Insmed Announces Closing of Public Offering of Common Stock

On May 24, 2019 Insmed Incorporated (Nasdaq: INSM) reported the closing of the previously announced public offering of its common stock. Insmed issued and sold in the public offering 9,615,385 shares of common stock, at a public offering price of $26.00 per share, resulting in gross proceeds of approximately $250.0 million (Press release, Insmed, MAY 24, 2019, View Source [SID1234536571]). Insmed’s net proceeds from the offering, after deducting estimated offering expenses and underwriting discounts and commissions, were approximately $235.5 million. The underwriters have been granted 30-day options to purchase up to an additional 1,042,307 shares of common stock from Insmed and up to 400,000 shares of common stock from William H. Lewis, the Company’s Chairman and Chief Executive Officer.

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Insmed intends to use its net proceeds from this offering to continue to commercialize ARIKAYCE (amikacin liposome inhalation suspension); conduct further trials of ARIKAYCE, including Insmed’s required confirmatory trial to assess and describe the clinical benefit of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease; fund further clinical development of INS1007 and INS1009; invest in increased third-party manufacturing capacity for ARIKAYCE; fund business expansion activities in Europe and Japan; fund working capital, potential debt repayment, capital expenditures, and general research and development; and for other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates, technology or businesses.

Morgan Stanley & Co. LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC acted as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC, Stifel, Nicolaus & Company, Incorporated and H.C. Wainwright & Co. acted as co-managers for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (SEC), as amended by Post-Effective Amendment No. 1 thereto, and became automatically effective upon filing. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, telephone: 1-800-808-7525, ext. 6132 or email at [email protected]; and Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale

would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

FLX BIO ANNOUNCES NAME CHANGE TO RAPT THERAPEUTICS

On May 24, 2019 FLX Bio, a clinical-stage, immunology-based biopharmaceutical company, reported it has changed its name to RAPT Therapeutics, Inc., to more accurately represent the company’s dedication and focused efforts to develop and commercialize oral small molecule therapies for patients with significant unmet needs in cancer and inflammatory diseases using its expertise in immunology, small molecule drug discovery and computational biology (Press release, FLX Bio, MAY 24, 2019, https://www.rapt.com/flx-bio-announces-name-change-to-rapt-therapeutics/ [SID1234536570]).

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"The name RAPT Therapeutics embodies our commitment to apply our proprietary discovery and development engine to advance highly selective, oral treatments that intelligently target key immune drivers to more effectively and safely treat cancer and inflammatory diseases, and importantly, improve the lives of patients," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics, Inc. "Since our founding, we have internally discovered and advanced two unique drug candidates that target CCR4, with FLX475 in development for the treatment of multiple cancers and RPT193 expected to enter clinical studies in the second half of 2019."

RAPT’s lead oncology drug candidate, FLX475, selectively inhibits the migration of immunosuppressive regulatory T cells (Treg) into tumors. In a Phase 1 clinical study in 104 healthy volunteers, FLX475 was well tolerated and demonstrated favorable drug like properties and target engagement. The company is currently conducting a Phase 1/2 clinical study investigating FLX475 as a single agent and in combination with pembrolizumab, a PD-1 antibody, in patients with "charged" tumors who the company believes have the greatest probability of clinical benefit. RAPT expects to generate proof-of-concept data from this study in the first half of 2020.

RAPT’s lead inflammation drug candidate, RPT193, selectively inhibits the migration of type 2 T helper cells (Th2) into allergically-inflamed tissues, which are clinically validated drivers of allergic diseases such as atopic dermatitis, asthma, chronic urticaria (skin rash), allergic conjunctivitis, rhinosinusitis and eosinophilic esophagitis (inflammation of the esophagus). In multiple preclinical models, oral administration of RPT193 demonstrated activity in reducing inflammation comparable with leading injectable biologics with validated clinical activity. Preclinical toxicology studies demonstrated a safety profile consistent with chronic dosing. RAPT believes the preclinical safety and efficacy results combined with the convenience of oral dosing support a profile competitive with standard of care, including steroids and dupilumab, as well as clinical product candidates, such as the JAK inhibitors. The company expects to file an investigational new drug (IND) application for this drug candidate in the second half of 2019 with initial clinical development planned for atopic dermatitis.

In addition, RAPT is identifying lead compounds that inhibit general control nonderepressible 2 (GCN2), which is a fundamental regulator of antitumor immunity and tumor cell survival. In preclinical studies, our lead molecule has demonstrated the ability to fully restore T-cell proliferation and function in nutrient-deprived conditions, enhance tumor cell death and elicit anti-tumor responses in preclinical tumor models. We anticipate filing an IND with the FDA in 2020.

RAPT is also pursuing a range of targets including HPK1 that are in the discovery stage of development.

Alpine Immune Sciences to Present at Upcoming Investor Conferences

On May 24, 2019 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported the company will participate in three upcoming investor conferences in June (Press release, Alpine Immune Sciences, MAY 24, 2019, View Source [SID1234536569]).

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Jefferies 2019 Healthcare Conference

Date: Thursday, June 6, 2019

Time: 2:00 p.m. Eastern Time

Location: New York, NY

Raymond James Life Sciences and MedTech Conference

Date: Wednesday, June 19, 2019

Time: 1:15 p.m. Eastern Time

Location: New York, NY

JMP Securities Life Sciences Conference

Date: Thursday, June 20, 2019

Time: 1:30 p.m. Eastern Time

Location: New York, NY

A live webcast of each presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentations will be available on the company website for 90 days following the webcast.

Aclaris Therapeutics to Present at Jefferies 2019 Global Healthcare Conference

On May 24, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, reported that management will present a company overview at the Jefferies 2019 Global Healthcare Conference on Wednesday, June 5, 2019 at 3:30 PM ET at the Grand Hyatt Hotel in New York, New York (Press release, Aclaris Therapeutics, MAY 24, 2019, View Source [SID1234536568]).

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A live audio webcast of the presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events’ section. An archived version of the presentation will be available for 30 days.

FINAL RESULTS ANNOUNCEMENT for the twelve months ended 31 December 2018

On May 24, 2019 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is reported its final results for the twelve months ended 31 December 2018 (the "Period") (Press release, ImmuPharma, MAY 24, 2019, View Source [SID1234536567]).

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Key Highlights (including post Period review)

Stable financial performance over the Period
– Cash balance of £4.9 million (31 December 2017: £2.7 million)
– Loss for the period of £7.2 million (31 December 2017: £6.2 million)
– Research and development expenses of £4.7 million (31 December 2017: £5.1 million)
– Basic and diluted loss per share of 5.19p (31 December 2017: 4.75p)
– A successful, £10 million (gross) fundraising completed in January 2018
– Acquired a 15% stake in Incanthera Limited for £2 million
Lupuzor

Top line results of the Company’s pivotal Phase III trial of Lupuzor were announced on 17 April 2018– key highlights include:
Lupuzor demonstrated a superior response rate over placebo (52.5% vs 44.6% "responders") in the primary analysis on the Full Analysis Set of all 202 patients. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met
Across the whole study population, in those patients who had anti-dsDNA autoantibodies, Lupuzor demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) Lupuzor plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218)
The study confirmed the outstanding safety profile of Lupuzor, with no serious adverse events reported
Follow-on ‘extension’ open label study
– A total of 62 eligible patients from the original Phase III trial recruited
– The study is anticipated to report results in Q2 2019
Discussions continue with potential corporate partners as well as consulting with regulatory advisors on potential pathways to market. Whilst these activities continue, the commencement of the Managed Access Program for Lupuzor is postponed, until further clarification on these activities gained
As announced on 7 May 2019, a renewed focus on developing the P140 platform within different auto-immune indications outside of lupus – following encouraging pre-clinical data
Other program developments

Within our two further platforms, Elro Pharma (Nucant) and Ureka Sarl (Peptide), ImmuPharma is exploring options to license, divest or ‘spin-off’ the technologies of both of these subsidiaries to unlock future potential and enhance value to shareholders – as announced on 7 May 2019
All negotiations with Incanthera Limited on the Nucant cancer programme and broader collaboration discussions have now terminated – as announced on 7 May 2019
Advisors appointments
– Spark Advisory Partners Limited appointed as Nominated Advisor in December 2018
– Stanford Capital Partners and SI Capital appointed as Join Brokers in September 2018
Commenting on the statement and outlook Tim McCarthy, Chairman, said: ‘We are pleased to report our results for 2018 as well as the key highlights for our programs. Following on from the Phase III results, we are focused on progressing Lupuzor and the P140 autoimmune platform. Our plans to combine and either divest, spin off or license Elro Pharma (Nucant) and Ureka (Peptide Platform) are planned to unlock value for shareholders. We look forward to reporting on these developments in the coming months. We would also like to take this opportunity to thank our shareholders, scientific advisors, corporate collaborators and the CNRS.’

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")