Angiogenex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Angiogenex, 2017, NOV 13, 2017, View Source [SID1234522031]).

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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

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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]).

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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

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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 Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its first quarter ended September 30, 2017 (Press release, Palatin Technologies, NOV 13, 2017, View Source [SID1234521971]).

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Recent Highlights
● Bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):
– Entered into a collaboration and license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun"), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd in September 2017 for exclusive rights to develop and commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R.

● Received $4,500,000 in October 2017, consisting of an upfront payment of $5,000,000 less $500,000 which was withheld in accordance with tax withholding requirements in China.

– Working closely with AMAG Pharmaceuticals, Inc. ("AMAG") on completing the tasks and activities necessary to file a New Drug Application ("NDA") with the Food and Drug Administration ("FDA").

– Target NDA filing with the FDA for early calendar year 2018.

– U.S. Patent 7,700,592 issued July 11, 2017, on methods of treating female sexual dysfunction and HSDD with bremelanotide. The patent will expire in November 2033.

First Quarter Fiscal Year 2018 Financial Results
Palatin reported net income of $10.6 million, or $0.05 per basic and diluted share, for the quarter ended September 30, 2017, compared to a net loss of $(13.1) million, or $(0.08) per basic and diluted share, for the same period in 2016.

The difference in financial results between the three months ended September 30, 2017 and 2016 was primarily attributable to the recognition of $26.9 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG and our license agreement with Fosun.

-More-

Revenue
For the quarter ended September 30, 2017, Palatin recognized $21.9 million in license and contract revenue related to our license agreement with AMAG and $5.0 million in license revenue related to our license agreement with Fosun.

There were no revenues recorded in the quarter ended September 30, 2016.

Operating Expenses
Total operating expenses for the quarter ended September 30, 2017 were $15.7 million compared to $12.4 million for the comparable quarter of 2016. The increase in operating expenses was mainly attributable to the continued progress of the development of bremelanotide for HSDD.

Other Income/Expense
Total other expense, net was $0.4 million for the quarter ended September 30, 2017 compared to $0.6 million for the quarter ended September 30, 2016. Total other expense, net for both periods consisted primarily of interest expense related to Palatin’s venture debt.

Income Tax
Pursuant to the license agreement with Fosun, $500,000 was withheld in accordance with tax withholding requirements in China and will be recorded as an expense during the fiscal year ending June 30, 2018. For the quarter ended September 30, 2017, Palatin incurred $225,255 in income tax expense utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $274,745 was included in prepaid expenses and other current assets at September 30, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

Cash Position
Palatin’s cash, cash equivalents, accounts receivable and investments were $49.3 million as of September 30, 2017, compared to cash, cash equivalents, accounts receivable and investments of $55.6 million at June 30, 2017. Current liabilities were $19.3 million, net of deferred revenue of $20.2 million, as of September 30, 2017, compared to $19.9 million, net of deferred revenue of $35.1 million, as of June 30, 2017.

Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least the 2018 calendar year.

Conference Call / Webcast
Palatin will host a conference call and webcast on November 13, 2017 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-394-8218 (domestic) or 1-323-701-0225 (international), conference ID 2622306. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), passcode 2622306. The webcast and telephone replay will be available through November 18, 2017.

On November 13, 2017 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading immunotherapy company focused on developing treatments for autoimmune/inflammatory diseases and cancer, reported a corporate update and financial results for the third quarter ended September 30, 2017 (Press release, Alpine Immune Sciences, NOV 13, 2017, View Source [SID1234521994]).

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"The preclinical progress in our platform continues to be encouraging as a growing amount of data supports our vIgD platform’s unique potential to create first in class molecules for inflammatory and oncology indications," said Mitchell H. Gold, M.D., Executive

Chairman and Chief Executive Officer of Alpine. "This is an exciting time at Alpine and we look forward to additional, promising catalysts throughout the coming year."

Preclinical Highlights

Alpine presented preclinical data of its lead program, ALPN-101, at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting on November 6, 2017 in San Diego, CA, and of some of its immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (STIC) 32nd Annual Meeting on November 10, 2017 in National Harbor, MD.

At the 2017 ACR/ARHP Annual Meeting, Alpine’s poster disclosed preclinical studies evaluating ALPN-101 program dual ICOS/CD28 antagonists generated by the company’s variant immunoglobulin domain (vlgD) platform. ICOSL vIgD-Fc fusion proteins demonstrated potent activity in an animal model of rheumatoid arthritis and in a humanized mouse model of graft vs. host disease (GvHD), suggesting that ALPN-101 candidates could have potential clinical utility in multiple inflammatory diseases.

At the SITC (Free SITC Whitepaper) 32nd Annual Meeting, Alpine’s poster disclosed distinct preclinical data from multiple novel immuno-oncology programs, all also generated from its vlgD platform. Multiple formats of vIgD-based proteins were functionally active, utilizing multiple mechanisms of action. Some suppressed tumors in an animal model. The demonstrated versatility of the vlgD platform suggests it has the potential to contribute to the next generation of immuno-oncology therapeutics.

In addition, Alpine will present posters at the following upcoming scientific meetings in 2017:

40th Annual San Antonio Breast Cancer Symposium (SABCS)

Abstract Title: ICOSL Anti-HER2 V-mAbs: Localizing Engineered ICOSL Costimulatory Agonists to HER2+ Tumors and Through Trastuzumab
Abstract #: P1-09-10
Session Title: Treatment: Novel targets and Targeted Agents
Location: San Antonio, TX
Date: December 6, 2017
Time: 5:00 PM – 7:00 PM CT
American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting

Abstract Title: Novel Variant lg Domain (vlgD) Proteins Generated Via Directed Evolution of IgSF Domains Have Therapeutic Efficacy in Animal Models of Graft Versus Host Disease
Abstract #: 1892
Session Title: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I
Location: Atlanta, GA
Date: December 9, 2017
Time: 5:30 PM – 7:30 PM ET
Completion of Preferred Financing and Merger with Nivalis Therapeutics

On July 24, 2017, Alpine closed its merger with Nivalis Therapeutics, with the combined company named Alpine Immune Sciences, Inc., and began trading on the NASDAQ Global market on July 25, 2017 under the ticker symbol "ALPN."

Upon completion of the merger, Alpine had approximately $90 million in cash, cash equivalents, and short-term investments. This includes $17.0 million in proceeds from the purchase of Alpine convertible preferred shares immediately prior to the merger from current Alpine investors OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures at a purchase price of $12.74 per share.

Third Quarter 2017 Financial Results

Alpine ended the third quarter of 2017 with $87.2 million in cash, cash equivalents, and short-term investments compared to $11.8 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $10.7 million.
Revenue for the third quarter of 2017 was $0.1 million compared to $0.7 million in the third quarter of 2016. Revenues in both periods are attributable to the collaboration agreement with Kite, a Gilead (NASDAQ:GILD) company. As previously announced, this research collaboration and license agreement was extended on October 20, 2017. The extended research term does not change the $530.0 million in potential research, clinical and regulatory milestones payable to Alpine. Kite will continue to have access to two programs from Alpine’s TIP technology for use in CAR-T and TCRs during the extended research term.
Research and development expenses for the third quarter of 2017 were $2.7 million compared to $0.8 million for the same period in 2016. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the third quarter of 2017 were $1.9 million compared to $0.3 million for the same period in 2016. The $1.6 million increase was primarily attributable to professional and legal service fees to support the merger with Nivalis and the associated expense of transitioning to a public company structure.
The excess of the estimated fair value of net assets acquired over the acquisition consideration paid for Nivalis resulted in a bargain purchase gain to the statement of operations. This is a non-cash item.
Cash Guidance

Based on current expectations following Alpine’s recent merger, the company expects to have cash to fund operations into 2020.

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]).

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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.