On May 19, 2020 Oncology Venture A/S ("Oncology Venture") (OV:ST) reported that its executive management will host a live webcast on May 29, 2020, at 5:00 p.m. CEST to discuss the company’s first quarter 2020 results and provide a business and financial update (Press release, Oncology Venture, MAY 19, 2020, https://oncologyventure.com/press-release/oncology-venture-a-s-invites-investors-for-q1-2020-report-conference-call/ [SID1234558282]). The webcast will follow the publication of Oncology Venture’s Q1 2020 report, also scheduled for release on May 29, 2020.

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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

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Interested parties may register for the event and access the live webcast via the Events and Presentations section of the Oncology Venture website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

Agenda:

General business update by CEO Steve Carchedi
Financial update by CFO Henrik Moltke
Q&A
Pre-submitted questions will be prioritized for the Q&A. To pre-submit a question, please email it to [email protected], no later than 3 pm CEST on 29 May.

Online webcast/conference call:

Attendees are encouraged to pre-register and join the call online in order to be able to watch the presentation slides using this link:

View Source

On May 19, 2020 Pfizer Inc. (NYSE: PFE) reported the pricing of a debt offering consisting of four tranches of notes (Press release, Pfizer, MAY 19, 2020, View Source [SID1234558281]):

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$750,000,000 aggregate principal amount of 0.800% notes due 2025

$1,000,000,000 aggregate principal amount of 1.700% notes due 2030

$1,000,000,000 aggregate principal amount of 2.550% notes due 2040

$1,250,000,000 aggregate principal amount of 2.700% notes due 2050

Pfizer intends to use the net proceeds for general corporate purposes, including to repay a portion of its outstanding commercial paper and/or to refinance, redeem or repurchase existing debt.

The closing of the offering is expected to occur on May 28, 2020, subject to satisfaction of customary closing conditions.

Barclays Capital Inc., Citigroup Global Markets Inc., Deutsche Bank Securities Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers for the offering.

The offering of these securities is being made only by means of a prospectus. Copies may be obtained by calling Barclays Capital Inc. at (888) 603-5847, Citigroup Global Markets Inc. at (800) 831-9146, Deutsche Bank Securities Inc. at (800) 503-4611 and J.P. Morgan Securities LLC at (212) 834-4533.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the notes, nor will there be any sale of the notes in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

On May 19, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that preclinical data for NT219, a novel agent addressing treatment resistance in advanced cancer, will be presented in a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting II (Press release, Kitov Pharmaceuticals , MAY 19, 2020, View Source [SID1234558280]).

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The presentation, titled, "NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models," includes preclinical data on NT219, a first-in-class, dual inhibitor of signal transducer and activator of transcription 3 (STAT3) and insulin receptor substrate 1 and 2 (IRS1/2), which have been associated with treatment resistance in a variety of cancer settings. Using multiple patient derived xenograft (PDX) models of subjects with head and neck squamous cell carcinoma (HNSCC), NT219 demonstrated growth inhibition, both as monotherapy (3/6 mice), as well as in combination with cetuximab, an epidermal growth factor receptor (EGFR) inhibitor, or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor (5/6 mice). Notably, in one study of a PDX model of a recurrent/metastatic HNSCC sample that was resistant to radiation, various chemotherapies and pembrolizumab, utilizing NT219 alone resulted in tumor growth inhibition (TGI) of 69% (p=0.017). Moreover, while cetuximab alone was not effective (TGI=17%), the combination of cetuximab with NT219 showed synergistic effect and induced regression of all tumors (p=0.001).

"These encouraging preclinical data strongly suggest that the inhibition of the STAT3 and IRS-AKT pathways has the potential to address the tumor resistance phenotype," said Isaac Israel, Chief Executive Officer of Kitov. "Based on the significant compelling preclinical evidence generated in various studies with NT219, including these data, our planned Phase 1/2 trial of NT219 will evaluate our promising product candidate both as a monotherapy treatment in patients with advanced solid tumors and in combination with cetuximab in patients with HNSCC. We look forward to initiating this Phase 1/2 trial soon."

Presentation Details:

Title: NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models
Date: June 22, 2020
Abstract: View Source!/9045/presentation/2911

On May 19, 2020 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that the initial purchasers of the previously announced offering of its 1.25% Senior Subordinated Convertible Notes due 2027 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended elected to exercise in full their 13-day option to purchase an additional $50 million aggregate principal amount of the notes (the "Additional Notes") (Press release, BioMarin, MAY 19, 2020, View Source [SID1234558279]). The sale of the Additional Notes closed today.

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The Additional Notes have identical terms to the 1.25% Senior Subordinated Convertible Notes due 2027 sold on May 14, 2020 (the "Original Notes" and, together with the Additional Notes, the "Notes") and, following today’s closing, there is a total of $600 million aggregate principal amount of Notes outstanding. The aggregate net proceeds from the offering of the Notes was approximately $585.8 million after deducting the initial purchasers’ discounts and commissions and estimated expenses payable by BioMarin. BioMarin used approximately $50.0 million of the net proceeds from the offering to repurchase shares of its common stock concurrently with the offering of the Original Notes in privately negotiated transactions with purchasers of the notes effected through one of the initial purchasers or its affiliate, as BioMarin’s agent. BioMarin intends to use a majority of the net proceeds from the offering of the Notes to repay, repurchase or settle in cash some or all of its 1.50% senior subordinated convertible notes due in 2020, although it did not effect any such repayment, repurchase or settlement concurrently with the offering. BioMarin intends to use the remainder of the net proceeds for general corporate purposes.

The offer and sale of the Notes and the shares of BioMarin common stock issuable upon conversion of the Notes have not been registered under the Securities Act or any state securities laws, and unless so registered, the Notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 19, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the first quarter 2020 (Press release, Cue Biopharma, MAY 19, 2020, View Source [SID1234558278]).

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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

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"We have successfully maintained momentum in meeting our business goals and clinical trial objectives for the first quarter and early second quarter of 2020, despite the rapid onset of COVID-19 and the many challenges it has presented," said Daniel Passeri, chief executive officer of Cue Biopharma. "I am grateful for the dedication of the Cue Biopharma team during this pandemic as we continue to work together and safely execute on our mission of bringing novel therapies to patients with serious diseases."

According to Kerri-Ann Millar, vice president of finance and principal financial and accounting officer of Cue Biopharma, "We successfully navigated the beginning of the pandemic and finished the first quarter of 2020 in a solid financial position which was further strengthened by the successful deployment of an ATM facility in April that enabled us to boost our cash position by an additional $34.3 million."

First-Quarter 2020 Financial Results

The Company reported collaboration revenue of approximately $0.9 million and $0.4 million for the three months ended March 31, 2020 and 2019, respectively.

Research and development expenses were $9.9 million and $8.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in research and development expenses of $1.5 million was primarily due to clinical trial costs related to our on-going CUE-101 mono-therapy trial that was initiated in the latter part of the third quarter of 2019. During the first quarter of 2020, we initiated the manufacturing of CUE-101 to supply our recently announced combination trial of CUE-101 with Merck’s KEYTRUDA which also contributed to the increase in research and development costs.

General and administrative expenses were $3.9 million and $3.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in general and administrative expense of $0.5 million was primarily due to an increase in stock-based compensation expense and legal and accounting fees incurred in the first quarter of 2020 as compared to the same period in 2019.

Recent News & Business Updates

Extended cash runway through an ATM equity offering sales agreement for aggregate proceeds of $34.3 million, net of commissions paid, with Stifel, who acted as sales agent. As of April 30, 2020, the Company had sold 1,824,901 shares of common stock under the sales agreement.

Completed our first analysis of clinical biomarker samples from the CUE-101 Phase 1 clinical trial and the early data provides favorable insights into clinical metrics that bolster our confidence in CUE-101 and our entire IL-2-based CUE-100 series.

Completed a clinical collaboration agreement with Merck in April 2020 to evaluate the combination of CUE-101 with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as a first-line therapy in patients with advanced HPV16+ head and neck cancer in a planned dose-escalation Phase 1 study to be called KEYNOTE-A78.