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.

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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.

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 [SID1234522003]).

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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.

On November 13, 2017 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that the Company’s management will participate in two upcoming investor conferences. These two conferences include (Press release, MacroGenics, NOV 13, 2017, View Source [SID1234522005]):

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Stifel 2017 Healthcare Conference in New York, NY. MacroGenics’ presentation is scheduled to take place on Tuesday, November 14, 2017 at 9:30 am ET.
Citi 2017 Global Healthcare Conference in New York, NY. MacroGenics’ management will participate in one-on-one meetings with investors on Thursday, December 7, 2017.

A webcast of the Stifel conference presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.

On November 13, 2017 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) reported its unaudited financial results for the quarter and the nine month period ended September 30, 2017 (Press release, ProMetic Life Sciences, NOV 13, 2017, View Source [SID1234522008]).

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"Both our plasma-derived and small molecules lead clinical programs continue to progress as planned throughout advanced stages of the regulatory approval pathway. The PDUFA date has been set for plasminogen and PBI-4050 has been cleared to commence the pivotal phase 2/3 placebo controlled IPF clinical trial," said Pierre Laurin, President and Chief Executive Officer of Prometic. "Our focus is now centered on the completion of our commercial and marketing infrastructure in order to be ready to rapidly proceed with the launch of RyplazimTM, pending a positive final outcome of the regulatory approval process for our first plasma-derived drug".

"The third quarter 2017 financial results continue to be in line with our expectations, the previous quarters and guidance provided. The results demonstrate that the R&D and administration, selling and marketing expenses have stabilized at expected levels as we prepare to operate at a commercial scale," declared Mr. Bruce Pritchard, Prometic’s Chief Operating Officer and interim Chief Financial Officer. "As recently demonstrated, we will continue to put in place all the necessary elements to insure we can bridge the funding gap to value creation events and financial sustainability as efficiently as possible".

Third Quarter 2017 Therapeutic Highlights

Plasma-Derived Therapeutics:

Plasminogen:

The Corporation presented new long term clinical data from its pivotal Phase 2/3 trial of Ryplazim (Plasminogen IV) for the additional 36-week treatment period. The new data demonstrated no recurrence of lesions in the 10 patients treated with RyplazimTM for a total of 48 weeks. No safety or tolerability issues related to this longer-term dosing were observed.
The Corporation secured a Rare Pediatric Disease Designation by the FDA for RyplazimTM, a plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency.
Small Molecule Therapeutics:

PBI-4050:

Idiopathic Pulmonary Fibrosis (IPF):

The Corporation received FDA acceptance of its PBI-4050 Investigational New Drug (IND) application to commence the pivotal Phase 2/3 clinical trial in patients suffering from IPF.
Alström Syndrome

The Corporation announced that longer-term data from its ongoing Phase 2 open labeclinical trial in subjects suffering from Alström Syndrome in the United Kingdom confirmed that the beneficial clinical effects previously observed are sustained during prolonged treatment.
Third Quarter 2017 Corporate and Operational Highlights

Corporate:

The Corporation executed definitive agreements in relation to the previously announced partnership with affiliates of Shenzhen Royal Asset Management Co., Ltd. (SRAM).
The Corporation closed the previously announced $53.1 million bought deal equity offering of common shares through a syndicate of underwriters led by Cantor Fitzgerald Canada Corporation as the lead underwriter and sole bookrunner. Pursuant to the offering, Prometic issued 31,250,000 common shares at a price of $1.70 per share for gross proceeds of $53,125,000.
Subsequent highlights to Third Quarter 2017:

The Corporation received confirmation from the FDA that its BLA for its plasminogen replacement therapy (RyplazimTM) had been accepted and granted priority review status with a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018;
The Corporation received priority review status for the New Drug Submission (NDS) the company plans to file with Health Canada for RyplazimTM for the treatment of patients with plasminogen deficiency;
The Corporation entered into a binding letter of intent to secure a USD $80 million (CAD $100 million) line of credit from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc.
2017 Third Quarter Financial Results

The Corporation incurred a net loss of $17.8 million for the quarter ended September 30, 2017, compared to a net loss of $28.0 million for the quarter ended September 30, 2016. The Corporation incurred a net loss of $78.4 million during the nine months ended September 30, 2017 compared to $70.6 million during the nine months September 30, 2016. The decrease in net loss for the third quarter of 2017 as compared to the third quarter of 2016 was mainly attributable to the significantly higher revenues generated from milestone payments and licensing activities. The increase in net loss for the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016 is mainly attributable to the higher research and development ("R&D") and administrative, selling and marketing expenses related to the setting up of the extensive commercial and manufacturing infrastructure ahead of the planned commercialization Ryplazim.

Total revenues for the third quarter ended September 30, 2017 were $24.0 million compared to $3.7 million for the third quarter ended September 30, 2016. Revenues from the sale of goods amounted to $3.9 million for the third quarter ended September 30, 2017, compared to $2.4 million for the quarter ended September 30, 2016. Milestone payments and licensing revenues amounted to $19.7 million for the third quarter ended September 30, 2017 compared to nil for the third quarter of 2016. Total revenues for the nine months ended September 30, 2017 were $32.5 million compared to $12.3 million for the nine months ended September 30, 2016.

The Corporation incurred total R&D costs of $23.2 million for the quarter ended September 30, 2017 compared to $23.6 million for the third quarter of 2016. The Corporation incurred total R&D costs of $72.0 million during the nine months ended September 30, 2017 compared to $59.4 million during the nine months ended Jun 30, 2016. The overall R&D expense is primarily driven by the Plasma-derived therapeutics business, where the Corporation is operating as its own proprietary end-to-end source and supply, while the small molecule business is a much smaller contributor to the expense growth.

The plasma-derived therapeutics are produced by Prometic at its Laval plant and at the Winnipeg CMO while the small molecule therapeutics are manufactured by a third party for Prometic. The manufacturing cost of the therapeutics to be used in clinical trials and other R&D purposes represented approximately $22.9 million of the $72.0 million in R&D expenses reported during the nine months ended September 30, 2017 and $22.8 million of the $59.4 million in R&D expenses during the nine months ended September 30, 2016.

The increase in R&D expenses, excluding the manufacturing cost of therapeutics to be used in R&D activities discussed above (other R&D), as compared to the nine months of 2016 was primarily due to higher salary and benefit expenditures reflecting the increase in employees working on the clinical trials and at our research facilities. In addition, Contract Research Organizations ("CRO") and investigator expenses incurred in relation to the clinical trials and pre-clinical activities increased reflecting the increase in the number of trials in progress, the duration and higher patient enrolment of the trials.

Administrative, selling and marketing expenses amounted to $7.7 million during the third quarter of 2017, compared to $6.5 million for the quarter ended September 30, 2016. Administrative, selling and marketing expenses amounted to $22.7 million during the nine months ended September 30, 2017 compared to $16.5 million during the nine months ended September 30, 2016. The increase was mainly attributable to the higher salary and benefit expenses resulting from an increase in headcount mostly in marketing and commercial operations and overall salary increases.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Tuesday November 14, 2017. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available from Tuesday November 14, 2017 at 2:00 pm until November 21, 2017. The numbers to access the replay are 1-416-849-0833 (passcode: 3866799) and 1-855-859-2056 (passcode: 3866799). A live audio webcast of the conference call, with slides, will be available through the following : View Source;s=1&k=99570B881A8129DE3DCA8DE3EBD93544

Additional Information in Respect to the Third Quarter 2017

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2017 will be filed on SEDAR (View Source) and will be available on the Corporation’s website at www.prometic.com.

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, RestorGenex, NOV 13, 2017, View Source [SID1234522010]).

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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.