On March 12, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Regulus, MAR 12, 2020, View Source [SID1234555489]).

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"We have made significant progress over the past few months, including receiving notification from FDA of their decision to lift the partial clinical hold on our Phase 1 multiple ascending dose clinical study for RGLS4326, enabling the initiation of dosing of the second cohort of that study for the treatment of autosomal dominant polycystic kidney disease this past February," said Jay Hagan, CEO of Regulus. "This important milestone, coupled with the closing of the second tranche of financing, enables us to advance the program toward key data read-outs."

Corporate Highlights

Closed $26 Million Second Tranche of Private Financing: In December 2019, following the announcement of the Company’s plan to recommence the Phase 1 Multiple Ascending Dose ("MAD") clinical study of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease ("ADPKD") in the first quarter of 2020, the Company completed a second and final closing under the May 2019 securities purchase agreement, pursuant to which the Company sold and issued 3,288,390 shares of non-voting Class A-2 convertible preferred stock, in lieu of shares of common stock, at a price of $6.66 per share, and accompanying warrants to purchase an aggregate of 32,883,900 shares of common stock at a price of $0.125 for each share of common stock underlying such warrants. Each share of the non-voting Class A-2 convertible preferred stock is convertible into 10 shares of common stock, subject to certain beneficial ownership conversion limitations. The warrants are exercisable for a period of five years following the date of issuance and have an exercise price of $0.666 per share, pursuant to proportional adjustments in the event of stock splits or combinations or similar events. Together with the first tranche, which closed in May 2019, the Company raised a total of $42.7 million from the private financing, which the Company expects will provide cash resources to fund planned activities into mid-2021.

Program Highlights

Initiated Dosing of the Second Cohort in RGLS4326 Phase 1 for ADPKD: In February 2020, the Company initiated dosing of the second cohort of the MAD clinical study of RGLS4326, a novel oligonucleotide designed to inhibit miR-17 for the treatment of ADPKD. The Company expects to complete this study in mid-2020 with topline results available thereafter.

The Company is also planning to initiate a Phase 1b short-term dosing study in patients with ADPKD in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity. The re-initiation of the MAD study was allowed following a satisfactory complete response provided to FDA in November 2019 to address the partial clinical hold placed on the clinical program in July 2019. A partial clinical hold on studies of RGLS4326 dosed for extended durations remains in effect until the second set of requirements outlined by FDA have been satisfactorily addressed. Information from the Phase 1 clinical studies, together with information from additional nonclinical studies, will be used to address the second set of requirements to support studies of extended duration.

Financial Results

Cash Position: As of December 31, 2019, Regulus had $34.1 million in cash and cash equivalents.

Research and Development (R&D) Expenses: R&D expenses were $2.1 million and $12.3 million for the quarter and year ended December 31, 2019, respectively, compared to $5.3 million and $34.0 million for the same periods in 2018. The decreases were largely driven by decreases in external development expenses, primarily attributable to the pause of the RGLS4326 MAD study in the third quarter of 2018 and transfer of the RG-012 program to Sanofi beginning in the fourth quarter of 2018. Additionally, the decreases were driven by reductions in personnel and internal expenses, primarily attributable to a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million and $11.3 million for the quarter and year ended December 31, 2019, respectively, compared to $2.7 million and $12.9 million for the same periods in 2018. The decreases were mostly driven by a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.

Revenue: Revenue was less than $0.1 million and $6.8 million for the quarter and year ended December 31, 2019, respectively, compared to less than $0.1 million and $0.1 million for the same periods in 2018. The increase for the year ended December 31, 2019 was attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of the RG-012 program to Sanofi.

Net Loss: Net loss was $4.9 million and $18.6 million for the quarter and year ended December 31, 2019, respectively, compared to a net loss of $8.6 million and $48.7 million for the same periods in 2018. Basic and diluted net loss per share was $0.23 and $1.08 for the quarter and year ended December 31, 2019, respectively, compared to $0.98 and $5.59 for the same periods in 2018.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD. The RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration by the U.S. Food and Drug Administration.

On March 12, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat chronic diseases and extend healthy lifespan, reported its financial results for the fourth quarter ended December 31, 2019 (Press release, CohBar, MAR 12, 2020, View Source [SID1234555488]).

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"We made substantial progress in this past quarter," said Steven Engle, CohBar’s Chief Executive Officer. "We completed the Phase 1a stage of our ongoing Phase 1a/1b clinical trial of CB4211, initiated the Phase 1b stage, and announced promising preclinical data in two new programs, a novel family of CXCR4 antagonists for cancer and other indications, and anti-fibrotic peptides for the potential treatment of fibrotic diseases such as idiopathic pulmonary fibrosis. We now have five mitochondrial derived peptide programs, up from three last summer. These new data provide additional evidence supporting the breadth of biological effects and therapeutic potential of mitochondrial peptides and strengthen our belief that our platform will continue to identify even more mitochondria based therapeutics going forward."

Fourth Quarter 2019 and R&D and Business Highlights

●CB4211 Clinical Study: In November, the company announced the completion of the Phase 1a stage of the company’s ongoing Phase 1a/1b study evaluating the safety, tolerability, and activity of CB4211, and the initiation of recruitment for the Phase 1b stage. The Phase 1b stage is designed to assess the safety, tolerability, and activity of CB4211 in obese subjects with non-alcoholic fatty liver disease (NAFLD). The double-blind, placebo-controlled evaluation will be conducted over four weeks in twenty patients randomized 1:1 to receive either CB4211 or placebo. Assessments will include changes in liver fat as determined by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity. CohBar has previously presented evidence that the novel mechanism of action of CB4211 enhances insulin effects on fat cells (adipocytes) leading to reduction of liver fat in preclinical models. Clinical data from both stages of the study are expected in the third quarter of 2020.

●New CXCR4 Inhibitor Program for Cancer and Other Indications: Recently, the company announced its discovery of MBT5 analogs, a novel family of potent and selective peptide inhibitors of the chemokine receptor, CXCR4. Analogs of MBT5 have demonstrated high potency at nanomolar levels in in vitro studies of CXCR4 inhibition in cultured cells. In a difficult to treat in vivo animal model of melanoma, the B16F10 syngeneic tumor model, an analog of MBT5 showed enhanced antitumor activity in combination with the chemotherapeutic agent temozolomide. CXCR4 is overexpressed in more than 75% of cancers and high levels of the receptor are associated with poor survival prognosis.

●MBT2 Analogs for Fibrotic Diseases: In December, CohBar announced the further demonstration of the therapeutic potential of a novel peptide in a preclinical model of idiopathic pulmonary fibrosis (IPF). In a therapeutic animal model of IPF, CohBar’s peptide analog, MBT2, demonstrated reductions in all parameters of the disease including lung fibrosis, inflammation, and collagen levels. These data further support earlier positive findings in a prophylactic model of IPF. IPF is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.

CohBar is continuing to refine and evaluate these novel analogs in preclinical models of multiple indications. In addition, the company continues to develop its programs in cancer immunotherapy and type 2 diabetes.

●Investment Community Outreach: In October 2019, CohBar presented an overview of the company and its clinical development program at the BIO Investor Forum. In January 2020, CohBar met with investors, bankers, and analysts at the JP Morgan Healthcare Conference. In February 2020, CohBar presented at the BIO CEO and Investor conference.

●Expanded the Company’s Board of Directors: In October 2019, Misha Petkevich, Chief Investment Officer of V2M Capital, joined the CohBar board of directors. Mr. Petkevich’s appointment adds extensive financial and investment expertise. His past experience includes roles at V2M Capital, Robertson Stephens & Co. and Hambrecht & Quist.

During the fourth quarter and subsequent period, Dr. Pinchas Cohen and Dr. Nir Barzilai continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases:

Dr. Cohen received the Irving S. Wright Award of Distinction from the American Federation for Aging Research in New York in November 2019. In addition, he delivered a keynote presentation on "Endocrine Gerontology: from IGFs to Mitochondrial Peptides" at the Annual Meeting of the Gerontological Society of America, in Austin, Texas. Dr. Cohen also published a paper entitled "The mitochondrial-derived peptide MOTS-c is a regulator of plasma metabolites and enhances insulin sensitivity" in the journal Physiological Reports.

Dr. Barzilai delivered keynotes at Harvard’s Boston Pepper Center OAIC Mini-Symposium on Geroscience in Boston in December 2019 and at The Science and Economy of Aging World Economic Forum in Davos, Switzerland in January 2020. In January 2020 he also participated in a panel on aging during the JP Morgan Healthcare Conference and at the Longevity Therapeutics conference. Dr. Barzilai authored two articles in the prestigious Nature Medicine Journal, titled "Undulating changes in human plasma proteome profiles across the lifespan" and "Chronic inflammation in the etiology of disease across the lifespan." He also authored two papers on the latest advances in aging research and drug discovery in the Journal of Aging, titled "Screening human embryos for polygenic traits has limited utility" and "Varying Effects of APOE Alleles on Extreme Longevity in European Ethnicities."

Fourth Quarter 2019 Financial Highlights

●Cash and Investments. CohBar had cash and cash equivalents of $12.6 million as of December 31, 2019, compared to $22.2 million as of December 31, 2018. The cash burn for the quarter ended December 31, 2019, was approximately $2.2 million.

●R&D Expenses. Research and development expenses were $1.9 million for the three months ended December 31, 2019, compared to $2.1 million in the prior year quarter. The decrease was primarily due to lower clinical and preclinical costs in the quarter, partially offset by an increase in costs associated with CohBar’s research programs focused on the continuing development of peptides.

●G&A Expenses. General and administrative expenses were $1.7 million for the three months ended December 31, 2019, compared to $2.0 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to severance and non-cash stock-based compensation costs related to the termination of CohBar’s former CEO in the prior year period and a decrease in recruiting fees, partially offset by an increase in payroll related accruals, legal fees and D&O insurance premiums.

●Net Loss. For the three months ended December 31, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.7 million, or $0.09 per basic and diluted share. For the three months ended December 31, 2018, net loss, which included $1.0 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share.

Fourth Quarter Investor Call and Slide Presentation:

Date: March 12, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

- Dial-in U.S. and Canada: (877) 451-6152
- Dial-in International: (201) 389-0879
- Conference ID No.: 13698823

Slide Presentation

-Go to www.webex.com, click on the ‘Join’ button and enter meeting number 925 797 732 and Password CWBR, or
-Go to www.cohbar.com and click on Q4 2019 Shareholder Presentation at top of homepage.

We kindly request that you please call into the conference audio and log into Webex approximately 10 minutes prior to the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 12, 2020, through 11:59 p.m. Eastern Time on April 2, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13698823. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On March 12, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 12, 2020, View Source [SID1234555487]).

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"In the fourth quarter of 2019, Harpoon closed a potentially transformational option and license transaction and expanded an existing discovery collaboration with AbbVie that further validates our proprietary TriTAC technology," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are expecting continued clinical milestone progress throughout 2020 with data updates for HPN424 potentially at ASCO (Free ASCO Whitepaper) and proof of concept data for HPN536 in the second half of the year."

Fourth Quarter 2019 Business Highlights and Other Recent Developments

In November, Harpoon and AbbVie announced an exclusive worldwide development and option agreement for HPN217, which targets BCMA. Under the terms of the development and option agreement, Harpoon granted to AbbVie an option to license worldwide exclusive rights to HPN217 for BCMA. AbbVie may exercise its option after completion of the Phase 1/2 clinical trial, which Harpoon expects to initiate in the first half of 2020. The development and option agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales, of which a $30 million upfront payment was received in December 2019 and up to $50 million for dosing the first patient in the HPN217 clinical trial, which we expect to occur in the first half of 2020.

In November 2019, Harpoon and AbbVie also announced the expansion of its existing discovery collaboration for up to six additional targets. The expanded discovery collaboration represents a deal transaction value of up to $1.86 billion, with an upfront payment of $20 million received in December 2019.

In October, Harpoon presented preclinical data on HPN328 for the treatment of small cell lung cancer at the 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) in Boston. The presentation demonstrated that HPN328 has the potential to be an efficacious, well-tolerated and convenient therapeutic for patients with DLL3-expressing malignancies. HPN328 was well-tolerated in cynomolgus monkeys at 1 and 10 mg/kg and pharmacokinetic data support the potential for once weekly dosing. Harpoon expects to initiate a Phase 1/2a trial in the second half of 2020.

Patient enrollment and dose escalation continues in the Phase 1 trial for HPN424 in metastatic castration resistant prostate cancer and the Phase 1/2a trial for HPN536, initially for ovarian cancer. Harpoon has submitted an abstract and to plans to present a clinical trial update with interim HPN424 results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting and plans to present preliminary data for HPN536 in second half of 2020.

Anticipated Milestones

HPN424 – present interim data from the dose escalation phase of our Phase 1 trial at ASCO (Free ASCO Whitepaper) 2020 and initiate expansion cohort in 2020

HPN536 – present interim data from Phase 1/2a trial in the second half of 2020

HPN217 – initiate Phase 1/2 trial in the first half of 2020

HPN328 – initiate Phase 1/2a trial in the second half of 2020

Fourth Quarter and Full Year 2019 Financial Results

Harpoon ended 2019 with $155.1 million in cash, cash equivalents and marketable securities compared to $89.5 million as of December 31, 2018. Net cash provided by financing activities for the year ended December 31, 2019 was $71.6 million, primarily comprised of approximately $70.7 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations. Net cash used in investing activities for the year ended December 31, 2019 was $69.3 million, primarily related to the purchase and maturities of marketable securities. Net cash used in operations for the year ended December 31,2019 was $2.9 million.

Revenue for the fourth quarter ended December 31, 2019 was $2.2 million compared to $1.1 million for the fourth quarter ended December 31, 2018. Revenue for the year ended December 31, 2019 was $5.8 million, compared to $4.8 million for the prior year. The increase in revenue for both comparative periods was primarily due to collaboration and license revenue recognized from the upfront payment under the Development and Option Agreement with AbbVie, which occurred during the fourth quarter of 2019. During both the fourth quarter and year ended December 31, 2019, revenue primarily consisted of the revenue recognized related to research and development services performed under the Collaboration Agreement and the Development and Option Agreement with AbbVie.

Research and development expense for the fourth quarter ended December 31, 2019 was $12.2 million compared to $8.7 million for the fourth quarter ended December 31, 2018. R&D expense for the year ended December 31, 2019 was $41.6 million, compared to $26.4 million for the prior year. The increases over both comparative periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expenses for the quarter ended December 31, 2019 was $4.4 million compared to $2.2 million for the quarter ended December 31, 2018. General and administrative

expenses for the year ended December 31, 2019 were $22.4 million, compared to $6.1 million for the prior year. The increases over both comparative periods were due to higher expenses primarily related to legal fees associated with ongoing Maverick litigation, consulting and accounting services, an increase in headcount, and other professional services to support our ongoing operations as a public company.

Net loss for the fourth quarter ended December 31, 2019 was $14.3 million compared to $9.7 million for the fourth quarter ended December 31, 2018. Net loss for the year ended December 31, 2019 was $55.6 million, compared to $27.4 million for the prior year.

Conference Call Information

Harpoon will host a conference call and live audio webcast this afternoon at 1:30 p.m. PT / 4:30 p.m. ET to discuss the fourth quarter and full year 2019 financial results and provide a corporate update. The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-261-0624 for international callers and using conference ID: 5468929. A live webcast of the call will be available online from the investor relations section of the Harpoon Therapeutics website at View Source

An archived replay of the webcast will be available on Harpoon Therapeutics’ website shortly after the conference call.

On March 12, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 12, 2020, View Source [SID1234555487]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the fourth quarter of 2019, Harpoon closed a potentially transformational option and license transaction and expanded an existing discovery collaboration with AbbVie that further validates our proprietary TriTAC technology," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are expecting continued clinical milestone progress throughout 2020 with data updates for HPN424 potentially at ASCO (Free ASCO Whitepaper) and proof of concept data for HPN536 in the second half of the year."

Fourth Quarter 2019 Business Highlights and Other Recent Developments

In November, Harpoon and AbbVie announced an exclusive worldwide development and option agreement for HPN217, which targets BCMA. Under the terms of the development and option agreement, Harpoon granted to AbbVie an option to license worldwide exclusive rights to HPN217 for BCMA. AbbVie may exercise its option after completion of the Phase 1/2 clinical trial, which Harpoon expects to initiate in the first half of 2020. The development and option agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales, of which a $30 million upfront payment was received in December 2019 and up to $50 million for dosing the first patient in the HPN217 clinical trial, which we expect to occur in the first half of 2020.

In November 2019, Harpoon and AbbVie also announced the expansion of its existing discovery collaboration for up to six additional targets. The expanded discovery collaboration represents a deal transaction value of up to $1.86 billion, with an upfront payment of $20 million received in December 2019.

In October, Harpoon presented preclinical data on HPN328 for the treatment of small cell lung cancer at the 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) in Boston. The presentation demonstrated that HPN328 has the potential to be an efficacious, well-tolerated and convenient therapeutic for patients with DLL3-expressing malignancies. HPN328 was well-tolerated in cynomolgus monkeys at 1 and 10 mg/kg and pharmacokinetic data support the potential for once weekly dosing. Harpoon expects to initiate a Phase 1/2a trial in the second half of 2020.

Patient enrollment and dose escalation continues in the Phase 1 trial for HPN424 in metastatic castration resistant prostate cancer and the Phase 1/2a trial for HPN536, initially for ovarian cancer. Harpoon has submitted an abstract and to plans to present a clinical trial update with interim HPN424 results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting and plans to present preliminary data for HPN536 in second half of 2020.

Anticipated Milestones

HPN424 – present interim data from the dose escalation phase of our Phase 1 trial at ASCO (Free ASCO Whitepaper) 2020 and initiate expansion cohort in 2020

HPN536 – present interim data from Phase 1/2a trial in the second half of 2020

HPN217 – initiate Phase 1/2 trial in the first half of 2020

HPN328 – initiate Phase 1/2a trial in the second half of 2020

Fourth Quarter and Full Year 2019 Financial Results

Harpoon ended 2019 with $155.1 million in cash, cash equivalents and marketable securities compared to $89.5 million as of December 31, 2018. Net cash provided by financing activities for the year ended December 31, 2019 was $71.6 million, primarily comprised of approximately $70.7 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations. Net cash used in investing activities for the year ended December 31, 2019 was $69.3 million, primarily related to the purchase and maturities of marketable securities. Net cash used in operations for the year ended December 31,2019 was $2.9 million.

Revenue for the fourth quarter ended December 31, 2019 was $2.2 million compared to $1.1 million for the fourth quarter ended December 31, 2018. Revenue for the year ended December 31, 2019 was $5.8 million, compared to $4.8 million for the prior year. The increase in revenue for both comparative periods was primarily due to collaboration and license revenue recognized from the upfront payment under the Development and Option Agreement with AbbVie, which occurred during the fourth quarter of 2019. During both the fourth quarter and year ended December 31, 2019, revenue primarily consisted of the revenue recognized related to research and development services performed under the Collaboration Agreement and the Development and Option Agreement with AbbVie.

Research and development expense for the fourth quarter ended December 31, 2019 was $12.2 million compared to $8.7 million for the fourth quarter ended December 31, 2018. R&D expense for the year ended December 31, 2019 was $41.6 million, compared to $26.4 million for the prior year. The increases over both comparative periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expenses for the quarter ended December 31, 2019 was $4.4 million compared to $2.2 million for the quarter ended December 31, 2018. General and administrative

expenses for the year ended December 31, 2019 were $22.4 million, compared to $6.1 million for the prior year. The increases over both comparative periods were due to higher expenses primarily related to legal fees associated with ongoing Maverick litigation, consulting and accounting services, an increase in headcount, and other professional services to support our ongoing operations as a public company.

Net loss for the fourth quarter ended December 31, 2019 was $14.3 million compared to $9.7 million for the fourth quarter ended December 31, 2018. Net loss for the year ended December 31, 2019 was $55.6 million, compared to $27.4 million for the prior year.

Conference Call Information

Harpoon will host a conference call and live audio webcast this afternoon at 1:30 p.m. PT / 4:30 p.m. ET to discuss the fourth quarter and full year 2019 financial results and provide a corporate update. The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-261-0624 for international callers and using conference ID: 5468929. A live webcast of the call will be available online from the investor relations section of the Harpoon Therapeutics website at View Source

An archived replay of the webcast will be available on Harpoon Therapeutics’ website shortly after the conference call.

On March 12, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, CTI BioPharma, MAR 12, 2020, View Source [SID1234555486]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"In the latter half of 2019 and beginning of 2020, we further advanced our pacritinib development program, including presenting data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that reinforced the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients." said Adam R. Craig, M.D., Ph.D. "Severely thrombocytopenic myelofibrosis patients have limited, and often ineffective, therapeutic options. In an effort to advance pacritinib as quickly as possible to these patients, we established an accelerated approval pathway with the U.S. Food and Drug Administration ("FDA") by amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of Spleen Volume Reduction ("SVR") rates on the first 168 patients, with an end-of-study analysis of Total Symptom Score ("TSS") and Overall Survival ("OS") following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, we intend to submit a New Drug Application ("NDA") under the FDA’s subpart H regulations. We expect to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022. Additionally, we recently raised an additional $59.3 million in a rights offering, which provides us with additional cash runway into Q1 2022 as we continue to develop pacritinib."

Fourth Quarter Financial Results
Operating loss was $9.5 million and $40.7 million for the three months and year ended December 31, 2019, respectively, compared to operating income of $0.2 million and operating loss of $32.9 million for the respective periods in 2018. The operating loss during the three-month period ended December 31, 2019 as compared to the operating income for the comparable period in 2018 resulted primarily from the decrease in license and contract revenue as discussed below, partially offset by a decrease in operating expenses. The increase in operating loss for the year ended December 31, 2019 as compared to the same period in 2018 resulted primarily from a decrease in license and contract revenues between periods as discussed below, partially offset by a decrease in operating expenses. As of December 31, 2019, cash, cash equivalents and short-term investments totaled $33.7 million, compared to $67.0 million as of December 31, 2018. In March 2020, we completed our rights offering and received approximately $59.3 million in net proceeds. We expect current cash, cash equivalents and short-term investments,

when combined with the net proceeds we received from the rights offering, will enable us to fund our operations into the first quarter of 2022.

License and contract revenues for the three months ended December 31, 2018 were $14.1 million while no revenues were recognized during the three months ended December 31, 2019. License and contract revenues for the three months ended December 31, 2018 were primarily related to milestone revenues recognized upon the achievement of a regulatory milestone under the license and collaboration agreement for PIXUVRI with Les Laboratoires Servier and Institut de Recherches Internationales Servier as well as the attainment of a worldwide net sales milestone of TRISENOX (arsenic trioxide) under the agreement with Teva Pharmaceutical Industries Ltd. ("Teva"). License and contract revenues for the years ended December 31, 2019 and 2018 were $3.3 million and $26.3 million, respectively. The decrease between periods primarily resulted from milestone revenues recognized in 2018 from Teva related to the achievement of a milestone for FDA approval of TRISENOX for first-line treatment of acute promyelocytic leukemia, in addition to the license and contract revenues recognized during the three months ended December 31, 2018, as discussed above.

Net loss attributable to common stockholders for the three months ended December 31, 2019 was $8.2 million, or $(0.14) for basic and diluted loss per share, compared to net income attributable to common stockholders of $0.8 million, or $0.01 for basic and diluted income per share, for the same period in 2018. Net loss attributable to common stockholders for the year ended December 31, 2019 was $40.0 million, or $(0.69) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $29.4 million, or $(0.52) for basic and diluted loss per share, for the same period in 2018.