On March 8, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the fourth quarter and full year ended December 31, 2018, and provided updates on its development programs (Filing, 8-K, Conatus Pharmaceuticals, MAR 8, 2019, View Source [SID1234534163]).

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Program Updates
The company is conducting three double-blind, placebo-controlled Phase 2b clinical trials in collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan, a first-in-class pan-caspase inhibitor, in patients with liver fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH).

The ENCORE-NF (for NASH Fibrosis) clinical trial, initiated in the first quarter of 2016, has enrolled approximately 330 patients with baseline NASH Clinical Research Network (CRN) fibrosis scores of F1 (up to 20% of enrolled patients), F2, and F3. The primary endpoint is a biopsy-based one point or greater improvement in NASH CRN fibrosis score compared with placebo at week 72, with no worsening of steatohepatitis. The primary endpoint will be evaluated and can be achieved in either of two prospectively defined patient populations – the F1/F2/F3 population or the F2/F3 population. Either of these populations may be used in a future Phase 3 trial. The company believes that the ENCORE-NF analysis plan has the potential to facilitate discussions with regulatory authorities regarding its use as a study to support regulatory approval. Top-line results from ENCORE-NF are expected in the first half of 2019.

The ENCORE-LF (for Liver Function) clinical trial, initiated in the second quarter of 2017, has enrolled approximately 210 patients with stable decompensated NASH cirrhosis. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or ≥4 points progression in Model for End-stage Liver Disease (MELD) score. Enrollment was completed in the first quarter of 2019. Top-line results triggered by reaching a prespecified number of events are expected in mid-2019.

The ENCORE-PH (for Portal Hypertension) clinical trial, initiated in the fourth quarter of 2016, enrolled 263 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three emricasan dosing groups compared with placebo. Top-line results were reported in December 2018 showing HVPG trends consistently favoring emricasan compared with placebo in the overall population but not meeting the primary endpoint. Post hoc analyses showed clinically meaningful treatment effects for emricasan compared with placebo and a trend toward clinical benefit in the prespecified subpopulation of compensated patients, with the greatest improvement in compensated patients with baseline HVPG ≥16 mmHg. Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period to evaluate longer term safety, liver function and clinical outcomes. Results following the extension period are expected in mid-2019.
In its internal development program, the company has assembled a proprietary portfolio of orally active molecules that inhibit the NLRP3 inflammasome pathway and the activation of the potent inflammatory cytokine IL-1b. Inhibition of IL-1b is a clinically validated approach to treating inflammatory diseases, with several injectable biologic products using that mechanism of action already on the market. The NLRP3 inflammasome pathway is dependent upon caspase 1, which activates IL-1b. Caspase 1 occupies a uniquely central position in the inflammasome pathway, and the company has leveraged its scientific expertise in caspase research and development to design potent, selective and orally bioavailable inhibitors of caspase 1. Excess IL-1b has been linked to a variety of diseases including rare genetic inflammatory diseases, cancer, liver and other gastrointestinal diseases, and cardiovascular diseases.

The company is announcing today the selection of its first internally developed product candidate, CTS-2090, based on its preclinical profile, including high selectivity for caspase 1, and drug-like properties. CTS-2090 is currently in preclinical development and IND-enabling studies, with an initial clinical trial expected to begin by the first half of 2020. Additional details will be discussed in the conference call and webcast scheduled for 4:30 p.m. ET today (information below).

Financial Results
The net loss for the fourth quarter of 2018 was $3.9 million compared with $4.4 million for the fourth quarter of 2017. The net loss for the full year 2018 was $18.0 million compared with $17.4 million for the full year 2017.

Total revenues were $7.4 million for the fourth quarter of 2018 compared with $8.8 million for the fourth quarter of 2017, and $33.6 million for the full year 2018 compared with $35.4 million for the full year 2017. Total revenues consisted of collaboration revenues related to the Novartis agreement. The decreases in revenues for both periods were primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues related to the Novartis agreement, partially offset by the effects of adopting the ASC 606 revenue recognition standard.

Research and development expenses were $8.9 million for the fourth quarter of 2018 compared with $10.9 million for the fourth quarter of 2017. Research and development expenses were $41.4 million for the full year 2018 compared with $43.2 million for the full year 2017. The decreases in both periods were primarily due to lower costs related to the ENCORE clinical trials, as well as lower costs related to emricasan manufacturing activities, partially offset by higher costs related to new product candidate development.

General and administrative expenses were $2.5 million for the fourth quarter of 2018 compared with $2.3 million for the fourth quarter of 2017. General and administrative expenses were $10.5 million for the full year 2018 compared with $9.7 million for the full year 2017. The increases in general and administrative expenses for both periods were primarily due to higher personnel costs and recognition of deferred collaboration costs due to adoption of the new revenue recognition standard.

In December 2018, the company, at its option, converted the outstanding principal plus accrued and unpaid interest of the Novartis note into shares of the company’s common stock. Cash, cash equivalents and marketable securities were $40.7 million at December 31, 2018, compared with $74.9 million at December 31, 2017, and a projected year-end 2019 balance, without including any potential milestone payments under the Novartis collaboration, of between $10 million and $15 million.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. ET today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 3249458. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On March 8, 2019 Bayer reported that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Bayer, MAR 8, 2019, View Source [SID1234534165]).

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"Men are typically asymptomatic at this stage of prostate cancer. Therefore, it is critical that they have treatment options, which not only delay the development of metastases, but also limit burdensome side effects of therapy, so that these men can continue with their day-to-day lives," said Scott Z. Fields, M.D., senior vice president and head of Oncology Development of Bayer AG’s Pharmaceutical Division. "With this submission, we are taking an important step toward providing patients, caregivers, and physicians with a potential new treatment option for nmCRPC."

The submission to the EMA is based on data from the Phase III ARAMIS trial in men with nmCRPC, which were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine, showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT).(1)

Bayer recently completed the rolling submission of a New Drug Application to the United States Food and Drug Administration (FDA) and submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan. Bayer is also in discussions with other health authorities regarding submissions.

The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About ARAMIS
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

About darolutamide
Darolutamide is a non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In preclinical studies, darolutamide demonstrated lower blood-brain barrier penetration compared to other currently available AR antagonists.(2)

In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.(3) In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.(3) Prostate cancer is the fifth leading cause of death from cancer in men.(3) Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man´s reproductive system.(4) It mainly affects men over the age of 50, and the risk increases with age.(5) Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.(6) However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.(7)

CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no approved treatment options for CRPC patients who have rising prostate-specific antigen (PSA) levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a rapid PSA doubling time has been consistently associated with reduced time to first metastasis and death.(8)

On March 8, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB) ("Selecta"), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR (SVP Rapamycin), reported that it will report its fourth quarter full year end 2018 financial results and provide a corporate update before the open of the U.S. financial markets on Friday, March 15, 2019 (Press release, Selecta Biosciences, MAR 8, 2019, View Source [SID1234534122]).

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At 8:30 a.m. ET that day, Selecta will host a conference call and live audio webcast to discuss the year end 2018 financial results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10127200.

On March 8, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the fourth quarter and full year ended December 31, 2018 (Press release, Mersana Therapeutics, MAR 8, 2019, View Source [SID1234534166]).

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"In 2018 we made significant progress with XMT-1536, our first-in-class ADC candidate targeting NaPi2b. We remain encouraged by the safety, tolerability, and early signs of activity seen in heavily pretreated, unselected patients in the dose escalation trial. Within the second quarter of 2019 we plan to report data from the dose escalation portion of the study, select a go forward dose and initiate the Phase 1 expansion cohorts," said Anna Protopapas, President and CEO of Mersana Therapeutics. "More recently, we strengthened our balance sheet through an equity financing that provides us with the capital necessary to advance XMT-1536 and our potential next ADC candidate through to important future value inflection points."

Recent Highlights and Updates

Clinical Program

Continued the Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing cancers. XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer (NSCLC) adenocarcinoma. The data to date from the ongoing XMT-1536 dose escalation study indicate that the trial has reached clinically relevant dose levels, starting at 20 mg/m2 but has not yet reached a maximum tolerated dose. The once-every-three-week dosing regimen has been fully explored. In the once-every-four-week dosing regimen, the Company has completed dosing patients in the 20 mg/m2 and 30 mg/m2 dose cohorts. Both dosing regimens have thus far been well tolerated and dosing of the 36 mg/m2 cohort has been initiated. The Company is planning to report data from the dose escalation portion of the study in the second quarter of 2019.
Discovery & Platform Progress

On track to disclose its next ADC clinical candidate in the second half of 2019 further strengthening its scientific leadership in ADC development.

Presented data on two new platforms at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in November 2018. Details of the abstracts are below:
º The first abstract, titled "Discovery of the novel, homogeneous payload platform Dolasynthen for Antibody-Drug Conjugates" characterized Dolasynthen, a next-generation platform allowing for drug homogeneity and precise control of the Drug-to- Antibody ratio of an ADC.
º The second abstract, titled "Indole-Biaryl Pyrrolobenzodiazepines (I-BiPs): A potent and well-tolerated class of DNA mono-alkylating payload for antibody-drug conjugates (ADCs)" characterized Alkymer, a DNA damaging platform demonstrating superiority to existing DNA damaging platforms.
Corporate Updates

Appointed Dirk Huebner, M.D., as Chief Medical Officer. Dr. Huebner’s 25 years of drug development experience, including significant experience in the development and approval of ADCs, will contribute to Mersana’s leading clinical development organization.
Strengthened balance sheet through important equity financing. On March 5, 2019, the Company announced the closing of a public offering of approximately 24.4 million shares of its common stock at the price of $4.00 per share. Aggregate gross proceeds from the offering were approximately $97.8 million.
Upcoming Events

Mersana will give a corporate presentation at the Cowen & Co. Annual Health Care Conference on March 13, 2019, in Boston, MA.
Mersana will present on the Dolasynthen platform as well as a dual payload ADC containing both a microtubule inhibitor and a DNA alkylator, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29 – April 3, 2019, in Atlanta, GA.
2018 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2018, were $70.1 million, compared to $125.2 million as of December 31, 2017.

Fourth Quarter 2018

Collaboration revenue for the fourth quarter 2018 was approximately $1.2 million, compared to $3.3 million for the same period in 2017. The decrease was largely the result of a decrease in efforts to support partnered programs.
Research and development expenses for the fourth quarter 2018 were approximately $19.8 million, compared to $14.6 million for the same period in 2017, driven primarily by an increase in clinical and regulatory expenses due to the progress of our XMT-1536 program and manufacturing costs to support the future clinical development of XMT-1536.
General and administrative expenses for the fourth quarter 2018 were approximately $4.2 million, compared to $3.1 million for the same period in 2017, driven primarily by increased employee-related expenses due to an increase in headcount and increased professional fees.
Net loss for the fourth quarter 2018 was $22.4 million, or $0.97 per share, compared to a net loss of $14.0 million, or $0.61 per share, for the same period in 2017. Weighted average common shares outstanding for the years ended December 31, 2018 and December 31, 2017, were 23,184,459 and 22,750,425, respectively.
Full Year 2018

Collaboration revenue for the full year 2018 was approximately $10.6 million, compared to $17.5 million for the full year 2017. The decrease was primarily the result of a decrease in efforts to support partnered programs and a change in total projected efforts associated with timelines used to measure XMT-1522 revenue under ASC 606.
Research and development expenses for the full year 2018 were approximately $59.9 million, compared to $46.7 million for the full year 2017. The increase was primarily due to an increase in pre-clinical platform development, clinical and regulatory expenses due to the progress of XMT-1536 and XMT-1522, and manufacturing costs to support future clinical development.
General and administrative expenses for the full year 2018 were approximately $16.3 million, compared to $10.5 million for the full year 2017, driven primarily by increased employee-related expenses due to an increase in headcount and increased professional fees.
Net loss for the full year 2018 was $64.3 million, or $2.79 per share, compared to a net loss of $38.7 million, or $3.22 per share, for the full year 2017. Weighted average common shares outstanding for the periods ended December 31, 2018 and December 31, 2017, were 23,032,250 and 12,022,733, respectively.
2019 Financial Update

On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.
Associated with the discontinuation of the XMT-1522 program, the Company expects to recognize remaining deferred revenue under ASC 606 in the first quarter of 2019 to reflect termination of the Takeda agreement. Mersana announced the discontinuation of the development of XMT-1522 due to the competitive landscape and to prioritize its resources on advancing XMT-1536. In line with this decision, the Company and its partner, Takeda, have terminated their research and development partnerships.
Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 a.m. ET on March 8, 2019 to report financial results for the fourth quarter and full year 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 1969536. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen highly expressed in the majority of non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

On March 8, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter and year ended December 31, 2018 (Press release, Oncolytics Biotech, MAR 8, 2019, View Source [SID1234534139]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”With a growing number of large pharma collaborations, continued advancement with our registration program in metastatic breast cancer and recently announced biomarker data, we have made tremendous progress in a short period of time,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. ”In 2019 we expect to generate data that will allow us to finalize our registration program in breast cancer, while at the same time advancing studies in indications with prior evidence of clinical activity, as defined by an inflamed phenotype. With the global market for checkpoint inhibitors expected to reach $25 billion in 2022 and checkpoint inhibitors only able to treat approximately twenty percent of patients, the data demonstrating pelareorep’s ability to create an inflamed phenotype and boost PD-L1 expression makes it a potential backbone for this drug class. Furthermore, we believe pelareorep can potentially expand the utility of checkpoint inhibitors into additional indications and this work is already underway with Merck’s Keytruda in both multiple myeloma and pancreatic cancer, Bristol-Myers Squibb’s Opdivo in multiple myeloma and Roche’s Tecentriq in breast cancer.”

Selected highlights since January 1, 2018

Clinical & Scientific Updates

Received confirmation from the FDA and EMA that only a single phase 3 study is required for approval
Granted a Special Protocol Assessment (SPA) from the FDA
Advised to identify a biomarker prior to the final study design
Announced a Master Clinical Supply Agreement (MCSA) with F. Hoffmann-La Roche Ltd (Roche) to supply Tecentriq for use in the company’s clinical development program
Announced an abstract identifying a potentially predictive and prognostic biomarker to be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Entered into a clinical collaboration with SOLTI, a world-leading cooperative group specializing in breast cancer, to conduct our AWARE-1 window of opportunity breast cancer study, to confirm the utility of our recently identified biomarker
Marks the first use of our MCSA with Roche
Presented data highlighting increased expression of PD-L1 on multiple myeloma cells in patients treated with pelareorep at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, leading to our phase 1b combination study with Bristol-Myers Squibb’s Opdivo in multiple myeloma
Presented data suggesting efficacy signal in combination with PD-1 inhibitor at the Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper), leading to a phase 2 combination study with Merck’s Keytruda in second line pancreatic cancer
Presented data at the European Society for Medical Oncology 2018 Congress highlighting patients with KRAS mutant metastatic colorectal cancer who were treated with pelareorep and FOLFIRI/Bevacizumab had progression-free survival of 65.6 weeks and overall survival of 107.5 weeks, exceeding expectations when compared to analogous historical data
Initiated additional clinical collaborations:
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in pancreatic cancer
Pelareorep plus Bristol-Myers Squibb’s checkpoint inhibitor Opdivo in multiple myeloma
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in multiple myeloma
Announced a publication in Cancer Immunology Research demonstrating that intravenously administered pelareorep effectively targets tumors even in the presence of neutralizing antibodies
Corporate Updates

Announced the appointment of Dr. Rita Laeufle, M.D., Ph.D., as Chief Medical Officer
Dr. Laeufle brings more than 15 years of experience in oncology drug development, having previously served at Coherus Biosciences, Clovis Oncology, Roche, Genentech and Novartis
Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY"
Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million
Announced a USD $30.0 million At-the-Market facility with Canaccord Genuity LLC
Entered into a common stock purchase agreement for up to USD $26.0 million with Lincoln Park Capital Fund, LLC
Anticipated Milestones

Initiate AWARE-1 in the coming weeks
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1 data is available
* Guidance provided by principal investigator

Financial

At December 31, 2018, the company reported $13.7 million in cash and cash equivalents
As at March 7, 2019, the company had an unlimited number of authorized common shares with 18,840,010 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,569,326 options and share units
Operating expense for the fourth quarter of 2018 was $2.4 million and $7.2 million for the year 2018, compared to $2.2 million in the fourth quarter 2017 and $6.2 million for the year 2017
R&D expense for the fourth quarter of 2018 was $2.5 million and $9.4 million for the year 2018, compared to $2.5 million in the fourth quarter 2017 and $9.4 million for the year 2017
The net loss for the fourth quarter of 2018 was $4.8 million and $17.0 million for the year 2018, compared to $4.7 million in the fourth quarter 2017 and $15.6 million for the year 2017, which equates to a loss of $1.06 per share in 2018 compared to a net loss of $1.12 per share in 2017, on a consolidated basis
Webcast and Conference Call

Management will host a conference call for Analysts and Institutional Investors at 8:30 a.m. ET, today, Friday, March 8, 2019. The live call may be accessed by dialing (877) 407-9205 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months. A replay of the call will be available approximately two hours after the call has ended at (877) 481-4010, using the replay code 44902 and will remain available for one week.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.