Lilly Announces Cash Tender Offer for Up to $2.0 Billion Aggregate Principal Amount of Its Outstanding Debt Securities

On October 24, 2019 Eli Lilly and Company (NYSE: LLY) reported that it has commenced a cash tender offer for up to $2.0 billion aggregate principal amount (the "tender cap") of specified series of its outstanding debt (Press release, Eli Lilly, OCT 24, 2019, View Source [SID1234542490]). Pursuant to the tender offer, Lilly is offering to purchase, under certain conditions and subject to certain limitations, its 3.950% Notes due 2047, 3.700% Notes due 2045, 3.875% Notes due 2039, 7.125% Notes due 2025, 6.77% Notes due 2036, 5.950% Notes due 2037, 5.55% Notes due 2037, 5.50% Notes due 2027, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 (collectively, the "notes").

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 early tender date is 5:00 p.m., New York City time, on November 6, 2019, unless extended. The expiration date of the tender offer is 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated. The terms, conditions and limitations of the tender offer are described in the Offer to Purchase dated as of today’s date.

Holders of notes must validly tender and not validly withdraw their notes before the early tender date to be eligible to receive the total consideration (as described below). Tendered notes may only be withdrawn prior to 5:00 p.m., New York City time, on November 6, 2019. Notes tendered after the withdrawal date and before the expiration date may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

Subject to the tender cap, tendered notes will be accepted in the order of the acceptance priority levels set forth in the table above, except that the aggregate principal amount of the 3.950% Notes due 2049 accepted will not exceed the 3.95% note cap, the aggregate principal amount of the 4.150% Notes due 2049 accepted will not exceed the 4.15% note cap, and the aggregate principal amount of the 2.350% Notes due 2022 accepted will not exceed the 2.35% note cap. Lilly reserves the right, but is not obligated, to increase the tender cap or the note caps. Tenders of 3.950% Notes due 2047, 3.875% Notes 2039, 3.700% Notes due 2045, 5.950% Notes due 2037, 5.50% Notes due 2027, 5.55% Notes due 2037, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 will be accepted only in principal amounts equal to $2,000 and integral multiples of $1,000 in excess thereof. Tenders of 6.77% Notes due 2036 and 7.125% Notes due 2025 will be accepted only in principal amounts equal to $1,000 and integral multiples thereof.

The total consideration for each $1,000 principal amount of notes tendered and accepted for payment by Lilly pursuant to the tender offer will be determined in the manner described in the Offer to Purchase by reference to a fixed spread specified in the table above for each series of the notes and over the yield based on the bid-side price of the U.S. Treasury Security specified in the table above, as calculated by Citigroup Global Markets Inc., Morgan Stanley & Co. LLC, BNP Paribas Securities Corp. and J.P. Morgan Securities LLC for the tender offer at 10:00 a.m., New York City time, on November 7, 2019. Holders of notes who validly tender their notes after the early tender date will, if such notes are accepted by Lilly, receive the tender consideration, which is equal to the total consideration minus $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued and unpaid interest up to, but excluding, the applicable settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

Lilly reserves the right, but is under no obligation, at any point following the early tender date and before the expiration date of the tender offer, to accept for purchase any notes validly tendered (and not validly withdrawn) at or prior to the early tender date. The initial settlement date will be determined at Lilly’s option and is currently expected to occur on November 8, 2019. Regardless of whether Lilly chooses to exercise its option to have an initial settlement date, Lilly will purchase any remaining notes that have been validly tendered (and not validly withdrawn) by the expiration date of the tender offer and accepted for purchase (subject to the tender cap, the note caps, and the application of the acceptance priority levels), promptly following the expiration date of the tender offer.

All notes validly tendered and not validly withdrawn before the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any tendered notes having a lower acceptance priority level, and all notes validly tendered after the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any notes tendered after the early tender date having a lower acceptance priority level. However, notes validly tendered and not validly withdrawn on or before the early tender date will be accepted for purchase (subject to the tender cap and the note caps) in priority to other notes tendered after the early tender date, even if such notes tendered after the early tender date have a higher acceptance priority level than notes tendered prior to the early tender date.

Notes accepted for purchase in accordance with the terms and conditions of the tender offer may be subject to proration (rounded down to avoid the purchase of notes in a principal amount other than in integral multiples of $1,000), so that Lilly will only accept for purchase notes in an aggregate principal amount up to the tender cap, including the maximum amount of 3.950% Notes due 2049 that may be purchased pursuant to the 3.95% note cap, 4.150% Notes due 2059 that may be purchased pursuant to the 4.15% note cap, and 2.350% Notes due 2022 that may be purchased pursuant to the 2.35% note cap. If purchasing all of the tendered notes of a series of notes of an applicable acceptance priority level on any settlement date would cause the tender cap and the note caps to be exceeded, the amount of that series of notes purchased on that settlement date will be prorated based on the aggregate principal amount of that series of notes tendered in respect of that settlement date such that the tender cap and the note caps will not be exceeded. Furthermore, if the tender offer is fully subscribed as of the early tender date, holders who validly tender notes after the early tender date will not have their notes accepted for payment.

The offer for each series of notes is conditioned upon the satisfaction of certain conditions, including the completion of an offering of debt securities by Lilly on terms and conditions satisfactory to Lilly that results in the receipt of net proceeds that, when taken together with cash on hand, is sufficient to pay the consideration for all tendered notes validly tendered (and not validly withdrawn) and accepted for purchase by Lilly, plus related accrued and unpaid interest and fees and expenses. The offer is not conditioned on a minimum principal amount of notes being tendered nor the consummation of any other offer. The offer with respect to one or more series of the notes may be amended, extended, terminated or withdrawn separately.

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.

Syros Announces New Data from Phase 2 Trial of SY-1425 in Combination with Azacitidine Demonstrating High Response Rates, Rapid Onset of Action and Favorable Tolerability Profile in RARA-Positive Newly Diagnosed Unfit AML Patients

On October 24, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that updated clinical data from its ongoing Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with azacitidine, continue to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in a genomically defined subset of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy (Press release, Syros Pharmaceuticals, OCT 24, 2019, View Source [SID1234542486]). These data are being presented at the European School of Haematology (ESH) 5th International Conference Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment in Estoril, Portugal.

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!

"I am very encouraged by these data. AML patients continue to need new treatment options, despite recent advances in the field, that are well-tolerated and can be used in combination to extend survival and improve quality of life," said Stéphane de Botton, M.D., Head of Acute Myeloid Malignancies at Institut Gustave Roussy and a clinical investigator in the Phase 2 trial of SY-1425. "These data show that SY-1425, a targeted therapy, in combination with azacitidine is highly active in a subset of patients that can be readily identified and that the combination is generally well-tolerated even in very sick AML patients. I believe SY-1425 is a promising combination agent with the potential to provide a meaningful benefit for a subset of AML patients, and I look forward to its continued development."

"These data mark an important milestone in the development of SY-1425," said David A. Roth, M.D., Chief Medical Officer of Syros. "SY-1425 in combination with azacitidine continues to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in RARA-positive AML patients. As we study the combination in more patients, we are also seeing a high rate of transfusion independence and early evidence of durable responses. We are gratified to see our discovery of this novel patient subset, as defined by our RARA biomarker, translating into clinical benefit. These results demonstrate the power of our gene control platform to identify which genes to modulate in which patients to maximize the chances of providing them with a profound benefit. We look forward to continuing to evaluate SY-1425 in our ongoing study and to reporting potential proof-of-concept data next year in RARA-positive relapsed or refractory AML patients."

Updated Clinical Data on SY-1425 in Combination with Azacitidine in Newly Diagnosed, Unfit AML Patients

Syros presented updated data from its Phase 2 trial of SY-1425 in combination with azacitidine, a standard-of-care hypomethylating agent, in newly diagnosed unfit AML patients. The trial evaluated the safety and efficacy of the combination in patients with either the RARA or IRF8 biomarker, as well as in patients without the biomarkers. All patients were treated with azacitidine administered at standard daily doses of 75 mg/m2 intravenously or subcutaneously for seven days, followed by SY-1425 administered at 6 mg/m2/day orally, divided in two doses, for the remainder of each 28-day cycle.

As of Aug. 22, 2019, 40 newly diagnosed unfit AML patients had been enrolled in the trial and were eligible for the safety analysis. The median age of patients enrolled in the study was 76. Of the 17 biomarker-positive patients evaluable for response, 13 were RARA-positive and four were IRF8-positive. Enrollment in the newly diagnosed unfit cohorts of the ongoing Phase 2 trial is nearly complete. Syros will continue to follow patients enrolled in the trial to further characterize the overall profile of the combination, including safety, efficacy and durability of response.

Clinical Activity Data

62% complete response (CR) and complete response with incomplete blood count recovery (CRi) rate, as defined by Revised International Working Group, IWG, criteria), in RARA-positive patients.

54% CR rate in RARA-positive patients, consisting of seven CRs, including three molecular CRs and three cytogenetic CRs.

Most initial responses were seen at the first response assessment.

Duration of these responses in RARA-positive patients was up to 344 days, with three of the eight responding patients having responses lasting beyond seven months at the time of the data cutoff.

82% of RARA-positive patients achieved or maintained transfusion independence.

Responses were seen in RARA-positive patients across AML risk groups, including patients with mutations that are typically associated with poor outcomes.

In patients with only the IRF8-biomarker, the CR/CRi rate was 0%, supporting Syros’ decision to use RARA as the sole biomarker for patient selection in SY-1425 clinical trials going forward. Based on data from 112 newly diagnosed patients screened for its clinical trial, Syros believes that approximately 30% of newly diagnosed AML patients are RARA-positive.

In the 22 response-evaluable RARA-negative patients, the CR/CRi rate was 27%, which is consistent with the published response rates of 18-29% observed in newly diagnosed unfit AML patients treated with single-agent azacitidine.

Safety Data

SY-1425 in combination with azacitidine was generally well-tolerated with no evidence of increased toxicities beyond what is seen with either SY-1425 or azacitidine alone.

Rates of myelosuppression, including neutropenia, were comparable to reports of single-agent azacitidine in this AML population.

The majority of non-hematologic AEs were low grade.

Across all grades and causalities, the most commonly reported AEs were nausea (38%), decreased appetite (38%), constipation (33%), fatigue (33%) and peripheral edema (30%).

The most commonly reported Grade 3 or higher AEs (all causality) were thrombocytopenia (25%), anemia (23%), and febrile neutropenia (23%).

The poster presented at ESH is now available on the Publications and Abstracts section of the Syros website at www.syros.com.

The ongoing Phase 2 trial is actively enrolling patients with relapsed or refractory AML patients who are positive for the RARA biomarker. Syros expects to report potential proof-of-concept from the cohort in relapsed or refractory AML patients in 2020. Additional details about the Phase 2 trial of SY-1425 can be found using the identifier NCT02807558 at www.clinicaltrials.gov.

Replimune Announces First Patient Enrolled in Phase 1 Clinical Trial of RP2 Alone and in Combination with Opdivo® in Advanced Cancer Patients

On October 24, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that the company has enrolled the first patient in its Phase 1 clinical trial of RP2 (Press release, Replimune, OCT 24, 2019, View Source [SID1234542485]). RP2 expresses a genetically encoded anti-CTLA-4 antibody-like molecule, in addition to GALV-GP-R- and GM-CSF, both of which are expressed in Replimune’s first product candidate, RP1. This is intended to block the inhibition of the initiation of immune responses caused by CTLA-4.

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!

"We are excited to be advancing RP2, our second novel Immulytic product candidate, into clinical studies," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "CTLA-4 inhibition is an established mechanism of action for cancer treatment, including proven synergy with anti-PD1 therapy. By combining the expression of anti-CTLA-4 with oncolytic tumor destruction and antigen release directly in the tumor and draining lymph nodes, we believe that the efficacy of CTLA-4 inhibition can be enhanced with RP2, while reducing toxicity as compared to systemic administration."

The Phase 1 clinical trial will study RP2 as a single agent and in combination with Opdivo (nivolumab) in patients with advanced solid tumors. The Phase 1 clinical trial is designed to assess the safety, tolerability and to determine the optimal dose of RP2 alone and in combination with anti-PD1 therapy and is being conducted as a collaboration with Bristol-Myers Squibb Company (BMS). BMS has granted Replimune a nonexclusive, non-transferable, royalty-free license to, and will supply at no cost, Opdivo, for use in combination with RP2. BMS has no further development-related obligations under this collaboration.

About RP2

RP2 is Replimune’s second Immulytic product candidate and like RP1, is based on a proprietary new strain of herpes simplex virus which expresses GM-CSF and the fusogenic protein GALV-GP R-. In addition to the properties of RP1, RP2 expresses an anti-CTLA-4 antibody-like protein in order to block the inhibition of the immune response otherwise caused by CTLA-4. In preclinical studies comparing RP1 to RP2 to determine the effect of expressing anti-CTLA-4, RP2 demonstrated enhanced efficacy both alone and in combination with anti-PD1 therapy both in tumors which were injected with RP1 or RP2 and in tumors which were left uninjected

Intellia Therapeutics to Hold Conference Call to Discuss Third Quarter 2019 Earnings and Company Update

On October 24, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present third quarter 2019 results and operational highlights in a conference call on October 31, 2019 at 8 a.m. ET (Press release, Intellia Therapeutics, OCT 24, 2019, View Source [SID1234542484]).

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 join the call:

U.S. callers should dial 888-208-1711 and use conference ID# 7693636, approximately five minutes before the call.
International callers should dial +1 856-344-9299 and use conference ID# 7693636, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com, beginning on October 31, 2019 at 12 p.m. ET.

Onconova Affirms Planned Completion of Pivotal Phase 3 INSPIRE Study of Rigosertib in Myelodysplastic Syndromes by 1H20 And Provides Research & Development Update

On October 24, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported that the Company believes it remains on target to report top-line data from the global Phase 3 INSPIRE Trial with intravenous (IV) rigosertib in second-line, higher-risk MDS patients in the first half of 2020 following full enrollment and 288 death events (Press release, Onconova, OCT 24, 2019, View Source [SID1234542483]). The Company anticipates completion of the INSPIRE Trial in the first half of 2020 based on approaching 90 percent or 324 randomized patients of the required 360 randomized patients, and the number of confirmed death events reached to date.

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!

Steven M. Fruchtman, M.D., President and Chief Executive Officer, stated, "Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. We are approaching 90 percent of planned enrollment. Based on enrollment and the number of reported events reached, which exceeded 75% of the required 288 events at end of September 2019, we continue to anticipate reporting top-line data in the first half of 2020 following full enrollment and 288 death events. Enrollment in Brazil is expected to begin in November, and we look forward to the Brazilian Association of Hematology, Hemotherapy and Cellular Therapy Congress in Rio de Janeiro, November 6-9."

Dr. Richard Woodman, Chief Medical Officer of Onconova, continued, "Prior to readout of the INSPIRE trial, the Company plans to focus Onconova’s research and development activities on completing the INSPIRE trial. After completion of the INSPIRE trial, based on recent feedback from the FDA, we plan to conduct a randomized Phase 2 Trial with a control arm of single agent azacitidine for the continued development of oral rigosertib plus azacitidine in first-line higher-risk MDS patients. We also plan to consult with key opinion leaders on the design of a Phase 2 controlled study for submission to the FDA as the next step in the development of oral rigosertib. The proposed Phase 2 Study does not require a Special Protocol Assessment (SPA)."

In addition to the pivotal Phase 3 INSPIRE study, a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence by early 2020 as an investigator-initiated study. Ras-mutated cancers represent about a third of all human cancers. We recently participated in the RAS Drug Discovery Summit in Boston and plan to participate in the next RAS Drug Discovery Summit in Vienna, Austria in February 2020. We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer. The IND has been submitted in China by our corporate partner Han X.