On November 13, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported business highlights and financial results for the third quarter and first nine months of 2017 (Press release, BeiGene, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316622 [SID1234521997]).

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"BeiGene has achieved several important milestones since the beginning of the third quarter. Our strategic collaboration with Celgene Corporation has transformed us into a commercial-stage company in China and is expected to enhance the potential of our investigational PD-1 inhibitor, BGB-A317. We have also made important clinical progress with the expansion of the global pivotal program for our BTK inhibitor BGB-3111, the initiation of the first Phase 3 study for BGB-A317 in China, and the completion of patient enrollment of our first China pivotal trials for both BGB-3111 and BGB-A317. In addition, we strengthened our balance sheet with the upfront payment and investment from Celgene as well as our public offering in August," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Looking ahead, we plan to present additional data on BGB-3111 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. We also look forward to initiating additional pivotal trials for our portfolio assets in the coming months," commented Mr. Oyler.

Third Quarter 2017 and Recent Business Highlights

Clinical Programs:

BGB-3111, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

• Completed enrollment in the pivotal Phase 2 trial in China of BGB-3111 in relapsed/refractory mantle cell lymphoma;

• Initiated the following trials:

Global Phase 3 trial of BGB-3111 compared to bendamustine and rituximab in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma patients;

Global pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA (obinutuzumab) in relapsed or refractory follicular lymphoma patients; and

Pivotal Phase 2 trial in China of BGB-3111 in Waldenström’s macroglobulinemia.
BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

• Presented data from patients with gastric cancer, esophageal cancer, head and neck squamous cell carcinoma, and ovarian cancer enrolled in the global Phase 1 trial of BGB-A317 in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress;

• Presented preliminary Phase 1 data on BGB-A317 in Chinese patients with advanced tumors at the 20th Annual Meeting of the Chinese Society of Clinical Oncology;

• Completed enrollment in the pivotal Phase 2 trial of BGB-A317 in China in relapsed/refractory classical Hodgkin’s lymphoma;

• Completed enrollment in the global Phase 1a/1b trial of BGB-A317 in advanced tumors with a total of over 450 patients;

• Initiated the following trials:

Phase 3 trial in China of BGB-A317 as a second- or third-line treatment for patients with advanced lung cancer;

Pivotal Phase 2 trial in China of BGB-A317 in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer;

Phase 2 trial in China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and

Phase 2 trial in China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.
BGB-290, an investigational small molecule PARP inhibitor

• Presented updated data from the global Phase 1 trial of BGB-290 in patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) 2017 Congress;

• Initiated the following trials:

Global Phase 1 trial of BGB-290 in combination with temozolomide in locally advanced or metastatic solid tumors; and

Global Phase 1b/2 trial of BGB-290 in combination with radiation therapy and/or temozolomide in glioblastoma.
Corporate Development:

• Closed our global strategic collaboration with Celgene Corporation.

Expected Upcoming Milestones

BGB-3111 (BTK Inhibitor)

• Present additional Phase 1 data for BGB-3111 in non-Hodgkin’s lymphoma, updated Phase 1 data for the combination of BGB-3111 and Gazyva (obinutuzumab), and initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, GA, December 9-12, 2017.

BGB-A317 (PD-1 Antibody)

• Present initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th ASH (Free ASH Whitepaper) Annual Meeting in Atlanta, GA, December 9-12, 2017; and

• Initiate Phase 3 trials of BGB-A317 in China in the fourth quarter of 2017 or the first quarter of 2018.

BGB-290 (PARP Inhibitor)

• Initiate a pivotal trial in China in the fourth quarter of 2017.

Third Quarter 2017 Financial Results

Cash, Cash Equivalents, and Short-Term Investments were $757.44 million as of September 30, 2017, compared to $407.43 million as of June 30, 2017 and $368.17 million as of December 31, 2016. The increase in the quarter was primarily attributable to the Celgene strategic collaboration. Funding from Celgene includes upfront licensing fees of $263.00 million, $92.05 million of which was received as of September 30, 2017 and the rest of which is payable in the fourth quarter of 2017, and an equity investment of $150.00 million. In addition, net proceeds from our August 2017 follow-on public offering contributed $188.52 million, after deducting underwriting discounts and offering-related expenses. These were partially offset by cash used in operating activities and for capital expenditures during the three months ended September 30, 2017.

The Company consolidates the BeiGene Biologics joint venture in its consolidated financial statements. As of September 30, 2017, cash, cash equivalents and short-term investments included $141.64 million of cash held by BeiGene Biologics.

Cash provided by operations for the three months ended September 30, 2017 was $6.60 million, compared to a use of cash of $24.28 million for the same period in 2016. The increase in cash flow from operating activities was primarily attributable to upfront licensing fees of the Celgene collaboration, which offset increased research and development (R&D) and selling, general and administrative (SG&A) expenses in the period. Capital expenditures for the quarter ended September 30, 2017 were $18.79 million, including $13.94 million attributable to BeiGene Biologics, compared to $6.68 million for the same period in 2016. The increase was primarily attributable to increased investment in our manufacturing facilities in Guangzhou and Suzhou.

Revenue for the three months ended September 30, 2017 was $220.21 million, compared to nil in the same period in 2016, and was comprised of $8.82 million of net product revenue and $211.39 million of collaboration revenue. The product revenues represent net product sales of Abraxane and Revlimid in China following the effective date of the Celgene transaction, August 31, 2017. The collaboration revenue recognized in the period relates to the upfront fee allocated to the BGB-A317 license element of the arrangement.

R&D Expenses for the three months ended September 30, 2017 were $87.66 million, compared to $30.11 million in the same period in 2016. The increase was primarily attributable to increased spending on clinical activities and manufacturing for BGB-3111, BGB-A317, and BGB-290 due to expansion of ongoing clinical programs and increased employee compensation-related expenses as a result of increased headcount to support a broader clinical program. R&D-associated share-based compensation expense was $10.38 million for the three months ended September 30, 2017, compared to $2.14 million for the same period in 2016, primarily due to increased headcount, higher share price, and increased expense attributable to non-employee consultant awards.

SG&A Expenses for the three months ended September 30, 2017 were $15.64 million compared to $4.72 million in the same period in 2016. The increase was primarily attributable to increased employee compensation-related expenses as a result of increased headcount, including personnel costs for the employees transferred from Celgene China and higher share price as well as higher professional service fees, including legal, finance and accounting fees related to the Celgene transaction, patent prosecution activities and costs to support our growing operations. In addition, SG&A-associated share-based compensation expense was $2.95 million for the three months ended September 30, 2017, compared to $0.64 million for the same period in 2016.

Net Income attributable to BeiGene, Ltd. for the three months ended September 30, 2017 was $117.39 million compared to a net loss of $35.49 million in the same period in 2016.

On November 13, 2017 Cellectis S.A. (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported its results for the three-month period ended September 30, 2017 and for the nine-month period ended September 30, 2017 (Press release, Cellectis, NOV 13, 2017, View Source [SID1234521998]).

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Earnings Call Details

Cellectis will host an earnings call on November 14, 2017 at 8:30am Eastern Time to discuss its financial results and provide a general business update.

Dial-In Numbers:

Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104

Live PARTICIPANT Dial-In (International): +1 201-493-6792

Replay Information:

Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): +1 201-612-7415

Expiration Date: 11/28/17

Webcast URL (Archived for 6 months): http://cellectis.equisolvewebcast.com/q3-2017

Third Quarter 2017 and Recent Highlights

Cellectis – Therapeutics

UCART123: Cellectis’ TALEN gene-edited, allogeneic CAR T product candidate in AML and BPDCN Patients

As of November 6, 2017, Cellectis announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on both Phase 1 trials of UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). In connection with the lifting of the clinical hold, Cellectis agreed with the FDA to certain revisions to be implemented in Phase 1 UCART123 protocols. Cellectis is currently working with the investigators from Weill Cornell Medicine New York – Presbyterian Hospital and MD Anderson Cancer Center to obtain approval of the revised protocols from their respective institutional review boards in order to resume patient enrollment.

UCART19: TALEN gene-edited, allogeneic CAR T product candidate in ALL patients, exclusively licensed to Servier

Preliminary results of the first-in-human clinical trials of UCART19 will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (the "ASH Annual Meeting") to be held from December 9 to 12, 2017 in Atlanta, GA. Results from the UCART19 clinical trial in adult ALL patients will be presented orally by Reuben Benjamin, principal investigator for the trial and consultant hematologist at King’s College Hospital, United Kingdom. Results from the UCART19 clinical trial in pediatric ALL patients will be presented during a poster session by Waseem Qasim, principal investigator for the trial and consultant in pediatric immunology and reader in cell and gene therapy at Great Ormond Street Hospital for Children, United Kingdom.

UCARTCS1, UCART22 & UCART123

Three abstracts regarding other Company’s off-the-shelf CAR T product candidates have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting:

UCARTCS1: Universal SLAMF7-Specific CAR T-Cells As Treatment for Multiple Myeloma (oral presentation)
UCART22: Pre-clinical Activity of Allogeneic Anti-CD22 CAR T-Cells for the Treatment of B-cell Acute Lymphoblastic Leukemia (oral presentation)
UCART123 product candidate targeting Blastic Plasmacytoid Dendritic Cell Neoplasm (poster presentation)

Corporate Governance

On October 4, 2017, Mathieu Simon M.D., Executive VP and Chief Operating Officer, as been appointed as Interim Chief Medical Officer. In accepting this position, Dr. Simon assumes the responsibilities of Loan Hoang-Sayag, who left Cellectis to pursue other professional opportunities. Effective on October 11, 2017, Dr. Simon also resigned from his position as a member of the board of directors in order to focus on his additional responsibilities as Interim Chief Medical Officer.

Calyxt, Inc. – Cellectis’ plant science subsidiary

Products

Calyxt’s herbicide-tolerant wheat, its third wheat product candidate, and improved oil composition canola, its first canola product candidate, have advanced to Phase 1 of development. With these phase advancements, Calyxt now has a total of nine product candidates in Phase 1 of development or later across its five crops: soybeans, wheat, canola, potatoes and alfalfa.

The first of Calyxt’s two alfalfa product candidates has been designated as a non-regulated article under the "Am I Regulated?" Process by Biotechnology Regulatory Services of the Animal and Plant Health Inspection Service (APHIS), an agency of the USDA. The improved quality alfalfa is the sixth Calyxt product candidate to be confirmed as a non-regulated article by the USDA including its high oleic soybean, high oleic / low linolenic soybean, powdery mildew resistant wheat, cold storable potatoes and reduced browning potatoes.

Corporate

Initial Public Offering: On July 25, 2017, Calyxt completed an initial public offering of its common stock, selling an aggregate of 8,050,000 shares of common stock at a price of $8.00 per share (including 1,050,000 shares of common stock pursuant to the exercise by the underwriters of their option to purchase additional shares). Calyxt received net proceeds of approximately $58.0 million, after deducting underwriting discounts and commissions and offering expenses. As part of the IPO, Cellectis purchased 2,500,000 shares of common stock for a value of $20.0 million, which is included in the net proceeds that Calyxt received. Calyxt used $5.7 million of the proceeds to cover a portion of the outstanding obligations owed to Cellectis. Following Calyxt’s IPO, Cellectis owns 79.8% of the outstanding Calyxt’s common shares.

Sale Leaseback Transaction: On September 6, 2017, Calyxt consummated a sale-leaseback transaction including a lease agreement between Calyxt and a third party with respect to the Calyxt’s lease of certain real property and improvements located in Roseville, Minnesota for a term of twenty years with option to extend the term for up to an additional twenty years.

Headquarters Construction: Calyxt has broken ground on its new 40,000-square-foot headquarters, which will be housed on the 11-acre site in Roseville, together with state-of-the-art research completed approximately 11,000-square-foot greenhouses.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("GAAP").

Effective in the third quarter of 2017, Cellectis changed the presentation currency of its consolidated financial statements from the euro to the U.S. dollar, in order to enhance comparability with peers, which primarily present their financial statements in U.S. dollar.

Third quarter 2017 Financial Results

Cash: As of September 30, 2017, Cellectis had $304.1 million in total cash, cash equivalents and current financial assets compared to $271.2 million as of June 30, 2017. This increase of $32.9 million reflects (i) an increase of $38.0 million attributable to Calyxt IPO, (ii) the net cash provided by investing activities of $6.1 million included $7.0 million of proceeds from Calyxt’s sale leaseback transaction and (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $3.1 million; partially offset by (iv) the net cash flows used by operating activities of $15.5 million.

Cellectis expects that its cash, cash equivalents and current financial assets of $304.1 million as of September 30, 2017 will be sufficient to fund its current operations into 2020.

Revenues and Other Income: During the quarters ended September 30, 2016 and 2017, we recorded $12.6 million and $7.3 million, respectively, in revenues and other income. This decrease of $5.4 million is mainly due to (i) a $5.0 million decrease in collaboration revenues of which $4.0 million represented revenue from payments by Servier during the quarter ended September 30, 2016 for the supply of raw materials and batches of UCART19 products, that did not recur during the quarter ended September 30, 2017, $0.6 million represented decreased recognition of upfront already paid to Cellectis and a $0.3 million decrease in research and development cost reimbursements, (ii) a $0.2 million decrease in license revenue and (iii) a $0.2 million decrease in research credit tax.

Total Operating Expenses: Total operating expenses for the third quarter of 2017 were $33.0 million, compared to $25.5 million for the third quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were $12.8 million and $13.5 million, respectively.

R&D Expenses: For the quarters ended September 30, 2016 and 2017, research and development expenses increased by $4.9 million from $15.4 million in 2016 to $20.3 million in 2017. Personnel expenses decreased by $2.1 million from $10.3 million in 2016 to $8.1 million in 2017, primarily due to a $2.3 million decrease in non-cash stock based compensation expense, partly offset by a $0.2 million increase in wages and salaries. Purchases and external expenses increased by $6.8 million from $4.9 million in 2016 to $11.7 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses for process development and expenses associated with the use of laboratories and other facilities. Other expenses increased by $0.2 million for the third quarter of 2017 compared to the third quarter of 2016.

SG&A Expenses: During the quarters ended September 30, 2016 and 2017, we recorded $9.7 million and $12.2 million, respectively, of selling, general and administrative expenses. The increase of $2.4 million primarily reflects an increase of $2.2 million in personnel expenses from $7.4 million to $9.6 million, attributable, among other things, to an increase of $0.5 in wages and salaries and an increase of $1.6 million in non-cash stock-based compensation expense, as well as an increase of $0.3 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was $1.2 million for the third quarter of 2016 compared with a financial loss of $3.4 million for the third quarter of 2017. The change in financial result was primarily attributable to an increase in net foreign exchange loss of $3.2 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts, partially offset by an increase of $0.8 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and an increase of $0.2 million in interest received from our financial investment.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended September 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $14.1 million (or $0.40 per share on both a basic and a diluted basis) and net loss attributable to shareholders of Cellectis of $26.2 million (or $0.73 per share), respectively. Adjusted loss attributable to shareholders of Cellectis for the third quarter of 2017 was $13.3 million ($0.37 per share) compared to adjusted loss attributable to shareholders of Cellectis of $0.5 million ($0.02 per), for the third quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis for the third quarter of 2017 and 2016 excludes non-cash stock-based compensation expense of $12.8 million and $13.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted income (loss) attributable to shareholders of Cellectis.

First Nine Months 2017 Financial Results

Cash: As of September 30, 2017, Cellectis had $304.1 million in total cash, cash equivalents and current financial assets compared to $ 291.2 million as of December 31, 2016. This increase of $12.9 million primarily reflects (i) the proceeds of $38.0 million as part of the Calyxt IPO, (ii) the net cash provided by investing activities of $2.3 million which includes $7.0 million of proceeds from Calyxt’s sale leaseback transaction and (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $13.1 million; partially offset by the net cash flows used by operating activities of $42.8 million.

Revenues and Other Income: During the nine-month period ended September 30, 2016 and 2017, we recorded $43.5 million and $26.7 million, respectively, in revenues and other income. This decrease of $16.8 million is mainly due to (i) a $16.9 million decrease in collaboration revenues of which $8.5 million represented one-time milestones revenues received during the second quarter of 2016 with the first patient dosed in the Phase 1 clinical trial for UCART 19, $4.8 million represented decreased recognition of upfront fees already paid to Cellectis and $1.5 million represented decrease in research and development cost reimbursements and $2.2 million represented decreased revenue from payment by Servier for the supply of raw materials and batches of UCART19 products, and (ii) a $0.4 million decrease in other licenses revenue, partially offset by (iii) an increase of $0.5 million in research tax credits.

Total Operating Expenses: Total-operating expenses for the nine-month period ended September 30, 2017 were $91.8 million, compared to $90.3 million for the nine months ended September 30, 2016. The non-cash stock-based compensation expenses included in these amounts were $38.9 million and $44.5 million, respectively.

R&D Expenses: For the nine months ended September 30, 2016 and 2017, research and development expenses increased by $0.3 million from $58.3 million in 2016 to $58.5 million in 2017. Personnel expenses decreased by $8.5 million from $36.4 million in 2016 to $27.9 million in 2017, primarily due to a $6.7 million decrease in non-cash stock based compensation expense, and a $1.9 million decrease in social charges on stock options grants partly offset by a $0.1 million increase in wages and salaries. Purchases and external expenses increased by $8.4 million from $20.7 million in 2016 to $29.1 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses for process development and expenses associated with the use of laboratories and other facilities. Other expenses increased by $0.4 million for the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016.

SG&A Expenses: During the nine months ended September 30, 2016 and 2017, we recorded $31.1 million and $31.8 million, respectively, of selling, general and administrative expenses. The increase of $0.8 million primarily reflects (i) an increase of $1.1 million in personnel expenses from $23.9 million to $25.0 million, attributable to a $1.6 million increase in wages and salaries, a $1.1 million increase in non-cash stock based compensation expense, partly offset by a decrease of $1.6 million of social charges on stock options grants, (ii) a $0.2 increase in other expenses, partially offset by a $0.5 million decrease in purchases and external expenses.

Financial Gain (Loss): The financial loss was $7.1 million for the nine months ended September 30, 2016 compared with financial loss of $10.0 million for the nine months ended September 30, 2017. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts for $7.3 million partially offset by the fair value adjustment on our derivative instrument and financial current asset for $4.2 million and the interest received from our financial investment for $0.2 million.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the nine months ended September 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $53.9 million (or $ 1.53 per share) and a net loss attributable to shareholders of Cellectis of $72.3 million (or $2.03 per share), respectively. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2017 was $33.3 million ($0.94 per share) compared to adjusted loss attributable to shareholders of Cellectis of $9.4 million ($0.27 per share), for the nine months ended September 30, 2016. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2017 and 2016 excludes a non-cash stock-based compensation expense of $38.9 million and $44.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

On November 13, 2017 CohBar, Inc. (OTCQX: CWBR and TSXV: COB.U) ("CohBar" or the "Company"), an innovative biotechnology company focused on developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the third quarter ended September 30, 2017 (Press release, CohBar, NOV 13, 2017, View Source [SID1234522000]).

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"The third quarter was significant for CohBar as we raised new capital, selected CB4211 for clinical studies, and designed a new Phase 1a/b clinical strategy to accelerate activity readouts," said Simon Allen, CohBar CEO. "By extending our phase 1 trial to include obese subjects with NAFLD, we can potentially accelerate activity readouts by more than a year compared to a standard phase 2 follow-on study. At the same time, several new peptides are demonstrating significant early stage potential for treating neurodegenerative diseases, Type 2 diabetes, and several cancer types, further evidencing the potential of the mitochondrial genome as a source of therapeutic peptides for a wide range of age-related diseases. We continue to focus on initiating our ‘first mitochondrial based therapeutic in human’ trial with CB4211 next year, while further optimizing and validating the potential of a number of our new peptides as possible clinical candidates."

Preclinical Developments and Business Highlights

● Expanded Lead Clinical Program. During the quarter, CohBar selected CB4211 as its lead clinical candidate for nonalcoholic steatohepatitis (NASH) and obesity, and continued to advance it through IND-enabling activities. More recently, the Company expanded its clinical plan with the addition of a phase 1b study to include obese subjects with NAFLD, in order to substantially accelerate activity readouts relevant to NASH and obesity.

● Presented Preclinical Data on CB4209 and CB4211 at AASLD Liver Meeting in October 2017. The Company presented previously undisclosed data from its lead candidate program in a poster entitled "CB4209 and CB4211 Reduce the NAFLD Activity Score in the STAM Model of NASH, Reduce Triglyceride Levels, and Induce Selective Fat Mass Loss in DIO Mice." CohBar scientists and their collaborators provided in vitro evidence that CB4209 and CB4211 regulate adipocyte lipolysis, a process that is foundational in the development of liver steatosis. The data corroborates previous in vivo evidence of anti-steatotic effects of the peptides on livers of mice on a high fat diet, where a corresponding reduction in circulating fat and biomarkers of liver damage was observed. The poster presentation can be viewed at www.cohbar.com.

● New CohBar Mitochondrial-Derived Peptides (MDPs). Using its proprietary technology platform, the Company identified a novel analog of a mitochondrial-derived peptide demonstrating early stage therapeutic potential for neurodegenerative diseases such as Alzheimer’s Disease, in addition to other recently identified MDPs showing therapeutic potential for Type 2 diabetes and cancer. These peptides are early stage analogs of previously unexplored natural peptides encoded within the mitochondrial genome which were identified by the Company’s mitochondrial genome mining activities. CohBar also filed provisional patent applications related to these natural peptides and their analogs.

● Mining the Mitochondrial Genome. The Company completed its comprehensive investigation of the mitochondrial genome, which identified previously unexplored peptides with therapeutic potential. To date, these discovery efforts have resulted in the identification of more than 100 new peptides, which are currently being evaluated for therapeutic potential, and prioritized for further development.

● Intellectual Property. The Company filed a PCT patent application covering its clinical candidate CB4211 as well as CB4209 and other analogs of MOTS-c with claims directed to both composition-of-matter and methods of use. To date, CohBar has filed more than 65 US and International patent applications.

● Pharma Partnering Activities. CohBar’s senior management together with advisor Torreya Partners continued to interact with major pharma companies as part of the Company’s expanded partnering program, including meetings with potential partners at the BIO Investor Forum in San Francisco in October, 2017.

● Investment Community Outreach. CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the Rodman & Renshaw 19th Annual Global Investment Conference in New York in September, 2017.

● Completed $5.2 Million Private Placement. During the quarter the Company completed a private placement issuing 3,438,053 units at a price of $1.50 per unit for total proceeds of approximately $5.2 million. Each unit consisted of one share of the Company’s common stock and one common stock purchase warrant exercisable at $2.25 per warrant.

During the third 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 lecture entitled "Nutrigenomics Meets the Mitochondria" at the 11th Congress of the International Society of Nutrigenetics and Nutrigenomics. He was also named one of PBS-Next Avenue’s Top 50 Influencers in Aging, and was elected to the USC Chapter of the National Academy of Inventors.

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● Dr. Barzilai was a featured presenter on the topic "Targeting Aging with Metformin (TAME)" at the 21st IAGG World Congress of Gerontology and Geriatrics. He was also a panelist at the AFAR 2017 Luncheon Awards’ "The Architects of Aging", a symposium in biotechnology and longevity, and a keynote speaker at the 4th Human Genetics Conference in New York. During the quarter, the NBC Today Show showcased Dr. Barzilai in a segment with correspondant Maria Shriver discussing the TAME (Targeting Aging with Metformin) Trial, and Dr. Barzilai’s TEDMED talk entitled "Can We Grow Older Without Growing Sicker" was released to the public.

Third Quarter 2017 Financial Highlights

● Cash and Investments. CohBar had cash and investments of $10,342,242 on September 30, 2017, compared to $8,686,420 on December 31, 2016.

● Note Payable. During the three months ended September 30, 2017, the Company paid $117,274 to the Alzheimers Drug Discovery Foundation as the final payment on its note payable. As of September 30, 2017, the Company had no debt on its balance sheet.

● R&D Expenses. Research and development expenses were $2,316,454 in the three months ended September 30, 2017 compared to $1,056,429 in the prior year quarter. The increase was due primarily to the costs related to our IND-enabling activities for advancing our lead drug candidates into clinical studies, an increase in stock-based compensation related to the fair value of new grants, and the revaluation performed at each balance sheet date of equity granted to consultants.

● G&A Expenses. General and administrative expenses were $549,505 in the three months ended September 30, 2017, compared to $598,507 in the prior year quarter. The decrease was primarily due to lower professional fees, since legal costs associated with our patents were capitalized, and we previously had a non-recurring recruiting fee in the prior year quarter.

● Net Loss. For the three months ended September 30, 2017, net loss was $2,861,107, or $0.07 per basic and diluted share, compared to a net loss of $1,653,729, or $0.05 per basic and diluted share, for the three months ended September 30, 2016.

Third Quarter Investor Call Information

Date: November 13, 2017
Time: 2:00 p.m. (Pacific Time)
Dial-in U.S. and Canada: 1-888-599-8667
Dial-in International: 1-719-325-2494
Conference ID# 6432383

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Slide Presentation – www.webex.com, click on the ‘Join’ button and enter Meeting Number 921656999 and Password Q3Call.

For individuals participating in the Investor Call and Slide Presentation, we request you please call into the audio and log into WebEx approximately 10 minutes before the start of the presentation so that we can begin promptly.

An audio recording of the call will be available beginning at 6:00 p.m. (Pacific Time) on November 13, 2017, through 9:00 p.m. (Pacific Time) on November 27, 2017. To access the recording please dial 1-844-512-2921 in the U.S. and Canada or 1-412-317-6671 internationally and reference Conference ID# 6432383.

The audio replay along with the slide presentation will also be available at www.cohbar.com beginning November 14, 2017 through November 27, 2017.

About CohBar’s Lead Program

CohBar’s lead preclinical development program is based on MOTS-c, a mitochondrial-derived peptide discovered in 2012 by the Company’s founders and their academic collaborators, whose research has shown that MOTS-c plays a significant role in the regulation of metabolism. The Company has developed novel, improved analogs of the MOTS-c peptide, CB4209 and CB4211, which have demonstrated significant therapeutic potential in preclinical models of obesity and nonalcoholic steatohepatitis (NASH).

On November 13, 2017 CTI BioPharma Corp. presents Corporate Presentation (Presentation, CTI BioPharma, NOV 13, 2017, View Source [SID1234522001]).

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!

On November 13, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the first quarter ended September 30, 2017 (Press release, DelMar Pharmaceuticals, NOV 13, 2017, View Source [SID1234522002]). DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 14, 2017 at 4:30 p.m. Eastern Standard Time.

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!

KEY DEVELOPMENTS

Initiated the STAR-3 pivotal Phase 3 clinical trial of VAL-083 in refractory GBM and enrolled its first patient.
Initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM.
Received a notice of allowance from the FDA to commence with a Phase 1/2 VAL-083 REPROVe clinical trial in platinum-resistant ovarian cancer.
Presented new data and promising research results at peer-reviewed scientific meetings supporting the potential of VAL-083 in the glioblastoma and ovarian cancer treatment landscape.
Granted a new patent from the U.S. Patent and Trademark Office covering improved analytical methods related to the manufacturing of VAL-083.
Completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million.
"I am extremely pleased with the progress achieved this past quarter across clinical and corporate development fronts. As we transition to a late stage development company with a balanced pipeline of oncology indications, including a pivotal Phase 3 study, I am looking forward to playing an integral role in guiding the company to its next phase of growth," commented Saiid Zarrabian, Interim Chief Executive Officer.

The first quarter of 2018 proved to be an important period for the clinical development of the VAL-083 pipeline of therapeutic candidates. In July, the Company initiated its pivotal Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") and during the quarter enrolled our first patient. The STAR-3 GBM trial is an adaptive design, randomized, controlled, pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and Avastin, for whom there is currently no standard-of-care therapy. A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive VAL-083 or "investigator’s choice salvage therapy" in a 2:1 fashion. The primary endpoint of the trial is overall survival of VAL-083 versus a control arm consisting of physician’s choice of temozolomide, lomustine or carboplatin chemotherapy. The statistical design between the two arms of the study is 90% power, and includes an interim analysis at 50% of events.

In September, DelMar initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM. The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population. The primary efficacy endpoint of this trial is progression free survival (PFS). Results will be used to guide the design of global randomized studies, which if successful, will position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) in newly diagnosed GBM patients, particularly for the approximately 2/3 of patients whose tumors feature MGMT-unmethylated GBM. Patients with an unmethylated-MGMT promoter express high levels of MGMT, which inhibits the anti-tumor activity of temozolomide, the current standard-of-care chemotherapy used in the treatment of GBM, resulting in treatment resistance and poor patient outcomes.

Also in September, the Company received a notice of allowance from the FDA to commence with a multi-center Phase 1/2 Study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer ("VAL-083 REPROVe Trial"). Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. The American Cancer Society estimates that in 2017, approximately 22,440 women in the US will be diagnosed with ovarian cancer and approximately 14,080 will die from their disease. The majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. DelMar plans to initiate the REPROVe trial as soon as practicable.

Throughout the period, DelMar presented new data and promising research results supporting the therapeutic potential of VAL-083 at peer-reviewed scientific conferences. Highlights included, presenting data supporting the effectiveness of VAL-083 in the treatment of GBM at the annual meetings of the American Society for Clinical Oncology ("ASCO"), the American Association of Cancer Research ("AACR"), the World Federation of NeuroOncology Societies ("WFNOS"), the European Association for NeuroOncology and the recent AACR (Free AACR Whitepaper) Special Conference on Ovarian Cancer.

On the corporate development front, DelMar continued to enhance its operational capabilities and overall positioning. In September, the U.S. Patent and Trademark Office granted DelMar a new patent covering improved analytical methods related to manufacturing of VAL-083. The patent strengthens the Company’s control over VAL-083’s manufacturing process. VAL-083 is currently protected by eight US patents and eight patents outside of the US, with issued claims providing patent protection into 2033 in the United States.

In April and September, DelMar completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million. The Company intends to use the net proceeds of these offerings for clinical trials and general corporate purposes, which may include working capital, capital expenditures, research and development and other business initiatives

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2017

At September 30, 2017, the Company had cash and clinical trial deposits on hand of approximately $14.1 million (unaudited).

For the quarter ended September 30, 2017, the Company reported a net loss of $2,666,406 or $(0.18) per share, compared to a net loss of $2,290,339, or $(0.23) per share, for the quarter ended September 30, 2016.

The following represents selected financial information as of September 30, 2017. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis ("MD&A"), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Excluding the impact of non-cash expense, research and development expenses increased to $1,939,617 during the current quarter compared to $676,892 for the same period in the prior year. The increase was largely attributable to VAL-083 clinical development and manufacturing costs related to the Company’s pivotal STAR-3 refractory-GBM clinical trial and two Phase 2 clinical trials in MGMT-unmethylated GBM, all of which were initiated during the past 9 months.

Excluding the impact of non-cash expenses, general and administrative expenses decreased in the quarter ended September 30, 2017 to $676,258 compared to $726,414 for the quarter ended September 30, 2016.

Based on current estimates, the Company believes that it will be able to fund operations beyond the next 12 months.

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss its financial results for the quarter ended September 30, 2017 and provide a corporate update on Tuesday, November 14, 2017, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1 866 831 8713 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.