On August 30, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company that develops antibody-based drug candidates for tumor-directed immunotherapy, reported that the company will participate as a presentation company at the investor conference of the 20th Annual Rodman & Renshaw Global Investment Conference, a joint venture with HC Wainwright & Co., LLC (Press release, Alligator Bioscience, AUG 30, 2018, https://alligatorbioscience.se/alligator-bioscience-presenterar-pa-20th-annual-rodman-renshaw-global-investment-conference/ [SID1234529415]). The conference will take place on 4-6 September on St. Regis New York Hotel in New York, USA.

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CEO Per Norlén will provide a status overview of the company during the company presentation and also participate in individual meetings with investors registered at the conference.

Event: Corporate Presentation at 20th Annual Rodman & Renshaw Global Investment Conference
Date: September 6, 2018
Time: at. 21.25-21.50 CEST (15.25-15.50 local time)
Location: Library (2nd floor); the st. Regis New York Hotel in New York City, USA

The presentation will be live live. To listen to the presentation, please use the following direct link: View Source or visit View Source . The webcast is available for 90 days after the presentation.

For further information please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Telephone: 046-286 44 95
Email: [email protected]

On August 30, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported financial results for its first fiscal quarter ended June 30, 2018, and provided an update on its business (Press release, Replimune, AUG 30, 2018, View Source [SID1234529395]).

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"With the completion of our successful initial public offering, Replimune is well funded to advance our new generation of oncolytic immunotherapy product candidates derived from our Immulytic platform through clinical trials in multiple tumor types and to establish in-house manufacturing capabilities," said Robert Coffin, Ph.D., co-founder and CEO of Replimune. "We are pleased with the preparations underway to initiate clinical studies under our collaboration agreements with Bristol-Myers Squibb, entered in February, for the development of RPI in combination with the anti-PD-1 antibody nivolumab, and with Regeneron, entered in May, for the development of RP1 in combination with the anti-PD1 antibody cemiplimab. We were also pleased to enter an agreement for the lease of a manufacturing site in Framingham, MA where we intend to produce supplies for later-stage clinical development and ultimate commercialization of our product candidates."

Recent Business Highlights

·The investigational new drug (IND) application for RP1 submitted with the U.S. Food and Drug Administration (FDA) is progressing on track. Replimune submitted an amendment to the IND in early August to include the longer-term toxicology data previously requested by the FDA and expects to receive acceptance of the IND in the U.S. in the coming months. Replimune’s Phase 1/2 clinical trial with RP1 is currently ongoing in the United Kingdom, and Replimune plans to open the clinical trial in the U.S. later in the year. The first part of the clinical trial is testing RP1 initially alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors, and the second part of the clinical trial will test RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers, under Replimune’s collaboration agreement with Bristol-Myers Squibb (BMS).

· Entered into a strategic collaboration with Regeneron Pharmaceuticals. In May, Replimune entered into an open-ended agreement with Regeneron that allows for clinical development of Replimune’s Immulytic product candidates in combination with Regeneron’s cemiplimab (REGN2810), an investigational PD-1 antibody, on a 50/50 cost sharing basis. The first clinical trial under this agreement is intended to be a randomized, controlled Phase

2 clinical trial of RP1 combined with cemiplimab compared to cemiplimab alone in cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma, and while no drugs are currently FDA-approved for its treatment, cemiplimab has been filed with the FDA for approval based on encouraging data with cemiplimab in this disease.

·Entered into a collaboration with BMS. In February, Replimune entered into a collaboration agreement with Bristol-Myers Squibb under which BMS will provide to Replimune, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in the ongoing Phase 1/2 clinical trial.

·Signed an agreement for the lease of a manufacturing facility to support late-stage development and commercialization. Replimune signed an agreement in June for the lease of a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class, multi-product manufacturing capabilities for its Immulytic product candidates. The facility is expected to be operational in the first half of 2020.

·Continued to build a strong leadership team. In June, Replimune appointed Dieter Weinand and Hyam Levitsky to the Board of Directors. Mr. Weinand is the current President of Bayer Pharmaceuticals and serves on the board of Bayer AG. Dr. Levitsky is a pioneer in immuno-oncology research with expertise in multiple areas including adoptive T cell therapies, cancer vaccines, and immunomodulatory therapies for the treatment of hematologic malignances and solid tumors, and most recently served as Chief Scientific Officer of Juno Therapeutics prior to its acquisition by Celgene Inc.

·Successfully completed an Initial Public Offering (IPO). In July, the Company completed its IPO, raising approximately $111 million in gross proceeds, before underwriting discounts and commissions and other offering expenses. Replimune intends to use the net proceeds to fund the development of multiple product candidates derived from its Immulytic platform into and through clinical trials, fund the fit-out and commissioning of its manufacturing facility, and general corporate expenses.

Guidance on Upcoming Events

· RP1 — In the second half of calendar 2018, define the dose of RP1 intended for future use and initiate dosing of RP1 combined with nivolumab in a cohort of 12 advanced cancer patients with a range of solid tumors, in the second part of the Phase 1 stage of the ongoing Phase 1/2 study.

· RP1 — In the first half of 2019, initiate dosing of approximately 120 patients with RP1 in combination with nivolumab, in four defined indications: metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers.

· RP1 — In the first half of 2019, initiate a randomized, controlled Phase 2 clinical trial of RP1 in combination with cemiplimab, compared to cemiplimab alone, in approximately 240 patients with CSCC.

· RP2 — In the first half of 2019, file an IND with the FDA and/or a CTA with the MHRA in the United Kingdom. RP2 is a version of RP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody.

· In the second half of calendar 2018, finalize the RP3 product candidate to be progressed into clinical trials. RP3 is intended to additionally express immune co-stimulatory pathway

activating ligands, with the goal of activating immune co-stimulatory pathways, in addition to blocking immune co-inhibition through CTLA-4.

Financial Highlights

Replimune reported a net loss of $10.0 million for the quarter ended June 30, 2018 compared with $3.6 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses, change in fair value of warrant liability, as well as expenses related to Replimune’s IPO.

Research and development expenses for the quarter ended June 30, 2018 were $3.9 million compared with $2.3 million for same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 28 on June 30, 2017 to 36 on June 30, 2018.

General and administrative expenses were $1.9 million for the quarter ended June 30, 2018 compared with $0.9 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $52.0 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The decrease reflected continuing expenses in the ordinary course, along with a transfer of $1.8 million to restricted cash in connection with the signing of a lease for our manufacturing facility in Framingham, MA. Following the end of the first quarter, the Company received net proceeds of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.

On August 30, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, reported that Shalini Sharp, the Company’s Chief Financial Officer, will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, AUG 30, 2018, View Source [SID1234529336]):

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Baird Global Healthcare Conference on Thursday, September 6, 2018 at 10:15am ET in New York.
Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 4:40pm ET in New York.
The live and archived webcast of the Company presentations will be accessible from the Company’s website at View Source The replay of the webcast will be available for 90 days.

On August 30, 2018 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported its financial results for the quarter ended June 30, 2018 and provided an update on its operations (Press release, RedHill Biopharma, AUG 30, 2018, View Source [SID1234529318]).

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"There is a tremendous amount of enthusiasm among the RedHill team which remains focused on the successful execution of our development plans and commercial operations. With enrollment nearly completed, we are on track to generate top-line results from the confirmatory Phase III study with TALICIA for H. pylori infection in the fourth quarter of this year," said Dror Ben-Asher, Redhill’s CEO. "We are also excited by the robust top-line results from the ground-breaking MAP US Phase III study with RHB-104 for Crohn’s disease which met both its primary and key secondary endpoints. We will provide an update on next steps after we speak with the FDA about the results and the development path to potential approval. Our financial standing is solid, as we remain debt-free with approximately $43 million total cash on hand as of today, with steadily declining cash burn."

Financial highlights for the quarter ended June 30, 20181:

Net Revenue for the second quarter of 2018 was $2.4 million, compared to $0.5 million in the second quarter of 2017. The increase was due to the advancement of promotional activities for Donnatal, and EnteraGam and the initial promotion of Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in late 2017.

Gross Profit for the second quarter of 2018 was $1.6 million, compared to $0.2 million in the second quarter of 2017. Gross margin increased to 69% for the second quarter of 2018 from 44% in the second quarter of 2017.

Research and Development Expenses for the second quarter of 2018 were $6.0 million, a decrease of 28% from $8.4 million for the second quarter of 2017. The decrease was mainly due to the initiation of the Company’s cost reduction plan, the completion of patient treatment for primary endpoint assessment in the Phase III study with RHB-104 and completion of the Phase III and Phase II studies with BEKINDA (RHB-102) for gastroenteritis and IBS-D, respectively.

Selling, Marketing and Business Development Expenses for the second quarter of 2018 were $3.1 million, a decrease of 7% from $3.4 million for the second quarter of 2017. The decrease was due to the continued implementation of the Company’s cost reduction plan and optimization measures.

General and Administrative Expenses for the second quarter of 2018 were relatively flat year-over-year at $2.0 million.

Operating Loss for the second quarter of 2018 was $9.6 million, a decrease of 29% from $13.5 million for the second quarter of 2017. The decrease was due to the increase in net revenue and gross profit, and a decrease in operating expenses by 19%.

Net Cash Used in Operating Activities for the second quarter of 2018 was $8.4 million, a decrease of 14% from $9.7 million for the second quarter of 2017. The decrease was mainly due to the advancement of the Company’s clinical development programs, including completion of patient treatment for primary endpoint assessment in the positive Phase III study of RHB-104 in Crohn’s disease, completion of the Phase III and Phase II studies with BEKINDA in gastroenteritis and IBS-D, respectively, and overall optimization of the Company’s operations.

Cash Balance2 as of June 30, 2018 was $27.9 million. Subsequent to the end of the quarter, on August 14, 2018, RedHill announced the closing of an underwritten offering for gross proceeds of approximately $25 million, before commissions and other offering expenses. RedHill’s cash balance as of August 30, 2018 is approximately $43 million.

NASDAQ Uplisting
On July 20, 2018, RedHill’s American Depositary Shares (ADSs) started trading on the Nasdaq Global Market after being uplisted from the Nasdaq Capital Market. The Company’s ADSs continue to trade under the symbol "RDHL".

Select R&D Highlights:

RHB-104 – Crohn’s disease (positive first Phase III study)

On July 30, 2018, RedHill announced positive top-line safety and efficacy results from the first Phase III study with orally-administered RHB-104 for Crohn’s disease (MAP US study). The study successfully met both its primary endpoint and key secondary endpoints. The randomized, double-blind, placebo-controlled first Phase III study enrolled 331 subjects with moderately to severely active Crohn’s disease (defined as Crohn’s Disease Active Index (CDAI) between 220 and 450) in the U.S., Canada, Europe, Australia, New Zealand and Israel. Subjects were randomized 1:1 to receive RHB-104 or placebo, on-top of baseline background medication, including 5-ASAs, corticosteroids, immunomodulators or anti-TNFα agents.

The top-line results from the MAP US study demonstrated the superiority of RHB-104 over placebo in achieving remission at week 26, defined as CDAI value of less than 150, the primary endpoint of the study. The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo (37% vs. 23%, p= 0.013). The study also successfully met key secondary endpoints, demonstrating a consistent benefit to Crohn’s disease patients treated with RHB-104. RHB-104 was found to be generally safe and well tolerated. RedHill will continue to assess additional data as it becomes available. The Company will meet with key opinion leaders and the U.S. Food and Drug Administration (FDA) to present the data package and discuss the development path to potential FDA approval and will continue discussions with potential partners for RHB-104.

On July 2, 2018, RedHill announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) and an Intention to Grant from the European Patent Office (EPO) for two new patents covering RHB-104, expected to be valid until at least February 5, 2029, once granted. On August 13, 2018, the Company announced that it has received a Notice of Allowance from the USPTO for a new formulation patent, expected to be valid until at least 2029, that further expands the Company’s intellectual property portfolio covering RHB-104 for Crohn’s disease and RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections.

TALICIA (RHB-105) – H. pylori infection (confirmatory Phase III) (FDA Fast Track)

To date, over 444 patients have been enrolled in the ongoing confirmatory Phase III study with TALICIA (RHB-105)3 for H. pylori infection (ERADICATE Hp2 study). RedHill expects to announce top-line results in the fourth quarter of 2018.

Subject to a successful outcome of the study and additional regulatory feedback, the ERADICATE Hp2 study is expected to complete the clinical package required for a potential submission of a U.S. New Drug Application (NDA) for TALICIA in early 2019, which is eligible to benefit from priority review of six months.

RHB-204 – nontuberculous mycobacteria (NTM) infections (planned pivotal Phase III) (FDA Fast-Track QIDP status)

A pivotal Phase III study with RHB-204 for the treatment of pulmonary nontuberculous mycobacteria (NTM) infections is expected to be initiated in the first quarter of 2019, subject to completion of a supportive non-clinical program and additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 as a first-line treatment for pulmonary NTM infections caused by Mycobacterium avium complex (MAC).

BEKINDA (RHB-102) 24 mg – Gastroenteritis (Phase III)

Following the positive results of the Phase III study with BEKINDA 24 mg for acute gastroenteritis (GUARD study) and guidance provided by the FDA, RedHill is currently in discussions with the FDA on the design of a confirmatory Phase III study to support a potential NDA.

BEKINDA (RHB-102) 12 mg – IBS-D (Phase II)

Following positive results of the Phase II study with BEKINDA 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D), RedHill is in discussions with the FDA on the design of pivotal Phase III studies and path to potential NDA approval.

An abstract4 (number: 2908495), describing the results of the Phase II study with BEKINDA 12 mg for the treatment of IBS-D, was presented as a Poster of Distinction at Digestive Disease Week (DDW) in June 2018.

YELIVA (ABC294640) – cholangiocarcinoma (Phase IIa) (FDA Orphan Drug designation)

Enrollment in the single-arm Phase IIa study with YELIVA (ABC294640) for the treatment of cholangiocarcinoma (bile duct cancer) is expected to be completed by the end of 2018. The study is being conducted at the Mayo Clinic’s major campuses in Arizona and Minnesota, University of Texas MD Anderson Cancer Center, the Huntsman Cancer Institute, University of Utah Health, and at Emory University. The study is designed to enroll up to 39 patients.

RHB-106 – encapsulated bowel cleanser licensed to Salix Pharmaceuticals

On August 20, 2018, RedHill announced that it had received a Notice of Allowance from the USPTO for a new formulation patent covering RHB-106, which is expected to be valid until at least 2033.

RedHill recently amended its 2014 worldwide license agreement with Salix Pharmaceuticals ("Salix"), a wholly-owned subsidiary of Bausch Health Companies Inc., relating to RHB-106, as well as additional related rights. The amendment clarified Salix’s future development efforts and provides for enhanced involvement by RedHill in certain intellectual property matters and increased the lower end of the range of royalty payments to be paid to RedHill on net sales from low single digits to high single digits. Milestone payments remain unchanged. RedHill continues to assist Salix in the development of RHB-106, as needed.

U.S. Commercial Highlights:

On June 28, 2018, RedHill announced that it had entered into a co-promotion agreement with Napo Pharmaceuticals, a human health company developing and commercializing novel gastrointestinal prescription products, granting RedHill the exclusive right to co-promote Mytesi (crofelemer 125 mg delayed-release tablets)5 in the U.S. to certain gastroenterologists and primary care physicians for the approved indication in people living with HIV/AIDS. Mytesi is an FDA-approved anti-diarrheal prescription drug indicated for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on anti-retroviral therapy (ART). On July 25, 2018, RedHill announced that it had initiated the promotion of Mytesi. Mytesi is the fourth product being promoted by RedHill’s gastrointestinal-focused U.S. salesforce, in preparation for potential U.S. launch of RedHill’s late clinical-stage products.

Conference Call and Webcast Information:

The Company will host a conference call today, August 30, 2018 at 8:30 a.m. EDT to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-800-263-0877; International: +1-646-828-8143; and Israel: +972-3-721-9463. The access code for the call is: 9460445.

The conference call will be broadcasted live and will be available for replay on the Company’s website, View Source, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.

On August 30, 2018 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported that Christopher K. Mirabelli, Ph.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 20TH Annual Global Investment Conference, being held in New York City on September 4-6, 2018 (Press release, Leap Therapeutics, AUG 30, 2018, View Source;p=RssLanding&cat=news&id=2365574 [SID1234529242]).

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Leap Presentation Details:

H.C. Wainwright 20th Annual Global Investment Conference
Date: Thursday, September 6, 2018
Time: 9:35 A.M.

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at www.investors.leaptx.com, where a replay of the event will also be available for a limited time.