On November 8, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported financial results and business highlights for the third quarter ended September 30, 2018 (Press release, Magenta Therapeutics, NOV 8, 2018, View Source [SID1234531017]).

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!

"Over the third quarter of 2018, Magenta has continued its progress across the portfolio and remains well funded and on track for our 2020 vision of three programs moving forward in the clinic in multiple indications," said Jason Gardner, D.Phil., chief executive officer and president, Magenta Therapeutics. "We look forward to sharing important data updates on our stem cell expansion, mobilization and targeted conditioning programs at ASH (Free ASH Whitepaper) this year as we work to build a fully integrated company with the singular goal of allowing more patients to receive curative cell therapies."

Recent Business Highlights:

Nine Clinical and Preclinical Abstracts Accepted for Presentation at the ASH (Free ASH Whitepaper) Annual Meeting: Magenta announced on November 1st, 2018 that nine abstracts from the Company and its collaborators were accepted for presentation at the ASH (Free ASH Whitepaper) annual meeting in December 2018. The abstracts cover the breadth of Magenta’s integrated portfolio of programs and include preliminary clinical data from the Company’s Phase 2 study of cell therapy MGTA-456 in patients with inherited metabolic disorders.

Continued to Strengthen Robust Intellectual Property Position: Magenta’s first U.S. patent, directed to dosage regimens of mobilization therapy MGTA-145 and plerixafor, was issued in August 2018. The Company’s second U.S. patent was issued for the C200 conditioning program in October 2018, with claims directed to methods of treatment using an anti-CD117-amatoxin antibody-drug conjugate (ADC). For the C100 targeted patient preparation program, an Australian patent application was allowed with claims directed to methods of treatment using an anti-CD45-amatoxin ADC.

Financial Results:

Cash Position: Cash and cash equivalents as of September 30, 2018, were $159.7 million compared to $51.4 million on December 31, 2017. The increase is primarily driven by net proceeds from the $52.2 million Series C preferred stock financing completed in April 2018, and net proceeds of $89.9 million from Magenta’s IPO completed in June 2018. Magenta anticipates that its cash and cash equivalents will be sufficient to fund operations and capital expenditures through at least the first quarter of 2020 on the Company’s current business plan.

Research and Development Expenses: Research and development (R&D) expenses were $11.4 million in the third quarter of 2018, compared to $5.2 million for the same period in 2017. The increase was largely due to increased preclinical costs, toxicology studies and manufacturing to support our mobilization program, the advancement of the MGTA-456 Phase 2 clinical trial, continued progression of the Company’s pipeline and increased costs associated with the growth of the Company.

General and Administrative Expenses: General and administrative (G&A) expenses were $5.3 million for the third quarter of 2018, compared to $1.8 million for the same period in 2017. The increase was largely due to increased G&A personnel and facility costs associated with the growth of the Company.

Net Loss: Net loss was $16 million for the third quarter of 2018, compared to net loss of $6.9 million for the same period in 2017

On November 8, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that members of its management team are scheduled to present at the following healthcare conferences (Press release, Pacira Pharmaceuticals, AUG 8, 2018, View Source;p=irol-newsArticle&ID=2376187 [SID1234531035]):

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!

Jefferies 2018 Healthcare Conference in London, on Wednesday, November 14, 2018 at 2:40 PM GMT (9:40 AM ET)
Piper Jaffray 30th Annual Healthcare Conference in New York, on Tuesday, November 27, 2018 at 12:30 PM ET
A live audio webcast of the Pacira presentations can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcasts will be archived on the Pacira website for two weeks following the presentation dates.

On November 8, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will webcast a business overview and update by Bob Azelby, Alder’s president and chief executive officer, at each of the following upcoming healthcare conferences (Press release, Alder Biopharmaceuticals, NOV 8, 2018, View Source [SID1234531052]):

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!

Credit Suisse 27th Annual Healthcare Conference at 4:00 p.m. MT on Wednesday, November 14, 2018 in Scottsdale, AZ.
Piper Jaffray 30th Annual Healthcare Conference at 12:00 p.m. ET on Wednesday, November 28, 2018 in New York, NY.
A live audio webcast of each event can be accessed on the Events & Presentations page of the Investors section of Alder’s website at View Source, or by following the link below in your web browser. An archived replay of the webcast will be available on Alder’s website for at least 30 days after each live event concludes.

On November 8, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported that it has set key dates and pricing structure for its previously announced rights offering of $45,000,000 of its common stock (Press release, Pulse Biosciences, NOV 8, 2018, View Source [SID1234531168]).

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!

Pulse Biosciences intends to issue non-transferable subscription rights to purchase shares of its common stock to common stockholders as of 5:00 p.m. Eastern Time on Monday November 19, 2018 (the "Record Date"). Any person who purchases shares prior to the Record Date will be deemed a holder of record with respect to those shares only if the transaction has settled by the Record Date. The standard settlement cycle in the United States is currently the trade date plus two business days. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer to ensure the settlement of transactions prior to the Record Date.

Following the Record Date, the Company intends to mail to stockholders of record on the Record Date a prospectus and related documents for use in exercising subscription rights. The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on Thursday December 6, 2018 (the "Expiration Date").

Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase up to $45,000,000 of shares of its common stock at a subscription price per share equal to the lesser of (i) $13.33 per share, the closing price on November 7, 2018 (the "Initial Price") or (ii) the volume weighted average price (the "Alternate Price") of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Stockholders wishing to exercise subscription rights must timely pay $13.33 per share, the Initial Price, for the number of shares of common stock they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional shares in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional shares that are not purchased by other stockholders, on a pro rata basis and subject to availability and ownership limitations.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in offering documents. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information and subscription agent for the rights offering, after the Record Date by calling (888) 789-8409 (toll-free) or by emailing [email protected].

On November 8, 2018 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2018 financial results (Press release, Constellation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531184]).

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!

"We are excited about the progress we have made this year with our clinical programs and our entire epigenetics platform," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "In 2019, we look forward to further progress in our pipeline, as we expect to evaluate proof of concept for both our ProSTAR and MANIFEST clinical trials in mid-2019 as well as initiate clinical development of our second-generation EZH2 inhibitor CPI-0209."

Recent News

Continued enrollment in ProSTAR Phase 1b/2 study of CPI-1205 in metastatic castration-resistant prostate cancer (mCRPC). As planned, 34 sites are activated and enrolling patients in each of the two cohorts of the Phase 1b portion of the study. The Company expects to determine a recommended Phase 2 dose and begin the randomized portion of the trial in the fourth quarter of 2018.

Enhanced and expanded the Phase 2 portion of the ongoing MANIFEST study of CPI-0610 in myelofibrosis (MF). Constellation modified the MANIFEST trial design to stratify for transfusion-dependent status in second-line treatment and to initiate a first-line treatment arm in combination with ruxolitinib in JAK 1/2-inhibitor-naïve patients with MF. These changes are intended to provide additional measures of potential clinical activity and to expand the potential addressable population of MF patients for CPI-0610, thereby enabling multiple potential paths to registration. More than a dozen sites are now open for MANIFEST in the US, Canada, and Europe, with more sites expected to open in the next few months. Preliminary data in this trial as of May 25 included evidence of reductions in spleen volume, improvements in symptom scores, and increased hemoglobin levels, as well as one case of a transfusion-dependent patient achieving transfusion independence.

Announced Fast Track designation for CPI-0610 for the treatment of MF. The FDA awarded CPI-0610 Fast Track status based on preliminary results from the Phase 2 MANIFEST study. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.

Expanded Board of Directors with experts in mCRPC and MF. Constellation announced the appointments of Dr. Elizabeth G. Tréhu and Steven L. Hoerter to its Board of Directors, bringing considerable experience working in the disease areas of mCRPC and MF.

Presenting preclinical data from EZH2 franchise in prostate cancer. Constellation will be presenting data at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13-16 in Dublin, Ireland, and at the AACR (Free AACR Whitepaper)-KCA Joint Conference on Precision Medicine in Solid Tumors on November 15-17 in Seoul, South Korea.
Third Quarter 2018 Financial Results

Cash and cash equivalents as of September 30, 2018 grew 45% to $128.5 million compared to June 30, 2018, primarily due to capital raised in the initial public offering in July, partially offset by operating expenses.

Research and development (R&D) expenses increased 66% year over year to $12.7 million in the third quarter of 2018 mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 86% year over year to $3.7 million in the third quarter of 2018, primarily due to costs related to building out the organization as the Company evolved from a preclinical-stage company to a multi-candidate clinical-stage company, as well as costs associated with operating as a public company.

The net loss attributable to common stockholders increased 9% year over year to $15.9 million mainly due to increases in G&A and R&D expenses, partly offset by the inclusion of unpaid cumulative dividends in 2017 that were waived in 2018. The net loss per share attributable to common stockholders decreased 95% to $0.81 per share for the third quarter of 2018 due to an increase in shares outstanding as a result of the initial public offering and conversion of the preferred stock to common stock.
Financial Guidance

We expect that cash as of September 30, 2018, will fund planned operations into the first quarter of 2020.

Anticipated Milestones

The Company continues to anticipate achieving the following milestones during the upcoming twelve months:

Fourth Quarter 2018

Initiate the Phase 2 portion of the ProSTAR study with CPI-1205
Early 2019

Determine safety and the recommended Phase 2 dose in the ORIOn-E trial for CPI-1205 in combination with checkpoint inhibitors in solid tumors
Mid 2019

Initiate the Phase 1 trial with CPI-0209, a second-generation EZH2 inhibitor
Evaluate proof of concept for CPI-1205 in the ProSTAR trial
Evaluate proof of concept for CPI-0610 in the MANIFEST trial
Financial Results (Unaudited)

Constellation Pharmaceuticals, Inc.
Statements of operations and comprehensive loss (unaudited)