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 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported financial results for the three months ended March 31, 2018 (Press release, Altimmune, MAY 15, 2018, View Source [SID1234526633]).

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Recent Corporate Highlights

Announced positive proof-of-concept data from its Phase 2a intranasal flu vaccine trial with NasoVAX vaccine when compared with a licensed injectable seasonal flu vaccine;
Announced positive pre-clinical data for survival and immunogenicity from the Company’s Phase 2 SparVax-L program when compared against BioThrax to prevent anthrax infection;
Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office; and
Consolidated multiple Gaithersburg sites, including laboratory buildout, into new headquarters in Gaithersburg.
"We have had a very data-rich few months with results being reported from our NasoVAX, HepTcell, and SparVax-L programs," said William J. Enright, Chief Executive Officer of Altimmune. "The positive results from our NasoVAX trial give us strong confidence that we have a truly novel approach to combat flu and we look forward to getting Phase 2b clinical trials started next year. NasoVAX has tremendous potential as an effective, easy-to-administer flu vaccine that could provide better protection than current vaccines."

"We are also excited by the results on our SparVax-L study where two doses of SparVax-L produced levels of protective immunity that were significantly greater than that obtained following two doses of the licensed vaccine and we look forward to moving that program forward once we secure additional government funding," Mr. Enright added. "We continue to evaluate our HepTcell results and will update investors on our next steps after we complete the data analysis from the remaining timepoints and better understand our initial results. Operationally, we are focused on executing and moving our programs forward towards licensure as we believe our vaccines offer significant advantages."

Financial Results for the first-quarter of 2018

Revenues for the first-quarter of 2018 were $2.7 million compared to $0.3 million for the same period in 2017. The change was primarily due to a $1.6 million increase in revenue from our contract with the Biomedical Advanced Research and Development Authority ("BARDA") compared to the same period in 2017. Revenue for first-quarter 2018 also included $0.8 million from a contract with the National Institute of Allergy and Infectious Disease ("NIAID").

Research and development expenses were $5.7 million for the first-quarter of 2018 as compared to $2.8 million for same period in 2017. The change was due to an increase of $1.2 million in spending on the development of the NasoShield product candidate; an increase of $0.6 million in HepTcell costs from additional study analysis efforts; an increase of $0.4 million related to the addition of research and development costs of the SparVax-L asset; an increase of $0.3 million in costs due to our NasoVAX Phase 2 trial and an increase of $0.5 million in other research and development costs, compared to the same period in 2017.

General and administrative expenses were $2.4 million for the first-quarter of 2018 as compared with $2.0 million for the same period in 2017. The change was the combined result of an increase of $0.9 million in public company costs, an increase of $0.2 million in salaries and benefits, offset by a decrease of $0.8 million in costs related to the merger with PharmAthene compared to the same period in 2017.

Goodwill impairment charges of $0.5 million reported during the first-quarter of 2018 represented an adjustment recorded during the measurement period to reduce the tax refund receivable acquired in connection with the merger. The adjustment to reduce the tax refund receivable resulted in a corresponding increase in goodwill which was determined to be fully impaired during the year ended December 31, 2017. The non-cash charge has no effect on our current cash balance or operating cash flows.

Net loss attributed to common stockholders for the first-quarter of 2018 was $5.1 million as compared to $4.7 million for the same period in 2017. Excluding the non-cash goodwill impairment charges, net loss attributed to common stockholders for the first quarter of 2018 would have been $4.6 million.

Net loss per share attributed to common stockholders for the first-quarter of 2018 was $0.25 compared with $0.68 for the same period of 2017. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the first quarter of 2018 would have been $0.23, compared to $0.68 for the same period of 2017.

At March 31, 2018, the Company had cash and cash equivalents of $8.1 million

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 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the first quarter ended March 31, 2018 (Press release, AmpliPhi Biosciences, MAY 15, 2018, View Source [SID1234526634]).

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"From the ongoing expanded access program, we are gathering initial evidence of safety and efficacy of AB-SA01 and AB-PA01 in patients with serious and life-threatening infections," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "We continue to target a meeting with the FDA in mid-2018 to define a path forward to regulatory approval, with the potential for us to initiate a Phase 2 or registrational clinical study as early as the fourth quarter of 2018."

Recent Business Highlights

Announced positive topline results for the initial seven patients treated with AB-SA01 or AB-PA01 under the ongoing single-patient expanded access program. Six of the seven patients (86%) achieved treatment success (physician’s assessment), defined as complete resolution or significant improvement of baseline signs and symptoms. All patients were severely ill with life-threatening infections and unresponsive to antibiotics at the time of treatment. Treatment was well tolerated in all patients, with over 500 doses administered intravenously or by inhalation.
Announced the presentation at the International Society of Heart and Lung Transplant Annual Meeting in April 2018, describing the case of a lung transplant recipient suffering from recurrent episodes of multidrug-resistant Pseudomonas aeruginosa pneumonia who received treatment with bacteriophage therapeutics, including AB-PA01. The patient clinically responded to bacteriophage and antibiotic therapy with resolution of pneumonia and improved respiratory status.
Signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and a collaboration with the Western Sydney Local Health District and the Westmead Institute for Medical Research covering expanded access to AB-SA01 and AB-PA01 for patients with serious and life-threatening infections unresponsive to antibiotics.
Completed a public offering of 4,000,000 shares of common stock in January 2018, at a price to the public of $1.00 per share, for gross proceeds of $4.0 million and a registered direct offering of common stock in March 2018, at a price of $1.10 per share, for gross proceeds of $3.0 million.
First Quarter 2018 Financial Results

Research and development (R&D) expenses for the first quarter of 2018 and for the first quarter of 2017 were $1.5 million.
General and administrative (G&A) expenses were $1.6 million for the first quarter of 2018 compared to $1.9 million for the first quarter of 2017. The decrease was primarily due to lower legal and professional fees as well as a decrease in non-cash stock-based compensation.
Net cash used in operating activities for the three months ended March 31, 2018 was $3.5 million compared to $3.3 million for the three months ended March 31, 2017.
Cash and cash equivalents as of March 31, 2018 totaled $8.2 million.
As of May 15, 2018, there were 16.5 million shares of common stock outstanding.
Conference Call and Webcast

AmpliPhi will hold a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (866) 652-5200 for domestic callers and (412) 317-6060 for international callers, and the passcode is 10120002. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (877) 344-7529 for domestic callers and (412) 317-0088 for international callers. Please use passcode 10120002 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.

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.