Palatin Technologies, Inc. Reports First Quarter Fiscal Year 2018 Results; Teleconference and Webcast to be held on November 13, 2017

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.

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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.

NewLink Genetics to Participate in November Investor Conferences

On November 13, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that it will participate in the following investor conferences this week (Press release, NewLink Genetics, NOV 13, 2017, View Source [SID1234521970]):

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Stifel 2017 Healthcare Conference on Tuesday, November 14th, at 5:00pm ET in New York City
Jefferies 2017 London Healthcare Conference on Thursday, November 16th, at 17:20 GMT (12:20pm ET)
A live webcast of both conference presentations will be on the Company’s website at www.newlinkgenetics.com in the "Investors & Media" section under "Events and Presentations."

MabVax Therapeutics to Present Positive Development Study Results Enabling Manufacturing of Two Radionuclide Products for Phase 1 Clinical Trials at the 2017 AAPS Annual Meeting

On November 13, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported the results from the manufacturing process development and characterization of the Company’s immunoPET imaging agent (MVT-2163) and radioimmunotherapy agent (MVT-1075) which are being evaluated in advanced pancreatic cancer and other CA19-9 positive cancers. The results will be presented in a poster presentation at the American Association of Pharmaceutical Scientists to be held in San Diego, CA, November 12 – 15, 2017.

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Paul W. Maffuid, PhD, Executive Vice President of Research and Development at MabVax, will present the development and characterization studies that were performed to establish a reproducible process for the manufacture of the Company’s immunoPet imaging agent and radioimmunotherapy drug product.

Title of Presentation: Characterization of the HuMab-5B1 antibody conjugated with bi-functional agents clinically demonstrated as radioisotope chelators.
Poster Number: M5094
Location: Manufacturing Process / Scale-up and Optimization
Session Date: Monday, November 13
Time: 1:00 PM to 2:00 PM (Pacific Time)

"These studies were critical to establish a well-defined manufacturing process for the reproducible delivery of a well characterized investigational drug product to our clinical sites," remarked David Hansen, CEO of MabVax. He added, "These results demonstrate that our HuMab-5B1 antibody is readily conjugated without diminishing its target specificity. Earlier this year the Company reported results from our Phase 1a clinical trial with our immunoPet imaging agent MVT-2163 where radiotracer uptake above background was observed in primary tumors and metastases from day 2 and continuously increased through day 7 of the study. The data from our imaging trial has provided significant insight into our development strategy for the MVT-1075 program."

The MVT-1075 Phase 1 first-in human clinical trial is an open-label, multi-center study evaluating the safety and efficacy in up to 22 patients for patients with locally advanced or metastatic adenocarcinoma of the pancreas ("PDAC") or other CA19-9 positive malignancies including colon and lung cancers. The primary objective is to determine the maximum tolerated dose and safety profile in late stage patients with recurring disease who have failed prior therapies. Secondary objectives include evaluating tumor response rate and duration of response by RECIST 1.1, and determining dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The study is currently enrolling subjects at Memorial Sloan Kettering and HonorHealth.

Karyopharm Therapeutics to Present at the Jefferies 2017 London Healthcare Conference

On November 13, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will present at the Jefferies 2017 London Healthcare Conference on Thursday, November 16, 2017 at 8:00 a.m. GMT at the Waldorf Hilton in London, UK (Press release, Karyopharm, NOV 13, 2017, View Source [SID1234521968]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

Poster presented by Iovance Biotherapeutics, Inc. on November 10, 2017 at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting.

On November 10, 2017 Iovance Biotherapeutics, Inc. presented Poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting. (Poster, 8-K Iovance Biotherapeutics, NOV 13, 2017, View Source [SID1234521967])

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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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