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Roivant Sciences Reports First Fiscal Quarter 2021 Financial Results and Provides Business Update

On September 21, 2021 Roivant Sciences Ltd. ("Roivant" or the "Company"), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the fiscal quarter ended June 30, 2021 and provided an update on the Company’s operations (Press release, Roivant Sciences, SEP 21, 2021, View Source [SID1234590062]).

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"Over the past quarter we have made significant progress as a business, both at Roivant centrally and across our family of companies," said Matthew Gline, Chief Executive Officer of Roivant. "I look forward to providing an update on these developments and an overview of key milestones to come at our R&D Day next week."

On September 28, Roivant will host its annual R&D Day, at which the Company will provide updates on clinical development at the Vants and Roivant’s new small molecule discovery engine. The webcast for this virtual event will begin at 1 p.m. ET and can be accessed at View Source

Recent Developments

Datavant: In June 2021, Datavant and Ciox Health entered into a definitive agreement to merge the two companies. The combined entity, named Datavant, is the nation’s largest health data ecosystem, enabling patients, providers, payers, health data analytics companies, patient-facing applications, government agencies and life science companies to securely exchange their patient-level data. The merger closed on July 27, 2021. At closing, Roivant received approximately $320 million in cash and a minority equity stake in the combined company.
Aruvant: In June 2021, Aruvant announced data published on ARU-2801, an investigational gene therapy, that showed improved survival out to 18 months in hypophosphatasia mice.
Immunovant: In August 2021, Roivant made a $200 million investment in Immunovant. Following this transaction, Roivant owns 73,398,664 shares of Immunovant common stock, representing approximately a 63.8% ownership interest.
Dermavant: In August 2021, the FDA accepted for filing Dermavant’s NDA for tapinarof for the treatment of plaque psoriasis in adult patients. The FDA has assigned a PDUFA target action date in the second calendar quarter of 2022. In September 2021, Dermavant dosed the first patient in a Phase 3 trial of tapinarof for the treatment of atopic dermatitis.
Genevant: In August 2021, Genevant entered into a global collaboration and license agreement with Takeda for the development and commercialization of novel nonviral gene therapies for up to two rare liver diseases. Genevant will be eligible for up to $303 million in upfront and potential milestone payments, plus royalties on product sales. This is the second collaboration between Genevant and Takeda.
Major Upcoming Milestones

Roivant: We expect to close our business combination with MAAC, along with a concurrent PIPE financing, and commence trading on Nasdaq on October 1 under the symbol "ROIV." Assuming no redemptions by MAAC shareholders, the business combination and concurrent PIPE financing are expected to deliver approximately $575 million in net proceeds to Roivant.
Dermavant: We expect a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second calendar quarter of 2022. We also expect to report topline data from Dermavant’s Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
Immunovant: Contingent upon FDA feedback, Immunovant plans to initiate a pivotal trial evaluating IMVT-1401 for the treatment of myasthenia gravis in the early part of calendar year 2022. Immunovant also plans to announce at least two new indications and submit INDs with their trial designs to the FDA over the next 12 months.
Aruvant: We expect Aruvant to report additional clinical data from the ongoing Phase 1/2 trial of ARU-1801 in sickle cell disease patients in the second half of calendar year 2021.
First Fiscal Quarter 2021 Financial Summary

Research and Development Expenses

Research and development expenses increased by $19.9 million to $78.6 million for the three months ended June 30, 2021 compared to $58.7 million for the three months ended June 30, 2020. The increase is primarily due to an increase in personnel-related expenses, which is partially driven by additional headcount to support drug discovery efforts using our computational discovery technology and targeted protein degradation platform, following the acquisition of Silicon Therapeutics in March 2021 and Oncopia Therapeutics, Inc. in November 2020.

General and Administrative Expenses

General and administrative expenses increased by $25.6 million to $82.8 million for the three months ended June 30, 2021 compared to $57.1 million for the three months ended June 30, 2020. The increase was primarily due to increases in professional and transaction fees, personnel-related expenses and share-based compensation expense.

Capital Resources

As of June 30, 2021, we had cash and cash equivalents of approximately $2.0 billion.

Lilly Announces the Pricing Terms of Its Cash Tender Offer for Up to $1.5 Billion Combined Aggregate Principal Amount of Its Outstanding Debt Securities

On September 21, 2021 Eli Lilly and Company (NYSE: LLY) reported the pricing terms of its previously announced cash tender offer for specified series of its outstanding debt securities (Press release, Eli Lilly, SEP 21, 2021, View Source [SID1234590061]).

Holders of notes subject to the tender offer who validly tendered, and did not validly withdraw, their notes on or before 5:00 p.m., New York City time, on September 20, 2021 (the early tender date), and whose notes are accepted for purchase by Lilly, are eligible to receive the applicable total consideration. The total consideration for each $1,000 principal amount of notes tendered and accepted for payment in the tender offer is based on the applicable reference yield plus a fixed spread, in each case as set forth in the table below, and is payable to holders of the notes listed in the table below who validly tendered and did not validly withdraw their notes on or before the early tender date and whose notes are accepted for purchase by Lilly. The reference yields listed in the table were calculated at 10:00 a.m., New York City time, on September 21, 2021. The applicable total consideration for each series of notes includes an early tender premium of $30 per $1,000 principal amount of notes validly tendered and not validly withdrawn and accepted for purchase by Lilly.

Title of Security

CUSIP No.

Acceptance
Priority
Level

Reference U.S. Treasury
Security

Reference
Yield

Fixed
Spread

Total
Consideration(1)(2)

4.150% Notes due 2059

532457 BU1

1(3)

2.375% due May 15, 2051

1.865%

80 bps

$1,347.88

3.950% Notes due 2049

532457 BT4

2(4)

2.375% due May 15, 2051

1.865%

70 bps

$1,268.49

7.125% Notes due 2025

532457 AM0

0.750% due August 31, 2026

0.820%

15 bps

$1,222.65

6.770% Notes due 2036

532457 AP3

1.250% due August 15, 2031

1.321%

105 bps

$1,530.04

5.950% Notes due 2037

532457 BC1

1.750% due August 15, 2041

1.816%

55 bps

$1,478.64

5.550% Notes due 2037

532457 BA5

1.750% due August 15, 2041

1.816%

50 bps

$1,418.71

5.500% Notes due 2027

532457 AZ1

0.750% due August 31, 2026

0.820%

40 bps

$1,226.23

4.650% Notes due 2044

532457 BG2

1.750% due August 15, 2041

1.816%

75 bps

$1,351.36

3.950% Notes due 2047

532457 BR8

2.375% due May 15, 2051

1.865%

70 bps

$1,255.48

3.875% Notes due 2039

532457 BS6

1.750% due August 15, 2041

1.816%

45 bps

$1,225.74

3.700% Notes due 2045

532457 BJ6

2.375% due May 15, 2051

1.865%

65 bps

$1,205.60

3.375% Notes due 2029

532457 BV9

1.250% due August 15, 2031

1.321%

15 bps

$1,130.16

3.100% Notes due 2027

532457 BP2

0.750% due August 31, 2026

0.820%

35 bps

$1,100.66

2.750% Notes due 2025

532457 BH0

0.750% due August 31, 2026

0.820%

0 bps

$1,065.36

2.350% Notes due 2022

532457 BQ0

1.750% due May 15, 2022

0.070%

10 bps

$1,014.09

(1) Per $1,000 principal amount of notes that are tendered and accepted for purchase.

(2) The applicable total consideration includes an early tender premium of $30 per $1,000 principal amount of notes that are tendered and accepted for purchase.

(3) Lilly has removed the previously announced note cap setting forth the maximum principal amount of 4.150% Notes due 2059 that Lilly will accept for purchase pursuant to the tender offer.

(4) Lilly has removed the previously announced note cap setting forth the maximum principal amount of 3.950% Notes due 2049 that Lilly will accept for purchase pursuant to the tender offer.

All payments for notes accepted for purchase in connection with the early tender date will also include accrued and unpaid interest on the principal amount of such notes to, but excluding, the initial settlement date, which is currently expected to be September 22, 2021.

Holders of notes subject to the tender offer who validly tender and do not validly withdraw their notes after the early tender date will, if such notes are accepted by Lilly, receive the applicable 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 from the last interest payment date for the applicable series of notes to, but excluding, the applicable settlement date will be paid in cash in respect of all validly tendered notes accepted for purchase by Lilly in the tender offer.

The tender offer is scheduled to expire at 11:59 p.m., New York City time, on October 4, 2021, unless extended or terminated earlier.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on September 20, 2021. 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 on the terms and subject to the conditions set forth in the Offer to Purchase, dated September 7, 2021 (the "Offer to Purchase"), and the related Letter of Transmittal, each as supplemented by the press release, dated September 21, 2021, that removed the note caps for the 3.950% Notes due 2049 and the 4.150% Notes due 2059.

Lilly has retained BofA Securities, Inc. and Citigroup Global Markets Inc. to serve as lead dealer managers for the tender offer, and Barclays Capital, Inc., BNP Paribas Securities Corp. and Deutsche Bank Securities Inc. 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 +1 (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 BofA Securities, Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. toll-free at +1 (800) 558-3745 or collect +1 (212) 723-6106.

This press release is for informational purposes only and is not an offer to purchase, the solicitation of an offer to sell any notes. The tender offer is being made only pursuant to the Offer to Purchase and the information in this press release is qualified by reference to 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. None of Lilly or its affiliates, their respective boards of directors, the Dealer Managers, Global Bondholder Services Corporation or the trustee with respect to any series of notes is making any recommendation as to whether holders should tender any notes in response to the tender offer, and neither Lilly nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their notes, and, if so, the principal amount of notes to tender.

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.

Leap Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

On September 21, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has commenced an underwritten public offering of its common stock and, in lieu of common stock, Leap intends to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock (Press release, Leap Therapeutics, SEP 21, 2021, View Source [SID1234590060]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Leap. Leap intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the securities offered in the public offering. The offering is subject to market, regulatory, and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Piper Sandler & Co., Raymond James & Associates, Inc. and Mizuho Securities USA LLC will act as book-running managers for the offering. Robert W. Baird & Co. Incorporated will act as lead manager for the offering.

Leap intends to use the net proceeds from the offering to fund: (i) the continued development of DKN-01; (ii) manufacturing of clinical trial material; and (iii) general corporate purposes, including working capital and other general and administrative expenses.

The securities will be issued pursuant to an effective shelf registration statement on Form S-3 (File No. 333-248797) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on September 14, 2020 and declared effective by the SEC on October 16, 2020. A preliminary prospectus supplement and the related prospectus will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, by telephone at (800) 747-3924, or by e-mail at [email protected]. These documents may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected]; or from Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY, 10020, by telephone at (212) 205-7600, or by e-mail 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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Heron Therapeutics to Present at the 2021 Cantor Virtual Global Healthcare Conference

On September 21, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET (Press release, Heron Therapeutics, SEP 21, 2021, View Source [SID1234590059]).

A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

AXIM® Biotechnologies Appoints Joseph Tauber, MD, Chief Medical Officer and Chairman of its Medical Advisory Board

On September 21, 2021 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," or "the Company"), an international healthcare solutions company targeting oncological, COVID-19 and dry eye disease (DED) diagnostics, reported that it has appointed Joseph Tauber, MD as Chief Medical Officer and Chairman of its Medical Advisory Board (Press release, AXIM Biotechnologies, SEP 21, 2021, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-appoints-joseph-tauber-md-chief-medical-officer-and-chairman-of-its-medical-advisory-board [SID1234590057]).

With over 30 years of clinical experience, Dr. Tauber is an internationally recognized authority in the field of ocular surface diseases including dry eye and meibomitis management. He is an entrepreneurial private

AXIM Chief Medical Officer and Chairman of its Medical Advisory Board

practice ophthalmologist with extensive experience as a clinical trials researcher and business consultant to global health product companies and institutional investors. Dr. Tauber has served on numerous scientific advisory boards and as the Ophthalmology representative at institutional investor-focused conferences.

"Dr. Tauber is arguably among the world’s leading authorities on dry eye and ocular surface disease, including researching the causes, treating, and diagnosing patients with dry eye disease," said John W. Huemoeller II, AXIM Biotech Chief Executive Officer. "Our goal is to build a powerful diagnostic company, which begins with assisting doctors to diagnose DED faster and more efficiently than alternative methods. We are honored and excited to have such a distinguished ophthalmic DED professional to help guide our strategy and future innovations to capture a larger share of the growing Dry Eye Disease market."

Joseph Tauber, MD Summary Bio
Dr. Tauber is the founder and CEO of Tauber Eye Center, a practice focused on corneal disease, uveitis and ocular immunology and complex corneal surgical procedures as well as Medical Director of Saving Sight, the US’ third largest eye bank.

Dr. Tauber has been centrally involved in virtually every significant dry eye development project during the past 25 years. He has served as a Principal Investigator in over 140 multicenter clinical trials including those that led to the approval of all four medications currently approved by the FDA for the treatment of dry eye – Restasis, Xiidra, Cequa and Eyesuvis. He has been avidly involved in research for nearly three decades, and a principal investigator in over 140 research studies across a broad range of eye conditions, including high-risk corneal transplantation, inflammation and allergic eye diseases, corneal infectious diseases and numerous ocular surface conditions.

Dr. Tauber received his doctorate from Harvard Medical School, residency training in internal medicine at Beth Israel Hospital and in ophthalmology at Tufts-New England Medical Center, and fellowship training in Ocular Immunology and in Corneal Diseases and Surgery at the Massachusetts Eye & Ear Infirmary, all in Boston, Massachusetts.
Dr. Tauber has also written eight book chapters and over 80 peer-reviewed articles in the fields of ocular surface and immunologic disease for prestigious medical journals as Ophthalmology, Investigative Ophthalmology and Visual Science, Journal of Cataract and Refractive Surgery and Cornea. He has been awarded the Heed Ophthalmic Foundation Fellowship Award and a National Eye Institute Individual NRSA Award.

Dry Eye Disease Market
Recent estimates of the prevalence of dry eye disease are that over 26 million people in the United States and over 300 million globally suffer with dry eye disease. The prevalence is growing in both young and old adults, making it more urgent that clinicians are better able to diagnose and treat DED. As many as two-thirds of patients with symptoms of dry eye have never been diagnosed by their physician. Diagnosing DED is a challenge because of the multifactorial nature of the disease, with symptoms similar to other ocular surface conditions. It is well known that there is often a discordance between signs and symptoms, highlighting the need for more sensitive and accurate diagnostic tools.