On March 10, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the fourth quarter and full year ended December 31, 2019, and provided an update on its clinical development programs (Press release, Protagonist, MAR 10, 2020, View Source [SID1234555371]).

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"We are pleased to have made great progress in 2019, creating multiple opportunities to execute on our clinical development plans with three platform-generated therapeutic candidates," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "Our priorities for 2020 include evaluating PTG-300 in multiple blood disorders with the intent of selecting the first clinical indication for a pivotal study, continuing Phase 2 development of PTG-200 with our partner Janssen Biotech, and advancing PN-943 into Phase 2 development in ulcerative colitis. Our financial position provides us with sufficient resources through the end of 2021 which should enable us to reach definitive conclusions for all of the ongoing clinical proof of concept studies."

Product Development Update

PTG-300: Injectable Hepcidin Mimetic for Blood Disorders

·The Company is conducting Phase 2 proof of concept studies with PTG-300 in patients with beta-thalassemia, polycythemia vera and hereditary hemochromatosis.
·In December 2019, the Company reported observations of dose-related reductions from high baseline serum iron and transferrin saturation (TSAT) levels in the ongoing open-label TRANSCEND Phase 2 study of PTG-300, supporting continued evaluation with additional dose regimens and longer follow-up time periods.
·An investigator-sponsored study of PTG-300 in patients with myelodysplastic syndromes, a fourth potential indication for PTG-300, is expected to begin in the first half of 2020.

PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease

Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (or JNJ-67864238) through completion of a Phase 2a study in patients with moderate-to-severe Crohn’s disease, with the anticipation of completion in the first half of 2021.
Protagonist achieved milestones leading to payments from Janssen Biotech of $25 million received in 2019 triggered by the decision to advance PTG-200 in a Phase 2a study and expansion of the existing collaboration agreement, and $5 million received in early 2020 on the nomination of a second-generation oral IL-23 receptor antagonist.

PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

·Results from a Phase 1 study of PN-943 demonstrated a sustained and superior target engagement as compared with the first-generation oral alpha-4-beta-7 integrin antagonist PTG-100. These results were highlighted in an oral presentation at the 2019 Digestive Disease Week conference.
·The Company plans to initiate a Phase 2 study in patients with ulcerative colitis in the second quarter of 2020, with topline data expected in the second half of 2021.
·Preclinical research findings on PN-943 were presented on February 14, 2020, at the 15th Congress of the European Crohn’s and Colitis Organization (ECCO) in Vienna.
·Preclinical research findings for PN-943 have been accepted for presentation at the 2020 Digestive Disease Week conference taking place May 2-5, 2020, in Chicago.

Financial Results

·Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2019 were $133.0 million. The Company expects current cash, cash equivalents and marketable securities and access to its debt facility to be sufficient to fund its planned operating and capital expenditures through year-end 2021.
·License and Collaboration Revenue: License and collaboration revenue of $2.7 million for the fourth quarter of 2019 was in line with $2.4 million for the same period of 2018. License and collaboration revenue for the full year 2019 was $0.2 million, compared to $30.9 million for 2018. The Company recognized $9.6 million of license and collaboration revenue for the full year 2019, which was offset by the one-time cumulative adjustment related to the application of revenue recognition principles following the May 2019 amendment of the Janssen Biotech collaboration agreement that reduced the revenue by $9.4 million for the year, resulting in net revenue recognition of $0.2 million for the full year 2019.
·Research and Development ("R&D") Expenses: R&D expenses for the fourth quarter and full year 2019 were $15.9 million and $65.0 million, respectively, as compared to $14.2 million and $59.5 million, respectively, for the same periods of 2018. The increases were primarily due to increased clinical development costs related to PTG-300 and PN-943, offset in part by lower clinical development costs related to PTG-200 and PTG-100.

·General and Administrative ("G&A") Expenses: G&A expenses for the fourth quarter and full year 2019 were $4.1 million and $15.7 million, respectively, as compared to $3.5 million and $13.7 million, respectively, for the same periods of 2018. The increases were primarily due to increases in salaries and employee-related expenses driven by increased headcount and professional services to support the growth in our operations.
·Net Loss: The fourth quarter net loss was $17.5 million, or a net loss of $0.63 per share, and the full year 2019 net loss was $77.2 million, or a net loss of $2.98 per share.

Conference Call and Webcast Information

Protagonist executives will host a conference call at 4:30 p.m. EDT/1:30 p.m. PDT today. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 5591627. A live and archived webcast of the call will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On March 10, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the first quarter of 2020 (Press release, Zimmer Holdings, MAR 10, 2020, View Source [SID1234555387]).

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The cash dividend of $0.24 per share is payable on April 30, 2020 to stockholders of record as of the close of business on March 27, 2020.

On March 10, 2020, Rexahn Pharmaceuticals, Inc. ("Rexahn") and BioSense Global LLC ("BioSense") reported that it has entered into an amendment (the "Amendment") to the Collaboration and License Agreement, dated as of February 25, 2019, by and between Rexahn and BioSense, as previously amended (the "Original Agreement" and, as amended by the Amendment, the "Amended Agreement") (Filing, 8-K, Rexahn, MAR 10, 2020, View Source [SID1234555611]). Under the terms of the Amended Agreement, the aggregate upfront payments were reduced to $1.65 million, $1.5 million of which had previously been paid as part of the upfront payment under the Original Agreement. Upon payment in full of the remaining unpaid portion, Rexahn will (i) grant an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 ("Licensed Products") for any indication in the Republic of Singapore, China, Hong Kong, Macau and Taiwan (the "Territory") and (ii) assign and transfer to BioSense all of Rexahn’s patents and patent applications related to RX-3117 in the Territory.

Pursuant to the Amendment, BioSense has agreed to use commercially reasonable efforts to develop a Licensed Product in the Territory, file an investigational new drug application relating to a Licensed Product in China, and take certain other actions relating to commercialization upon any regulatory approval.

The Amendment reflects the agreement of the parties to terminate and remove collaboration provisions under the Original Agreement, reflects the intention of Rexahn not to conduct or sponsor any additional trials with RX-3117, and reduces the milestone payments and royalties payable under the Original Agreement. Under the Amended Agreement, Rexahn is eligible to receive milestone payments in an aggregate of up to $74.5 million upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties in the mid-single digits to low tens on annual net sales in the Territory.

Until March 31, 2020, pursuant to the Amended Agreement, BioSense has the option to obtain an exclusive license to develop and commercialize Licensed Products outside the Territory upon the payment of an additional upfront fee.

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On March 10, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the year and three months ended December 31, 2019 and reported on corporate developments (Press release, Aptose Biosciences, MAR 10, 2020, View Source [SID1234555356]).

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The net loss for the quarter ended December 31, 2019 was $7.7 million ($0.13 per share) compared with $6.3 million ($0.17 per share) for the quarter ended December 31, 2018. The net loss for the year ended December 31, 2019 was $26.3 million ($0.52 per share) compared with $28.9 million ($0.86 per share) for the year ended December 31, 2018. Total cash and cash equivalents and investments as of December 31, 2019 were $97.6 million. Based on current operations, we expect that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into early 2022.

"2019 was a transformative year for Aptose as we became a true clinical-stage company, treating patients in two distinct clinical programs – with our first in class FLT3 / BTK inhibitor CG-806 and our MYC inhibitor APTO-253," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We have been treating patients with ascending doses in each trial and have reported early clinical data that illustrate initial pharmacologic activity for both compounds, in addition to clean safety profiles to date.

"We expect 2020 to be a year of continued execution. We believe we are approaching a therapeutic dose with CG-806 in our current trial in B-cell cancers and plan to initiate a clinical trial for patients with AML who are resistant or refractory to current standard-of-care therapies. Indeed, we look forward to bringing a new treatment option to these patients, while bringing a long-term value proposition to Aptose shareholders."

Key Corporate Highlights

CG-806 Phase 1 a/b B-cell Malignancy Clinical Trial –- During the year, Aptose initiated dosing of CG-806 in the Phase 1 a/b clinical trial: a multicenter, open-label, dose-escalation study in patients with relapsed or refractory B-cell malignancies (BCM), including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or non-Hodgkin lymphomas (NHL). After dosing one patient each at the 150 mg BID and 300 mg BID dose levels, and after review from the Cohort Safety Review Committee (CSRC), the Company proceeded to the 3rd dose cohort of 450 mg BID which requires a minimum of three patients. The 450 mg BID dosing cohort is expected to be completed imminently, and the resulting data will be reviewed by the CSRC. Upon satisfactory review of the data, we plan screening and dosing patients for the 4th dose cohort of 600 mg BID followed by planned ascending dose cohorts with three patients each at 750 and 900 mg BID, with the intent to select the recommended phase 2 dose for patients with B-cell cancers, including relapsed or refractory CLL/SLL or NHL. Upon selection of a phase 2 dose, we plan to enroll up to 100 patients in an expansion phase of the trial. Currently, 18 U.S. sites are open for screening and enrolling patients for the study, with additional sites scheduled to come on board. More information is available at www.clinicaltrials.gov (here).

CG-806 Proposed AML Study –- In 2019, preclinical data presented at a number of respected medical conferences supported Aptose’s plans to develop CG-806 for patients with acute myeloid leukemia (AML). Tested against AML primary patient samples and cell lines, CG-806 was more potent than other FLT3 inhibitors including midostaurin, sorafenib, sunitinib, dovitinib, quizartinib, crenolanib and gilteritinib. Now in 2020, Aptose is well under way with the clinical protocol for an AML trial and, upon identification of a potential therapeutic dose for AML patients in the ongoing Phase 1 a/b trial in patients with CLL and NHL, we plan to seek allowance from the FDA to initiate clinical testing in patients with AML.

APTO-253 Phase 1b Clinical Study –- Throughout the year, Aptose successfully completed three dose cohorts in the Phase 1b trial of MYC inhibitor APTO-253 in patients with AML and myelodysplastic syndromes (MDS). We have completed dosing of one patient at the fourth dose cohort of 100 mg/m2 and now are screening for the second and third patients for the 100 mg/kg dose cohort and expect to complete this dose cohort in Q2. No drug-related toxicities have been observed, including no myelosuppression, and dosing will continue to ascend until a maximum tolerated dose is reached. MYC biomarker data from patients at all dose levels thus far continue to demonstrate reductions of MYC gene expression in their peripheral blood cells. The dose escalation portion of the study is designed to transition, as appropriate, to single-agent expansion cohorts in AML and MDS, followed by combination studies. More information can be found at www.clinicaltrials.gov (here).

2019 Financial Equity Offerings –- During 2019, Aptose closed two public offerings of common shares, raising gross proceeds of $74.2 million in December and $21.3 million in June. Aptose is using the net proceeds of the offerings to accelerate and expand its clinical trial programs, and for working capital and general corporate purposes.
RESULTS OF OPERATIONS

Net loss of $26.3 million for the year ended December 31, 2019 decreased by approximately $2.6 million as compared with $28.9 million for the year ended December 31, 2018, primarily as a result of a decline in research and development expenses of $5.0 million in license fees paid to CG for development and commercial rights of CG-806 in fiscal 2018 and a decrease in stock option compensation expense of approximately $2.0 million, offset by increased expenditures of approximately $3.7 million on our CG-806 and 253 development programs, reflecting program costs and related labor and higher cash-based general and administrative expenses of $1 million in the year ended December 31, 2019. The net loss was also lower in 2019 due to higher net finance income, which increased by $341 thousand compared to 2018, mostly as a result of higher interest earned on larger balances of cash equivalents and investments held during the year ended December 31, 2019.

Research and Development Expenses

Research and development expenses of $16.8 million for the year ended December 31, 2019, decreased by approximately $1.9 million compared with $18.7 million for the prior year, primarily as a result of the following events:

License fees paid in the year ended December 31, 2018 to CG of $2.0 million for development and commercial rights of CG-806 in all territories outside of Korea and China, and a further $3.0 million paid for development and commercial rights of CG-806 in China. CG is eligible for development, regulatory and commercial-based milestones, as well as royalties on future product sales. There were no license fees paid to CG or other collaborators in the year ended December 31, 2019.

An increase in research and development activities related to our CG-806 development program of approximately $2.4 million, mostly as a result of increases to our clinical trial operating costs for our CG-806 BCM phase 1a/b clinical trial and planned CG-806 AML phase 1 clinical trial. For the year ended December 31, 2019, program costs consisted mostly of manufacturing costs to supply our clinical trials, operating costs to conduct our CG-806 BCM phase 1a/b clinical trial, which was approved by the FDA in March 2019, as well as preparation costs for our planned CG-806 AML clinical trial. For the year ended December 31, 2018, program costs consisted mostly of manufacturing costs to supply our clinical trials, for preclinical studies to support the IND application we filed in February of 2019 to test CG-806 in patients with BCM, and for consultant and CRO costs to prepare for the CG-806 BCM trial.

A decrease in research and development activities related to our APTO-253 development program of approximately $313 thousand related to lower manufacturing costs to supply the trial, and offset by an increase in costs associated with conducting the phase 1b clinical trial for APTO-253. For both the fiscal years ended December 31, 2018 and 2019, program costs consisted of costs for manufacturing APTO-253 to supply the trial, and for operating costs to conduct the ongoing phase 1b clinical trial. The APTO-253 clinical trial, which had been on a clinical hold since November 2015 was taken off clinical hold in June 2018.

An increase in personnel expenses of $1.6 million in the year ended December 31, 2019, as compared with prior year mostly related to additional clinical research staff to support two Phase 1 clinical trials. At December 31, 2019, we had 23 employees in research and development, including clinical operations as compared to 16 employees as at December 31, 2018.

A decrease in stock option compensation of approximately $552 in the year ended December 31, 2019, related mostly to higher forfeitures in the year ended December 31, 2019, as well as faster vesting of certain stock options granted in the period ended December 31, 2018. In the three-month period ended March 31, 2018, 100,000 stock options with a grant date fair value of $2.03 vested immediately, contributing to higher expenses in that period.
General and Administrative Expenses

General and administrative expenses of $10.0 million for the year ended December 31, 2019, decreased by approximately $352 thousand as compared with $10.4 million for the prior year. Changes to the components of our general and administrative expenses presented in the table above are primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment increased by approximately $1.0 million to $8.1 million for the year ended December 31, 2019, primarily as a result of higher compensation costs, increased travel, rent, consulting and office administrative costs associated with additional employees to support increased operations of the Company, and offset by lower professional and regulatory costs.
Stock-based compensation decreased for the year ended December 31, 2019, by approximately $1.4 million compared with the year ended December 31, 2018, mostly related to faster vesting of certain stock options granted in 2018 when 850,000 of the approximately 1.7 million stock options granted had immediate vesting.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the year and quarter ended December 31, 2019 today, Tuesday, March 10, 2020 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll free number) and 1-574-990-9707 (international/toll number) and using conference ID # 1097606. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 1097606.

The press release, the financial statements and the management’s discussion and analysis for the year and quarter ended December 31, 2019 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On March 10, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Sunesis, MAR 10, 2020, View Source [SID1234555372]). Loss from operations for the three months and year ended December 31, 2019 was $5.4 million and $23.3 million. As of December 31, 2019, cash and cash equivalents, restricted cash, and marketable securities totaled $34.6 million.

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"We concluded 2019 having made solid progress across our portfolio. Vecabrutinib, our non-covalent BTK inhibitor, demonstrated a very favorable safety profile combined with evidence of clinical activity in patients with and without BTK C481-mutations. We continue to advance and characterize our proprietary PDK1 inhibitor, SNS-510, with findings supporting development in both hematologic and solid tumors. We are also building value in our product pipeline through partnerships. In December, we partnered vosaroxin with Denovo Biopharma and TAK-580 with DOT Therapeutics-1 to advance these programs to the market," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "Looking ahead, we remain on track to complete the Phase 1b dose escalation component of our Phase 1b/2 vecabrutinib trial in the second quarter and to advance SNS-510 to an IND by the end of year."

Vecabrutinib Phase 1b/2 Clinical Update. Since the presentation of clinical data through cohort 5 at ASH (Free ASH Whitepaper) in December 2019, Sunesis has enrolled patients in cohorts 6 and 7 of the ongoing Phase 1b/2 trial of vecabrutinib.

Cohort 5 (300mg): Sunesis announced at ASH (Free ASH Whitepaper) 2019 that stable disease was observed in three of five patients from cohort 5 (300mg BID). As of today, one chronic lymphocytic leukemia (CLL) patient remains on study in cycle 8 at 300mg BID with a 47% reduction in tumor burden at their second scan, improving from their initial 41% reduction, with normalized hematology parameters.

Cohort 6 (400mg BID): Four patients, three CLL and one diffuse large B cell lymphoma (DLBCL), were enrolled in the cohort. The DLBCL patient was nonevaluable due to disease progression during cycle one. The three CLL patients

completed the safety evaluation period, remain on treatment, and results of their first response assessments will be available later this month.

Cohort 7 (500mg BID): Six patients, four with CLL and two with mantle cell lymphoma (MCL), cleared the safety evaluation period and four of the patients remain on treatment. We expect first response assessments for these patients in the second quarter. Additional patients are being evaluated for the cohort.

Vecabrutinib has been very well tolerated, with no Grade 3 or higher drug-related adverse events reported to date across cohorts 3 – 7.

SNS-510, first-in-class PDK1 inhibitor. In October, at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Sunesis presented data profiling the oral PDK1 inhibitor SNS-510 showing potent activity in hematologic and solid tumor cancer models. New results of in vitro combination studies indicate that SNS-510 can combine synergistically with several drugs including inhibitors of CDK4/6, KRAS G12C, and BCL2. The IND-enabling program is progressing as planned and an IND filing is targeted for the end of 2020.

Partnering TAK-580 and vosaroxin. In December, Sunesis consented to Takeda Oncology’s assignment of our agreement relating to the pan-Raf inhibitor TAK-580 to DOT Therapeutics-1, Inc. ("DOT-1"). Coincident with the transaction, Sunesis and DOT-1 entered into a new agreement covering TAK-580 and DOT-1 paid Sunesis an upfront fee of $2.0 million. Under the new TAK-580 agreement, DOT-1 agreed to pay Sunesis up to $57.0 million in pre-commercialization milestone payments, plus royalties on future sales of TAK-580. Also in December, Sunesis licensed vosaroxin to Denovo Biopharma LLC ("Denovo"). Sunesis received a $0.2 million upfront payment and is eligible to receive up to $57.0 million in regulatory and commercial milestones, plus double-digit royalties on future sales of vosaroxin.

Financial Highlights

Cash and cash equivalents, restricted cash and marketable securities totaled $34.6 million as of December 31, 2019, compared to $13.7 million as of December 31, 2018. The increase of $20.9 million was primarily due to $45.1 million of net proceeds from the issuance of common and preferred stock, and $5.5 million of proceeds from the SVB loan, partially offset by $22.2 million net cash used in operating activities and a $7.5 million principal repayment of the prior loan from Western Alliance Bank and Solar Capital Ltd.

Revenue was $2.1 million in 2019 compared to $0.2 million in 2018. Revenue in both periods was derived from license agreements. The increase of $2.0 million in 2019 was primarily due to revenue recognized from the upfront payments received under the license agreements with DOT-1 and Denovo.

Research and development expense was $15.4 million in 2019 compared to $14.6 million in 2018, primarily relating to the vecabrutinib development program. The increase of $0.8 million in 2019 was primarily due to a $1.8 million increase in professional services and clinical expenses related to the preparation for the Phase 2 portion of our ongoing clinical trial for vecabrutinib, offset by a $1.0 million decrease in salary and personnel expenses.

General and administrative expense was $9.9 million in 2019 compared to $11.3 million in 2018. The decrease of $1.4 million in 2019 was primarily due to a $1.1 million decrease in salary and personnel expenses due in large part to lower stock-based compensation and a $0.8 million decrease in professional services expenses due to lower legal and vosaroxin patent expenses. The decreases in the comparable periods were partially offset by a $0.3 million increase in insurance premiums.

Interest expense was $0.5 million in 2019 compared to $1.2 million in 2018. The decrease in 2019 was primarily due to lower interest paid under the SVB Loan Agreement compared to the prior loan.

Cash used in operating activities was $22.2 million in 2019, compared to $24.4 million in 2018. Cash used in the 2019 period resulted primarily from the net loss of $23.3 million and changes in operating assets and liabilities of $0.7 million, offset by net adjustments for non-cash items of $1.8 million.

Loss from operations was $5.4 million and $23.3 for the three months and year ended December 31, 2019, compared to $5.8 million and $25.7 million for the same periods in 2018. Net loss was $5.3 million and $23.3 million for the three months and year ended December 31, 2019, compared to $6.0 million and $26.6 million for the same periods in 2018.

Conference Call Information

Sunesis will host a conference call today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 2388763. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks