On July 1, 2020 Akari Therapeutics, Plc ("Akari" or the "Company") (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, reported that it has entered into a Securities Purchase Agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Akari Therapeutics, JUL 1, 2020, View Source [SID1234561611]). Under the terms of the Agreement, Aspire Capital has committed to purchase up to $30 million of Akari’s American Depositary Shares ("ADSs") at Akari’s request from time to time during a period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with the Agreement. Akari will control the timing and amount of all sales of its ADSs to Aspire Capital.

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"Akari is very pleased to announce a second transaction with Aspire Capital, a long-term and supportive shareholder. During the second quarter 2020, Akari raised an additional $9.3 million from Aspire thereby completing our initial $20 million agreement. This new capital of $9.3m plus opportunistic access to an additional $30 million under our new agreement leaves Akari in a strong and flexible financial position to execute on its further development of nomacopan in critical areas of unmet need including Bullous Pemphigoid, Thrombotic Micro-angiopathy, Atopic Keratoconjunctivitis and COVID-19. This is an important partnership ahead of what we hope will be a transformative year for Akari as we seek to transition nomacopan into pivotal, phase III trials," said Clive Richardson, CEO of Akari Therapeutics.

"We’re delighted to extend this additional commitment to Akari during such an important and exciting transition period for the company. Given the strong safety and efficacy we have observed thus far across a broad range of inflammatory diseases, we firmly believe nomacopan is uniquely positioned amongst the field of complement inhibitors and other novel anti-inflammatory agents. Not only has nomacopan demonstrated deep and consistent suppression of aberrant complement activity in patients but its proven inhibition of leukotriene – LTB4 provides exciting differentiation and expands its potential application in disease settings where granulocyte infiltration is also driving pathology," said William Blank, Principal, Life Sciences at Aspire Capital.

Proceeds are intended to be used by Akari for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. Akari has the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligation under the Agreement, Akari will issue 40,760,900 ordinary shares at approximately $0.02 per ordinary share (equivalent to 407,609 ADSs at approximately $2.21 per ADS) to Aspire Capital as a commitment fee. Akari also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. Additional detail regarding the Agreement and the related Registration Rights Agreement is set forth in Akari’s Current Report on Form 6-K filed today with the SEC.

On July 1, 2020 Sprint Bioscience AB (publ) reported that Petra Pharma, in accordance with the opportunities provided by the parties’ licensing agreements, has transferred the licensing agreement and the resulting collaboration project PIP4K2 to the newly formed company Ravenna Pharmaceuticals, Inc (Press release, Sprint Bioscience, JUL 1, 2020, View Source [SID1234561609]). Ravenna Pharmaceuticals thus assumes responsibility for the continued development and financial commitments to Sprint Bioscience. The project aims to develop a new type of drug for leukemia.

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Sprint Bioscience is eligible for up to $ 240 million in interim payments plus royalties on the sale of potential drugs generated within the scope of the project. To date, USD 5 million has been received. A drug candidate has been nominated and the next interim payment occurs when the first patient is dosed in a clinical trial.

"The transfer of the PIP4K2 project to Ravenna Pharmaceuticals does not affect Sprint Bioscience’s rights to future interim and royalty payments, and the newly started company has the same obligations as Petra Pharma to drive the project forward. We look forward to following the continued development of this urgent project, which is based on a whole new approach to the treatment of leukemia, "says Sprint Bioscience CEO Jessica Martinsson.

Ravenna Pharmaceuticals was founded by the same ownership group that was involved in Petra Pharma, including global pharmaceutical companies such as Eli Lilly, AbbVie, Johnson & Johnson and Pfizer.

On July 1, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2020 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Friday, July 31 (Press release, Merck & Co, JUL 1, 2020, View Source [SID1234561608]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Members of the media are invited to monitor the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On July 1, 2020 ISA Pharmaceuticals B.V., reported that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer (Press release, ISA Pharmaceuticals, JUL 1, 2020, View Source [SID1234561604]).

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According to the latest statistics of the Centers for Disease Control and Prevention, HPV causes more than 34,000 cases of cancer in the United States each year. Cervical cancer is the most common HPV-associated cancer in women, with HPV16 being responsible for approximately 50% of cases. HPV16-positive cervical cancer is the number 2 cause of cancer for women in the age 15-44 in the US. At 1% annually, rates of cervical cancer have been dropping only marginally due to prevention through screening and prophylactic vaccination. There is an important medical need for disease modifying therapies to treat women with this terrible disease. For 2020, SEER databases project 13,800 new cases and 4,290 women dying from cervical cancer in the US.

ISA101b is a clinical-stage immunotherapy targeting HPV16-induced diseases such as cervical and oropharyngeal cancer. It induces specific immune responses to the oncogenic E6 and E7 proteins of HPV16 and is based on ISA’s proprietary Synthetic Long Peptide (SLP) technology.

"We are pleased to have Orphan Drug Designation for our ISA101b program targeting HPV16-positive cervical cancers," said Kees Melief, Chief Scientific Officer of ISA Pharmaceuticals. "Our mission is to unleash the power of the patient’s own immune system to eradicate their cancer while maintaining optimal quality of life. We believe the best and most logical way to do this is through the use of SLPs. The metastatic form of cervical cancer has a particularly high unmet medical need with 5 year survival rates not going beyond 17%. The Orphan Drug Designation for ISA101b recognizes the urgent need for more efficacious treatment options for patients suffering from metastatic HPV16-positive cervical cancer."

About Orphan Drug Designation (ODD)

Orphan drugs are intended for the treatment, diagnosis or prevention of serious diseases that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. FDA evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. FDA provides incentives for sponsors to develop products for rare diseases, including development program tax benefits and a waiver of the NDA application user fee, as well as market exclusivity for up to seven years in the US once the product has been approved, provided that the product is first to market.