLIA Validation study in the Company’s CLIA laboratory. Then, OncoCyte plans to initiate a blinded prospective Clinical Validation Study of DetermaVu, which is the final step prior to commercialization. Completion of the Clinical Validation Study is targeted for the first half of 2019.
Second Quarter 2018 Financial Results

For the second quarter ended June 30, 2018, OncoCyte incurred a net loss of $4.5 million, or $0.12 per share, compared to a net loss of $3.8 million, or $0.13 per share, in the second quarter of 2017.

Operating expenses for the three months ended June 30, 2018 were $4.2 million, as reported, and were $3.0 million, on an as adjusted basis. The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the quarter ended June 30, 2018 were $2.3 million compared to $2.0 million for the same period in 2017, an increase of $0.3 million. The current quarter research and development expense includes a $0.6 million noncash impairment charge for noncore, therapeutic intangible assets mainly comprised of patents and patent rights that OncoCyte had acquired for therapeutic uses that it no longer plans to develop or commercialize. The impact of that impairment charge was partially offset by a decrease in laboratory expenses of $0.1 million and a decrease in stock-based compensation expense of $0.1 million.

General and administrative expenses for the three months ended June 30, 2018 were $1.3 million compared to $1.1 million for the same period in 2017, an increase of $0.2 million. This increase is primarily attributable to $0.1 million in stock-based compensation expense and $0.1 million in personnel and related expenses.

Cash used in operations was $3.96 million for the second quarter of 2018, which included approximately $0.8 million in aggregate cash payments for legal fees, financing related costs and bonuses paid for retention and performance.

At June 30, 2018, OncoCyte had $10.3 million of cash and cash equivalents in addition to marketable equity securities valued at $0.7 million. Subsequent to the end of the second quarter, OncoCyte received proceeds of $3.3 million, net of financing expenses, from an at-market registered direct offering of common stock and warrants.

Conference Call

OncoCyte will host a conference call today, August 14, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 800-458-4148; for international participants, the number is +1-323-794-2598. For all callers, please refer to Conference ID 5162879. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial +1-719-457-0820. Use the Conference ID 5162879. Additionally, the archived webcast will be available at View Source

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.

On August 14, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter and six-month period ended June 30, 2018 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, designed to enable cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, AUG 14, 2018, View Source [SID1234528871]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer, and its immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of ovarian cancer.

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"Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1. We expect to complete enrollment in our 550-patient global, pivotal Phase III OPTIMA Study in primary liver cancer and initiate patient enrollment in our 130-patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer during the third quarter," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We have a strong balance sheet and are well positioned financially to continue to advance these key programs, with several important announcements for both of our clinical programs expected over the next six to 12 months, including the final progression-free survival data from our OVATION I Phase IB clinical trial of GEN-1 and the first pre-planned interim analysis of the ThermoDox Phase III OPTIMA Study."

Recent Developments

ThermoDox Phase I Clinical Study Results Published in The Lancet Oncology. On July 10, 2018, the Company announced that results from a Phase I trial of ThermoDox were published in the peer-reviewed journal, The Lancet Oncology. Conducted by a multi-disciplinary team of biomedical engineers, oncologists, radiologists and anesthetists at the University of Oxford, United Kingdom, the trial evaluated the safety and efficacy of ThermoDox with focused ultrasound for the treatment of liver cancer.

Referred to as the TARDOX Study, the trial demonstrated that the ThermoDox plus focused ultrasound technique increased doxorubicin delivery to tumors between two- and ten-fold in the majority of patients in this 10-patient trial. A lysolipid thermally sensitive liposome encapsulating the chemotherapy agent, doxorubicin, ThermoDox is designed to release targeted levels of doxorubicin into and around liver tumors with heat activation. In this Phase I study, and consistent with the ThermoDox heat-activated design, the amount of drug passively reaching the tumor was low and estimated to be below therapeutic levels before ultrasound exposure. Following focused ultrasound application with ThermoDox, chemotherapy concentrations within the liver tumor were between two and ten times higher in seven out of 10 patients, with an average increase of 3.7 times across all patients.

The Phase I trial evaluated patients with inoperable primary or secondary liver tumors and who had previously received chemotherapy. The procedure was carried out under general anesthesia, and patients received a single intravenous dose of 50 mg/m2 of ThermoDox. The target tumor was selectively heated to over 39.5o C using an approved ultrasound-guided focused ultrasound device at the Churchill Hospital in Oxford. In six patients, the temperature at the target tumor was monitored using a temporarily implanted probe, while in the remaining four patients, ultrasonic heating was carried out non-invasively. Side effects were monitored for 30 days after the procedure, and apart from the existing side effects caused by general anesthetic and chemotherapy, no additional side effects were observed.

The TARDOX Study, supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust.

Data Monitoring Committee Unanimously Recommended Continuation of the OPTIMA Study in Primary Liver Cancer Following its Planned Safety and Data Review from 411 Patients. On April 9, 2018, the Company announced that the independent Data Monitoring Committee (DMC) for the Company’s 550-patient, pivotal Phase III clinical study of ThermoDox in combination with radiofrequency ablation (RFA) for primary liver cancer (the OPTIMA Study), unanimously recommended that the study continue according to protocol to its data readout. The DMC’s recommendation was based on the Committee’s assessment of safety and data integrity of the first 75% of patients randomized in the trial as of February 5, 2018 and concluded that the integrity of the study was intact and that ThermoDox was safe for continued enrollment of newly diagnosed, intermediate-stage patients. An analysis of blinded data from the intent-to-treat population, consolidated for both arms, indicated that median progression free survival (PFS) was 20.8 months. This compared favorably to the HEAT Study subgroup (285 patients treated with RFA greater than 45 minutes) median PFS of 19.7 months and was consistent with the hypothesis-generating estimates from the HEAT Study manuscript published in the October 2017 issue of the peer-reviewed medical journal, ‘Clinical Cancer Research.’ The OPTIMA Study’s design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.

The DMC analysis in April 2018 was the last planned interim analysis prior to enrollment completion, which is currently expected in the third quarter of 2018, with results from the first interim efficacy analysis expected in the first half of 2019.

Corporate Development

Raised $10 Million From A Strategic Loan Facility with Horizon Technology Finance Corporation. On June 28, 2018, the Company announced it entered into a $10 million loan agreement with Horizon Technology Finance Corporation which it drew down upon closing. The Company will use the funding provided under the agreement for working capital and advancement of its product pipeline, including ThermoDox and GEN-1, as well as other strategic initiatives designed to broaden its product pipeline. The funding is in the form of secured indebtedness bearing interest at a calculated LIBOR-based variable rate. Payments under the loan agreement are interest only for the first twenty-four (24) months after loan closing, followed by a 24-month amortization period of principal and interest through the scheduled maturity date.

Celsion Added to the Russell Microcap Index. On June 25, 2018, the Company was added to the Russell Microcap Index as part of the Russell indexes annual reconstitution, effective after the U.S. market opens today. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell U.S. Indexes primarily by objective, market-capitalization rankings and style attributes.

Financial Results

For the quarter ended June 30, 2018, Celsion reported a net loss attributable to common shareholders of $8.2 million, or a loss of $0.46 per share, compared to $4.9 million, or a loss of $0.79 per share, in the same period of 2017. Operating expenses were $8.1 million in the second quarter of 2018 compared to $4.7 million in the same period of 2017. During the second quarter of 2018, the Company incurred $3.2 million in non-cash stock option expense compared to $0.7 million in the same comparable period of 2017.

For the six-month period ended June 30, 2018, the Company reported a net loss attributable to common shareholders of $12.7 million, or a loss of $0.73 per share, compared to $10.4 million, or a loss of $1.75 per share, in the same six-month period of 2017. Operating expenses were $12.5 million during the first six months of 2018 compared to $9.6 million in the same period of 2017. During the first half of 2018, the Company incurred $3.4 million in non-cash stock option expense compared to $0.8 million in the same comparable six-month period of 2017.

Net cash used for operating activities was $8.8 million in the first six months of 2018, compared to $7.3 million in the same period in 2017. This was in line with our projected cash utilization for 2018 of approximately $16 million, averaging approximately $4 million per quarter. The Company ended the second quarter of 2018 with $26.3 million of total cash, cash equivalents, investment securities and interest receivable, which included the $10 million in gross proceeds from the Company’s new venture debt facility completed on June 27, 2018 with Horizon Technology Finance Corporation. The Company believes it has sufficient capital resources to fund its operations into the first half of 2020.

Research and development costs increased $1.6 million, from $3.0 million in the second quarter of 2017 to $4.6 million in the second quarter of 2018. Clinical development costs for the Phase III OPTIMA Study increased to $2.0 million in the second quarter of 2018, compared to $1.5 million in the second quarter of 2017. This $0.5 million increase was attributable to higher patient enrollment in this pivotal Phase III trial during the first half of 2018. Costs associated with the startup of the OVATION II Study were $0.1 million in the second quarter of 2018. Other costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development programs increased by $0.2 million in the second quarter of 2018 when compared to the same prior-year period. In the second quarter of 2018, the Company also incurred an increase of $0.7 million in non-cash stock compensation expense compared to the same period of 2017.

Research and development costs increased $0.8 million, from $6.5 million in the first six months of 2017 to $7.3 million in the first half of 2018. Clinical development costs for the Phase III OPTIMA Study increased to $3.3 million in the first half of 2018, compared to $3.0 million in the first half of 2017. This $0.3 million increase was attributable to higher patient enrollment in the pivotal Phase III trial during 2018. Costs associated with the startup of the OVATION II Study were $0.2 million in the first half of 2018. Other costs related to for clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development programs increased by $0.2 million in the first half of 2018 when compared to the same prior-year period. In the first half of 2018, the Company also incurred an increase of $0.8 million in non-cash stock compensation expense, compared to the same period of 2017. Partially offsetting these increased costs was a Company initiated plan in the first half of 2017 designed to reduce costs associated with the support of ThermoDox clinical studies and other initiatives in Europe. The majority of the $0.5 million in cost savings for personnel and support services in Europe were realized in the first half of 2017.

General and administrative expenses were $3.5 million in the second quarter of 2018, compared to $1.6 million in the same period of 2017. General and administrative expenses were $5.2 million in the first six months of 2018, compared to $3.1 million in the same period of 2017. These increases were primarily attributable to (i) an increase in non-cash stock compensation expense totaling $1.8 million in the second quarter and first half of 2018 when compared to the same periods in 2017 and (ii) an increase in professional fees of approximately $0.2 million primarily related to recruiting fees for several new positions to support the anticipated regulatory and commercialization efforts for ThermoDox.

During the three-months and six-months ended June 30, 2017, the Company recognized deemed dividends totaling $0.4 million related to multiple agreements with certain warrant holders, pursuant to which these warrant holders agreed to exercise, and the Company agreed to reprice, certain warrants. Warrants to purchase 790,410 shares of common stock were repriced at $2.70 and warrants to purchase 506,627 shares of common stock were repriced at $1.65. The Company received $3.0 million in gross proceeds from the sale of these repriced warrants.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss its second quarter 2018 financial results at 11:00 a.m. EDT on Tuesday August 14, 2018. To participate in the call, interested parties may dial 1-877-260-1479 (Toll-Free/North America) or +1-334-323-0522 (International/Toll) and ask for the Celsion Corporation Second Quarter 2018 Earnings Call (Conference Code: 1373876). Listeners are encouraged to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on Tuesday, August 14, 2018 and will remain available until Tuesday August 28, 2018. The replay can be accessed at 1-888-203-1112 (Toll-Free/USA) or +1-719-457-0820 (International/Toll) using Conference ID: 1373876. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT on Tuesday, August 14, 2018.

On August 14, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the second quarter ended June 30, 2018 (Press release, CohBar, AUG 14, 2018, View Source [SID1234528872]).

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"CohBar had a stellar second quarter as we joined the Russell 2000 Index, raised approximately $22 million and identified a novel mechanism of action of CB4211, our lead MBT candidate," said Simon Allen, CohBar CEO. "In early July, we accomplished a major milestone in CohBar’s transition to a clinical stage company by launching the first human study of a drug candidate based on a mitochondrial-derived peptide. We believe we are well positioned with additional funding to progress our lead program through the clinic, while ramping up our efforts to expand and extend our preclinical pipeline into new therapeutic areas."

Second Quarter and Recent Highlights:

●Initiated Clinical Study for CB4211. In early July, the company initated a Phase 1a/1b safety and biomarker study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity. CB4211 is the first mitochondria based therapeutic to enter clinical testing. The double-blind, placebo-controlled clinical study will initially assess the safety, tolerability, and pharmacokinetics of CB4211 following single and multiple-ascending doses in healthy subjects. The final Phase 1b stage of the study will be an assessment of safety, tolerability, and activity in obese subjects with non-alcoholic fatty liver diseases (NAFLD). Assessments will include changes in liver fat assessed by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity. Data from the study are expected to be available in early 2019.

●CB4211 Mechanism of Action Findings Presented at ADA Conference. The company presented preclinical data on the molecular mechanisms underlying CB4211’s efficacy in animal models of non-alcoholic steatohepatitis (NASH) at the ADA (American Diabetes Association) 78th Scientific Sessions in June. The poster presentation entitled: "CB4211 is a Potential Treatment for Metabolic Diseases with a Novel Mechansim of Action: Sensitization of the Insulin Receptor," provided in vitro support that CB4211 inhibits adipocyte lypolisis through an insulin-dependent mechanism, a process that is fundamental in the development of liver steatosis. (ADA poster may be viewed at: View Source)

●Completed $20 Million Equity Offering. In June, the company sold 2,186,855 shares of common stock at an average price of $9.14 per share under a Controlled Equity Offering program with Cantor Fitzgerald & Co. acting as sales agent. The company received aggregate gross proceeds of approximately $20 million, before commissions and other estimated offering expenses totaling approximately $0.7 million.

●Completed Private Placement. With the final closing in April, the company issued and sold a total of $3.9 million of non-convertible unsecured promissory notes, together with warrants to purchase 780,500 shares of the company’s common stock. Insider participation accounted for more than $500,000 of the financing.

●CohBar added to the Russell Indexes. On June 22, the company was added to the Russell 2000Ò and 3000Ò Indexes. The Russell 2000 Index serves as a leading benchmark for small-cap stocks in the United States.

●Philippe P. Calais PhD. Appointed to the CohBar Board. With an extensive background in pharmacology and over 30 years as a business executive in biotech and the pharmaceutical industry, Dr. Calais adds important strategic and drug development experience to the CohBar board.

During the second quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

●Dr. Cohen delivered a number of lectures during the quarter including the Schüeler Distinguished Lecture in Pharmacology, entitled "Mitochondrial Peptides" at Tulane University, New Orleans, LA, "Mitochondrial Systems Biology in Aging" at the Oklahoma GeroScience Symposium, "Mitohormesis and Mitochondrial Peptides" at the Yonsei University Mitochondrial Symposium, Seoul, South Korea, and "A kinesio-genomic SNP in MOTS-c is a diabetes risk factor in Japanese Men" addressed to the Japanese Endocrine Society. He also authored an article for Forbes entitled "How Universities Drive Innovation in Aging" and co-authored "Mitochondrial peptides modulate mitochondrial function during cellular senescence" published in Aging.

●Dr. Barzilai was a keynote speaker at multiple events including the "11th Diabetologists Conference and Drug Market Summit", New York, "The Oklahoma Geroscience Symposium" Oklahoma City, OK, "Aging Research Day" at the University of Rochester, Rochester, NY and "Target: Aging – Innovation in Research", Westchester BioTech Project, Westchester, NY. He also was symposium organizer and speaker at "SEBM: Can we Target Aging", in San Diego, CA.

Second Quarter 2018 Financial Highlights

●Cash and Investments. CohBar had cash and investments of $28,023,015 on June 30, 2018, compared to $8,452,459 on December 31, 2017.

●R&D Expenses. Research and development expenses were $1,832,459 in the three months ended June 30, 2018, compared to $1,274,634 in the prior year quarter. The increase was primarily due to costs of our clinical activities and an increase in stock-based compensation related to equity granted to consultants, offset by a decrease in costs related to the timing of IND-enabling activities.

●G&A Expenses. General and administrative expenses were $1,315,316 for the three months ended June 30, 2018, compared to $635,007 in the prior year quarter. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation related to option grants made in the current year quarter, an increase in accrued bonuses, and an increase in directors fees paid in the current quarter.

●Net Loss. For the three months ended June 30, 2018, net loss was $3,316,113, or $0.08 per basic and diluted share, compared to a net loss of $1,906,539, or $0.05 per basic and diluted share, for the three months ended June 30, 2017.

Second Quarter Investor Call Information

Date: August 14, 2018
Time: 2:00 p.m. Pacific Time

Dial-in U.S. and Canada: (800) 239-9838

Dial-in International: (323) 794-2551

Conference ID# 9205786

For individuals participating in the Investor Call, we kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 5:00 p.m. Pacific Time on August 14, 2018, through 9:00 p.m. Pacific Time on September 4, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 9205786. The audio replay will also be available at www.cohbar.com from August 14, through September 4, 2018.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. CB4211 entered a Phase 1a/1b clinical trial in mid-2018, which includes a potential activity readout relevant to NASH and obesity expected in early 2019. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On August 14, 2018 GT Biopharma Inc. (OTCQB: GTBP) and (Euronext Paris: GTBP.PA), an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary platforms, reported the Chief Executive Officer, Dr. Raymond W. Urbanski, will present at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, at 1:50pm (Press release, GT Biopharma , AUG 14, 2018, View Source [SID1234539525]).

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Dr. Urbanski’s presentation will provide a corporate overview and highlight the company’s proprietary technology platforms. These innovative platforms include the tri- and tetra-specific natural killer cell engagers (TriKEs and TetraKEs) as well as their bi-specific antibody drug conjugates. In addition, Dr. Urbanski will provide an update to their current clinical and preclinical programs.

Dr. Urbanski said, "We are very excited to present at the Wedbush PacGrow Healthcare Conference. Conferences such as this gives us the opportunity to engage with leading institutional investors and interact with other global companies. It also allows us to further demonstrate that GT Biopharma is at the forefront of immune-oncology therapeutics."

A webcast of the conference presentation will be available on the company website at gtbiopharma.com after the conference.