New Data from 18 Approved and Investigational Pfizer Medicines to be Showcased at ASCO20 Virtual Scientific Program

On May 12, 2020 Pfizer Inc. (NYSE: PFE) reported that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, from May 29-May 31 (Press release, Pfizer, MAY 12, 2020, View Source [SID1234557591]). The data that will be presented build on Pfizer’s strong track record in oncology by providing new insights in areas like breast, colorectal and genitourinary cancers, which include bladder, prostate, and kidney cancer. Data from Pfizer’s early stage pipeline, including a novel anti-HER2 antibody-drug conjugate, will also be presented as Pfizer aims to transform the cancer treatment landscape well into the future.

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!

"Our data presentations will highlight the depth and breadth of our cancer portfolio, including our current medicines and new generation of potential therapies," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "We are particularly excited to share the first presentation of detailed overall survival results from the JAVELIN Bladder 100 trial of BAVENCIO and the final overall survival data from the PROSPER trial of XTANDI. These data will support our rapidly expanding efforts in bladder cancer and add to the growing body of clinical evidence generated with XTANDI in prostate cancer."

New data will be featured in nine oral presentations, including a Plenary Session presentation of data from the JAVELIN Bladder 100 trial evaluating BAVENCIO (avelumab) as a first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC). Additional data provide insights on Pfizer’s medicines, including IBRANCE (palbociclib), BRAFTOVI (encorafenib), XTANDI (enzalutamide) and lorlatinib, as well as its cutting-edge, investigational compounds, including a HER2-targeted antibody-drug conjugate in patients with solid tumors. BAVENCIO is being developed and commercialized in collaboration with Merck KGaA, Darmstadt, Germany. As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI.

To help interested non-scientists better understand the latest research, Pfizer has also developed summaries in non-technical language for results of company-sponsored studies being presented in the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program called "abstract plain language summaries (APLS)." Those interested in learning more can visit www.Pfizer.com/apls to access the summaries directly starting May 29.

Key presentations featuring Pfizer medicines in the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program include:

Pfizer-Sponsored Studies

Plenary Session Oral Presentation (Abstract LBA1)

Sunday, May 31, 1 pm ET

Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase 3 interim analysis.

Powles T

Oral Presentation (Abstract 4001)

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E metastatic colorectal cancer: updated survival results from a randomized, three-arm, phase 3 study versus choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)

Kopetz S

Poster Discussion (Abstract 5515)

Final overall survival (OS) from PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC)

Sternberg CN

Poster Presentation (Abstract 1039)

A phase 1 dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF-06804103) in patients with HER2-positive solid tumors

Meric-Bernstam F

Poster Presentation (Abstract 5080)

Axitinib plus pembrolizumab in patients with advanced renal cell carcinoma: Long term efficacy and safety from a phase 1b study

Atkins MB

Investigator Sponsored Studies and Clinical Research Collaborations

Oral Presentation (Abstract 1010)

Prognostic impact of ESR1 mutations in ER+ HER2- MBC patients prior treated with first line AI and palbociclib: An exploratory analysis of the PADA-1 trial

Bidard FC

Oral Presentation (Abstract 10504)

Phase 1 trial of lorlatinib in patients with ALK-driven refractory or relapsed neuroblastoma: A New Approaches to Neuroblastoma Consortium study

Goldsmith KC

Oral, poster discussion, and poster sessions, as well as track-based clinical science symposia, will be available on demand for registered participants beginning Friday, May 29 at 8:00 AM ET. A complete list of Pfizer-sponsored abstracts is available at View Source

Merck KGaA, Darmstadt, Germany, and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.

As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Kaleido Biosciences to Host Conference Call and Webcast in Conjunction with First Quarter 2020 Financial Results on May 14, 2020

On May 12, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported that it plans to release first quarter 2020 financial results on May 14, 2020 before market open and will host a conference call and webcast at 8:30 a.m. ET that day to provide an update on its platform and pipeline (Press release, Kaleido Biosciences, MAY 12, 2020, https://investors.kaleido.com/news-releases/news-release-details/kaleido-biosciences-host-conference-call-and-webcast-conjunction [SID1234557607]).

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!

To access the live conference call, please dial (833) 423-0448 (domestic) or (956) 394-3566 (international) and reference conference ID 4182326. The live webcast can be accessed in the Investors & Media section of Kaleido’s website at: View Source Due to current high volume accessing virtual events, participants are encouraged to connect at least 15 minutes prior to the call to ensure a timely connection or to utilize the webcast link for listen-only access.

An archived webcast will be made available on Kaleido’s website shortly after the event and accessible for 90 days

Danaher Announces Closing Of Common Stock Offering And Mandatory Convertible Preferred Stock Offering

On May 12, 2020 Danaher Corporation (NYSE: DHR) ("Danaher") reported that it has closed concurrent offerings of 9,509,203 shares of common stock at a price to the public of $163.00 per share and 1,717,500 shares of 5.00% Series B Mandatory Convertible Preferred Stock at a price to the public of $1,000 per share (the "offerings") (Press release, Danaher, MAY 12, 2020, View Source [SID1234557623]). These offerings were made by means of separate prospectus supplements and were not contingent on each other. The shares of Series B Mandatory Convertible Preferred Stock sold include 167,500 shares issued pursuant to the exercise in full of the separate option granted to the underwriters in the Series B Mandatory Convertible Preferred Stock offering to purchase additional shares. The option granted to the underwriters to purchase an additional 1,426,379 shares of common stock in the common stock offering was exercised in full on May 12, 2020 and is anticipated to close on or about May 14, 2020.

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 net proceeds from the common stock offering and the Series B Mandatory Convertible Preferred Stock offering were approximately $1.50 billion and $1.67 billion, respectively, which includes the proceeds of the exercise in full of the underwriters’ option to purchase additional Series B Mandatory Convertible Preferred Stock, in each case after deducting issuance costs and discounts. The net proceeds from the closing of the option to purchase the additional 1,426,379 shares is anticipated to be approximately $225.5 million.

Danaher anticipates using the net proceeds for general corporate purposes, which may include, without limitation and in our sole discretion, funding potential future acquisitions and investments, working capital, capital expenditures, investments in or loans to our subsidiaries, refinancing of outstanding indebtedness, refinancing of outstanding capital securities, share repurchases (including, but not limited to, repurchases of our common stock), dividends and satisfaction of other obligations.

Goldman Sachs & Co. LLC, J.P. Morgan, Citigroup and Evercore acted as representatives of the underwriters and joint book-running managers for the offerings. Credit Suisse also served as a joint book-running manager for the offerings and BTIG, COMMERZBANK, Mizuho Securities, MUFG, Raymond James, RBC Capital Markets, Scotiabank, SMBC, TD Securities, US Bancorp and Wells Fargo Securities served as co-managers for the offerings.

The offerings were made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission. Each offering was made only by means of a prospectus supplement relating to such offering and the accompanying base prospectus. An electronic copy of each prospectus supplement, together with the accompanying prospectus, is available on the SEC’s website at www.sec.gov. Alternatively, copies of each prospectus supplement and accompanying prospectus relating to either offering can be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, Telephone: 1-866-471-2526, Email: [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, Email: [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: 1-800-831-9146; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, Telephone: 888-474-0200, Email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the common stock, the Series B Mandatory Convertible Preferred Stock or any other securities, nor shall there be any offer, solicitation or sale of any security mentioned in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

VBL Therapeutics Closes $10.0 Million Registered Direct Offering and Announces $8.1 Million Registered Direct Offering to Key Current Shareholders, Each Priced At-the-Market under Nasdaq Rules

On May 12, 2020 VBL Therapeutics (Nasdaq: VBLT), reported that it has closed the previously announced registered direct offering of 6,349,208 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, VBL Therapeutics, MAY 12, 2020, View Source [SID1234557562]). VBL has also issued to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 6,349,208 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, are immediately exercisable and will expire on November 11, 2020. The registered direct offering closed on May 11, 2020.

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!

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from this offering were approximately $10.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) were offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The offering of the ordinary shares was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares offered have been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

$8.1 Million Registered Direct Offering to Key Current Shareholders

VBL also announced today that it has entered into definitive agreements with two of the Company’s largest current shareholders (the "Second Offering") for the purchase and sale of 5,142,857 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules. VBL has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 5,142,857 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, will be immediately exercisable and will expire on November 11, 2021.

This Second Offering enables the participating shareholders to maintain, or increase, their relative holdings at the Company, under the same terms of the offering that was concluded on May 11, 2020.

The Second Offering is expected to close on or about May 12, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the Second Offering.

The gross proceeds from the Second Offering are expected to be approximately $8.1 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) to be issued in the Second Offering are being offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The Second Offering of the ordinary shares will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares being offered in the Second Offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above are being offered in the Second Offering in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Capital Increase in Genmab as a Result of Employee Warrant Exercise

On May 12, 2020 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 69,090 shares as a consequence of the exercise of employee warrants (Press release, Genmab, MAY 12, 2020, View Source [SID1234557592]).

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 increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

815 shares at DKK 31.75,
3,200 shares at DKK 40.41,
38,750 shares at DKK 46.74,
250 shares at DKK 66.60,
250 shares at DKK 67.50,
1,000 shares at DKK 199.00,
1,000 shares at DKK 210.00,
600 shares at DKK 220.40,
750 shares at DKK 225.30,
14,162 shares at DKK 225.90,
275 shares at DKK 231.50,
1,000 shares at DKK 337.40,
175 shares at DKK 466.20,
275 shares at DKK 623.50,
1,550 shares at DKK 636.50,
2,000 shares at DKK 815.50,
1,280 shares at DKK 939.50,
675 shares at DKK 1,136.00,
815 shares at DKK 1,145.00,
150 shares at DKK 1,233.00, and
118 shares at DKK 1,402.00

Proceeds to the company are approximately DKK 12 million. The increase corresponds to approximately 0.11% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription, i.e. inter alia full rights to dividends for the financial year 2020. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No 377 of April 2, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,280,093 which is made up of 65,280,093 shares of a nominal value of DKK 1 each, corresponding to 65,280,093 votes.