On May 9, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported to inform shareholders that the Company has concluded its review of all data outputs and corresponding analyses from its successfully completed Phase 2 Brilacidin-OM trial (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (Severe OM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAY 9, 2018, View Source [SID1234526372]).

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"The Company would like to thank the trial’s patients who volunteered for this study. It is often a difficult decision for a patient to volunteer for a clinical trial with a placebo arm—and gratitude is owed to all who participated in the face of their respective cancer battles," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer of Innovation Pharmaceuticals. "We would also like to thank our shareholders and institutional partners that have made it possible to advance Innovation’s drug candidates."

"Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward," said Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. "The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise."

Summary of Brilacidin-OM Phase 2 Study Results

Key Efficacy Outcomes were:

· Reduced Incidence of Severe OM (Primary Endpoint)

o Placebo 60.0%, reduced to Brilacidin 42.9% [Modified Intent to Treat (mITT) Population].

o Placebo 60.0%, reduced to Brilacidin 36.8% [Per Protocol (PP) Population].

· Delayed Onset of Severe OM (Secondary Endpoint)

o For those patients in the Brilacidin group who did experience Severe OM, onset occurred generally later during radiation therapy.

· Reduced Duration of Severe OM (Secondary Endpoint)

o Severe OM median duration was 0.0 days for Brilacidin (mITT and PP Populations), indicating that more than half of all patients on active treatment did not experience Severe OM.

o Overall Severe OM median durations for placebo were 3.0 days and 5.5 days for the mITT and PP Populations, respectively.

Brilacidin was more effective in decreasing the incidence of Severe OM in patients receiving the more aggressive chemotherapy regimen – cisplatin administered in a higher concentration (80-100 mg/m2), approximately every 21 days – as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.

· Reduced Incidence of Severe OM, 21-day Cisplatin Regimen subset

o Placebo 71.4%, reduced to Brilacidin 25.0% [mITT Population] (p=0.048).

o Placebo 72.7%, reduced to Brilacidin 14.3% [PP Population] (p=0.025).

· Delayed Onset of Severe OM, 21-day Cisplatin Regimen subset

o The time to onset of Severe OM was delayed with Brilacidin treatment compared to placebo, even more markedly in the 21-day cisplatin regimen subgroup.

A 65.0% (mITT Population) and 80.3% (PP Population) relative risk reduction ([incidence control- incidence active]/incidence control) in the incidence of Severe OM was achieved with Brilacidin compared to placebo, for the approximately every 21 days cisplatin regimen subset. The academic literature indicates that a once-every-3-weeks cisplatin regimen, versus once-a-week, largely remains the recommended dosing schedule for the treatment of HNC.

The ‘Blue Sky’ Commercial Opportunity in Severe Oral Mucositis

There is no drug approved to prevent or treat Severe OM in patients with HNC. This is not due to lack of effort, however, with many companies having tried to address the unmet medical need with limited success (see ClinicalTrials.gov). According to posted information, over 250 clinical studies (as of 05-May-2018) have been, or are being, conducted targeting Oral Mucositis—indicative of the substantial pharmaceutical industry effort and investment toward attempting to identify new OM treatments.

The commercial potential for Brilacidin-OM in HNC is substantial and untapped, with no effective drug currently approved worldwide. In the U.S. alone, the annual incidence of HNC is estimated to be approximately 65,000 new cases, and worldwide, these numbers approach approximately 750,000 new cases each year. With Brilacidin-OM, Innovation Pharmaceuticals is positioned to fill a substantial void in supportive cancer care by reducing the incidence of Severe OM in HNC, making a considerable difference to the general well-being of these patients.

About Unmet Need in Treating Severe Oral Mucositis

Severe Oral Mucositis is a serious, costly, complex and frequent complication of treatment for HNC. In cases of Severe OM, patients cannot eat solid food (Grade 3) and cannot consume either solids or liquids (Grade 4)—a situation that can result in, most critically, suspension of cancer therapy. As noted in a video on Severe OM published on the "Healthy Body, Healthy Mind" website, negative effects of developing Severe OM can also be overwhelming to a patient’s physical well-being and positive mental attitude.

Severe OM incidence rates in HNC can range from 60-70 percent, on the low end, to over 90 percent. Further, morbidity attributable to ulcerative and Severe OM can result in not just chemoradiation treatment interruption, but also placement of feeding tubes, and potentially greater mortality due to deleterious effects of subsequent treatment interruptions (worsening local tumor control and lower overall survival). Added health care costs attributable to Severe OM average ~$18,000 to $25,000 per case when patients require hospitalization.

It is widely acknowledged that there is a large unmet need for novel therapeutics in this area, with many interventions limited in their application and/or ranging widely in quality and with conflicting results, as conveyed in the Multinational Association of Supportive Care in Cancer (MASCC) and International Society of Oral Oncology (ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy.

On May 9, 2018 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, reported financial results for the third quarter ended March 31, 2018 (Press release, Immunomedics, MAY 9, 2018, View Source [SID1234526371]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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"We have made tremendous progress in achieving our regulatory, clinical and organizational objectives in the prior quarter. Through the outstanding work of our colleagues, we remain on track to file our first BLA with the FDA later this month for the approval of sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA has previously granted us Breakthrough Therapy Designation for the treatment of patients with mTNBC who received at least two prior therapies for metastatic disease," stated Michael Pehl, President and Chief Executive Officer of Immunomedics. "In addition, Rob Iannone joined us as the Head of R&D and Chief Medical Officer, and under his leadership we will continue to unlock the full potential of sacituzumab govitecan, as well as new value creation opportunities with our unique ADC platform."

Highlights of Recent Progress

In March 2018, the Phase 3 ASCENT study dosed the first patient in Europe, reflecting the encouraging progress of the confirmatory trial with sacituzumab govitecan in patients with mTNBC.

In March 2018, the Company’s abstract on the efficacy of sacituzumab govitecan for treatment-refractive, HR+, HER2- mBC was selected for oral presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

In April 2018, Immunomedics further expanded its executive leadership team with the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer. Dr. Iannone brings more than 13 years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

In April 2018, the FDA agreed to the Company’s proposed amendments to the confirmatory ASCENT trial protocol that is under a Special Protocol Assessment (SPA). The amendments incorporated recommendations from EU National Health authorities and advice from key breast cancer experts. As a result, the sample size will be increased to 488 patients, and will ensure robust power to evaluate the key objectives in the primary population of interest. Based on strong early enrollment trends, these changes are not expected to meaningfully impact overall study timelines. Immunomedics believes that the FDA’s agreement to this SPA amendment may further increase the probability of success of the study, while leaving key study objectives and endpoints intact.
Key Upcoming Events/Anticipated Milestones

BLA submission for accelerated approval of sacituzumab govitecan in third-line mTNBC (May 2018).

Oral presentation of results with sacituzumab govitecan in patients with HR+/HER2- mBC at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting (morning of Sunday, June 3, 2018).

Investor Event at ASCO (Free ASCO Whitepaper) (evening of Sunday, June 3, 2018).
Third Quarter and Nine Months Fiscal 2018 Results

Total revenues were $0.5 million for the third fiscal quarter ended March 31, 2018 and $1.8 million for the nine months ended March 31, 2018, compared to $1.3 million in the third fiscal quarter ended March 31, 2017 and $2.4 million for the nine months ended March 31, 2017. The decreases were due primarily to lower sales volume of LeukoScan in Europe. The Company discontinued the sale of LeukoScan during the third quarter of fiscal 2018 to focus on its ADC business.

Total costs and expenses were $38.1 million for the quarter and $90.4 million for the nine months ended March 31, 2018, compared to $23.4 million in the third quarter and $54.9 million for the nine months for the prior fiscal year. The higher costs and expenses in the third quarter and nine months of fiscal 2018 were due primarily to increases in research and development expenses as well as in sales and marketing expenses. The increases in third quarter costs and expenses of fiscal 2018 were offset partially by a $3.6 million decrease in general and administrative expenses in the third quarter due primarily to higher legal and advisory fees incurred in fiscal 2017 during the Company’s proxy contest.

The increases in research and development expenses were due primarily to increases in clinical trial costs as well as increases in labor related costs in connection with preparations for the regulatory submission and launch of sacituzumab govitecan in the United States for patients with mTNBC. The increases in sales and marketing expenses were due primarily to commercial launch preparation activities.

The Company recognized $9.8 million in non-cash income for the quarter and $49.8 million in non-cash expense for the nine months ended March 31, 2018, compared to $28.3 million in non-cash expense for the third quarter and $35.6 million for the nine months for the prior fiscal year. The changes in non-cash cost were due to the change in the fair value of warrant liabilities.

Net loss attributable to stockholders was $35.5 million, or $0.21 per share, for the quarter ended March 31, 2018, compared to net loss attributable to stockholders of $59.3 million, or $0.55 per share, for the same quarter in fiscal 2017. Net loss attributable to stockholders was $156.8 million, or $1.08 per share, for the nine months ended March 31, 2018, compared to net loss attributable to stockholders of $99.9 million, or $0.97 per share, for the same period in fiscal 2017.

As of March 31, 2018, the Company had $358.8 million in cash, cash equivalents, and marketable securities which it believes is sufficient to support its next phase of growth and continue operations into 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the third quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 9679918. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

On May 9, 2018 IGEM Therapeutics (IGEM), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported the award of a £1.45 million grant from the UK’s innovation agency, Innovate UK (Press release, IGEM Therapeutics, MAY 9, 2018, View Source [SID1234526370]). IGEM will use the Biomedical Catalyst award to further the development of IGEM-Ch, a novel IgE antibody targeting solid tumours.

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IGEM-Ch is a novel and proprietary humanised IgE antibody that binds to the cancer antigen CSPG4 (chondroitin sulphate proteoglycan 4). The CSPG4 antigen is overexpressed in melanoma and various other cancers including triple-negative breast cancer (TNBC). Pre-clinical studies in the laboratory of Dr Sophia Karagiannis at King’s College London demonstrated that an anti-CSPG4 IgE outperformed an equivalent IgG antibody in a variety of challenging models. The company will receive £1.02M in net funding from the Biomedical Catalyst award to help progress IGEM-Ch into clinical trials by generation of a pre-clinical development package and efficient GMP manufacturing process. IGEM has issued patents covering the antibody in the US, Europe and Australia.

IGEM is building a portfolio of IgE antibodies directed against various cancer antigens including folate receptor alpha, CSPG4, HER2 and EGFR. The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. IGEM has demonstrated superior efficacy for IgE versus IgG equivalent antibodies in a range of pre-clinical cancer models. The company’s scientific founders, Dr Sophia Karagiannis, Professor James Spicer and Dr Vivienne Cox have previously transitioned the first-in-class IgE, IGEM-F, into a Phase 1 clinical trial in cancer patients.

On May 9, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the Bank of America Merrill Lynch 2018 Healthcare Conference on Wednesday, May 16, 2018, at 1:00 p.m. PDT at the Encore Hotel in Las Vegas, NV (Press release, Heron Therapeutics, MAY 9, 2018, View Source [SID1234526369]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On May 9, 2018 FibroGen, Inc. (NASDAQ: FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2018, View Source [SID1234526368]).

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"FibroGen and AstraZeneca are preparing to complete patient enrollment in five Phase 3 roxadustat CKD anemia trials this quarter. We look forward to reporting topline data in the fourth quarter of this year. With our partners, we are continuing to see positive data from our global roxadustat Phase 3 programs, most recently in Japan from Astellas," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "Pamrevlumab continues to reveal its potential in the treatment of fibrotic and fibro-proliferative diseases. We are working towards achieving regulatory alignment with the FDA on pivotal study designs for both IPF and pancreatic cancer. We will be presenting data at the ATS conference in May from our placebo-controlled Phase 2 study in IPF representing the first known significant attenuation of fibrosis progression as measured by quantitative HRCT, and we will report Phase 2 data at ASCO (Free ASCO Whitepaper) in June showing that a majority of unresectable locally advanced pancreatic cancer patients treated with pamrevlumab and chemotherapy were assessed as resectable after six months of treatment. We will also report that there appears to be a survival benefit in this study for patients who have undergone tumor resection. Patients continue to be followed in this study for survival."

Recent Developments and Highlights

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and ROW

Phase 3 trial enrollment to complete in the second quarter of 2018

Topline Phase 3 clinical studies data expected in the fourth quarter of 2018

In its most recent review in March, the DSMB recommended Phase 3 clinical studies continue under current protocols with no changes

Roxadustat for Anemia in CKD in China

NDA review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA) is ongoing; anticipate regulatory approval by year-end 2018

Roxadustat for Anemia in CKD in Japan

Positive topline data from two Phase 3 studies in dialysis-dependent CKD patients with anemia, a long-term ESA conversion study and an ESA-naïve correction study, were reported in April 2018 by our partner Astellas

Astellas expects to submit a NDA for anemia associated with dialysis-dependent-CKD in Japan in 2018

Astellas expects data readout in one of the Japan Phase 3 studies in non-dialysis-dependent CKD anemia patients in the fourth quarter of 2018

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Multiple abstracts accepted for presentation at the 2018 American Thoracic Society (ATS) Conference in May

Results from our Phase 2 IPF clinical trial

HRCT quantitative imaging of lung fibrosis;

Health-related quality of life assessments; and

PK/PD modeling

Preclinical results from a highly predictive animal model of lung fibrosis

Pamrevlumab for Pancreatic Cancer

Fast Track designation granted by the FDA for the treatment of patients with locally advanced unresectable pancreatic cancer in the first quarter of 2018

Phase 2 clinical trial results have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Pamrevlumab for Duchenne Muscular Dystrophy

Completed clinical trial enrollment in the first quarter of 2018

Corporate and Financial

Net loss for the first quarter was $41.4 million, or ($0.50) per share, compared to $30.6 million, or ($0.48) per share, for the first quarter of 2017, primarily due to ongoing investments in our research and development and general and administrative initiatives

We recast our condensed consolidated statement of operations and condensed balance sheet from the amounts previously reported upon the adoption of the new revenue guidance under Accounting Standards Codification 606 as of January 1, 2018. The impact for the first quarter 2017 was a $2.6 million increase in revenue. The cumulative reduction in revenue of $34.7 million through 2017 for all years impacted on a fully retrospective basis, will be recognized over the future remaining development periods.

At March 31, 2018, FibroGen had $730.4 million of cash, restricted time deposits, cash equivalents, investments, and receivables

The weighted average number of common shares used to calculate net loss per share was 82.9 million shares and 64.0 million shares for the first quarters of 2018 and 2017, respectively, reflecting equity offerings completed in 2017. Total shares outstanding as of March 31, 2018 were 83.4 million shares.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Wednesday, May 9, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen first quarter 2018 financial results conference call, and use passcode 46778299#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46778299#.

About Roxadustat

Roxadustat is a first-in-class oral therapeutic in global Phase 3 clinical development as a treatment for anemia associated with chronic kidney disease (CKD) with the potential to offer a safer and more effective, convenient, and accessible treatment than current therapies. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis, or the production of red blood cells, by increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin, including in the presence of inflammation and without need for supplemental intravenous iron.

The roxadustat Phase 3 program is the largest Phase 3 clinical program in anemia to date, and is supported by extensive Phase 2 results demonstrating correction and maintenance of hemoglobin levels in anemia in multiple subpopulations of CKD dialysis and non-dialysis patients. A New Drug Application (NDA) has been accepted for review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA). In the U.S., data readout for the Phase 3 program is expected in the fourth quarter of 2018. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic syndromes (MDS). For information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has been well tolerated in multiple Phase 2 clinical studies, with a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.