On March 26, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, Curis, MAR 26, 2019, View Source [SID1234534631]).

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"2018 was a pivotal year for Curis as we transitioned from a company broadly engaged in discovery research and pipeline expansion into a company singularly focused on clinical execution," said James Dentzer, President and Chief Executive Officer of Curis. "We now have three novel programs in the clinic, all potential blockbusters and all with significant data catalysts expected in 2019."

Dentzer continued, "With our recently announced agreement with Oberland Capital, we secured the financial flexibility needed to ensure we can continue to move forward aggressively in our clinical execution on all three programs and produce the data readouts everyone is so excited to see.

"As we move through 2019, we are focused on the development of first-in-class and best-in-class precision medicines that we hope will transform the lives of patients," he concluded.

Full Year and Fourth Quarter 2018 Financial Results

For the year ended December 31, 2018, Curis reported a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis, as compared to a net loss of $53.3 million, or $1.79 per share on both a basic and diluted basis in 2017. For the fourth quarter of 2018, Curis reported a net loss of $5.9 million or $0.18 per share on both a basic and diluted basis, as compared to a net loss of $8.0 million, or $0.24 per share on both a basic and diluted basis for the same period in 2017.

Revenues for the year ended December 31, 2018, were $10.4 million as compared to $9.9 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2018 and 2017 were $2.8 million and $3.3 million, respectively.

Operating expenses for the year ended December 31, 2018 were $39.8 million as compared to $59.7 million for the same period in 2017. Operating expenses for the fourth quarter of 2018 were $7.9 million, as compared to $10.4 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.6 million for the year ended December 31, 2018 as compared to $0.5 million for the same period in 2017. Cost of royalty revenues were $0.1 million for the fourth quarter of 2018, as compared to $0.2 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $24.4 million for the year ended December 31, 2018, as compared to $45.1 million for the same period in 2017. The decrease was primarily due to aggregate payments to Aurigene of $7.5 million, for an exclusivity option that was paid in 2017 as well as decreased costs related to ongoing clinical activities for CA-170. These costs included decreased clinical site, patient, clinical research organization, formulation and manufacturing and consulting costs for our ongoing Phase 1 clinical trial. Employee-related expenses decreased over the prior year period primarily due to a reduction in headcount that occurred in the fourth quarter of 2018. Research and development expenses were $4.7 million for the fourth quarter of 2018 as compared to $6.9 million for the same period in 2017.

General and Administrative Expenses. General and administrative expenses were $14.8 million for the year ended December 31, 2018 as compared to $14.1 million for the same period in 2017. The increase in general and administrative expenses was driven primarily by higher legal, professional and consulting services and other administrative expenses, partially offset by lower stock-based compensation for the period. General and administrative expenses were $3.0 million for the fourth quarter of 2018, as compared to $3.3 million for the same period in prior 2017.

Other expense, net, was $3.2 million for the year ended December 31, 2018, as compared to $3.6 million for the same period in 2017. Other expense, net primarily consisted of interest expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of Curis). The decrease in interest expense in the current year was related to a lower principal balance on Curis Royalty’s outstanding debt with HealthCare Royalty, which was refinanced in the first quarter of 2017. Other expense, net was $0.8 million and $0.9 million for the fourth quarter of 2018 and 2017, respectively.

As of December 31, 2018, Curis’ cash, cash equivalents, marketable securities and investments totaled $24.3 million and there were approximately 33.2 million shares of common stock outstanding. The previously announced sale of a portion of Erivedge royalties to Oberland Capital Management will provide net proceeds of approximately $30 million before closing costs and transaction fees.

Full Year 2018 and Recent Operational Highlights

Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Curis initiated its study of fimepinostat (a MYC inhibitor) with venetoclax (a BCL-2 inhibitor) combination regimen in diffuse large B-cell lymphoma (DLBCL), including patients with Double-Hit/Double-Expressor Lymphoma. In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
In December 2018 at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) annual meeting, Curis presented a pooled analysis of patients with relapsed/refractory DLBCL treated with fimepinostat, including individuals with MYC-alterations that demonstrated the treatment’s safety and durable benefit in this patient population.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In 2018, Curis initiated and continued to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a Phase 1 dose escalation study. CA-4948 is designed to target cancers with MYD88 mutations present in various tumor cell lines including DLBCL, Waldenström’s macroglobulinemia (WM), and acute myeloid leukemia.
In December 2018, at the ASH (Free ASH Whitepaper) annual meeting, Curis presented preclinical results showing potent anti-tumor in vivo activity for CA-4948 as a single agent as well as an enhanced effect when combined with other agents supporting the potential for IRAK4-based combination regimens.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

In November 2018, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting, Curis presented three posters providing an update to the ongoing CA-170 Phase 1 trial and preclinical support of VISTA’s role as an oncology target of interest. At the same conference, collaborator Aurigene presented a poster detailing key findings from its ongoing Phase 2 trial of CA-170 in patients with advanced solid tumors and Hodgkin lymphoma who are immunotherapy treatment-naïve.
In January 2019, Curis announced the first mesothelioma patient dosed in its ongoing Phase 1 CA-170 trial, which recently started to enroll patients with mesothelioma, following evidence supporting high levels of VISTA expression in mesothelioma tumor samples. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.
Full Year 2018 and Recent Corporate Highlights

Curis announced a 1-for-5 reverse stock split that came into effect on May 29, 2018.
In May 2018, Curis appointed Robert Martell, M.D., Ph.D., a practicing oncologist, experienced drug developer and former CMO of Tesaro, as Head of Research and Development.
In September 2018, Curis announced the appointment of James Dentzer to the position of President and Chief Executive Officer.
In October 2018, Curis implemented a 27% reduction in headcount and a re-allocation of pre-clinical resources to strengthen focus on clinical development. The result of these changes reduced the forecasted cash burn from approximately $11 million to $8 million per quarter going forward.
In March 2019, Curis announced that it sold a portion of its Erivedge royalties to Oberland Capital for up to $135.7 million, including $65 million upfront and $70.7 million in future milestones.
2019 Data Catalysts

Curis expects to report initial data on the combination of fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE Lymphoma, in the second half of 2019.
Curis expects to report initial efficacy data from its CA-4948 dose escalation study in patients with D/DE DLBCL in mid-year 2019.
Curis expects to report initial efficacy data from its CA-170 Phase 1 trial in patients with mesothelioma (high VISTA expressors) in the second half of 2019.
Conference Call Information

Curis management will host a conference call today, March 26, 2019, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 (from the United States) or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed in the Investors section on the Curis website at www.curis.com.

On March 26, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it intends to offer and sell units consisting of shares of common stock and warrants in an underwritten public offering (Press release, Moleculin, MAR 26, 2019, View Source [SID1234534647]). All units in the offering will be sold by Moleculin. The proposed offering is subject to market and other conditions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 26, 2019 OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), reported a new research collaboration agreement with premier cancer research hospital, Léon Bérard Cancer Center in Lyon, France, to use artificial intelligence (AI)-based bioanalysis and bioinformatics to identify novel targets in immuno-oncology (Press release, OSE Immunotherapeutics, MAR 26, 2019, View Source [SID1234553881]).

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Léon Bérard Cancer Center (CLB) has both a cancer immunotherapy laboratory and translational research laboratory and is recognized as a scientific expert in oncology, particularly in tumor targeting and in the immune environment. Additional resources at CLB include its state-of-the-art bioinformatics platform and biological resource center. Their experience in analyzing and integrating data from The Cancer Genome Atlas (TCGA) allows detailed analysis of clinically relevant targets in populations that could potentially benefit from an innovative therapeutic approach.

This new collaborative immuno-oncology research program will use different patient cohorts and tumor biopsies to identify novel molecular targets associated with the primary and secondary resistance to
PD-1/PD-L1 immune checkpoint inhibitors and to validate a strategy of combining drugs based on target expression profile.

The research is based on an artificial intelligence approach jointly developed which will be applied to analyze gene expression in the human tumor microenvironment and the composition of tumor infiltrates. The findings from this collaboration will be used for the selection and validation of innovative targets for early development of new drug candidates from the platform of bispecific fusion proteins targeting PD-1 and innovative targets (BiCKI).

"We are very excited to begin a new collaboration with an expert team and the CLB, a premier cancer research center. The goal of this partnership is to identify and validate new targets that will help streamline the development of new treatment approaches for cancer, especially in difficult to treat tumors," said Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

Professor Jean-Yves Blay, M.D., Ph.D., director of the Léon Bérard Cancer Center commented, "Our AI approach combined with our translational and immunological research platforms will enable us to analyse tumor immune parameters and to identify potential new pathways to address unmet needs for cancer patients. This partnership brings together top experts in oncology research and translational science with the hopes of rapidly advancing the discovery of first-class treatment options for cancer patients. We are very pleased to work in collaboration on this cutting-edge research with OSE Immunotherapeutics."

On March 26, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the fourth quarter and year ended December 31, 2018 (Press release, AEterna Zentaris, MAR 26, 2019, View Source [SID1234534653]).

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All Amounts are in U.S. Dollars

Highlights

Total revenue for fiscal 2018 was $26.9 million, compared to $0.9 million for fiscal 2017

Income from operations for fiscal 2018 was $9.8 million, compared to a loss from operations of $23.1 million for fiscal 2017

Net income for fiscal 2018 was $4.2 million, compared to a net loss of $16.8 million for fiscal 2017

Total revenue for Q4 2018 was $1.4 million, compared to $0.2 million for Q4 2017

After our year-end, in January 2019, European Medicines Agency (EMA) granted marketing authorization for macimorelin for diagnosis of adult growth hormone deficiency

As of December 31, 2018, we had $14.5 million of unrestricted cash and cash equivalents
Summary of Full-Year Results

For the year ended December 31, 2018, we reported a consolidated net income of $4.2 million, or $0.25 per common share, as compared with a consolidated net loss of $16.8 million, or $1.12 loss per common share, for the year ended December 31, 2017. The $21 million improvement in results arose primarily from a $23.9 million increase in gross profit (which resulted primarily from the $24 million royalty payment received from Strongbridge Biopharma) and a $9.1 million reduction in operating expenses. These improvements were offset in part by the $5.55 million in tax expense in 2018 (compared to a tax recovery in 2017 of $3.5 million) and $1.6 million decrease in net finance income.

Revenues

Our total revenue for the year ended December 31, 2018 was $26.9 million as compared with $0.9 million for the same period in 2017, representing an increase of $26.0 million. The 2018 revenue comprised $24.3 million in license revenue, $2.2 million in product sales, $0.2 million in royalty income and $0.2 million in sales commissions as compared with $0.4 million in license fee and $0.5 million in license fees in 2017. The increase in total revenue in 2018 relates to license fees, royalty income and product sales associated with executing the License and Assignment Agreement for Macrilen (macimorelin) in January 2018.

Cost of sales

Our total cost of goods sold for the year ended December 31, 2018 was $2.1 million as compared with nil for the same period in 2017, reflecting the costs of our sales of Macrilen (macimorelin) inventory pursuant to an interim supply agreement under the License and Assignment Agreement.

Operating Expenses

Our total operating expenses for the year ended December 31, 2018 was $14.9 million as compared with $24.0 million for the same period in 2017, representing a decline of $9.1 million. This was primarily due to a $7.8 million decline in research and development costs, while the $2.0 million decrease in selling expenses was offset by $0.1 million increase in general and administrative expenses.

In 2018, our focus was on our PIP study for Macrilen (macimorelin), for which we received $0.4 million from our licensee for its share of such costs.

Our general and administrative expenses were higher in 2018 than expected as we incurred significant legal costs in the course of reaching settlement agreements for $1.4 million.

Our selling expenses are in-line with expectations and lower in 2018 than in 2017 due to the Q1 2018 termination of our North American sales team and our co-promotion activities as we shifted our focus to licensing Macrilen (macimorelin).

Net Finance Income

Our net finance income for the year ended December 31, 2018 was $1.2 million, as compared to $2.8 million for the same period in 2017, representing a decrease of $1.6 million. The decline in net finance income is primarily due to the change in fair value of our warrant liability. Such change in fair value results from the periodic "mark-to-market" revaluation via the application of pricing models to our outstanding share purchase warrants.

Summary of Fourth Quarter Results

For the three-month period ended December 31, 2018, we reported a consolidated net loss of $5.1 million, or $0.31 loss per common share, as compared with a consolidated net loss of $0.5 million, or $0.03 loss per common share, for the three-month period ended December 31, 2017. The $4.6 million increase in net loss in 2018, as compared with 2017, results primarily from $2.8 million in tax expense movement, $1.4 million increase in cost of goods, $0.9 million increase in finance costs and $0.8 million increase in settlements, offset by $1.2 million increase in total revenues. In the fourth quarter of 2018, unlike in 2017, we earned $0.2 million in royalty income from our licensee and expensed $0.8 million in one-time settlement costs to settle a lawsuit against the Company from two of our former executives. In the fourth quarter of 2018 we also actively began the EMA and FDA pediatric study for Macrilen (macimorelin).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and fiscal 2018, as well as the Company’s audited consolidated financial statements as at December 31, 2018, 2017 and for the years ended December 31, 2018, 2017 and 2016 will be available at www.zentaris.com in the "Investors" section or at the Company’s profile at www.sedar.com and www.sec.gov.

Annual and Special Meeting of Shareholders

The Company has scheduled its annual shareholders meeting for 10:00 am (Eastern time) on May 8, 2019 at 1155 René-Lévesque Blvd. West, 41st Floor, Montreal, Quebec. At that meeting, in addition to the presentation of the Company’s annual financial statements, the election of directors and the appointment of the Company’s auditors, shareholders will also consider resolutions to move the Company’s registered address from Quebec to Ontario, and to renew and amend the Company’s existing shareholders rights plan. These matters are described in detail in the Company’s 2019 Management Proxy Circular. This proxy circular and a copy of the proposed amended and restated shareholders rights plan will be available at www.sedar.com and www.sec.gov.

At the Company’s 2019 annual and special meeting, the Company will be proposing that the size of its board of directors be reduced from seven to five, with Mr. Mike Cardiff having resigned from the board of directors for personal reasons in March 2019 and Mr. Juergen Ernst having indicated to the Company his desire not to be nominated for re-election. The Company thanks both of them for their service to the Company.

On March 26, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the Phase II advanced liver cancer study did not achieve its primary end point of overall survival in the whole population (n=78) (Press release, Can-Fite BioPharma, MAR 26, 2019, View Source [SID1234534634]). At the same time, superiority in overall survival was found in the largest study subpopulation of CPB7 (n=56) and in secondary end points in the whole population, including objective response measured by CT or MRI. These data strongly support the progression into Phase III.

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Advanced liver cancer in patients with underlying cirrhosis is categorized into three subclasses based on the severity of cirrhosis, starting with Child Pugh A (CPA), mostly treated with Nexavar and progressing to Child Pugh B (CPB) and Child Pugh C (CPC), for which there are no drugs on market with proven efficacy.

In the study, the Company enrolled only patients with CPB stage liver cancer with CBP stage patients being further divided into three categories of increasing severity, namely CPB7, CPB8, and CPB9. These patients already failed first line Nexavar and were treated with Namodenoson (25mg), or placebo, as a second line treatment, twice daily, using a 2:1 randomization. The primary endpoint of the study was defined as the length of time the patients lived after receiving treatment or median overall survival (OS). Secondary endpoints included safety, the length of time tumors did not grow after treatment, or progression free survival (PFS), the percent of patients whose tumors partially shrank after treatment, or partial response (PR), and the percent of patients who were PR or stable, or disease control rate (DCR).

Findings from the study include the following:

1.For the whole population (n=78), median OS was 4.1 months for Namodenoson vs. 4.3 months for placebo (HR: 0.82).

2Pre-planned subpopulation analysis of the CPB7 patients (n=56), revealed that the Namodenoson treated group (n=34) showed median overall survival of 6.8 months vs 4.3 months in placebo (n=22) [HR: 0.77 (95% CI 0.49-1.40)]. Similarly, for this subgroup of patients, PFS was 3.5 months for the Namodenoson treated group vs 1.9 (HR: 0.87) in the placebo group.

3.Objective response in the whole patient population measured by CT or MRI, demonstrated that 9% treated by Namodenoson achieved PR vs 0% in the placebo group.
4.Consistent with safety results from previously completed clinical trials, Namodenoson was generally well-tolerated, with no treated patients being withdrawn for toxicity and no cases of treatment-related deaths.
5.DCR was 18.0% in the Namodenoson group vs 7.1% in the placebo group (p=0.013) after four months of treatment.
6.32.0% of patients treated with Namodenoson completed at least 12 months of treatment vs 14.3% who were treated with placebo (p=0.058).
7.As of today, two patients in the Namodenoson group are ongoing after 19 and 28 months of treatment, respectively. These patients will continue to receive Namodenoson.
8.All nine patients with CBP9 cirrhosis, the most severe grade allowed into the trial, were randomly assigned to the Namodenoson treatment group (OS=3.5 months), a fact which has distorted the results in the whole population.

Dr. Llovet, a Founder and Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine, New York University, and Professor of Research-ICREA in the BCLC Group, Liver Unit, IDIBAPS-Hospital Clínic, University of Barcelona, stated, "The global incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and currently there are no recommended systemic treatment options for patients with advanced HCC and severe liver dysfunction (Child Pugh B)." Dr. Llovet added, "Considering that patients with advanced HCC and severe liver dysfunction do not have any accepted standard of care, the current data from this Phase II trial suggest a signal of efficacy that supports continuing the development of Namodenoson with a Phase III study in this population. I will be happy to help with the design of the Phase III and serve as the principal investigator of the trial."

Dr. Salomon M Stemmer, Institute of Oncology, Davidoff Center, Rabin Medical Center, Petah Tikva/Sackler Faculty of Medicine, Tel Aviv University, Israel and the study principal investigator, added, "Given the evidence of Namodenoson’s clinical benefit, I plan on offering it to selected HCC CPB patients in the compassionate use setting."

"We are encouraged by the advantage shown by Namodenoson in the CPB7 HCC population, a group for which there are no drugs with proven effectiveness," stated Pnina Fishman, Chief Executive Officer of Can-Fite. "Since Namodenoson has a favorable safety profile and shows no evidence of hepatotoxicity, it may possess a unique therapeutic index in this high-need population. Given that Namodenoson has been granted Fast Track status by the FDA, we look forward to engaging regulatory authorities in a dialog at the earliest opportunity."

An abstract for the late-breaking session has been submitted to The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to take place May, 2019 in Chicago, IL, USA.

Conference Call

The Company’s management will host a conference call today at 8:30 a.m. Eastern time to discuss the results of the Phase II advanced liver cancer trial. To participate in the conference call, please dial 877-705-6003 (domestic) or 201-493-6725 (international) or 1 809 406 247 in Israel, five minutes prior to the start of the call and provide the Conference ID: 13689112. Investors may also listen via webcast at: View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 90 days following the call.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.