On August 8, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage Precision Cancer Medicine company, developing drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2019 (Press release, Trovagene, AUG 8, 2019, View Source [SID1234538549]). The company is issuing this press release in lieu of conducting a conference call.

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"We continue to make great progress with our clinical development of onvansertib with three clinical trials actively enrolling patients and advancing as planned," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "We initiated enrollment in our third study, a Phase 1b/2 clinical trial in metastatic Colorectal Cancer (mCRC) at USC Morris Comprehensive Cancer Center and the Mayo Clinic, and look forward to providing preliminary safety and efficacy readouts later this year. Additionally, we recently announced the acceptance of three abstracts for presentation at ESMO (Free ESMO Whitepaper) in September, including our AML clinical trial for an oral presentation. We believe this is an indication of the level of interest in, and potential value of onvansertib in the evolving cancer treatment landscape across a number of different cancer types."

Dr. Adams added, "We achieved a number of key milestones in the second quarter of 2019, including: preclinical data demonstrating significant synergy of onvansertib in combination with venetoclax (Venclexta – AbbVie), the emerging first-line standard of care in AML; updates to our Phase1b/2 AML trial showing patients achieving a complete response (CR and CRi) to treatment with onvansertib in combination with decitabine; early data from our Phase 2 study of onvansertib in combination with Zytiga in patients with mCRPC demonstrating response to treatment and the first patient to achieve the primary efficacy endpoint of disease stabilization; and our research collaboration with Nektar Therapeutics to evaluate the combination of onvansertib and Nektar’s pegylated irinotecan, Onzeald, in models of CRC."

The Company has advanced its business, with the following recent activities and milestone achievements:

Clinical Development:

Announced ESMO (Free ESMO Whitepaper) Accepts Trovagene AML Clinical Trial Abstract for Oral Presentation
On July 22, 2019, Trovagene announced the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in Barcelona on September 27 to October 1, 2019. The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.

Announced Initiation of Enrollment for Phase 1b/2 Clinical Trial in KRAS-Mutated Colorectal Cancer at Leading Cancer Centers
On July 9, 2019, Trovagene announced the initiation of patient enrollment of its Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410). The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic, under the leadership of recognized colorectal cancer key opinion leaders, Heinz-Josef Lenz, MD, FACP, Section Head of GI Oncology and Co-Director of the Colorectal Center at USC Norris, and Afsaneh Barzi, MD, PhD, oncologist at USC Norris and principal investigator of the trial.

Announced Research Collaboration with Nektar Therapeutics to Evaluate Efficacy of the Combination of Onvansertib and ONZEALD in Models of Colorectal Cancer
On May 23, 2019, Trovagene announced that it had entered into a research collaboration to explore the combination of Trovagene’s PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of metastatic colorectal cancer (mCRC). Under the collaboration, the two companies will evaluate the antitumor activity and tolerability of the combination of onvansertib and ONZEALD in two (HT29 – BRAF mutant and HCT-116 – KRAS mutant) preclinical tumor models of colorectal cancer.

Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax Resistant AML
On April 23, 2019, Trovagene announced preclinical data that provides support for clinical evaluation of onvansertib in combination with venetoclax (Venclexta – AbbVie) in patients with difficult-to-treat relapsed or refractory acute myeloid leukemia (AML). Preclinical data showed that the combination demonstrated synergy (the combined effect of the two drugs is greater than the sum of their individual effects) with a significant decrease in tumor cell viability.

Announced Update to Phase 1b/2 AML Trial Data Presented at AACR (Free AACR Whitepaper) – Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib
On April 5, 2019, Trovagene announced updates to the Phase1b/2 AML trial data presented at the AACR (Free AACR Whitepaper) conference on April 1, 2019. Complete response (2 CRs and 1 CRi) to treatment with onvansertib in combination with decitabine was achieved in 3 of 6 (50%) evaluable patients at the highest doses (27mg/m2 and 40mg/m2). The first complete response was achieved at the highest dose of onvansertib (40mg/m2) in combination with low-dose cytarabine (LDAC). Overall, approximately a 90% clinical benefit rate has been achieved to-date in the trial and there have been no dose limiting toxicities observed. Dose escalation is continuing with enrollment in the onvansertib 60mg/m2 cohort.

Announced Early Data from Phase 2 Trial Indicates Activity of Onvansertib in Prostate Cancer Patients Showing Initial Resistance to Anti-Androgen Therapy
On April 2, 2019, Trovagene announced early data from its ongoing Phase 2 study evaluating onvansertib in combination with Zytiga in patients with mCRPC. Early prostate specific antigen ("PSA") response was observed when onvansertib is added to abiraterone (Zytiga) in 2 of 6 patients to-date; the first patient achieved the primary efficacy endpoint of disease stabilization. The PSA trajectory in the patient achieving the primary efficacy endpoint indicates alteration of the natural history of early signs of resistance to Zytiga. Patients with observed responses to-date harbor the highly aggressive androgen receptor variant (AR-V7) which is known to be resistant to treatment with Zytiga.

Announced Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and Relative Durability with Complete Responses at Highest Dose Levels
On April 1, 2019, Trovagene announced the presentation of new data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in AML. The greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 (1 CR and 1 CRi) of 4 (50%) evaluable patients from the two highest dose levels. There have been no dose-limiting toxicities observed to-date and two-thirds of patients have completed ≥2 cycles of treatment, with 2 patients currently on treatment for more than 11 and 5 months, respectively. There has been a significant association observed between biomarker-positive patients and response to onvansertib treatment.

Financial:

Announced Equity Investments of $3.0 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital
On April 5 and May 13, 2019, respectively, Trovagene announced that it has entered into definitive purchase agreements with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park agreed to purchase in a registered direct offering shares of common stock and pre-funded warrants at a premium to the closing sale price on April 5 and May 10, 2019, respectively, on the Nasdaq Capital Market. In a concurrent private placement, Lincoln Park agreed to purchase warrants to purchase shares of common stock.

Second Quarter 2019 Financial Results

Total operating expenses were approximately $4.4 million for the three months ended June 30, 2019, a decrease of $0.2 million from $4.6 million for the same period in 2018. The decrease in operating expenses is attributed to a reduction of $0.6 million in SG&A, $0.2 million for cost of revenues related to the disposition of the CLIA lab and $0.2 million restructuring, and partially offset by an increase of $0.9 million in R&D costs.

Net cash used in operating activities in the second quarter of 2019 was approximately $3.4 million, compared to $3.3 million in the same period in 2018. The year-over-year increase of $0.1 million can be attributed primarily to the development of onvansertib as we advance our clinical trials, and partially offset by lower salaries and staff costs.

Research and development expenses increased by approximately $0.9 million to $2.8 million for the three months ended June 30, 2019 from $1.9 million for the same period in 2018. The overall increase in research and development expenses was primarily due to the increased outside service costs for clinical studies related to the development of our drug candidate, onvansertib. We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.

Selling, general and administrative expenses decreased by approximately $0.6 million to $1.5 million for the three months ended June 30, 2019 from $2.1 million for the same period in 2018. The significant components of the decrease were primarily due to the reduction in salaries and staff costs and stock-based compensation.

The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2019 was 5.2 million shares.

As of June 30, 2019, Trovagene had approximately $10.8 million of cash and cash equivalents.

On August 8, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported financial results for the second quarter ended June 30, 2019 (Press release, Akebia, AUG 8, 2019, View Source [SID1234538410]). The Company will host a conference call today, Thursday, August 8, 2019, at 9:00 a.m. Eastern Time to discuss its second quarter 2019 financial results and recent business highlights.

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"Akebia continues to make great progress advancing our strategy. Fueled by strong operational execution, we increased Auryxia revenue by 21 percent compared to the same period last year and reinforced the strength of our Auryxia intellectual property with an important ANDA settlement. We also achieved significant milestones with our development program for vadadustat, including a JNDA submission that we believe may establish vadadustat as the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to file for regulatory approval for the treatment of anemia due to chronic kidney disease (CKD) in both dialysis dependent and non-dialysis dependent adult patients in a major market," stated John P. Butler, President and Chief Executive Officer of Akebia. "While there is still much work ahead of us, we remain confident and believe we have tremendous opportunities to advance our mission to better the lives of people with kidney disease and deliver significant value to all our stakeholders. We’ve been very purposeful in developing our strategy, and it’s great to see the benefits of our work coming to light as the team continues to systematically execute on our priorities."

Butler continued, "We’re excited by the opportunities to continue advancing Auryxia’s long-term growth story. The 26 percent sequential revenue growth we achieved over the first quarter demonstrates that the team is successfully executing against our near-term growth initiatives. The prescription demand that

we’ve seen in the first four weeks of the third quarter is the highest of any quarter since Auryxia was launched, affirming our confidence that Auryxia is on a solid growth trajectory. We believe continued progress on our growth initiatives and underlying market demand will drive increased revenue for Auryxia across the second half of the year."

Auryxia Highlights

Auryxia (ferric citrate) net product revenue increased 20.7 percent year-over-year to $29.1 million for the second quarter of 2019, and increased 26 percent when compared with the first quarter of 2019. Total Auryxia prescriptions increased 22 percent year-over-year to 49,200 in the second quarter of 2019.

In August, Akebia settled Auryxia patent litigation with Par Pharmaceutical, Inc. (Par), resolving patent litigation brought in response to an Abbreviated New Drug Application (ANDA) filing by Par. The settlement allows Par to market its generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

In July, Akebia’s collaboration partner, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., reported positive top-line results from their pivotal Phase 3 comparative study evaluating Riona Tablets (generic name in Japan: ferric citrate hydrate) for the treatment of iron deficiency anemia (IDA) in adult patients in Japan. They have stated that they expect to file an application for approval of IDA as an additional indication for Riona in Japan upon successful completion of their Phase 3 program.

Vadadustat Highlights

In July, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization collaboration partner in Japan for vadadustat, submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD. The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide. This JNDA submission triggered a $10 million milestone payment from MTPC to Akebia, which was received in August.

In April, Akebia completed enrollment in its global Phase 3 INNO2VATE studies evaluating the safety and efficacy of vadadustat in dialysis-dependent CKD subjects with anemia due to CKD. The Company continues to expect to report top-line data from both INNO2VATE studies in the second quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE).

Akebia expects enrollment in its global Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD to be completed in 2019. The Company continues to expect to report top-line results in mid-2020, subject to the accrual of MACE.

Financial Results

Total revenue for the second quarter of 2019 was $100.8 million, compared to $48.8 million in the second quarter of 2018.

Auryxia net product revenue for the second quarter of 2019 was $29.1 million, compared to $24.1 million, as reported by Keryx Biopharmaceuticals, Inc. (Keryx) prior to its merger with the Company, during the same period in 2018. This represents a 20.7 percent increase in net product revenue from the second quarter of 2018 and a 26 percent increase compared to the first quarter of 2019. Auryxia is the Company’s FDA approved oral iron tablet to treat non-dialysis dependent adult CKD patients for IDA and dialysis-dependent adult CKD patients for hyperphosphatemia.

Collaboration revenue for the second quarter of 2019 was $71.7 million, compared with $48.8 million in the second quarter of 2018. The increase was primarily due to increased collaboration revenue of $11.4 million from Otsuka Pharmaceutical Co. Ltd (Otsuka), and $10.0 million from MTPC in accordance with the Company’s collaboration agreements. Otsuka began funding 80 percent of the development costs for vadadustat in the second quarter of 2019.

Cost of goods sold was $37.7 million for the second quarter of 2019, consisting of $9.6 million of costs associated with the manufacture of Auryxia and non-cash charges of $28.1 million related to the application of purchase accounting as a result of the merger with Keryx. These non-cash, merger-related charges include a $19.0 million inventory step-up charge and $9.1 million of amortization of intangibles.

Research and development expenses were $85.7 million for the second quarter of 2019 compared to $71.9 million for the second quarter of 2018. The increase was primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE Phase 3 studies of vadadustat as well as increases in headcount to support our research and development programs.

Selling, general and administrative expenses were $36.1 million for the second quarter of 2019 compared to $12.5 million for the second quarter of 2018. The increase in selling, general and administrative expenses was primarily attributable to commercialization costs associated with Auryxia, as there were no comparable commercialization costs in the second quarter of 2018.

The Company reported a net loss for the second quarter of 2019 of $58.2 million, or ($0.49) per share, as compared to a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018. The Company’s net loss for the second quarter of 2019 includes the impact of non-cash charges of $28.1 million related to the application of purchase accounting as a result of the merger with Keryx.

The Company ended the quarter with cash, cash equivalents and available-for-sale securities of $136.8 million. "As we continue to effectively manage and leverage our operations, we expect our cash resources, including committed research and development funding from collaborators, to fund our current operating plan beyond the next twelve months, into the third quarter of 2020," stated Jason A. Amello, Chief Financial Officer of Akebia.

Conference Call

Akebia will host a conference call today, Thursday, August 8, 2019, at 9:00 a.m. Eastern Time to discuss its second quarter 2019 financial results and recent business updates. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 7274126. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through August 14, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 7274126. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On August 8, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2019 (Press release, Nektar Therapeutics, AUG 8, 2019, View Source [SID1234538426]).

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Cash and investments in marketable securities at June 30, 2019 were $1.8 billion as compared to $1.9 billion at December 31, 2018.

"Nektar is making good progress advancing our multiple programs in immuno-oncology, immunology and pain," said Howard W. Robin, President and CEO of Nektar. "With our partner Bristol-Myers Squibb, although we’ve experienced some delays, we are working to finalize the development program for bempegaldesleukin in combination with nivolumab in a number of tumor types and which are designed to support registration for this unique I-O doublet. We have a number of registrational trials already started and we recently received a breakthrough designation from FDA for bempeg and nivo in the setting of first-line untreated metastatic melanoma. Our partner Eli Lilly will be initiating several new studies later this year for NKTR-358, our T regulatory stimulator candidate. These studies will expand the program with additional indications beyond lupus. We recently filed an IND with the FDA for NKTR-255, our IL-15 agonist, and will initiate our first-in-human clinical study this quarter in patients with relapsed, refractory NHL and in patients with multiple myeloma."

Nektar is hosting a conference call with analysts and investors today on which it will discuss quarterly results. On the call, the company will provide a specific update and discussion on its bempegaldesleukin clinical development program, including recent developments related to the manufacturing of bempegaldesleukin.

Revenue in the second quarter of 2019 was $23.3 million as compared to $1.088 billion in the second quarter of 2018. Year-to-date revenue for 2019 was $51.5 million as compared to $1.126 billion in the first half of 2018. Revenue was lower in the second quarter and first half of 2019 as compared to the same periods in 2018 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.

Total operating costs and expenses in the second quarter of 2019 were $134.3 million as compared to $114.1 million in the second quarter of 2018. Total operating costs and expenses in the first half of 2019 were $283.2 million as compared to $238.9 million in the first half of 2018. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the second quarter of 2019 was $106.7 million as compared to $88.3 million in the second quarter of 2018. For the first half of 2019, R&D expense was $225.1 million as compared to $187.8 million in the first half of 2018. R&D expense was higher in the second quarter and first half of 2019 as compared to the same periods in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255. These increases were partially offset by cost decreases related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing which were higher during the second quarter and first half of 2018.

General and administrative (G&A) expense was $22.6 million in the second quarter of 2019 as compared to $20.3 million in the second quarter of 2018. G&A expense in the first half of 2019 was $47.6 million as compared to $38.9 million in the first half of 2018. G&A expense was higher in the second quarter and first half of 2019 as compared to the same periods in 2018 primarily due to costs related to commercialization readiness activities for NKTR-181 and increased non-cash stock-based compensation.

Net loss in the second quarter of 2019 was $109.9 million or $0.63 basic and diluted loss per share as compared to a net income of $971.5 million or $5.33 diluted earnings per share in the second quarter of 2018. Net loss in the first half of 2019 was $228.4 million or $1.31 basic and diluted loss per share as compared to a net income of $875.7 million or $4.91 diluted earnings per share in the first half of 2018.

Second Quarter 2019 and Recent Business Highlights

·In August, the FDA granted Breakthrough Therapy Designation for bempegaldesleukin in combination with Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
·In July, for NKTR-181, Nektar received a General Advice Letter from FDA that stated that it is postponing product-specific advisory committee meetings for opioid analgesics, including the one previously scheduled for August 21, 2019 to discuss the NDA for the NKTR-181 product, while the agency continues to consider a number of scientific and policy issues relating to this class of drugs. The FDA indicated that it will continue to review the NDA for NKTR-181 according to the existing Prescription Drug User Fee Act ("PDUFA") timeline; however, because of the postponed Advisory Committee Meeting, it is possible the agency may not be able to meet the PDUFA goal date of August 29, 2019.
·In June, Nektar presented data from a first-in-human Phase 1a study evaluating single-ascending doses of NKTR-358, supporting development of the candidate as a first-in-class T regulatory cell stimulator for the treatment of autoimmune and other chronic inflammatory conditions.
·In June, Nektar presented data for NKTR-181 at the 81st Annual Scientific Meeting of the College on Problems of Drug Dependence. The data presented identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in Phase 3 trials according to the MADDERS system, the first standardized system for discerning abuse-related events.

·In June, Nektar presented biomarker and clinical data from the ongoing Phase 2 PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. Clinical data presented included 12 month follow-up for the Stage 4 first-line melanoma patient cohort and showed a deepening and durability of response over time. Registrational studies in melanoma, renal cell carcinoma and urothelial cancer are currently recruiting patients.
· In May, Nektar announced formation of Inheris Biopharma, Inc., a wholly-owned subsidiary responsible for launch preparation and commercialization for NKTR-181, a novel, first-in-class, investigational opioid molecule. NKTR-181 is currently under review with the U.S. Food and Drug Administration (FDA).
The company also announced the following upcoming presentations during the second half of 2019:

CAR-TCR Summit, Boston, MA:

· Presentation: "Utilizing Next Generation Cytokines to Enhance Efficacy and Durability of CAR-Ts"
o Presenter: Mario Marcondes, M.D., Nektar Therapeutics
o Session: Enhancing Efficacy with Combinations
o Date and Time: September 11, 2019, 6:18 – 6:48 p.m. EDT
Oxford Global 2nd Annual Advances In Immuno-Oncology USA Congress, San Diego, CA:

· Presentation: "Harnessing Potent Cytokine Agonist Pathways by Polymer Engineering to Develop Novel Immune Therapeutic Agents"
o Presenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
o Date and Time:October 9, 2019, 12:00 – 12:30 p.m. PDT
American Conference on Pharmacometrics (ACoP) 2019, Orlando, FL:

· Poster Title: "NKTR-262 Released Below Quantifiable Levels of TLR 7/8 Agonist in Human Plasma in Phase 1b/2 Clinical Study as Predicted A-Priori by PK Modeling and Scaling to Humans", Bhasi, K., et al.
o Date: October 20 – 23, 2019
Conference Call to Discuss Second Quarter 2019 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Thursday, August 8, 2019.

This press release and a live Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, September 9, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 2879328 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On August 8, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, Sierra Oncology, AUG 8, 2019, View Source [SID1234538442]).

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"During the second quarter, we achieved major milestones in the development programs for our drug candidates. We reported Phase 3 regulatory clarity and the granting of Fast Track designation by the U.S. Food and Drug Administration (FDA) for our lead asset, momelotinib, and we reported proof-of-concept clinical data for our Chk1 inhibitor, SRA737, at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, suggesting that this drug candidate has a defined clinical path forward toward potential initial registration," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Our current focus is on preparing for the launch of the MOMENTUM Phase 3 clinical trial, expected in the fourth quarter of 2019, designed to support potential registration of momelotinib on a global basis. We also continue to develop the assets in our DDR portfolio, SRA737 and SRA141, and have previously announced we are conducting a campaign intended to seek non-dilutive strategic options to support their further advancement."

Second Quarter 2019 Highlights:

Momelotinib (targeting JAK1/JAK2/ACVR1):

During the second quarter, Sierra obtained regulatory clarity with the FDA concerning the design of a Phase 3 clinical trial for momelotinib intended to support its potential registration.
Sierra also announced the design of the MOMENTUM Phase 3 clinical trial, planned for launch in the fourth quarter of 2019. The randomized double-blind trial is designed to enroll 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). 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, has been named Chief Investigator of the MOMENTUM trial.
Sierra also reported 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.
DNA Damage Response (DDR) portfolio (SRA737 and SRA141):

At the 2019 ASCO (Free ASCO Whitepaper) Annual meeting, Sierra reported preliminary efficacy and safety data from two ongoing clinical trials evaluating SRA737 across multiple indications, as monotherapy and when potentiated by non-cytotoxic low-dose gemcitabine (LDG). SRA737 demonstrated notable anti-cancer activity in multiple indications including a 30% Overall Response Rate in evaluable patients with anogenital cancer treated with SRA737+LDG, an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, evaluable RAS wild-type subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes across multiple indications, with an Overall Response Rate of 25%.
During the second quarter, Sierra announced plans to prioritize its resources on the development of momelotinib and that it has launched a campaign exploring non-dilutive strategic options to support the future continued development of its portfolio of DDR assets.
Second Quarter 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $11.7 million for the three months ended June 30, 2019, compared to $8.8 million for the three months ended June 30, 2018. The increase was primarily due to momelotinib related costs, including a $3.1 million increase in clinical trial and development related costs and a $1.2 million increase in third-party manufacturing costs, and a $1.1 million increase in personnel-related and allocated overhead costs. These increases were partially offset by decreases in SRA737 and SRA141 costs, including a $1.3 million decrease in third-party manufacturing costs, a $0.7 million decrease in clinical trial costs primarily related to SRA737, and a $0.5 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $1.2 million for the three months ended June 30, 2019 and 2018.

Research and development expenses were $21.9 million for the six months ended June 30, 2019, compared to $17.1 million for the six months ended June 30, 2018. The increase was primarily due to momelotinib related costs, including a $4.4 million increase in clinical trial and development costs and a $1.3 million increase in third-party manufacturing costs, and a $2.4 million increase in personnel-related and allocated overhead costs. These increases were partially offset by decreases in SRA737 and SRA141 costs, including a $2.2 million decrease in third-party manufacturing costs and a $1.2 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $2.4 million and $2.2 million for the six months ended June 30, 2019 and 2018, respectively.

General and administrative expenses were $3.5 million for the three months ended June 30, 2019, compared to $4.2 million for the three months ended June 30, 2018. This decrease was primarily due to decreases in professional fees of $0.4 million and personnel-related and allocated overhead costs of $0.3 million. General and administrative expenses included non-cash stock-based compensation of $0.5 million and $0.6 million for the three months ended June 30, 2019 and 2018, respectively.

General and administrative expenses were $6.8 million for the six months ended June 30, 2019, compared to $7.6 million for the six months ended June 30, 2018. This decrease was primarily due to decreases in professional fees of $0.5 million and personnel-related and allocated overhead costs of $0.3 million. General and administrative expenses included non-cash stock-based compensation of $1.0 million and $1.1 million for the six months ended June 30, 2019 and 2018.

For the three months ended June 30, 2019, Sierra incurred a net loss of $14.9 million compared to a net loss of $12.0 million for the three months ended June 30, 2018. For the six months ended June 30, 2019, Sierra incurred a net loss of $27.9 million compared to a net loss of $23.5 million for the six months ended June 30, 2018.

Cash and cash equivalents totaled $78.8 million as of June 30, 2019, compared to $106.0 million as of December 31, 2018. At June 30, 2019, there were 74,688,283 shares of common stock issued and outstanding, an additional 13,335,583 issuable upon exercise of stock options and warrants, and a term loan of $5.0 million.

Equity Inducement Plan

On August 5, 2019, the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 112,000 shares of its common stock to two new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $0.49 per share, which is equal to the closing price of Sierra’s common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

On August 8, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the quarter ended June 30, 2019 and provided a corporate update (Press release, Gossamer Bio, AUG 8, 2019, View Source [SID1234538460]).

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"Over the last several months, we have made significant progress advancing our diversified development portfolio, with five clinical trials now active," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We are poised for a steady cadence of data readouts throughout 2020. Supported by a strong balance sheet and our experienced and growing team, we are well positioned to advance toward our goal of becoming an industry leader in immunology, inflammation and oncology."

Pipeline Updates

GB001: Oral DP2 Antagonist for Asthma and Allergic Disease

Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma is on track, with an interim analysis expected in the first half of 2020. Full results from the LEDA study are expected in the second half of 2020.
Patient enrollment in the TITAN Phase 2 proof-of-concept study in chronic rhinosinusitis, with and without nasal polyps, commenced in the second quarter. Topline data from the TITAN study are expected in the second half of 2020.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

During the second quarter, the European Medicines Agency granted orphan medicinal product designation to GB002 for the treatment of PAH.
Sites have been initiated for a Phase 1b translational study in patients with PAH, with patient enrollment expected to begin in the third quarter. Results from the Phase 1b study are expected in the first half of 2020.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Patient enrollment in a Phase 1b study of active mild-to-moderate ulcerative colitis (UC) began during the second quarter, and the Company expects topline results from the study in the first half of 2020.
GB1275: Oral CD11b Modulator for Oncology Indications

Patient screening in a Phase 1/2 study in selected solid tumors is now underway, with patient enrollment expected to begin in the third quarter of 2019. Following monotherapy dose escalation, we will explore combinations with anti-PD-1 therapy and chemotherapy. Initial data from the Phase 1/2 study is expected in the second half of 2020.
Preclinical data supporting GB1275 were published in the July 3, 2019 edition of Science Translational Medicine by researchers at the Washington University School of Medicine in St. Louis and Rush University.
Financial Results for Quarter Ended June 30, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2019, were $464.0 million. The Company expects current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2021.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2019, R&D expenses were $35.7 million, including $2.5 million of stock-based compensation, compared to R&D expenses of $7.9 million for the quarter ended June 30, 2018. The increase was primarily due to costs related to the research and development of GB001, GB002, GB004 and GB1275.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended June 30, 2019, IPR&D expenses were $1.0 million, compared to $20.5 million for the quarter ended June 30, 2018, which included $20.0 million associated with the in-license of GB004.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2019, G&A expenses were $9.7 million, which included $2.7 million of stock-based compensation. This compared to G&A expenses of $4.6 million for the quarter ended June 30, 2018, which included $1.3 million of stock-based compensation. The increase was primarily attributable to personnel-related expenses, professional and legal fees, and stock-based compensation.
Net Loss: For the quarter ended June 30, 2019, net loss was $44.5 million, or a loss of $0.74 per share.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, Aug. 8, 2019, to discuss its second quarter 2019 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 1393207
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.