On November 14, 2019 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported financial results for the three and nine months ended September 30, 2019 and provided a corporate update (Press release, Aprea, NOV 14, 2019, View Source [SID1234551292]).

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Third quarter 2019 Corporate Update:

APR-246 Update

Earlier this month, the Company announced that it will present updated data from two Phase 1b/2 clinical studies at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) on December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim results from the French Phase 1b/2 trial of the Company’s lead product candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations at ASH (Free ASH Whitepaper). The titles of the oral presentations are:

· "Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)"; and

· "APR-246 combined with Azacitidine (AZA) in TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A phase 2 study by Groupe Francophone des Myélodysplasies (GFM)"

The Company will host a Clinical Update Meeting and Webcast on December 9, 2019 at 12:00 PM ET. This Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the Company’s website at View Source

Initial Public Offering

On October 7, 2019, Aprea completed its initial public offering (IPO) of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which included the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. The Company received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.

Third Quarter Financial Results

·Cash and cash equivalents: As of September 30, 2019, prior to completing its IPO on October 7, 2019, Aprea had $52.3 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018. In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in gross proceeds of approximately $97.75 million. The Company believes its cash and cash equivalents as of September 30, 2019 along with the proceeds received from its initial public offering will be sufficient to meet its current projected operating requirements into 2023.

·Research and Development (R&D) expenses: R&D expenses were $4.9 million for the quarter ended September 30, 2019, compared to $2.3 million for the comparable period in 2018. The increase in R&D expenses was primarily related to the advancement of the Company’s lead product candidate, APR-246. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of APR-246 with azacitidine for frontline treatment of TP53 mutant MDS which is supported by two ongoing Phase 1b/2 investigator initiated trials, one in the U.S. and one in France, testing APR-246 with azacitidine as frontline treatment in TP53 mutant MDS and AML patients.

·General and Administrative (G&A) expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2019, compared to $0.6 million for the comparable period in 2018. The increase in G&A expenses was primarily due to increased professional fees of approximately $1.3 million associated with preparation for the Company’s IPO, which was completed in October 2019, as well as increased personnel costs of $0.3 million.

·Net loss: Net loss was $6.2 million for the quarter ended September 30, 2019, compared to a net loss of $3.1 million for the quarter ended September 30, 2018.

On November 14, 2019 Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the third quarter ended September 30, 2019 (Press release, Viela Bio, NOV 14, 2019, View Source [SID1234551291]).

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"Our Company has achieved significant financial, regulatory and business development milestones underscored by our successful recent initial public offering and listing on the Nasdaq Global Select Market," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In August 2019, the U.S. FDA accepted for review our Biologics License Application for inebilizumab, and we now look forward to supporting global development and commercialization activities for this candidate, if approved. In preparation for the potential approval of inebilizumab, our commercial team is hard at work on product launch preparation, while our clinical team prepares to initiate a number of studies across our pipeline of novel autoimmune and severe inflammatory disease therapies."

Continued Dr. Yao, "Based on the positive results from our pivotal study of inebilizumab in neuromyelitis optica spectrum disorder, or NMOSD, we believe it may represent a transformative therapy for patients suffering from this rare and devastating disease. While we look forward to the continued planned expansion of our pipeline, our near-term priority remains delivering inebilizumab to the many patients who currently lack a viable treatment option."

PROGRAM HIGHLIGHTS

Inebilizumab

U.S. FDA Reviewing Inebilizumab BLA for NMOSD

In August 2019, the U.S. Food and Drug Administration (FDA) accepted for review the Company’s Biologics License Application (BLA) for inebilizumab, clinically studied as a first-line monotherapy for neuromyelitis optica spectrum disorder (NMOSD). The FDA set a Prescription Drug User Fee Act, or PDUFA, date of June 11, 2020.

Inebilizumab Commercial Planning Activities Underway

In preparation for inebilizumab’s potential commercialization, if approved, in the United States, Viela is focused on developing a dedicated commercial team to target medical centers of excellence.

Pivotal Trial Data Published in The Lancet

Peer-reviewed journal, The Lancet, published safety and efficacy results from the pivotal N-MOmentum trial, the largest global, placebo-controlled study in NMOSD. The data were also presented earlier this year during a plenary session at the 2019 American Academy of Neurology (AAN) Annual Meeting.

Company Preparing to Initiate Additional Inebilizumab Clinical Trial

Viela is planning to submit an investigational new drug (IND) application and initiate a pivotal trial in myasthenia gravis in first half of 2020. In addition, Viela is planning to submit an IND and initiate a Phase 2b trial in IgG4-Related Disease in the first half of 2020. Furthermore, Viela is planning to initiate a Phase 2 proof-of-concept study to explore the potential of inebilizumab, used alone or in combination with VIB4920, to reduce levels of alloantibodies in kidney transplant candidates thereby improving transplant outcomes before the end of 2019.

VIB4920

Company Prepares to Initiate Phase 2b Trial with VIB4920

Before the end of 2019, Viela expects to initiate a Phase 2b trial in Sjögren’s syndrome. Viela is also expected to initiate a Phase 2 proof-of-concept study with VIB4920 in kidney transplant.

VIB7734

VIB7734 Phase 1b Ongoing

The VIB7734 Phase 1b multiple ascending dose trial is ongoing. The trial includes a cohort of patients with multiple autoimmune diseases as well as separate cohorts of patients with cutaneous lupus erythematosus, in the presence or absence of SLE.

CORPORATE UPDATES

Viela Closed Initial Public Offering (IPO)

In October 2019, the Company closed its IPO of 9,085,000 shares of common stock, which included 1,185,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share. Including the option exercise, the gross proceeds to Viela Bio from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, were approximately $172.6 million.

Viela Entered into Collaborations to Expand Global Commercial Efforts for Inebilizumab

In October 2019, Viela announced a partnership with Mitsubishi Tanabe Pharma Corporation to develop and commercialize inebilizumab in nine Asia regions –including Japan– for NMOSD and other potential future indications. The Company will receive an upfront licensing fee of $30 million as well as development and commercialization milestones and payments based, in part, on sales revenue.

Viela is also currently partnered with Hansoh Pharmaceuticals Group Company Limited for the development and commercialization of inebilizumab for autoimmune diseases and hematologic cancers in China, Hong Kong and Macau. Viela received a $20 million upfront collaboration fee and is eligible to receive milestone payments of more than $203 million plus royalties on product sales.

FINANCIAL RESULTS

Cash Position: Viela reported cash, cash equivalents and current marketable securities of $198.2 million as of September 30, 2019. This does not include net proceeds from the IPO of approximately $157.2 million, which was subsequent to September 30, 2019. Also, upfront payments from the Company’s strategic partnerships of $35.0 million is expected before end of 2019, which was subsequent to September 30, 2019.

Research and Development Expenses: Research and development expenses were $38.7 million and $72.1 million for the three and nine months ended September 30, 2019, respectively.

General and Administrative Expenses: General and administrative expenses were $10.2 million and $24.6 million for the three and nine months ended September 30, 2019, respectively.

Net Loss: Net loss was $48.4 million and $74.9 million, or $65 and $150 per share, for the three and nine months ended September 30, 2019, respectively.

On November 11, 2019, X4 Pharmaceuticals, Inc. (the "Company") reported that it has entered into a lease agreement (the "Lease") with Beacon North Village, LLC (the "Landlord") for approximately 28,000 square feet of office space currently under construction in a building located at 61 North Beacon Street, Allston, Massachusetts (the "Premises") (Filing, 8-K, X4 Pharmaceuticals, NOV 14, 2019, View Source [SID1234551290]). The Lease will replace the lease for the Company’s current headquarters located at 955 Massachusetts Avenue, Cambridge, Massachusetts, which expires in July of 2022. The Company intends to move into the Premises in mid-2020.

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Monthly rent payments under the Lease are expected to commence on May 11, 2020 (the "Rent Commencement Date"), reflecting a 180-day rent-free period following the execution of the Lease, subject to the timely completion of construction of the Premises. The term of the Lease will continue until the end of the 84th full calendar month following the execution of the Lease, unless earlier terminated in accordance with the terms of the Lease.

Beginning on the Rent Commencement Date, the Company is obligated to make monthly rent payments in an amount of $2.92 per rentable square foot, at an annualized base rate of $35.00 per rentable square foot per year, which is subject to scheduled annual increases for the term of the Lease, plus certain operating expenses. Pursuant to the Lease, the Landlord will contribute up to $1.8 million toward the cost of tenant improvements for the Premises. The Company is also required to provide the Landlord with a $1.1 million security deposit in the form of a letter of credit.

The Company has the right to sublease the Premises, subject to landlord consent. The Company also has the right to renew the Lease for an additional five years at the then prevailing effective market rental rate.

The foregoing summary of the Lease does not purport to be complete and is qualified in its entirety by reference to the full text of the Lease, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the period ending December 31, 2019.

On November 14, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the Jefferies London Healthcare Conference on Thursday, November 21, 2019 at 5:20 p.m. GMT (12:20 p.m. EST) at the Waldorf Hilton London hotel (Press release, Heron Therapeutics, NOV 14, 2019, View Source [SID1234551289]).

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On November 14, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company entitled "Building Momentum for Patients with Myelofibrosis" at the Jefferies 2019 London Healthcare Conference in London, United Kingdom (Press release, Sierra Oncology, NOV 14, 2019, View Source [SID1234551288]).

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The presentation is scheduled for 6:00 p.m. GMT on Wednesday, November 20, 2019. A live audio webcast and archive of the presentation will be accessible through www.sierraoncology.com.