On August 13, 2019 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the quarter ended June 30, 2019 and provided an update on its corporate activities and product pipeline (Press release, Crinetics Pharmaceuticals, AUG 13, 2019, View Source [SID1234538716]).

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"This July marks the end of a full year as a public company for Crinetics and we are excited by the progress we made this past quarter, and our evolution during the past year," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "As the ACROBAT trials continue to enroll patients with acromegaly, we are progressing the rest of our pipeline, as highlighted by the initiation of our Phase 1 trial for CRN01941 aimed at neuroendocrine tumors and are making strides with our preclinical programs for Cushing’s Disease and congenital hyperinsulinemia."

Second Quarter and Subsequent Highlights

Initiated Phase 1 study of CRN01941 for the treatment of neuroendocrine tumors. In May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers with topline data expected in late 2019 or early 2020. CRN01941 is an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist designed for the treatment of neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas.

Received final award of SBIR grant from NIH for congenital hyperinsulinism. In July 2019, Crinetics announced that it would receive up to approximately $0.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) of the National Institutes of Health (NIH). The funds are being used to support the ongoing research and development of Crinetics’ nonpeptide somatostatin agonists for congenital hyperinsulinemias (CHI).

Expanded board of directors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience having spent her career in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Second Quarter 2019 Financial Results

Research and development expenses were $10.3 million for the three months ended June 30, 2019, compared to $5.2 million for the same period in 2018. The increases were primarily attributable to development and manufacturing activities for CRN00808 and CRN01941 as well as the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $3.1 million for the three months ended June 30, 2019, compared to $1.1 million for the same period in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended June 30, 2019 was $12.4 million, compared to a net loss of $5.6 million for the same period in 2018.

Unrestricted cash, cash equivalents and investments totaled $145.0 million as of June 30, 2019, compared to $157.2 million as of March 31, 2019 and $163.9 million as of December 31, 2018.

As of July 31, 2019, the company had 24,199,972 common shares outstanding.

On August 13, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the second quarter ended June 30, 2019 (Press release, AEterna Zentaris, AUG 13, 2019, View Source [SID1234538757]).

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All Amounts are in U.S. Dollars

Highlights

On June 6, 2019, the Company announced that it was reducing the size of its German workforce and operations to more closely reflect the Company’s ongoing commercial activities in Frankfurt. This restructuring affects 8 employees in Frankfurt, Germany and resulted in $773,000 of severance costs that are expected to be paid by January 31, 2020.

Net income for the second quarter of 2019 was $0.2 million as compared to a net loss of $2.6 million for the same period in 2018. Net loss for the six-months ended June 30, 2019 was $4.7 million as compared to net income of $11.8 million for the same period in 2018.

In the first six months of 2019, the Company earned $21,000 from the license of Macrilen (macimorelin) as gross sales in the U.S. continue to disappoint. Novo Nordisk has advised that Macrilen (macimorelin) has been successfully integrated into their patient and provider support hub as they work to gain broader product coverage with payers and specialty pharmacies. We continue to work with Novo Nordisk on addressing the disappointing U.S. commercial execution and results to date.

The initial phase of the macimorelin pediatric development program (the dose ranging study), continued to progress with the first one-third of subjects having completed the protocol, all in accordance with our expected timeline.
Summary of Second Quarter Results and Year-to-date Second Quarter Results

For the three-month period ended June 30, 2019, we reported a consolidated net income of $0.2 million, or $0.01 income per common share (basic), as compared with a consolidated net loss of $2.6 million, or $0.16 loss per common share, for the three-month period ended June 30, 2018. The $2.8 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.1 million, offset by a loss in exchange rates of $0.7 million, an increase in operating expenses of $0.3 million and $0.2 million movement in tax recovery.

For the six-month period ended June 30, 2019, we reported a consolidated net loss of $4.7 million, or $0.28 loss per common share, as compared with a consolidated net income of $11.8 million, or $0.72 income per common share (basic), for the six-month period ended June 30, 2018. The $16.5 million decline in net results is primarily from a reduction of $24.5 million in gross income and $0.6 million decrease in net finance income, offset by a reduction of tax expense of $6.6 million and operating expenses of $1.9 million.

Condensed Interim Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, will be found at www.zentaris.com in the "Investors" section and at the Company’s profile at www.sedar.com and www.sec.gov.

The tables below set out summary consolidated financial information for the periods indicated. These tables should be read together with the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, which contain important information relating to the Company. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year or any future period. The information presented herein does not contain disclosures required by IFRS for consolidated financial statements and should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2018.

On August 13, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the six months ended June 30, 2019 (Press release, Trillium Therapeutics, AUG 13, 2019, View Source [SID1234538647]).

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"We made excellent progress in the second quarter toward achieving two key near-term milestones," said Robert L. Kirkman, M.D., Executive Chair of Trillium Therapeutics. "We have secured a meeting with the U.S. Food and Drug Administration later this quarter to discuss a proposed pivotal trial of intratumoral TTI-621 in patients with cutaneous T-cell lymphoma. We have enrolled patients under our amended TTI-621 intravenous protocol that will allow us to dose cutaneous T-cell lymphoma patients beyond 0.5 mg/kg."

Second Quarter 2019 Financial Results:

As of June 30, 2019, Trillium had a combined cash and cash equivalents and marketable securities balance of $42.8 million, compared to $45.4 million at December 31, 2018. The June 30, 2019 working capital balance was $31.4 million, compared to $34.2 million at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital was due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering.

Net loss for the six months ended June 30, 2019 of $17.2 million was lower than the loss of $20.9 million for the six months ended June 30, 2018. The net loss was lower due mainly to a net warrant liability revaluation gain of $6.1 million and lower clinical trial related expenses, which were partially offset by a net foreign currency loss of $1.1 million in the current year compared to a net foreign currency gain of $3.0 million in the prior year, and higher manufacturing costs.

On August 13, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported financial results for the quarter ended 30 June 2019 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, AUG 13, 2019, View Source [SID1234538833]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "ASLAN made significant progress through the second quarter of this year, highlighted by our agreement with K-MASTER investigating varlitinib in metastatic gastric cancer patients, updated results from the ongoing clinical program studying ASLAN003 in AML, as well as results from our ASLAN004 single ascending dose study supporting differentiation versus other IL4/IL13 receptor inhibitors. Based on this exciting new data, we amended the agreement with CSL Limited to include full global rights to develop, manufacture, and commercialise this first in class therapeutic antibody for atopic dermatitis and other indications. Looking forward to the remainder of the year, we await topline data from our pivotal TreeTopp trial as second line treatment for biliary tract cancer, in the fourth quarter."

Second quarter 2019 and recent business highlights

Clinical development Varlitinib

Signed an agreement with the Korean Cancer Diagnosis & Treatment Enterprise (K-MASTER) to investigate varlitinib in a phase 1b/2 multi-centre umbrella study to evaluate the safety and efficacy of varlitinib in combination with weekly paclitaxel as a second-line treatment in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients. The open label, multi-centre study will recruit approximately 400 patients, divided between four experimental arms and a common control arm based on biomarker profiling.

ASLAN003

The first part of a phase 2 clinical trial with ASLAN003 in patients with advanced relapsed/refractory acute myeloid leukaemia (AML) was fully recruited and four doses of ASLAN003 (100mg QD, 200mg QD, 100mg BID and 200mg BID) have been tested as monotherapy. Significant reductions in peripheral blood blast cells of up to 98% and fast onset of blast cell reduction were observed in a number of patients. ASLAN003 has been well-tolerated in AML patients with only one patient out of 24 experiencing febrile neutropenia and tumor lysis syndrome, which were classified as drug-related serious adverse events. ASLAN is now evaluating next steps in the development of ASLAN003.

ASLAN004

Completed a single ascending dose (SAD) study testing ASLAN004 in healthy volunteers and announced the updated data from the second part of the study that tested a subcutaneous formulation of ASLAN004. The results from the single ascending dose study confirmed ASLAN004’s favourable tolerability profile, complete inhibition of downstream mediators and potential for monthly dosing.

Amended license agreement with CSL Limited (CSL) so that ASLAN has full global rights to develop, manufacture and commercialise ASLAN004 in all indications. The amended agreement replaces the licensing agreement ASLAN and CSL signed in May 2014. Under the terms of the amended agreement,

ASLAN will make a first payment of US$30 million to CSL upon commencement of a phase 3 study of ASLAN004. CSL is also eligible to receive up to US$95 million of regulatory milestones, US$655 million of sales milestones and tiered royalties on net sales between mid-single digits and 10%.

Corporate updates

Elected Andrew Howden as non-executive Chairman of the Board. Dr Carl Firth, who has held the positions of Chairman and CEO since founding the company in 2010, will continue to serve as CEO and as a Director. This planned separation of the Chairman and CEO roles was conducted to align to best corporate governance practices.

Anticipated upcoming milestones

Presentation of new phase 1 data for varlitinib in combination with mFOLFIRI chemotherapy in advanced solid tumours at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 in late September.

Initiation of a multiple ascending dose trial for ASLAN004 in patients with moderate to severe atopic dermatitis in the second half of 2019.

Topline global pivotal trial (TreeTopp) data on varlitinib as second line treatment for biliary tract cancer in the fourth quarter of 2019.

Second quarter 2019 financial results

Cash used in operations for the quarter ended 30 June 2019 was US$6.5 million compared to US$10.0 million in the same period in 2018.

Research and development (R&D) expense was US$5.3 million and general and administrative (G&A) expense was US$1.9 million for the second quarter of 2019, compared to US$8.3 million and US$3.1 million, respectively, in the same period in 2018. The decrease in R&D expense was due to the completion of clinical studies and lower manufacturing expenses. The decrease in G&A expense in the period resulted from the restructuring implemented in January 2019.

Net loss for the second quarter of 2019 was US$7.9 million compared to a net loss of US$11.0 million for the second quarter of 2018.

Cash, cash equivalents and short-term investments totaled US$15.1 million as of 30 June 2019 compared to US$28.9 million as of 31 December 2018. Weighted average shares outstanding for the second quarter of 2019 was 160.2 million compared to 147.9 million for the second quarter of 2018. One American Depositary Share is the equivalent of five ordinary shares.

On August 13, 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 its proof of concept clinical trial to evaluate its p-STAT3 inhibitor, WP1220, for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL) has reached full enrollment (Press release, Moleculin, AUG 13, 2019, View Source [SID1234538648]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors.

"We believe there continues to be an unmet need for an improved topical therapy for Stage I-III CTCL skin lesions," commented Walter Klemp, Moleculin’s Chairman and CEO, "especially one that may avoid significant unwanted side effects. CTCL is known to frequently involve the upregulation of the activated form of STAT3 (p-STAT3), which has been linked to a range of tumor-related transcriptional activity. This proof of concept, if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor. We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year. This trial represents one of four clinical trials that we have underway."

Mr. Klemp concluded: "Notwithstanding the relatively rare nature of CTCL, we believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated."