On November 5, 2018 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the quarter ended September 30, 2018 (Press release, Sunesis, NOV 5, 2018, View Source [SID1234530858]). Loss from operations for the three and nine months ended September 30, 2018 was $6.3 million and $20.0 million. As of September 30, 2018, cash and cash equivalents totaled $20.2 million. This capital is expected to fund the company into the second quarter of 2019.

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"We remain focused on advancing our non-covalent BTK inhibitor vecabrutinib to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "We continue to learn more about this unique asset and its market opportunity and will share an update at the ASH (Free ASH Whitepaper) Annual Meeting in December. As announced last week, one of our accepted abstracts for presentation at ASH (Free ASH Whitepaper) includes an update on the Phase 1b/2 trial of vecabrutinib, and as presented in the published abstract, the pharmacokinetic profile is consistent with the results from our Phase 1a study. We continue to believe that 100mg to 300mg will be the potentially active dose levels. Thus far, vecabrutinib appears well tolerated in the context of advanced disease. We continue with the dose escalation part of the trial and look forward to sharing a complete clinical update at the meeting next month and at a company-sponsored webcast event concurrent with the meeting."

Recent Highlights

Announced Presentations at ASH (Free ASH Whitepaper) Annual Meeting. In November 2018, the Company announced that three presentations will be made at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego, California. Among the abstracts is an update on the Phase 1b/2 trial of vecabrutinib, titled "Preliminary Safety, Pharmacokinetic, and Pharmacodynamic Results from a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s Tyrosine Kinase Inhibitor (BTKi), Vecabrutinib, in B-Lymphoid Malignancies," (Publication 3141) which will be presented on Sunday, December 2, in a session titled "CLL: Therapy, excluding Transplantation: Poster II," (Session 642) from 6:00-8:00pm at the San Diego Convention Center, Hall GH. The other poster, titled "Vecabrutinib Is Efficacious In Vivo in a Preclinical CLL Adoptive Transfer Model" will be presented on Saturday, December 1, and an oral presentation "High Prevalence of BTK Mutations on Ibrutinib Therapy after 3 Years of Treatment in a Real-Life Cohort of CLL Patients: A Study from the French Innovative Leukemia Organization (FILO) Group" will be presented in sessions on Monday, December 3. The posters will be available on the Sunesis website following the presentations.

Expanded Clinical Trial Sites. In the third quarter, we added three additional clinical sites to our Phase 1b/2 trial: Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center and University California San Diego. We continue to identify and prepare for adding additional sites as we continue dose escalation and prepare for the Phase 2 expansion portion of the study.

Financial Highlights

Cash and cash equivalents totaled $20.2 million as of September 30, 2018, as compared to $31.8 million in cash, cash equivalents, and marketable securities as of December 31, 2017. This capital is expected to fund the company into the second quarter of 2019. The nine-month decrease of $11.6 million was primarily due to $17.9 million of net cash used in operating activities, partially offset by $6.3 million in net cash flows from financing activities.

Research and development expense was $3.6 million and $11.3 million for the three and nine months ended September 30, 2018, as compared to $6.8 million and $17.9 million for the same periods in 2017, primarily relating to the vecabrutinib and the vosaroxin development program in each period. The decreases of $3.2 million and $6.6 million between the comparable periods from last year was primarily due to a $2.5 million milestone payment made during the third quarter of 2017 to Biogen under the license agreement, a decrease in salary and personnel expenses, a decrease in professional services, and clinical trial expenses related to higher expenses incurred in 2017 due to the MAA with the EMA.

General and administrative expense was $2.7 million and $8.9 million for the three and nine months ended September 30, 2018, as compared to $3.2 million and $10.8 million for the same periods in 2017. The decreases of $0.5 million and $1.9 million between the comparable periods in 2017 were primarily due to reduced professional services, personnel, and commercial expenses.

Interest expense was $0.3 million and $0.9 million for the three and nine months ended September 30, 2018, as compared to $0.3 million and $1.1 million for the same periods in 2017. The decrease during the nine months period was primarily due to the decrease in the outstanding notes payable.

Cash used in operating activities was $17.9 million for the nine months ended September 30, 2018, as compared to $30.8 million for the same period in 2017. Net cash used in the 2018 periods resulted primarily from the net loss of $20.6 million, partly offset by net adjustments for non-cash items of $2.3 million and changes in operating assets and liabilities of $0.4 million. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, partly offset by net adjustments for non-cash items of $2.6 million.

Loss from operations was $6.3 million and $20.0 million for the three and nine months ended September 30, 2018, as compared to $9.9 million and $28.0 million for the

On November 5, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the third quarter ended September 30, 2018 (Press release, Alder Biopharmaceuticals, NOV 5, 2018, View Source [SID1234530734]).

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"We are pleased to have recently announced the positive results from our pharmacokinetic (PK) comparability study for eptinezumab as we are now in the final stages of compiling the integrated data package for our BLA submission, which continues to be on track for the first quarter of 2019," said Bob Azelby, president and chief executive officer of Alder. "Market research and positive physician feedback have reinforced our confidence in eptinezumab’s encouraging clinical profile, and we believe we are well-positioned to maximize eptinezumab’s potential to treat highly impacted migraine patients."

Recent Company Highlights

Announced positive results from a PK study intended to support the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability. Further, the test and reference products were well-tolerated with a similar adverse event profile, and this safety profile was consistent with what has previously been reported for eptinezumab.

Remains on track to complete a robust and integrated BLA submission in the first quarter of 2019, including chemistry, manufacturing, and controls (CMC) processes, positive results from the comparative PK study and data from eptinezumab’s PROMISE 1 and PROMISE 2 pivotal Phase 3 clinical trials, as well as the long-term safety study.

Continued to conduct commercial readiness activities, including expanding the Company’s Medical Science Liaison team; recruiting commercial personnel; and building its reimbursement and distribution services in anticipation of eptinezumab’s potential launch in the first quarter of 2020.

Third Quarter 2018 Financial Results

As of September 30, 2018, Alder had $484.7 million in cash, cash equivalents, investments and restricted cash compared to $536.1 million as of June 30, 2018.

Research and development expenses for the third quarter ended September 30, 2018 totaled $47.8 million, compared to $52.2 million for the same period in 2017. The decrease in expenses was primarily due to lower eptinezumab clinical trial expense as the Company nears completion of patient treatments for several clinical trials, offset by an increase in manufacturing activities and consulting fees to support the planned BLA submission and the production of commercial supply.

General and administrative expenses for the third quarter ended September 30, 2018 totaled $10.7 million, compared to $8.2 million for the same period in 2017. The increase in spending was primarily due to headcount growth and expenses to support commercial readiness activities.

Net loss applicable to common stockholders for the third quarter ended September 30, 2018 totaled $62.2 million, or $0.91 per share, compared to net loss of $59.6 million, or $0.92 per share on a fully-diluted basis, for the same period in 2017.

Financial Outlook

Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 9574606. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.

On November 5, 2018 Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms, reported that third quarter 2018 financial results will be released on Thursday, November 8, 2018 before the market opens (Press release, Cambrex, NOV 5, 2018, View Source [SID1234530775]).

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The Company will host a conference call to discuss the financial results.

Third Quarter 2018 Earnings Conference Call
When: Thursday, November 8, 2018 at 8:30 a.m. Eastern Time
Dial-in: 1-877-830-2649 for U.S.
+1-785-424-1824 for International
Passcode: 3109072
Dial-in Replay: 1-888-203-1112 for U.S.
+1-719-457-0820 for International
Passcode: 3109072
Available through Thursday, November 15, 2018
Webcast: www.cambrex.com

On November 5, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for PD-0325901, an investigational, oral, small molecule selective inhibitor of MEK1 and MEK2, for the treatment neurofibromatosis type 1 (Press release, SpringWorks Therapeutics, NOV 5, 2018, View Source [SID1234538852]).

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Neurofibromatosis type 1, or NF1, is a rare genetic disorder that is caused by mutations in the NF1 gene, and that affects both children and adults. NF1 mutations can result in a loss of activity in the protein neurofibromin, which can lead to MAPK pathway overactivation, uncontrolled cellular growth, and tumor formation.1 NF1 is a heterogeneous condition that frequently causes plexiform neurofibromas, which are painful, disfiguring tumors of the peripheral nervous system. It is estimated that there are approximately 100,000 patients in the United States living with NF1. 2

"There is an urgent need for an effective treatment for patients with NF1. We are pleased that the FDA has granted Orphan Drug designation for our MEK inhibitor, recognizing its potential to improve the outlook for patients and families facing NF1," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to working closely with the FDA as we prepare to initiate a Phase 2b study of PD-0325901 in patients with NF1-associated plexiform neurofibromas, a severe form of NF1 that causes tumors to grow on nerves throughout the body, which can cause severe pain, disfigurement, loss of range of motion, and shortened lifespan."

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to drugs and biologic products that are intended for treatment of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug status is intended to facilitate drug development for rare diseases and may provide certain benefits and incentives to drug developers, including seven years of market exclusivity if the drug is approved, FDA assistance in clinical trial design, and tax credits for qualified clinical trial costs. 3

SpringWorks expects to initiate a Phase 2b single-arm, open-label study of PD-0325901 in patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-associated PN) in the first half of 2019.

About Neurofibromatosis Type 1
Neurofibromatosis type 1, or NF1, is a rare genetic disorder that is caused by mutations in the NF1 gene, and that affects both children and adults. Throughout their lifetime, about 30 to 50 percent of NF1 patients progress to a more severe form of the disease that results in the development of plexiform neurofibromas (PN), which are progressive peripheral nerve sheath tumors that cause severe pain, morbidity, and can significantly shorten lifespan.4-6 The clinical course of NF1-associated PN is heterogeneous with varying manifestations and severity across patients.

It is estimated that NF1 affects 1 in 3,000 individuals worldwide, and that there are approximately 100,000 patients in the United States living with this disease.2 Most patients with NF1-associated PN are treated with surgical removal of the tumors, sometimes requiring amputation; however, surgery has variable success rates and a high rate of recurrence has been observed because of the aggressive nature of these tumors.7 There are no therapies currently approved for the treatment of NF1-associated PN.

About PD-0325901
PD-0325901 is an investigational, oral, small molecule, selective inhibitor of MEK1 and MEK2, proteins that play key roles in the MAPK pathway. The MAPK pathway is critical for cell survival and proliferation, and overactivation of this pathway has been shown to help enable tumor growth. By blocking activity of the MAPK pathway, PD-0325901 may help arrest uncontrolled cellular growth associated with many types of tumors.

PD-0325901 has been tested in several Phase 1 and Phase 2 clinical trials, and approximately 260 subjects have been exposed to treatment. SpringWorks is evaluating PD-0325901 as a monotherapy for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-associated PN). In addition, given the critical role that the MAPK pathway plays in the growth and proliferation of a large number of tumor types, SpringWorks is also pursuing PD-0325901 in combination with other rational anticancer agents across a range of solid tumors.

On November 5, 2018 South Korean pharmaceutical company Yuhan reported that it has signed a licensing and cooperation agreement valued at up to $1.25bn with Janssen Biotech to out-license a lung cancer drug candidate called Lazertinib (Press release, Genosco, NOV 5, 2018, View Source [SID1234530717]).

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The new clinical-stage therapeutic is an oral, mutant-selective, irreversible, third generation EGFR tyrosine-kinase inhibitor. It is intended for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations.

Under the terms of the agreement, Janssen will pay $50m upfront to Yuhan, which is also eligible for up to $1.205bn in potential development and commercial milestones.

Yuhan may also receive additional tiered double-digit royalties on net sales in the future.

As part of the collaboration, Janssen will develop, manufacture and commercialise Lazertinib. The deal provides the company with exclusive global rights to the drug candidate, excluding Korea, where Yuhan will retain licensing rights.

The companies will partner on global clinical trials, which are expected to commence next year, to assess Lazertinib as monotherapy and combination therapy.

Yuhan president and CEO Lee Jung-hee was quoted by koreaherald.com as saying: "Yuhan is committed to developing Lazertinib as an effective treatment option for patients suffering from NSCLC.

"Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission."
"And Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission. We are excited to start this collaboration and dive into advancing this treatment regimen with a focus on improving the lives of people who suffer from lung cancer."

Currently, Lazertinib is being investigated in Phase I and II trials in Korea. It is said to have demonstrated favourable disease activity in NSCLC patients with acquired resistance to EGFR-TKIs, with or without brain metastasis.

The drug candidate was also found to be well-tolerated with low Grade 3 or higher adverse events rates.