On August 15, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery and autoinjector devices, reported that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2028 (the "Convertible Notes") (Press release, Halozyme, AUG 15, 2022, View Source [SID1234618317]). The Convertible Notes are to be offered and sold to "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company also expects to grant a 13-day option to the initial purchasers to purchase up to an additional $75 million aggregate principal amount of Convertible Notes.

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The Convertible Notes will be senior, unsecured obligations of the Company and will accrue interest payable semi-annually in arrears. The Convertible Notes will mature on August 15, 2028, unless earlier redeemed, repurchased or converted in accordance with their terms prior to such date. Prior to the close of business on the business day immediately preceding February 15, 2028, the Convertible Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after February 15, 2028, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date, the Convertible Notes will be convertible regardless of these conditions. The Company will settle conversions in cash and, if applicable, shares of the Company’s common stock. The initial conversion rate, interest rate and other terms of the Convertible Notes will be determined at the time of pricing in negotiations with the initial purchasers of the Convertible Notes.

In connection with the offering, the Company intends to enter into privately negotiated capped call transactions with option counterparties that may include one or more of the initial purchasers and/or their affiliates and/or other financial institutions. If the initial purchasers exercise their option to purchase additional notes, the Company may enter into additional capped call transactions with the option counterparties. The capped call transactions are generally expected to reduce potential dilution to the Company’s common stock upon conversion of the convertible notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates (i) expect to purchase shares of the Company’s common stock and/or enter into derivative transactions with respect to the Company’s common stock concurrently with, or shortly after, the pricing of the Convertible Notes and (ii) may modify their hedge positions by entering into or unwinding derivative transactions with respect to the Company’s common stock and/or purchasing or selling the Company’s common stock or other securities of the Company in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes. These activities could have the effect of increasing, or preventing a decline in, the market price of the Company’s common stock concurrently with, or shortly following, the pricing of the Convertible Notes. The effect, if any, of these activities, including the direction or magnitude, on the market price of the Company’s common stock will depend on a variety of factors, including market conditions, and cannot be ascertained at this time. Any of these activities could, however, adversely affect the market price of the Company’s common stock.

The Company expects to use a portion of net proceeds of the offering to fund the cost of entering into the capped call transactions. The Company also expects to use a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions entered into concurrently with or shortly after the pricing of the proposed offering (the "Note Repurchases").

In parallel to this transaction, the Company expects to use a portion of the net proceeds of the offering for the repurchase of shares of its common stock (the "Share Repurchases") up to $200 million, concurrently with, or shortly after, the pricing of the offering in privately negotiated transactions or otherwise, which may be effected through one or more of the initial purchasers or any affiliate thereof.

The Share Repurchases, if consummated in full, would represent an increase of $100 million of the previously planned share repurchases to be made in 2022 under the Company’s ongoing three-year $750 million share repurchase program, which was commenced and previously announced in 2021.

Further, the Company expects to use a portion of the net proceeds of the offering to repay all of its outstanding $250 million term loan facility due 2026. The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company’s common stock from time to time under the existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions. If the initial purchasers exercise their option to purchase additional notes, the Company intends to use a portion of the net proceeds from the sale of additional notes to fund the cost of entering into additional capped call transactions.

The Note Repurchases and Share Repurchases could increase (or reduce the size of any decrease in) the market price of Halozyme common stock or the Convertible Notes. We also expect that some existing noteholders may purchase or sell shares of the Company’s common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases, Share Repurchases and any associated hedging by holders could affect the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes and could also result in a higher effective conversion price for the Convertible Notes.

This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, 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 the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

The offer and sale of the Convertible Notes and the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

On August 15, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the first quarter ended June 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, AUG 15, 2022, View Source [SID1234618316]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "I’m excited by the strong early signals we’re seeing from the ongoing VTAMA launch in psoriasis, including approximately 14,000 prescriptions in the first eleven weeks. The recent positive topline results from Torii Pharmaceutical and Japan Tobacco’s study of tapinarof in atopic dermatitis underscore our conviction in VTAMA’s potential in AD as our own Phase 3 trials progress. We are also pleased with recent execution across the rest of our pipeline, including the continued progress in our pivotal trials at Immunovant and Priovant. We are proud to advance the development of these important medicines for patients."

Roivant also announced today that Amy Mahery will be joining the company as Chief Commercial Officer and will serve as a member of the leadership team. Amy has more than twenty years of industry experience and has been involved in the commercialization and launch of therapies across oncology, neurology and immunology. Most recently, she was the Senior Vice President and Head of the Global Business Franchise, Neurology and Immunology (N&I) at EMD Serono, where she led commercial strategy for the N&I portfolio from clinical development to launch and late lifecycle.

On September 28, Roivant will host an investor day, at which the Company will provide updates on the ongoing VTAMA launch in psoriasis, clinical development at the Vants and continued progress in drug discovery. The webcast for this virtual event will begin at 11 a.m. EDT, and participants can register to attend at View Source

Recent Developments

Dermavant: Since its launch in late May, VTAMA has had approximately 14,000 prescriptions written by more than 3,000 unique prescribers based on the latest available IQVIA data through August 5 for prescriptions and July 29 for prescribers. VTAMA became the most prescribed branded topical for the treatment of psoriasis in the U.S. within eight weeks of launch. In July, Torii Pharmaceutical and Japan Tobacco announced positive topline results from their Phase 3 study of tapinarof in atopic dermatitis. In this trial, tapinarof showed statistical superiority to vehicle on the primary endpoint of efficacy, IGA response at week 8. In addition, tapinarof showed statistical superiority to vehicle for EASI achievement rate at week 8, a key secondary endpoint of efficacy. There were no new observed safety or tolerability findings reported.
Priovant: Priovant expects to complete enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single registrational Phase 3 trial.
Major Upcoming Milestones

Dermavant: Dermavant expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.
Priovant: Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.
Immunovant: Immunovant plans to initiate two pivotal trials to evaluate batoclimab for the treatment of thyroid eye disease in the second half of calendar year 2022, with topline results expected in the first half of calendar year 2025. Immunovant plans to announce two new indications for batoclimab and the third indication (in addition to MG and TED) it will initiate as a pivotal trial in calendar year 2022 on an investor call scheduled for September 7, 2022.
Hemavant: Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.
Kinevant: Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.
First Quarter Ended June 30, 2022 Financial Summary

Cash Position

As of June 30, 2022, we had cash, cash equivalents and restricted cash of approximately $2.0 billion.

Research and Development Expenses

Research and development (R&D) expenses were $135.8 million for the three months ended June 30, 2022 compared to $78.5 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in program-specific costs and personnel-related expenses, reflecting the progression of our programs and drug discovery. Additionally, share-based compensation expense increased largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP R&D expenses were $122.5 million for the three months ended June 30, 2022 compared to $76.2 million for the three months ended June 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $149.1 million for the three months ended June 30, 2022 compared to $82.8 million for the three months ended June 30, 2021. The quarter-over-quarter increase was primarily due to increases in share-based compensation expense largely as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended June 30, 2021 as the liquidity event requirement had not been met and was not deemed probable of being met. Additionally, SG&A expenses for Dermavant have increased as a result of the commercial launch of VTAMA in May 2022. Non-GAAP SG&A expenses were $87.7 million for the three months ended June 30, 2022 compared to $64.4 million for the three months ended June 30, 2021.

Net Loss

Net loss was $353.8 million for the three months ended June 30, 2022 compared to $101.1 million for the three months ended June 30, 2021. On a per common share basis, net loss was $0.48 for the three months ended June 30, 2022 and $0.13 for the three months ended June 30, 2021. Non-GAAP net loss was $210.7 million for the three months ended June 30, 2022 compared to $133.4 million for the three months ended June 30, 2021.

(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(2) Represents non-cash share-based compensation expense.

(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(6) Represents the one-time gain on termination of the options held by Sumitomo Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(7) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three months ended June 30, 2022. For the three months ended June 30, 2021, acquired IPR&D expense was $0.1 million.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 15, 2022 to report its financial results for the fiscal quarter ended June 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On August 15, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2022 and provided a business update on recent corporate and regulatory developments (Press release, Protalix, AUG 15, 2022, View Source [SID1234618315]).

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"Positive topline results from our phase III BALANCE clinical trial of PRX-102 for the treatment of adult patients with Fabry disease were announced last April. The clinical study report (CSR) for the trial is now complete," said Dror Bashan, Protalix’s President and Chief Executive Officer. "The final analysis of the BALANCE study, which was designed to evaluate the efficacy and safety of 1 mg/kg of PRX–102 administered every other week compared to agalsidase beta in patients previously treated with agalsidase beta, confirms the positive topline results and favorable tolerability profile. The results from the BALANCE study highlight our confidence that PRX–102 has the potential to become an important treatment option for patients with Fabry disease. We are excited to move closer to potential approval of PRX–102 and commercial launch, and thank our team members and external partners for their continued support."

2022 Second Quarter and Recent Business Highlights

Corporate Developments

On June 30, 2022, the Company announced the appointment of Shmuel "Muli" Ben Zvi, Ph.D. to the Board of Directors. Dr. Ben Zvi is serving as the new Chairman of the Audit Committee and as a member of the Compensation Committee.
Second Quarter 2022 Financial Highlights

The Company recorded revenues from selling goods of $3.4 million for the three months ended June 30, 2022, an increase of $0.2 million, or 6%, compared to revenues of $3.2 million for the same period of 2021.
Revenue from licenses and R&D services for the three months ended June 30, 2022 were $5.4 million, an increase of $2.2 million, or 69%, compared to $3.2 million for the same period in 2021. Revenues from license and R&D services are comprised primarily of revenues recognized in connection with the Chiesi Agreements.
Cost of goods sold for the three months ended June 30, 2022 was $4.1 million, a decrease of $0.6 million, or 13%, compared to cost of goods sold of $4.7 million for the same period in 2021. The decrease in cost of goods sold was primarily the result of decreased manufacturing costs due to higher yields and lower wastage.
Research and development expenses for the three months ended June 30, 2022 were $7.6 million, a decrease of $0.1 million, or 1%, compared to $7.7 million for the same period in 2021.
Selling, general and administrative expenses were $2.6 million for the three months ended June 30, 2022, a decrease of $0.6 million, or 19%, compared to $3.2 million for the same period in 2021. The decrease resulted primarily from a decrease in salary related and selling costs.
Financial income, net were $0.2 million for the three months ended June 30, 2022, compared to financial expenses, net of $2.1 million for the same period in 2021. The decrease resulted primarily from lower interest and debt amortization costs due to a decrease in the Company’s outstanding notes from an aggregate principal amount of $57.92 million of 2021 Notes to an aggregate principal amount of $28.75 million of 2024 Notes, and an increase in the exchange rate of New Israeli Shekels for U.S. Dollars over the period.
Cash, cash equivalents and short-term bank deposits were approximately $28.6 million at June 30, 2022.
Net loss for the three months ended June 30, 2022 was approximately $5.3 million, or $0.11 per share, basic and diluted, compared to a net loss of $11.2 million, or $0.25 per share, basic and diluted, for the same period in 2021.
Conference Call and Webcast Information

The Company will host a conference call today, August 15, 2022, at 8:30 a.m. Eastern Daylight Time, to review the corporate and clinical developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On August 15, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer (Press release, ALX Oncology, AUG 15, 2022, View Source [SID1234618314]). Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate ("ADC"), to determine the safety, tolerability and efficacy of this drug combination.

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"Patients with advanced breast cancer who develop resistance to therapies are in need of novel and tolerable treatment options," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are thrilled to partner with Quantum Leap, recognized as a leader in the development of research initiatives supporting new therapies, to accelerate the advancement of evorpacept in breast cancer. Moreover, this collaboration expands our solid tumor investigations with evorpacept in combination with an ADC. We believe the addition of evorpacept can improve ENHERTU’s anti-cancer activity without increasing toxicity."

The I-SPY-P1 TRIAL will be led by Paula Pohlmann, Associate Professor of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center. ALX Oncology will provide funding and supply evorpacept. As the study sponsor, Quantum Leap will be responsible for managing the trial.

On August 15, 2022 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported the U.S. Patent & Trademark Office’s Patent Trial and Appeal Board’s ("PTAB") decision to reject Thorne Research, Inc. attempt to invalidate U.S. Patent No. 8,197,807 ("the 807 patent") (Press release, ChromaDex, AUG 15, 2022, View Source [SID1234618313]). ChromaDex holds an exclusive license to the 807 patent for compositions including nicotinamide riboside (NR) from the Trustees of Dartmouth College. The decision, if upheld upon appeal, precludes Thorne Research, Inc. from raising these arguments, or any other arguments they could have reasonably raised before the PTAB in the New York District Court lawsuit ChromaDex brought against Thorne Research, Inc. wherein ChromaDex alleges Thorne Research, Inc. is infringing the 807 patent.

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ChromaDex is the exclusive supplier of nicotinamide riboside chloride, Niagen, a novel form of NR backed by 20 published and peer-reviewed clinical trials. Niagen has achieved regulatory acceptance by the world’s four leading regulatory bodies including the U.S. FDA, Health Canada, the European Commission, and the Therapeutic Goods Administration (TGA) of Australia.

ChromaDex maintains a strong and growing intellectual property portfolio for its proprietary ingredient, Niagen, including for use in supplements and foods, consisting of over 40 composition, process, and method of use patents for discoveries relating to NR and other precursors to NAD+ (nicotinamide adenine dinucleotide), a molecule at the forefront of healthy aging and cellular health.