On May 15, 2018 Palatin Technologies, Inc. (NYSE American: 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 third quarter ended March 31, 2018 (Press release, Palatin Technologies, MAY 15, 2018, View Source [SID1234526652]).

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Recent Highlights
Bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

March 2018 – our exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. ("AMAG"), submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for bremelanotide for the treatment of HSDD in premenopausal women.

If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.

"The submission of this NDA represents a significant milestone for the bremelanotide clinical program and our efforts to develop a treatment for HSDD," said Carl Spana, Ph.D., CEO and President of Palatin Technologies.

Melanocortin Receptor 1 Agonists ("MC1r") – under development for inflammatory bowel diseases and ocular indications:

May 2018 – Presented positive preclinical MC1r agonist data at TIDES: Oligonucleotide and Peptide Therapeutics 2018 Meeting.

April 2018 – Presented preclinical oral formulation data on PL-8177, an investigational MC1r agonist for Inflammatory Bowel Diseases at the 2018 Keystone Symposia on "The Resolution of Inflammation in Health and Disease."

Phase 1 First-in-Human clinical study of PL-8177 is in progress and on schedule for top line data in the third quarter of calendar year 2018.

Third Quarter Fiscal 2018 Financial Results
Palatin reported a net loss of $(0.7) million, or $(0.00) per basic and diluted share, for the quarter ended March 31, 2018, compared to a net loss of $(3.6) million, or $(0.02) per basic and diluted share, for the same period in 2017.

The difference in financial results between the three months ended March 31, 2018 and 2017 was mainly attributable to the decrease in total operating expenses of $4.3 million that is offset by a decrease of $1.8 million of recognized revenue during the 2018 period pursuant to our license agreement with AMAG.

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Revenue
For the quarter ended March 31, 2018, Palatin recognized $9.0 million in license and contract revenue compared to $10.8 million in the same period in 2017. For both periods, 100% of the revenue Palatin recognized was related to our license agreement with AMAG. As of March 31, 2018, and June 30, 2017, there was $0.6 million and $35.1 million, respectively, of current deferred revenue on the consolidated balance sheet related to this transaction.

Operating Expenses
Total operating expenses for the quarter ended March 31, 2018 were $9.5 million compared to $13.8 million for the same period in 2017. The decrease in operating expenses was mainly attributable to professional services rendered in connection with our license agreement with AMAG, which closed in February 2017, and secondarily to the decrease in development expenses of bremelanotide for HSDD as we continue our progress with our bremelanotide program.

Other Income/Expense
Total other income/expense, net was $0.2 million for the quarter ended March 31, 2018 compared to $0.6 million for the same period in 2017. Total other income/expense, net for both periods consisted primarily of interest expense related to Palatin’s venture debt.

Income Tax
Palatin licensed bremelanotide to Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun") for the People’s Republic of China, Taiwan, Hong Kong and Macau, and to Kwangdong Pharmaceutical Co. Ltd. ("Kwangdong") for the Republic of Korea. Pursuant to the license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and will be recorded as an expense during the fiscal year ending June 30, 2018. For the quarter ended March 31, 2018, Palatin recorded an income tax benefit of $18,746 related to those withholding amounts utilizing an estimated effective annual income tax rate applied to the loss for the quarter and the remaining balance of $275,111 was included in prepaid expenses and other current assets at March 31, 2018. 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, and cash equivalents were $25.7 million as of March 31, 2018, compared to cash, cash equivalents, accounts receivable and investments of $55.6 million at June 30, 2017. Current liabilities were $13.6 million, net of current deferred revenue of $0.6 million, as of March 31, 2018, compared to $19.9 million, net of deferred revenue of $35.1 million, as of June 30, 2017.

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In April 2018, Palatin entered into an equity distribution agreement ("at-the-market program") with Canaccord Genuity LLC, pursuant to which Palatin may, from time to time, sell shares of its common stock at market prices. Palatin has no obligation to sell any shares under this agreement and may, at any time, suspend solicitation and offers under this agreement.

Palatin believes that existing capital resources, together with proceeds from sales of common stock in its at-the-market program (if any), will be sufficient to fund our planned operations through at least June 30, 2019.

CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 15, 2018 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 1-800-263-0877 (domestic) or 1-323-794-2094 (international), conference ID 1551025. 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 1551025. The webcast and telephone replay will be available through May 22, 2018.

On May 15, 2018 Onconova Therapeutics, Inc.(NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the first quarter of 2018 ended March 31, 2018 (Press release, Onconova, MAY 15, 2018, View Source [SID1234526651]).

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"We have strengthened our balance sheet after completing a $28.75 million upsized underwritten public offering this month. Combined with the funds raised in February, we now have the resources necessary to advance our INSPIRE Phase 3 clinical trial of IV Rigosertib towards complete enrollment, which we expect in the first half of 2019," said Dr. Ramesh Kumar, President and Chief Executive Officer. "After enrollment of our expanded Phase 2 combination therapy trial and the advance of our CDK inhibitor preclinical program towards the clinic, we are well-positioned in our quest to serve the unmet needs of cancer patients."

Recent Highlights

In May, we strengthened our balance sheet with a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February, should permit the Company to advance its late stage programs in MDS to key milestones;
We executed a licensing agreement with Pint Pharma to commercialize Rigosertib for treatment of Myelodysplastic Syndromes in Latin America;
We presented promising Phase 2 data from the expansion study of oral Rigosertib and Azacitidine combination in patients with Myelodysplastic Syndromes at the 6th International Bone Marrow Failure Disease Symposium on March 26th;
We completed the Pre-IND consultation with the US Food and Drug Administration (FDA) regarding ON 123300, a dual ARK5+CDK4/6 inhibitor, in collaboration with our partner, HanX Biopharmaceuticals. This guidance will help advance our differentiated compound to the clinic;
We presented data on our first-in-class dual inhibitor of CDK4/6 + ARK5 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 on April 19th.
First Quarter 2018 Financial Results

Cash and cash equivalents as of March 31, 2018, totaled $7.3 million, compared to $4.0 million as of December 31, 2017. This excludes the proceeds from the financing completed in May 2018, in which the Company raised net proceeds of approximately $25.6 million in a public offering, including the exercise in full of the underwriter’s over-allotment option. Based on the Company’s current projections, Onconova expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019.

Net loss was $5.1 million for the first quarter ended March 31, 2018, compared to $8.3 million for the first quarter ended March 31, 2017, primarily due to a decrease in the fair value of warrant liability, and the recognition of revenue during the quarter from our license and collaborative development agreement with HanX Biopharmaceuticals. Research and development expenses were $4.6 million for the first quarter ended March 31, 2018, and $4.9 million for the comparable period in 2017. General and administrative expenses were $1.9 million for the first quarter ended March 31, 2018, and $2.1 million for comparable period in 2017.

The Company will host a conference call on Tuesday, May 15 at 9:00 a.m. Eastern Time to provide a corporate update and discuss first quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 2573768. The call will also be webcast live. Please click here to access the webcast. A replay will be available at this link until August 15, 2018.

On May 15, 2018 Oncobiologics, Inc. (NASDAQ:ONS) reported financial results and business highlights for its three and six months ended March 31, 2018 (Press release, Oncobiologics, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349253 [SID1234526650]).

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Recent Highlights:

Strengthened balance sheet with first closing of a $15.0 million private placement offering
Initiated ONS-5010 development program
Appointed Dr. Joerg Windisch and Randy Thurman to the Board of Directors
Dr. Windisch was appointed to the Compensation Committee
Mr. Thurman was appointed to the Nominating and Corporate Governance Committee and Chairman of the Compensation Committee
Oncobiologics’ Chairman and Chief Executive Officer Dr. Pankaj Mohan commented, "I am excited to report that our pipeline continues to offer significant opportunities to generate stockholder value. We recently entered into an agreement for a $15.0 million capital raise that will be used to advance the development of our portfolio, including ONS-5010, and support our operations through the end of this calendar year and have already received $7.5 million of the proceeds.

"We continue to make progress with the ONS-5010 development program and expect to initiate a clinical trial in 2018. Additionally, we are advancing our pre-clinical biosimilar product candidates and continue to engage with potential partners to lead the Phase 3 clinical trials for ONS-3010 and ONS-1045," continued Dr. Mohan.

"During the second quarter of fiscal 2018, we made progress implementing our new strategy to leverage our BioSymphony Platform to accelerate and maximize commercial revenues from our core expertise in drug development and manufacturing. The interest in leveraging our extensive development and manufacturing platform among potential biotech customers has been extremely positive. We expect to enter into our first customer agreement for our new contract development and manufacturing (CDMO) business and start recognizing revenue in the near future," concluded Dr. Mohan.

Anticipated Milestones (calendar year):
2018

Enter into first CDMO contract
Initiate clinical development program for ONS-3010 and/or ONS-1045 by partners in emerging markets
Initiate ONS-5010 clinical trials
Announce licensing/co-development partnership
2019

CDMO business cash flow positive by end of 2019
Initiate Phase 3 trial for ONS-1045 in major markets with development partner
2020

First revenue from emerging market partnerships
Initiate Phase 3 trial for ONS-3010 in major markets with development partner
Initiate ONS-3040 and ONS-4010 clinical development programs
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2018
For the fiscal second quarter ended March 31, 2018, the Company reported a net loss attributable to common stockholders of $8.6 million, or $0.34 per diluted share, compared to $8.0 million, or $0.38 per diluted share for the same period of 2017. For the three months ended March 31, 2018, net loss attributable to common stockholders includes $0.3 million of income from non-cash stock-based compensation, $0.7 million of depreciation and amortization, $0.2 million of income from a decrease in the fair value of warrant liability and a $0.4 million beneficial conversion charge related to the Company’s Series A convertible preferred stock. For the three months ended March 31, 2017, net loss attributable to common stockholders included $2.3 million of non-cash stock-based compensation expense, $0.7 million of depreciation and amortization and $1.0 million of income from a decrease in the fair value of warrant liability.

For the fiscal second quarter ended March 31, 2018, the Company reported an adjusted net loss attributable to common stockholders of $8.0 million, or $0.32 per diluted share, as compared to an adjusted net loss of $6.1 million, or $0.29 per diluted share in the same period of 2017. The primary reason for the increase in adjusted net loss attributable to common stockholders from the year earlier period is higher research and development expenses related to the initiation of preparations to move ONS-5010 into clinical development in 2018.

At March 31, 2018, the Company had cash of $5.9 million, compared to $3.2 million at September 30, 2017. On May 14, 2018, the Company announced the closing of the first tranche of its $15.0 million private placement offering, receiving $7.5 million in aggregate gross proceeds.

Nasdaq Listing Update
The Company received formal notice on May 14, 2018 that the Nasdaq Hearings Panel has granted the Company’s request for an extension through June 26, 2018 to evidence compliance with all applicable requirements for continued listing on Nasdaq, including the applicable $35.0 million market capitalization requirement.

On May 15, 2018 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), a pharmaceutical company developing therapies for ophthalmic diseases, reported financial results for its fiscal second quarter ended March 31, 2018 (Press release, Ohr Pharmaceutical, MAY 15, 2018, View Source [SID1234526649]).

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"During the fiscal second quarter we embarked on a process to evaluate a range of strategic alternatives to maximize shareholder value," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "We engaged Roth Capital to act as our exclusive financial advisor and are encouraged by the progress we have made to date."

Financial Results for the Second Quarter ended March 31, 2018

For the quarter ended March 31, 2018, the Company reported a net loss of approximately $2.2 million, or ($0.04) per share, compared to a net loss of approximately $7.7 million, or ($0.21) per share in the same period of 2017.
For the quarter ended March 31, 2018, total operating expenses were approximately $2.2 million, consisting of $0.6 million in general and administrative expenses, $1.8 million of research and development expenses, $0.3 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities. This compares to total operating expenses of $7.7 million in the same period of 2017, consisting of $1.4 million in general and administrative expenses, $6.0 million of research and development expenses, and $0.3 million in depreciation and amortization.
At March 31, 2018, the Company had cash and cash equivalents of approximately $5.2 million, compared to cash and equivalents of approximately $12.8 million at September 30, 2017.
Financial Results for the Six Months Ended March 31, 2018

For the six months ended March 31, 2018, the Company reported a net loss of approximately $6.3 million, or ($0.11) per share, compared to a net loss of approximately $14.7 million, or ($0.43) per share in the same period of 2017.
For the six months ended March 31, 2018, total operating expenses were approximately $6.4 million, consisting of $2.1 million in general and administrative expenses, $4.2 million of research and development expenses, $0.6 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities. This compares to total operating expenses of $14.7 million in the same period of 2017, comprised of approximately $3.2 million in general and administrative expenses, $10.9 million in research and development expenses, and $0.6 million in depreciation and amortization.

On May 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the first quarter of 2018 (Press release, Nanobiotix, MAY, 15, View Source [SID1234526647]).

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Activity and result during the first quarter of 2018

There has been no revenue booked during the first quarter of 2018, which is fully in line with the Company’s
expectations. In January, Nanobiotix presented first promising data from I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Annual Meeting (ASCO-GI).

The product has demonstrated a very good safety profile, with no adverse event (serious or not) related to NBTXR3
and no dose-limiting toxicity (DLT). Out of 10 patients treated, 7 were evaluable. Out of these 7 patients, 3 patients
achieved a complete response and 3 patients achieved a partial response as best overall response. These data are only first preliminary response data which will be completed with additional data. This is the third indication in the global development of NBTXR3 confirming transferability across different cancers.

Also in January, Nanobiotix partnered with the Providence Cancer Institute to run immunotherapeutic preclinical
research in pancreatic cancers. The collaboration with Providence Cancer Institute, located at the Robert W. Franz
Cancer Center in Portland, Ore., one of the world’s leading oncological research centers, will provide essential
preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response.