On August 14, 2018 Sesen Bio, Inc. (NASDAQ: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported pipeline updates and operating results for the second quarter ended June 30, 2018 (Press release, Eleven Biotherapeutics, AUG 14, 2018, View Source [SID1234528923]).

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"The first half of 2018 was full of successful milestones for Sesen Bio, and I am excited to have joined the company at such an important time in its evolution," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio, who was recently appointed on August 7, 2018. "The three-month data from the Phase 3 VISTA Trial demonstrate a strong complete response rate and favorable safety with Vicinium for high-grade non-muscle invasive bladder cancer, and we look forward to assessing twelve-month efficacy data in less than a year’s time. Now, with Fast Track designation for Vicinium, we are focused on advancing our engagement with the FDA, kicking off critical manufacturing readiness activities, initiating pre-commercial efforts and preparing for our very first BLA submission for Vicinium for this highly deserving patient population. I am very confident in what the future holds for Sesen Bio and look forward to delivering on the important milestones we have ahead."

Business Update

In June 2018, Sesen Bio completed an underwritten public offering of its common stock raising gross proceeds of approximately $46 million. The company believes this financing extends the company’s cash runway into 2020 based on its current operating plan.
Vicinium Program Updates

In August 2018, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive, high-grade non-muscle invasive bladder cancer (NMIBC). Fast Track designation is intended to expedite the development and review process of therapeutics that address unmet medical needs, including opportunities for more frequent interactions with the FDA.
In June 2018, the National Cancer Institute (NCI) initiated patient dosing in the Phase 1 trial of Vicinium in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, Imfinzi (durvalumab). The NCI is evaluating the combination under a Cooperative Research and Development Agreement, which was executed in June 2017.
In May 2018, Sesen Bio presented positive, three-month data from its ongoing Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG), during a plenary session at the American Urological Association Annual Meeting.
In the cohort of patients with carcinoma in situ (CIS) with or without papillary disease whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 39 percent. In evaluable patients in the cohort of patients with CIS with or without papillary disease whose cancer recurred after six months, but before 11 months, after their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 80 percent. This translates into a 42 percent complete response rate for the combined cohorts of CIS patients who were BCG-unresponsive within 12 months of their last BCG treatment.
In patients with papillary disease without CIS whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.
To date, Vicinium has been well-tolerated by patients in the VISTA Trial. Sesen Bio anticipates reporting twelve-month data from its Phase 3 VISTA Trial in mid-2019.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $62.9 million as of June 30, 2018, compared to $15.8 for the same period in 2017.
R&D Expenses: Research and development expenses were $2.8 million for the quarter ended June 30, 2018, compared to $2.9 million for the same period in 2017. This decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $2.4 million for the quarter ended June 30, 2018, compared to $2.2 million for the same period in 2017. This increase was due primarily to an increase in professional fees.
Net Loss: Net loss was $9.0 million, or $0.16 per share, for the quarter ended June 30, 2018, compared to net loss of $7.3 million, or $0.30 per share, for the same period in 2017.
Financial Guidance: Following the company’s public offering in June 2018, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.
About the VISTA Clinical Trial
The VISTA Trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS), which is cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) and/or papillary, which is cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue, who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease. Patients in the trial receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Twelve-month data are anticipated in mid-2019. To learn more about the Phase 3 VISTA Trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

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.