On November 7, 2017 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the three months ended September 30, 2017 (Press release, Galectin Therapeutics, NOV 7, 2017, View Source [SID1234521648]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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!

"All of the patients in our NASH Cirrhosis, NASH-CX Phase 2b Clinical Trial have completed all 52 weeks of infusions and 100% of the doses have been administered," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "The dropout rate was well below expectations, with 151 subjects out of the 162 enrolled having completed the full trial regimen. The data will be compiled and analyzed in expectation that we will meet our original target of reporting top line data in early December 2017."

Expected Upcoming Milestones

Company remains on track to report top line data from the NASH-CX Phase 2b Clinical Trial in December 2017.
Summary of Key Development Programs and Updates

Company is funded through February 2018, which is sufficient to report top line data of the NASH-CX Phase 2b Clinical Trial.
Dr. Peter G. Traber, M.D., the Company’s president, chief executive officer and chief medical officer was Chair of the Conference for NASH Summit Europe 2017, an industry nonalcoholic steatohepatitis (NASH) drug development forum that was held in Frankfurt, Germany from October 10-12, 2017.
The Company received a Decision to Grant from the Chinese Patent Office for its patent application for "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases," which, when issued, will extend composition of matter coverage of the Company’s lead compound, GR-MD-02, to China, where the prevalence of fatty liver disease has approximately doubled over the past two decades, with around 15% of the population experiencing NASH.
Financial Results

For the three months ended September 30, 2017, the Company reported a net loss applicable to common stockholders of $4.7 million, or $0.13 per share, compared with a net loss applicable to common stockholders of $4.5 million, or $0.16 per share, for the three months ended September 30, 2016. The decrease is largely due to lower general and administrative expenses and to lower stock compensation expenses.

Research and development expense for the three months ended September 30, 2017 was $3.5 million, compared with $3.3 million for the three months ended September 30, 2016. The increase primarily is primarily related to higher pre-clinical and drug manufacturing expenses.

General and administrative expense for quarter was approximately $900,000, compared with $1.2 million for the prior year, with the decrease being primarily related to lower investor relations and non-cash stock compensation expenses.

As of September 30, 2017, the Company had $7.0 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through December 31, 2017.

On November 7, 2017 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported recent events and financial results for the three and nine months ended September 30, 2017 (Press release, Regulus, NOV 7, 2017, View Source [SID1234521688]).

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!

Regulus Therapeutics Inc. Logo

"The third quarter was marked by the successful completion of our financing, as well as significant operational progress on our two clinical programs," said Jay Hagan, President and Chief Executive Officer of Regulus. "We are very pleased that both of our Alport studies are now active, the investigational new drug (IND) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) has been filed, and a Phase I study remains on track to initiate by year-end."

Third Quarter Corporate Highlights and Recent Events

In July 2017, Regulus completed a public offering of its common stock, and received net proceeds of approximately $43.0 million after deducting underwriting discounts, commissions and other offering expenses.
In September, Regulus initiated HERA, the Phase II randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of RG-012 in Alport syndrome patients. In parallel, the Phase I renal biopsy study was also initiated.
Recently, Regulus filed an IND application with the FDA for RGLS4326, targeting microRNA-17 for the treatment of ADPKD.
Third Quarter Financial Results

Cash Position: As of September 30, 2017, Regulus had cash, cash equivalents and short-term investments of $71.4 million.

Research and Development (R&D) Expenses: R&D expenses were $12.7 million and $42.7 million for the three and nine months ended September 30, 2017, respectively, compared to $14.6 million and $49.3 million for the same periods in 2016. The decrease in R&D expenses for the three months ended September 30, 2017 compared to 2016 was driven by the planned reduction in personnel-related costs as a result of our May 2017 corporate restructuring. The decrease in R&D expenses for the nine months ended September 30, 2017 compared to 2016 was primarily driven by the wind-down of clinical activities related to the RG-101 program.

General and Administrative (G&A) Expenses: G&A expenses were $2.7 million and $13.8 million for the three and nine months ended September 30, 2017, respectively, compared to $4.8 million and $13.6 million for the same periods in 2016. The decrease in G&A expenses for the three months ended September 30, 2017 compared to 2016 was attributable to the planned reduction in personnel-related costs and non-cash stock-based compensation.

Revenue: Revenue was less than $0.1 million for each of the three and nine months ended September 30, 2017, compared to $0.2 million and $1.2 million for the same periods in 2016.

Net Loss: Net loss was $15.8 million and $57.5 million for the three and nine months ended September 30, 2017, respectively, compared to a net loss of $19.5 million and $61.8 million for the same periods in 2016. Basic and diluted net loss per share was $0.18 and $0.88 for the three and nine months ended September 30, 2017, respectively, compared to $0.37 and $1.17 for the same periods in 2016.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss third quarter 2017 financial results and corporate highlights. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 9297128. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), conference ID 9297128. The webcast and telephone replay will be archived on the Company’s website following the call.

On November 7, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the company will be participating in the following upcoming investor conferences (Press release, Loxo Oncology, NOV 7, 2017, View Source [SID1234521631]):

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!

Stifel 2017 Healthcare Conference on November 14, 2017, in New York City. At 2:45 p.m. ET Joshua H. Bilenker, M.D., chief executive officer, will present a corporate overview.
Evercore ISI Biopharma Catalyst/Deep Dive Conference on November 30, 2017, in Boston. At 4:35 p.m. ET Joshua H. Bilenker, M.D., chief executive officer, and Jacob S. Van Naarden, chief business officer, will be participating in a fireside chat.
Live webcasts of the presentation and fireside chat will be available at View Source A replay of each webcast will be available on the company’s website for 30 days.

MabVax has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, MabVax, 2017, NOV 7, 2017, View Source [SID1234521697]).

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 7, 2017 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the third quarter ended September 30, 2017 (Press release, Compugen, NOV 7, 2017, View Source [SID1234521646]).

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!

"We are making important progress advancing our diverse pipeline as Compugen evolves into a clinical-stage company in 2018," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are completing CMC and IND-enabling activities necessary for the anticipated filing of our IND towards the end of the first quarter of 2018, and we are now working on finalizing the clinical protocol for our Phase I study, expected to start in 2018 and designed to test COM701 as a monotherapy and drug combination treatment. We are also concurrently advancing COM902 through preclinical testing with the aim of filing an IND in 2019.

"Our earlier-stage portfolio of novel myeloid targets is also progressing with newly disclosed data for certain of our programs suggesting their potential as drug targets for cancer immunotherapy. As previously announced, we are fortunate to have multi-year research collaborations with two leading academic institutions in the United States, the Johns Hopkins University School of Medicine and Mount Sinai Hospital in New York. These collaborations with world leading experts in immuno-oncology provide us with a broad and integrated infrastructure for testing the viability of our diverse set of target programs and advancing them to potentially serve as a basis for the development of new cancer immunotherapy treatments.

"We continue to hold discussions with potential industry partners with respect to the four program areas in our pipeline and we remain confident that we will achieve multiple collaborations. We cannot, however, predict the exact timing of completing any such collaboration, as most of our programs are novel and early stage, entailing a lengthy evaluation period by prospective partners, and are therefore taking longer than we originally anticipated to complete," concluded Dr. Cohen-Dayag.

Paul Sekhri, Chairman of the Board of Directors, added, "I’m excited to be working with the Compugen team and I am impressed by the Company’s promising novel immuno-oncology pipeline. The progress the Company has made in the last few years in advancing its internal development programs has positioned it well for future corporate growth. The Company’s predictive discovery platform generates promising targets and I am confident that Compugen’s pipeline has commercially valuable assets which will yield multiple collaboration agreements and bring first-in-class cancer immunotherapies to patients and physicians. I look forward to continue working with the Compugen team towards maximizing shareholder value and addressing unmet medical need."

Recent highlights:

Granted patent for COM701 under United States Patent and Trademark Office Moonshot Program.
Entered into a new research collaboration agreement with Mount Sinai Hospital in New York under the direction of Dr. Miriam Merad, a world leader in myeloid biology and a member of Compugen’s scientific advisory board (SAB).
Extended research collaboration with Johns Hopkins University School of Medicine under the direction of Prof. Drew Pardoll, chairman of the Company’s SAB.
Presented CGEN-15032, a newly-disclosed novel myeloid and epithelial immuno-oncology target, in an oral and a poster presentation at the 3rd annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) which took place September 6‑9, 2017 in Mainz/Frankfurt, Germany.
Entered into a process development and manufacturing service agreement with Bayer Healthcare LLC to produce COM902 for future use in clinical trials.
Financial Results
R&D expenses for the third quarter of 2017 and nine months ended September 30, 2017 were $7.6 million and $21.4 million, respectively, compared with $6.0 million and $18.2 million in the comparable periods in 2016. The increase primarily reflects expanded preclinical development activities involving our pipeline program candidates, mainly related to COM701 as well as COM902.

Net loss for the third quarter of 2017 was $9.9 million, or $0.19 per diluted share, compared with a net loss of $7.8 million, or $0.15 per diluted share, for the comparable period in 2016. Net loss for the nine months ended September 30, 2017 was $27.8 million, or $0.54 per diluted share, compared with a net loss of $23.0 million, or $0.45 per diluted share, for the comparable period in 2016.

As of September 30, 2017, cash and cash related accounts totaled $38.5 million, compared with $61.5 million as of December 31, 2016. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its third quarter 2017 results today, November 7, 2017, at 10:00 a.m. ET. To access the live conference call by telephone, please dial 1-888-281-1167 from the US, or +972-3-918-0644 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.