On January 15, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate restructuring to focus resources on its development pipeline, comprising five clinical-stage cancer programs in various solid tumor types and addressing multiple cell types in the tumor microenvironment (Press release, Five Prime Therapeutics, JAN 15, 2019, View Source [SID1234532659]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

"While we are on track for multiple data read-outs and potential phase advances from our pipeline in 2019, the Executive Team and Board felt it was necessary to sharpen our focus on our current clinical programs and the advancement of our later-stage research initiatives," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "This was a hard decision to make, but we believe that effective use of capital is crucial to supporting our strong pipeline of anti-cancer drug candidates. We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known."

The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount. The positions eliminated are primarily in areas relating to research, pathology and manufacturing. The company expects that the restructuring and other cost-saving efforts will result in a $10 million reduction in net cash used for operating activities during fiscal year 2019 as compared to 2018, with additional expected savings in 2020 and beyond due to lower ongoing personnel expense. Five Prime estimates that it will incur approximately $2 million of pre-tax charges for severance and other costs related to the restructuring, primarily during the first quarter of 2019.

The company’s financial guidance that it anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities reflects the expected reduction in the company’s operating expenses due to the elimination of positions. The company has no debt and ended 2018 with $270 million in cash, cash equivalents and marketable securities and believes this cash is sufficient to fund programs through multiple data readouts.

On January 15, 2019 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for fourth quarter and fiscal year 2018 following the close of market on Tuesday, January 29, 2019 (Press release, Illumina, JAN 15, 2019, View Source [SID1234532660]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 29, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (800) 708-4539, or 1 (847) 619-6396 outside North America, both with passcode 47970793.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On January 15, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate restructuring to focus resources on its development pipeline, comprising five clinical-stage cancer programs in various solid tumor types and addressing multiple cell types in the tumor microenvironment (Press release, Five Prime Therapeutics, JAN 15, 2019, View Source [SID1234532678]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

"While we are on track for multiple data read-outs and potential phase advances from our pipeline in 2019, the Executive Team and Board felt it was necessary to sharpen our focus on our current clinical programs and the advancement of our later-stage research initiatives," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "This was a hard decision to make, but we believe that effective use of capital is crucial to supporting our strong pipeline of anti-cancer drug candidates. We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known."

The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount. The positions eliminated are primarily in areas relating to research, pathology and manufacturing. The company expects that the restructuring and other cost-saving efforts will result in a $10 million reduction in net cash used for operating activities during fiscal year 2019 as compared to 2018, with additional expected savings in 2020 and beyond due to lower ongoing personnel expense. Five Prime estimates that it will incur approximately $2 million of pre-tax charges for severance and other costs related to the restructuring, primarily during the first quarter of 2019.

The company’s financial guidance that it anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities reflects the expected reduction in the company’s operating expenses due to the elimination of positions. The company has no debt and ended 2018 with $270 million in cash, cash equivalents and marketable securities and believes this cash is sufficient to fund programs through multiple data readouts.

On January 15, 2019, Stemline Therapeutics, Inc. ("Stemline" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, 8-K, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532699]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 8,888,889 shares (the "Firm Shares") of the Company’s common stock, $.0001 par value per share ("Common Stock"), at a price to the public of $9.00 per share, less underwriting discounts and commissions. Due to demand, this offering was upsized from the previously announced 6,600,000 shares. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,333,333 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on January 18, 2019, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The net proceeds to the Company are expected to be approximately $80,000,000, assuming no exercise of the option to purchase Additional Shares and after deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

On January 15, 2019 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Medicines Agency (EMA) has validated a type II variation application to add efficacy data to the Apealea product information (Press release, Oasmia, JAN 15, 2019, View Source [SID1234556566]). Validation of the application confirms that the submission is complete and that the EMA assessment process begins. Based on the EMAs procedural timelines, Oasmia anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of Q1 or beginning of Q2 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

The application is based on subpopulation data (n=599) from the OAS-07OVA study and aims to provide treating physicians with efficacy data for Apealea in combination with carboplatin for the approved indication; adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The current efficacy data describes the population in OAS-07OVA that also included patients with several disease relapses (n=789).

About the subpopulation analysis submitted as a type II variation:

The marketing authorisation approval for Apealea in the EEA was based on study OAS 07OVA conducted on 789 randomized patients with disease relapse. The results of the subpopulation analysis of patients experiencing their first relapse were based on 301 patients (Apealea arm) and 298 patients (Comparator arm) being part of the OAS-07OVA study. The results show that there is a statistically significant advantage for Apealea with regards to progression-free survival.

Key efficacy results in patients with their first relapse in the intention-to-treat population from the pivotal randomized clinical trial OAS-07OVA

Progression-free survival (PFS)
(N=301) Overall survival (OS)
(N=298)
Hazard ratio, HR1
(95% CI) 0.80
(0.66-0.97) 0.98
(0.79-1.21)

Apealea2 CrEL-paclitaxel2 Apealea2 CrEL-paclitaxel2
Median, months
(95% CI) 10.3
(10.1-11.1) 10.0
(9.6-10.2) 24.7
(21.9-28.0) 23.4
(20.5-26.7)
1A longer PFS or OS for Apealea compared to Cremophor-EL (CrEL)-formulated paclitaxel is indicated by a HR less than 1.0.
2In combination with carboplatin.

About epithelial ovarian cancer

Ovarian cancer is the seventh most common cancer in women. Approximately 239,000 women are annually diagnosed with ovarian cancer globally and 152,000 dies from the disease. Epithelial ovarian cancer is the most common form and accounts for about 90% of ovarian cancers. The disease is often diagnosed at an advanced staged since it has no symptoms at early stages. The five-year survival rate (i.e. survival of patients with ovarian cancer compared to survival in the general population at the same age) for ovarian cancer has been estimated to 38% in Europe. During 2018, approximately 68,000 women will be diagnosed with ovarian cancer in Europe and 45,000 are predicted to die from the disease. Carboplatin and paclitaxel are common chemotherapy drugs for treatment of ovarian cancer and are often used in combination.

About Apealea

Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion.