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BioTime to Participate in Upcoming Conferences

On November 13, 2017 BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases, reported that its management will participate in the following conferences (Press release, BioTime, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316395 [SID1234521958]):

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Torrey Hills Capital Emerging Growth Conference on Tuesday, November 14, 2017. This conference is being held at the Morgan Run Club and Resort in Rancho Santa Fe, CA.
LD Micro 10th Annual Main Event Conference on Wednesday, December 6, 2017. This conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.
At each conference mentioned above the Company will be hosting one-on-one and group meetings throughout the day. Analysts and portfolio managers that wish to attend the conference or would like to request a meeting should contact Torrey Hills Capital or LD Micro.

Repros Therapeutics Inc.® Reports Third Quarter 2017 Financial Results

On November 13, 2017 Repros Therapeutics Inc. (Nasdaq:RPRX) reported financial results for the third quarter ended September 30, 2017 (Press release, Repros Therapeutics, NOV 13, 2017, View Source [SID1234521974]).

Financial Results

Net loss for the three month period ended September 30, 2017, was ($1.6) million or ($0.04) per share as compared to a net loss of ($4.2) million or ($0.17) per share for the same period in 2016. The decreased loss for the three month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased clinical development expenses related to the Company’s Proellex and enclomiphene product candidates, as well as decreased R&D payroll and benefits expenses and legal expenses. The Company recorded, in other income, a change in fair value of the warrant liability for the three month period ended September 30, 2017, in the amount of $295,000.

Net loss for the nine month period ended September 30, 2017, was ($9.7) million or ($0.32) per share as compared to a net loss of ($13.3) million or ($0.55) per share for the same period in 2016. The decreased loss for the nine month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased clinical development expenses related to the Company’s Proellex and enclomiphene product candidates, as well as decreased R&D payroll and benefits expenses and legal expenses, partially offset by expenses associated with the departure of the Company’s former President and Chief Executive Officer.

For the three month period ended September 30, 2017, research and development ("R&D") expenses decreased 69%, or approximately $2.2 million, to $979,000, as compared to $3.2 million for the same period in the prior year. For the nine month period ended September 30, 2017, R&D expenses decreased 59%, or approximately $6.0 million, to $4.2 million, as compared to $10.2 million for the same period in the prior year. The decreases in both the three and nine month periods were primarily due to the decreased expenses related to the Company’s Proellex and enclomiphene product candidates in 2017, as well as decreased R&D payroll and benefits expenses and legal expenses.

General and administrative ("G&A") expenses decreased 6%, or approximately $57,000, to $940,000 for the three month period ended September 30, 2017, as compared to $997,000 for the same period in the prior year and increased 81%, or approximately $2.6 million, to $5.7 million for the nine month period ended September 30, 2017, as compared to $3.1 million for the same period in the prior year. The decrease in the three month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased non-cash stock based compensation, partially offset by an increase in professional services. The increase in the nine month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to a charge of $2.8 million related to the departure of the former officer, partially offset by a decrease in non-cash stock based compensation.

Total revenues and other income increased to $304,000 for the three month period ended September 30, 2017 as compared to $10,000 for the same period in the prior year. Total revenues and other income increased to $158,000 for the nine month period ended September 30, 2017 as compared to $41,000 for the same period in the prior year. The increases in revenues and other income in both periods were primarily due to the change in the fair value of the warrants issued by the Company in May 2017 during the three and nine month periods ended September 30, 2017. Excluding the change in the fair value of the warrants, revenues and other income decreased in both periods primarily due to lower cash balances during the three and nine month periods ended September 30, 2017, as compared to the comparable periods in the prior year.

Liquidity and Capital Resources

The Company had cash and cash equivalents of approximately $1.8 million as of September 30, 2017 as compared to $8.7 million as of December 31, 2016. Net cash of approximately $8.5 million and $12.5 million was used in operating activities during the nine month periods ended September 30, 2017 and 2016, respectively. The major use of cash for operating activities for the nine month period ended September 30, 2017 was to fund our clinical development programs and associated administrative costs. No cash was used in investing activities during the nine month period ended September 30, 2017. Cash provided by financing activities for the nine month period ended September 30, 2017 was approximately $3.5 million primarily from the May Public Offering.

Nasdaq Listing

As disclosed by the Company in a Current Report on Form 8-K filed with the Securities and Exchange Commission on November 13, 2017, on November 8, 2017, the Company received notification from The NASDAQ Stock Market LLC that, pending a hearing, the Company’s common stock will be delisted from Nasdaq. As further described in the Form 8-K, the Company intends to timely request a hearing before the Nasdaq Hearings Panel, which request will stay any suspension or delisting action by Nasdaq at least until the hearing process concludes and any extension granted expires. As such, the November 8, 2017 notice has no immediate effect on the listing of the common stock and the common stock will continue to trade on the NASDAQ Capital Market under the symbol "RPRX" at least until the hearing process concludes and any extension granted by the hearings panel expires.

As of September 30, 2017, we had 39,489,807 shares of common stock outstanding.

Diffusion Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Business Update

On November 13, 2017 Diffusion Pharmaceuticals Inc. (Nasdaq:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients using the novel small molecule trans sodium crocetinate (TSC) in conjunction with standard radiation and chemotherapy, reported financial results for the three and nine months ended September 30, 2017 and provided a business update (Press release, Diffusion Pharmaceuticals, NOV 13, 2017, View Source [SID1234521979]).

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, stated, "The FDA’s authorization of patient enrollment in our TSC Glioblastoma (GBM) Phase 3 pivotal study marks a major milestone, and the Agency’s agreement with our focus on inoperable GBM patients allows a greatly improved trial design. Because the inoperable GBM patients treated with TSC in the Phase 2 study showed a remarkable four-fold increase in overall survival at two years, the approved trial design can enroll fewer patients than the previous Phase 3 design and have a greater chance of reaching its overall survival endpoint. The thousands of patients diagnosed with inoperable GBM who are currently excluded from participation in most newly-diagnosed GBM clinical trials can now have renewed hope, with a novel treatment being developed specifically for them, to be used in conjunction with their standard of care radiation and chemotherapy treatments. We are ready to begin our GBM trial with a highly-regarded CRO engaged, sites identified and enough drug product on hand to conduct the entire trial. We are currently working with the sites’ Institutional Review Boards and remain on track to begin enrolling patients by the end of 2017."

"In an effort to bring the Company into compliance with Nasdaq’s listing requirements, our shareholders voted to modify the terms of our Series A Convertible Preferred Stock to allow dividends to be paid in either cash or common stock, thus allowing the common stock purchase warrants issued with our Series A Convertible Preferred Stock to be classified, for accounting purposes, as permanent equity rather than as a liability. We believe this change, which occurred subsequent to the close of the quarter, brings us into compliance with Nasdaq’s $2.5 million stockholders’ equity requirement. We are now awaiting confirmation from Nasdaq that we have demonstrated compliance with all applicable requirements for continued listing. This modification also permits additional financial flexibility as we advance our programs."

Mr. Kalergis continued, "We’ve also made important additions to our board and management during the third quarter. Robert Ruffolo, Jr. joined our board of directors, bringing comprehensive pharmaceutical industry experience and drug development knowledge, honed at Wyeth (now Pfizer) and SmithKline Beecham (now GlaxoSmithKline). William Hornung joined us as Chief Business Officer, with more than 20 years of finance and operations leadership experience in the biopharmaceutical industry with such companies as PTC Therapeutics, Elan Pharmaceuticals, The Liposome Company and Contravir Pharmaceuticals. Bill has already had a positive impact on our business development activities."

Recent Highlights

Research and Development

Diffusion received final protocol guidance from the U.S. Food and Drug Administration ("FDA") for the Phase 3 trial with its lead compound trans sodium crocetinate ("TSC") in patients newly diagnosed with inoperable glioblastoma multiforme ("GBM"), a type of brain cancer.

Diffusion selected the first 17 clinical trial sites in the U.S. under one Institutional Review Board, with 100 sites planned for the Phase 3 GBM trial. We anticipate our first patient dosing for the Phase 3 GBM before the end of 2017.

We engaged a contract research organization and completed a major TSC production run, providing sufficient Phase 3 drug product to conduct the entire trial.
Key Personnel and Other

Appointed Robert Ruffolo, Jr. Ph.D. to the Company’s Board of Directors.

Named William "Bill" Hornung as the Company’s Chief Business Officer, a new position.

In an effort to regain Company compliance with Nasdaq’s stockholders’ equity requirement, obtained shareholder approval to amend a provision of our Certificate of Incorporation relating to the Series A convertible preferred stock, enabling the Company to revalue and re-classify Series A warrants from liabilities to stockholders’ equity.

Participated in multiple investor conferences to present the Company’s business and interface with the investment community.
Financial Results for the Three Months Ended September 30, 2017

We had cash, cash equivalents and a certificate of deposit totaling $11.2 million as of September 30, 2017.

We recognized $1.8 million in research and development expenses during the three months ended September 30, 2017 compared to $1.9 million during the three months ended September 30, 2016. The decrease in research and development expense was attributable to a $1.0 million non-cash impairment charge recognized in the third quarter of 2016, a $0.2 million decrease in expense associated with animal toxicology studies and a $0.1 million decrease in stock-based compensation expense. These amounts were partially offset by a $0.9 million increase in costs associated with our GBM trials, a $0.1 million increase in API and drug manufacturing costs and a $0.1 million increase in salary related expenses.

General and administrative expenses were $1.6 million during the three months ended September 30, 2017 compared to $3.9 million during the three months ended September 30, 2016. The decrease in general and administrative expense was primarily due to a $2.5 million decrease in non-cash litigation settlement fees, partially offset by an increase in salary and stock-based compensation expense of $0.1 million and an increase in professional fees of $0.1 million.

In connection with the private placement of our Series A convertible preferred stock and common stock warrants, we determined the warrants to be classified as liabilities and subject to remeasurement at each reporting period. As a result of the liability classification, during the three months ended September 30, 2017, we recorded a $8.4 million non-cash gain for the change in fair value of our common stock warrant liabilities which was primarily attributable to the decrease in the market price for our common stock.

As noted above, at a Special Stockholders meeting held on November 1, 2017, holders of both our common stock and Series A convertible preferred stock approved an amendment to our Certificate of Incorporation to permit us to pay dividends on the Series A convertible preferred stock in either cash or shares of our common stock, rather than just shares. This amendment allowed us to revalue our Series A warrant liability on November 1, 2017 and reclassify the liability, for accounting purposes, to stockholders’ equity. As a result of the non-cash gain relating to the change in fair value of the warrant liabilities referred to above, we believe that this Certificate of Incorporation amendment will allow us to maintain our Nasdaq compliant status with respect to stockholders’ equity for the foreseeable future. See Note 12 of our unaudited condensed consolidated financial statements filed in Form 10-Q as of September 30, 2017 for further details.

ERYTECH to Host Third Quarter 2017 Conference Call and Business Update on November 14, 2017

On November 13, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Nasdaq and Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will host a Third Quarter 2017 conference call and webcast on Tuesday, November 14, 2017, at 2:30 PM CET/8:30 AM EST to discuss operational highlights (Press release, ERYtech Pharma, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316571 [SID1234521980]).

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 95373849#

USA: +1 6467224907 United-Kingdom: +44 2030432440
Switzerland: +41 225809022 Germany: +49 69222229031
France: +33 172001510 Belgium: +32 24029640
Sweden: +46 850334664 Finland: +358 942599700
Netherlands: +31 107138194 Spain: +34 914142021

The webcast can be followed live online via the link:
View Source;Name=&Conference=135311448&PIN=95373849

An archived replay of the call will be available for 90 days by dialing (US & Canada): +1 877 64 230 18, (UK): +44(0) 203 367 9460, (France): +33(0)1 72 00 15 00, (Spain): +34 917896320, Conference ID#: 311448#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com.

RXi Pharmaceuticals and Gustave Roussy Announce Research Collaboration

On November 13, 2017 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company developing a new class of RNAi-based therapeutics, and Gustave Roussy, a leading Comprehensive Cancer Centre in Europe, reported that they have entered into a collaborative research agreement to evaluate the potential of RXi’s novel sd-rxRNA technology platform for use in cancer treatments (Press release, RXi Pharmaceuticals, NOV 13, 2017, View Source [SID1234521983]). The agreement covers research to design and evaluate sd-rxRNA compounds in a human tumor xenograft model. Positive results may lead to further development of these compounds for treatment of cancer.

"We are excited to be working with Gustave Roussy on this research effort," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "We believe that our sd-rxRNA technology platform is broadly applicable to many therapeutic areas, including cancer. Considering our sd-rxRNA development for immuno-oncology applications, we look forward to working with the exceptional team at this prominent cancer center to leverage their expertise in this area."

Professor Caroline Robert, MD, PhD, head of the Dermatology Unit at the Gustave Roussy Institute which focuses on skin cancer research, said that "the innovative technology developed by RXi will allow us to address several critical questions in the field of cancer research and to explore future potential use of siRNAs in the clinic."

About Gustave Roussy

Gustave Roussy, the largest comprehensive cancer center in Europe, is a pole of expertise dedicated to the comprehensive care of patients, employing 3,100 health professionals for health care, research and teaching. – www.gustaveroussy.fr/en