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Sierra Oncology and Gilead Sciences Agree on Amendments to Asset Purchase Agreement for Momelotinib

On November 7, 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 it has agreed to amend its Asset Purchase Agreement with Gilead Sciences, Inc. for momelotinib upon Sierra closing a qualified financing (Press release, Sierra Oncology, NOV 7, 2019, View Source [SID1234550605]).

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"These are significant amendments that meaningfully enhance the potential long-term value of momelotinib for Sierra and its stockholders. The amendments also affirm Gilead’s support for the continued development of momelotinib with the goal of bringing meaningful benefit to patients with myelofibrosis," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Following the closing by Sierra of a qualified financing, Gilead will become a stockholder in Sierra, the annual royalty rates payable to Gilead will be reduced, which will benefit the company and all its stockholders should momelotinib prove commercially successful, and we will also eliminate a milestone payment that would be due to Gilead in the coming months with the anticipated initiation of the MOMENTUM Phase 3 trial for momelotinib, further extending our financial resources."

"We are pleased to enter into this amended agreement with Sierra in order to support the company’s continued advancement of momelotinib. Gilead continues to believe in the potential of momelotinib, and we are pleased that Sierra will continue development of the compound in hopes that it will benefit patients in the future," said Andrew Dickinson, Chief Financial Officer of Gilead.

In consideration for amending the royalty rates and milestones in the Asset Purchase Agreement, following the automatic conversion of shares of preferred stock to be issued in connection with Sierra’s recently announced financing, Sierra and Gilead Sciences would enter into a Securities Purchase Agreement, pursuant to which Sierra would issue to Gilead Sciences shares of Sierra Common Stock and a warrant to purchase Sierra Common Stock. The number of shares of Common Stock to be issued would be equal to 7.5% of Sierra’s outstanding shares of Common Stock, after giving effect to certain adjustments related to the financing. The Warrant would be exercisable to purchase up to an additional 7.5% of Sierra’s outstanding shares of Common Stock. The Warrant would include a blocker provision, that may be waived by Gilead upon specified notice, that prevents Gilead from exercising the warrant for a number of shares that would result in Gilead owning more than 9.99% of Sierra’s issued and outstanding shares of Common Stock.

Sierra Oncology Announces Pricing of $103 Million Public Offering of Convertible Preferred Stock and Warrants

On November 7, 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 the pricing of an underwritten public offering of Series A convertible preferred stock, together with Series A warrants and Series B warrants, each to purchase shares of common stock, with expected gross proceeds to Sierra Oncology of $103 million (Press release, Sierra Oncology, NOV 7, 2019, View Source [SID1234550604]). The offering is expected to close on November 13, 2019, subject to customary closing conditions.

The offering is comprised of 103,000 shares of Series A preferred stock, 312,090,000 Series A warrants to purchase up to an aggregate of 312,090,000 shares of common stock at an exercise price equal to $0.33 per underlying share of common stock, and 312,090,000 Series B warrants to purchase up to an aggregate of 102,989,700 shares of common stock at an exercise price equal to $0.33 per underlying share of common stock. Each share of Series A preferred stock is accompanied by (i) 3,030 Series A warrants to purchase an aggregate of 3,030 shares of common stock (which equates to 100% warrant coverage), and (ii) 3,030 Series B warrants to purchase an aggregate of 1,000 shares of common stock (which equates to 33% warrant coverage). Each share of Series A preferred stock, and the accompanying warrants was sold at a combined price to the public of $1,000.

Sierra Oncology intends to use the net proceeds from the public offering to fund MOMENTUM, its planned Phase 3 clinical trial of momelotinib, as well as for general corporate purposes.

Each share of Series A preferred stock will be initially convertible into that number of shares of common stock equal to the purchase price of the Series A preferred stock divided by the conversion price of the Series A preferred stock, which is initially equal to $0.33. Each share of Series A preferred stock will automatically convert to shares of common stock upon the fifth day of trading following the announcement of stockholder approval of the first reverse stock split following the offering, subject to certain beneficial ownership limitations. Each share of Series A preferred will be entitled to vote together with the common stock on an as-converted basis, subject to certain limitations, without regard to the beneficial ownership limitation, until such time that the shares of Series A preferred stock automatically convert to common stock. Following the automatic conversion described above, the Series A preferred stock will be non-voting.

Each Series A and Series B warrant will have an exercise price equal to $0.33 per underlying share of common stock, and will become exercisable following stockholder approval of an increase in authorized common stock sufficient to allow for the exercise of the warrants, subject to certain beneficial ownership limitations. The Series A warrants will expire five years from the date they first become exercisable and the Series B warrants will expire on the 75th day anniversary following the announcement of top-line date from Sierra Oncology’s planned Phase 3 clinical trial of momelotinib.

Shortly following the closing of the offering, Sierra Oncology expects to appoint four new directors who are affiliated with Vivo Capital, Longitude Capital, OrbiMed and Abingworth, each of which is an investor in this offering. Following such appointments, Sierra expects its board of directors will continue to consist of eight directors.

Jefferies is acting as the sole book-running manager for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

The securities described above are being offered by Sierra Oncology pursuant to a registration statement on Form S-3 (File No. 333-225650) that was declared effective by the Securities and Exchange Commission ("SEC") on June 21, 2018. A prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by 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 state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Lilly Announces the Early Tender Results and Upsizing of Its Pending Cash Tender Offer to Up to $2,000,006,000 Aggregate Principal Amount of Its Outstanding Debt Securities

On November 7, 2019 Eli Lilly and Company (NYSE: LLY) reported the early tender results for its previously announced cash tender offer of its outstanding debt securities (Press release, Eli Lilly, NOV 7, 2019, View Source [SID1234550603]). Lilly also announced that it had increased the previously announced tender cap from $2,000,000,000 to $2,000,006,000 aggregate principal amount of its debt securities, subject to further increase in its sole discretion. Except as described in this press release, all other terms of the tender offer as described in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal remain unchanged.

$3,479,144,000 in aggregate principal amount of the notes listed in the table below were validly tendered and not validly withdrawn on or prior to 5:00 p.m., New York City time, on November 6, 2019, the early tender date for the offer. The table below sets forth the aggregate principal amount of each series of notes subject to the tender offer that were validly tendered and not validly withdrawn on or prior to the early tender date.

(1) The maximum principal amount of 3.950% Notes due 2049 that will be purchased by Lilly is $200,000,000.

(2) The maximum principal amount of 4.150% Notes due 2059 that will be purchased by Lilly is $200,000,000.

(3) The maximum principal amount of 2.350% Notes due 2022 that will be purchased by Lilly is $250,000,000.

Subject to the conditions in the Offer to Purchase, Notes validly tendered and not validly withdrawn at or prior to the early tender date with Acceptance Priority Level 11 have been accepted for purchase using a proration factor of approximately 52.8%.

The settlement date for the notes accepted by Lilly in connection with the early tender date currently is expected to be on November 8, 2019.

Lilly expects to determine the pricing terms of the tender offer at 10:00 a.m., New York City time, on November 7, 2019. The tender offer is scheduled to expire at 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated.

Holders of notes subject to the tender offer who validly tendered and did not validly withdraw their notes on or prior to the early tender date are eligible to receive the total consideration, which includes an early tender premium of $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued interest up to, but not including, the settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on November 6, 2019. As a result, tendered notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

The tender offer is being conducted upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal, as supplemented by this press release.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

This press release is for informational purposes only and is not a tender offer to purchase or a solicitation of acceptance of a tender offer, which may be made only pursuant to the terms of the Offer to Purchase. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. In addition, this press release is not an offer to sell or the solicitation of an offer to buy any securities. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any such securities will be offered only by means of a prospectus, including a prospectus supplement relating to such securities, meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Ligand to Participate in the Stephens 2019 Nashville Investment Conference

On November 7, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that the company is scheduled to participate in the Stephens 2019 Nashville Investment Conference in Nashville, Tennessee (Press release, Ligand, NOV 7, 2019, https://investor.ligand.com/news/detail/396/ligand-to-participate-in-the-stephens-2019-nashville-investment-conference [SID1234550602]). The fireside chat is scheduled to take place on Wednesday, November 13, 2019 at 3:30 p.m. Eastern Time. Matt Korenberg, CFO will attend for Ligand.

GlycoMimetics Reports Third Quarter 2019 Financial Results and Recent Operational Developments

On November 7, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the quarter ended September 30, 2019 and highlighted recent business developments (Press release, GlycoMimetics, NOV 7, 2019, View Source [SID1234550601]). Quarter-end cash and cash equivalents were $170.9 million.

"In the third quarter of 2019, we continued to progress the late-stage clinical development of our wholly-owned product candidate, uproleselan. Our Company-sponsored Phase 3 trial in relapsed or refractory AML patients and the NCI-sponsored Phase 3 trial for newly diagnosed patients with AML both advanced during the quarter. We are also working with the Duke Cancer Institute towards initiating a single center, proof-of-mechanism Phase 1b trial for GMI-1359, our dual antagonist of E-selectin and CXCR-4, in breast cancer patients with bone metastases," said Rachel King, GlycoMimetics’ Chief Executive Officer.

Ms. King continued, "We are also very much looking forward to the ASH (Free ASH Whitepaper) meeting in December, which has always been an important conference for us, and this year is no different. The key takeaway for us at this year’s ASH (Free ASH Whitepaper) meeting is that data from multiple preclinical and clinical settings show that E-selectin ligand expression on leukemic cells is correlated with poor survival in AML. The data indicate that E-selectin ligand expression is a key driver of environmental-mediated chemoresistance in AML and suggest that uproleselan has the potential to break this chemoresistance, and thereby improve clinical outcomes. Based on this expanding dataset, we are exploring how use of biomarkers may help us in advancing our clinical program.

"Finally, as previously announced, Pfizer reported that its Phase 3 clinical trial evaluating rivipansel in SCD failed to meet its primary endpoint and key secondary endpoints. Of course, this is disappointing, but for some time our operational focus has been on our uproleselan program in AML, and we continue to focus our efforts on diligently and efficiently progressing that exciting clinical program," Ms. King added.

Key Third-Quarter 2019 and Recent Operational Developments:

GlycoMimetics’ pivotal Phase 3 trial of uproleselan in relapsed/refractory AML continued to initiate and activate clinical sites and to enroll patients in the U.S., Australia and now in Europe.
Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy.
Pfizer announced that the Phase 3 clinical trial evaluating rivipansel in SCD failed to meet the primary endpoint and key secondary endpoints.
As part of a commitment to eliminate certain non-core research and development spending, GlycoMimetics discontinued plans to collaborate with the Haemato Oncology Foundation for Adults in the Netherlands on a Phase 2 trial of uproleselan in newly-diagnosed patients unfit for chemotherapy.
The Company continued to work closely with the Duke Cancer Institute to initiate a Phase 1b proof-of-mechanism clinical trial of GMI-1359 in individuals with breast cancer whose tumors have spread to bone. The trial will evaluate safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer. The trial will be conducted at Duke University and is expected to initiate during the fourth quarter.
Third Quarter 2019 Financial Results:

Cash position: As of September 30, 2019, GlycoMimetics had cash and cash equivalents of $170.9 million as compared to $209.9 million as of December 31, 2018.
R&D Expenses: The Company’s research and development expenses increased to $10.7 million for the quarter ended September 30, 2019 as compared to $9.7 million for the third quarter of 2018. This increase was primarily the result of expenses relating to the Company’s Phase 3 clinical trial of uproleselan in relapsed or refractory AML patients and supporting the clinical trials of uproleselan conducted by or in collaboration with third parties.
G&A Expenses: The Company’s general and administrative expenses increased to $3.4 million for the quarter ended September 30, 2019 as compared to $2.8 million for the third quarter of 2018. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
Shares Outstanding: Shares outstanding as of September 30, 2019 were 43,359,949.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9845948. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. In the fourth quarter of 2019, the Company plans to initiate an exploratory clinical trial in individuals with breast cancer whose tumors have spread to bone.