On March 3, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported its financial and operational results for the year ended December 31, 2019 (Press release, Sierra Oncology, MAR 3, 2020, View Source [SID1234555128]).

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"Our focus is on achieving regulatory and commercial success with our Phase 3 drug candidate, momelotinib, which may become the first approved therapeutic capable of treating all three hallmarks of myelofibrosis; anemia, constitutional symptoms and enlarged spleen. Given its potentially unique profile, momelotinib could command an important role in the poorly addressed anemic and thrombocytopenic first-line and second-line myelofibrosis patient populations," said Dr. Nick Glover, President and CEO of Sierra Oncology. "During the fourth quarter of 2019, we launched the MOMENTUM Phase 3 clinical trial, setting Sierra on course to deliver top-line data in late 2021 and positioning momelotinib for potential registration filing in 2022. Our focus now is on activating global clinical trial sites over the coming months and driving enrollment for MOMENTUM, and we look forward to providing ongoing updates on our progress throughout this year."

"Myelofibrosis is characterized by progressive anemia and thrombocytopenia, and current JAK inhibitor therapies can induce or further exacerbate this myelosuppression, limiting their use in first line treatment and resulting in a population of second line patients who are no longer able to benefit from such therapies. Conversely, we believe momelotinib’s ability to address anemia, while either sparing platelets or reversing thrombocytopenia, are important potential drivers of its commercial opportunity. We plan to further highlight momelotinib’s differentiated durability, safety and efficacy profile during 2020 with additional dissemination of emerging data from the two previously completed SIMPLIFY Phase 3 trials that compared momelotinib head-to-head with ruxolitinib," added Dr. Glover. "Given momelotinib’s distinct clinical profile, we believe our drug candidate is also well positioned amongst the JAK inhibitor class for emerging combination approaches targeting myelofibrosis."

2019 Highlights for Momelotinib:

During the second quarter, Sierra obtained regulatory clarity with the FDA and announced the design of the MOMENTUM Phase 3 clinical trial intended to support the potential registration of momelotinib. Sierra also announced that Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, had been named Chief Investigator of the MOMENTUM trial.
Sierra also reported during the second quarter that the FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.
During the fourth quarter, Sierra launched the MOMENTUM clinical trial for patients with myelofibrosis. The randomized double-blind global Phase 3 trial is designed to confirm the efficacy of momelotinib on myelofibrosis symptoms, transfusion independence and splenomegaly, as compared to danazol. The trial is targeting enrollment of 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05). Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib in prior clinical studies, will form the basis of the global registration strategy for momelotinib.
During the fourth quarter, new analyses of RBC transfusion data from SIMPLIFY-1, a double-blind Phase 3 trial of momelotinib head-to-head versus ruxolitinib in JAK inhibitor naïve patients, were presented in a poster by Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida. These analyses demonstrated that patients who received momelotinib had significantly decreased transfusion requirements compared to those treated with ruxolitinib, including an odds ratio of nearly 10 for receiving no transfusions during the 24-week study period. Transfusion dependency and moderate to severe anemia are critical negative prognostic factors for overall survival in myelofibrosis.
Year End 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $53.2 million for the year ended December 31, 2019, compared to $41.1 million for the year ended December 31, 2018. In addition to a non-cash charge of $10.5 million pertaining to the obligation to issue common stock and a warrant in consideration for meaningfully reduced royalty rates and elimination of a near term milestone payment in an amendment to our Asset Purchase Agreement with Gilead Sciences, Inc. (Gilead), the increase was primarily due to costs related to momelotinib, including a $12.2 million increase in clinical trial and development costs, a $2.5 million increase in third-party manufacturing costs and a $1.4 million increase in personnel-related and allocated overhead costs. These increases were partially offset by a $3.0 million upfront fee paid to Gilead to acquire momelotinib in 2018 and decreases in SRA737 and SRA141 costs, including a $5.0 million decrease in clinical trial costs primarily related to SRA737, a $4.3 million decrease in third-party manufacturing costs, and a $2.1 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $3.9 million and $4.5 million for the year ended December 31, 2019 and 2018, respectively.

General and administrative expenses were $13.7 million for the year ended December 31, 2019, compared to $14.3 million for the year ended December 31, 2018. This decrease was primarily due to decreases in personnel-related and allocated overhead costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $2.3 million for the year ended December 31, 2019 and 2018, respectively.

Other income (expense), net was $21.4 million of other expense, net for the year ended December 31, 2019, compared to $1.8 million of other income, net for the year ended December 31, 2018. The increase was primarily attributable to a non-cash charge of $20.9 million related to the change in fair value of warrant liabilities and offering expenses of $1.3 million pertaining the issuance of the warrants in the 2019 public offering and a $0.7 million increase in interest expense incurred on the term loan that was repaid in December 2019.

For the year ended December 31, 2019, Sierra incurred a GAAP net loss of $88.3 million compared to a GAAP net loss of $53.3 million for the year ended December 31, 2018. The GAAP net loss for the year ended December 31, 2019 includes a non-cash charge of $20.9 million, related to the change in fair value of warrant liabilities included in other income (expense), net and a non-cash charge of $10.5 million pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above. In January 2020, Sierra fulfilled this obligation, issuing 725,283 shares of common stock to Gilead and a warrant to purchase an equivalent amount of common stock.

Non-GAAP adjusted net loss was $51.2 million for the year ended December 31, 2019, compared to a non-GAAP adjusted net loss of $46.5 million for the year ended December 31, 2018. Non-GAAP adjusted net loss excludes expenses related to the change in fair value of warrant liabilities, the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

Cash and cash equivalents totaled $147.5 million as of December 31, 2019, compared to $106.0 million as of December 31, 2018. This increase was due to an underwritten public offering in November 2019, pursuant to which the company raised gross proceeds of $103.0 million (net proceeds of $97.7 million). This increase was offset by cash used in operating activities of $51.2 million and the full repayment of a term loan in December 2019 in the amount of $5.4 million, including prepayment and final payment fees associated with terminating the debt facility.

In January 2020, all of the Series A convertible voting preferred stock converted into shares of common stock. As of January 31, 2020, there were 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. At December 31, 2019 were 327,862 shares issuable upon exercise of stock options and a warrant.

The company anticipates its current resources will be sufficient to execute on its development strategy for momelotinib into the second half of 2022. In addition, the Series B warrants issued in the underwritten public offering in November 2019, may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from the MOMENTUM Phase 3 trial. If these Series B warrants are fully exercised, the company will receive approximately $34.0 million in proceeds.

Conference Call Information

Today at 8:00 am Eastern Time, Sierra’s management will host a conference call to discuss the company’s and operational results for 2019 and provide a business update for 2020.

Date and Time: Tuesday, March 3 at 8:00 am ET

Domestic (Toll Free- US): 1-888-394-8218
International (Toll): 1-323-701-0225
Conference ID: 1052679
Webcast Link: www.sierraoncology.com
Direct Link: View Source

Call registration is available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

On March 3, 2020 eHealth, Inc. (NASDAQ:EHTH), which owns eHealth.com, a leading private online health insurance exchange, reported the pricing of its follow-on public offering of 1,800,000 shares of its common stock at a price to the public of $115.00 per share (Press release, eHealthInsurance, MAR 3, 2020, View Source [SID1234555146]). In addition, the Company has granted the underwriters a 30-day option to purchase up to 270,000 additional shares of its common stock. eHealth intends to use the net proceeds of the offering for general corporate purposes, including working capital.

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RBC Capital Markets, Credit Suisse and Deutsche Bank Securities are acting as joint book-running managers for the offering. Craig-Hallum Capital Group, Raymond James and SunTrust Robinson Humphrey are acting as co-managers for the offering.

An immediately effective registration statement relating to the common stock was filed with the Securities and Exchange Commission (SEC) on December 17, 2018 and amended on January 22, 2019 and March 2, 2020. The offering of these securities is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained from RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, New York 10281-8098, or by fax at (212) 428-6260; from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, New York 10010, or by phone at 1-800-221-1037 or by email at [email protected]; or from Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005, or by telephone at (800) 503-4611 or by email at [email protected].

On March 3, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the fourth quarter and full year 2019. Net loss for the fourth quarter was $30.6 million or $0.52 per share and net loss for the year 2019 was $121.7 million, or $2.11 per share. Net loss for the fourth quarter of 2018 was $26.5 million, or $0.48 per share and net loss for the year 2018 was $106.3 million, or $1.95 per share. Cash, cash equivalents and investments totaled $267.7 million at December 31, 2019.

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"We had a productive fourth quarter of 2019 which positions us well to deliver against our Vision 2025 that we recently announced pointing towards commercialization of our novel drug candidates, doubling our development pipeline and expanding the breadth of our muscle biology focused research," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In 2020, we look forward to reaching several key milestones, including sharing top-line results of GALACTIC-HF and completing enrollment in METEORIC-HF, both alongside continued preparations for the potential commercialization of omecamtiv mecarbil and the development of a co-promotion plan in collaboration with Amgen. We are also advancing our pipeline of cardiac myosin inhibitors, including CK-274 in REDWOOD-HCM and CK-271 which we expect to enter Phase 1 soon. We began 2020 with a strong balance sheet enabling our continued execution on key objectives that we believe will empower us to deliver on the promise of our science for patients."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, following the recently completed second and final planned interim analysis, which considered pre-specified criteria for futility and superiority. We expect top-line results in Q4 2020.

Announced the publication of a manuscript relating to the design of GALACTIC-HF in the Journal of American College of Cardiology: Heart Failure (JACC: HF).

Expect presentation of baseline characteristics from GALACTIC-HF at the American College of Cardiology meeting in March 2020.

Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect to complete enrollment in METEORIC-HF in 2020.

Presented results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) at the American Heart Association’s Scientific Sessions in Philadelphia. In this post-hoc analysis, patients with heart failure with reduced ejection fraction (HFrEF) treated with omecamtiv mecarbil, in addition to previously reported improvements in cardiac contractility measures (including systolic function, or pumping action of the heart), measures of diastolic function were not different from placebo and, for some measures, trended toward improvement.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under our joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect to complete the SAD/MAD cohorts of the study in 2H 2020.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Prepared for and started REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (HCM). REDWOOD-HCM started in Q1 2020 and will continue through 2020. We expect data from the first cohort of patients enrolled in REDWOOD-HCM to be available in 2H 2020.
CK-271 (CK-271, second cardiac myosin inhibitor)

We expect to file an IND and begin a Phase 1 study of CK-271 in 1H 2020.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Presented subgroup analyses of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS) at the 30th International Symposium on ALS/MND in Perth, Australia, showing that the effect of reldesemtiv on patients with ALS was similar whether or not patients were also receiving edaravone and/or riluzole.

Received Orphan Designation for reldesemtiv for the potential treatment of ALS by the U.S. Food and Drug Administration (FDA).

Held regulatory interactions and conducted feasibility and other planning activities in preparation for the potential advancement of reldesemtiv to a Phase 3 trial in patients with ALS. We expect to continue to engage with regulatory and reimbursement authorities in 2020 in preparation for the potential trial.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, under our collaboration with Astellas. We expect to continue the conduct of IND-enabling studies of CK-601 in 2020.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

We raised $120.5 million capital through a convertible note offering in November 2019. The convertible note carries a 4% coupon rate, a 27.5% convert premium, and matures in November 2026.
Financials

Revenues for the three and twelve months ended December 31, 2019 were $5.2 million and $26.9 million, respectively, compared to $9.4 million and $31.5 million for the corresponding periods in 2018. The decrease in revenues for the three and twelve months ended December 31, 2019 was due primarily to the winding down of FORTITUDE-ALS in addition to a lack of license revenue in 2019. License revenues in the fourth quarter and twelve months of 2018 were related to the Phase 2 trial of reldesemtiv in spinal muscular atrophy completed in 2018.

Research and development expenses for the three and twelve months ended December 31, 2019 were $18.3 million and $86.1 million, respectively compared to $23.3 million and $89.1 million for the same periods in 2018, respectively. The changes were primarily due to reduced spending for reldesemtiv as well as tirasemtiv following suspension of development of tirasemtiv in late 2017 offset by increased spending related to METEORIC-HF and the development of CK-274.

General and administrative expenses for the three and twelve months ended December 31, 2019 increased to $10.6 million and $39.6 million, respectively, from $7.6 million and $31.3 million for the same periods in 2018, respectively, due primarily to an increase in outside legal counsel and personnel related costs including stock-based compensation.

2020 Financial Guidance

The company also announced financial guidance for 2020. The company anticipates cash revenue will be in the range of $18 to $22 million, operating expenses will be in the range of $120 to $130 million, and net cash utilization will be approximately $105 to $115 million.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 8698309.

An archived replay of the webcast will be available via Cytokinetics’ website until March 17, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 8698309 from March 3, 2020 at 7:30 PM Eastern Time until March 17, 2020.

On March 3, 2020 Abpro, a biotechnology company dedicated to developing next-generation antibody therapeutics to improve the lives of patients with severe and life-threatening diseases, reported the formation of a strategic partnership to advance two bispecific antibodies in key Asian markets including Greater China, Japan, and South Korea (Press release, Abpro Therapeutics, MAR 3, 2020, View Source [SID1234555113]).

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The strategic partnership was formed with Abpro Bio Co. Ltd ("Abpro Bio") (KOSDAQ: 195990), formerly known as Ugint Co. Ltd. Under this partnership agreement, Abpro has granted an exclusive license to Abpro Bio to develop and commercialize two of Abpro’s bispecific antibody candidates: ABP-100 and ABP-201. ABP-100 is in development for immuno-oncology with initial indications including gastric, breast and endometrial cancers. ABP-201 is in development for ophthalmology with initial indications inclusive of Wet AMD (age-related macular degeneration) and diabetic macular edema. The collaboration will also leverage Abpro’s proprietary DiversImmune antibody platform for generating novel molecules.

"We are delighted to form this important partnership and expand our geographical reach across Asia for two of our key programs. We plan to partner with Abpro Bio to propel the development of ABP-100 and ABP-201 in diseases that have large unmet patient needs across Asia," said Mr. Ian Chan, CEO of Abpro. "This strategic partnership provides resources to accelerate our pipeline based on our Diversimmune platform in immuno-oncology and ophthalmology indications. Together, we plan to conduct preclinical and clinical development programs in both geographies."

Pursuant to the agreement, Abpro will lead global clinical development of the bi-specific candidates and work closely with Abpro Bio. Key terms of the agreement include:

Abpro will receive from Abpro Bio up to $1.1 billion in total payments, including a $30 million upfront equity investment, and an additional $1.05 billion based on clinical milestones, post-approval payments, and royalties as ABP-100 and ABP-201 progress through the clinical development and regulatory approval processes in Greater China, Japan, and South Korea.
In addition, Abpro Corporation’s two co-founders, Ian Chan and Eugene Chan, as well as Robert S. Langer, PhD, Institute Professor at MIT, will join the Board of Abpro Bio Ltd.
"We are excited to form this alliance with Abpro to bring these much needed therapies to Asia to treat patients suffering from cancer and eye disease. There are very large populations of patients in this region for these therapies. We look forward to progressing these therapies through the clinic and ultimately to patients. Abpro’s immuno-oncology and ophthalmology therapies, as well as the Diversimmune platform, will become a cornerstone for us as we build a leading biotechnology company in Asia," said Mr. Yang, Co-CEO at Abpro Bio.

Outside the partnership, Abpro continues to make headway on a number of other programs in immuno-oncology and other major disease areas. The company has multiple programs in development, including some with partners across the globe, including Memorial Sloan Kettering, AstraZeneca, and Nanjing Chia Tai Tianqing Pharmaceutical Co.

About ABP 100 and ABP 201

ABP-100 and ABP-201, two of Abpro’s lead programs, are bispecific antibody therapies for the treatment of solid tumors, including breast, gastric and colorectal, and ophthalmology diseases, such as Wet AMD and diabetic macular edema, respectively. ABP-100 targets HER2 and CD3 for the treatment of Her2+ solid tumors. ABP-201 is designed to block blood vessel formation and normalize damaged vessels through co-targeting VEGF and ANG2. Abpro is developing ABP-201 to treat vascular diseases of the eye, focusing on diabetic macular edema and Wet AMD.

On March 3, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will present an overview of the company’s business strategy and development-stage programs at the Barclays Global Healthcare Conference 2020 being held in Miami (Press release, Spectrum Pharmaceuticals, MAR 3, 2020, View Source [SID1234555129]). The company presentation is scheduled for Tuesday, March 10, 2020, at 4:50 p.m. EDT.

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A live webcast of the presentation will be available on Spectrum’s website at View Source with a replay available shortly after the event.