On November 1, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the completion of its expected tax-free distribution (Distribution) of 100% of Ligand’s interest in its subsidiary OmniAb on a pro rata basis to Ligand shareholders of record as of October 26, 2022 (Press release, Ligand, NOV 1, 2022, View Source [SID1234622674]). The Distribution was immediately followed by the closing (Closing) of the business combination (Business Combination) between Avista Public Acquisition Corp. II (APAC) (which prior to the Closing domesticated in Delaware and changed its name to OmniAb, Inc., (OmniAb)) and OmniAb, Inc. (which prior to the Closing changed its name to OmniAb Operations, Inc. (OmniAb Operations)). Regular-way trading in OmniAb stock is expected to begin on Nasdaq under the stock ticker symbol "OABI" tomorrow, November 2, 2022.

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Under the terms of the Business Combination, which was structured as a Reverse Morris Trust transaction, at the Closing shareholders of Ligand received 4.90007 shares of OmniAb common stock and 0.75842 earnout shares of OmniAb common stock (Earnout Shares) for each share of Ligand common stock.

The Earnout Shares will vest based upon the achievement of certain volume-weighted average trading prices (VWAP) for shares of OmniAb for any 20 trading days over a consecutive 30 trading-day period during the five-year period following the Closing, with (i) 50% of such Earnout Shares vesting upon achievement of a VWAP of $12.50 per share of OmniAb common stock or upon the occurrence of a change of control transaction that will result in the holders of OmniAb common stock receiving a price per share in excess of $12.50, and (ii) the remaining 50% of the Earnout Shares vesting upon achievement of a VWAP of $15.00 per share of OmniAb common stock or upon the occurrence of a change of control transaction that will result in the holders of OmniAb common stock receiving a price per share in excess of $15.00. The Earnout Shares are not transferrable until the vesting condition for the applicable tranche of Earnout Shares has been achieved.

As a result of the transactions, Ligand shareholders received 85.0% of the shares of OmniAb common stock outstanding, APAC’s existing public shareholders held 1.1% of the shares of OmniAb common stock outstanding, and APAC’s sponsor and related parties of APAC owned 13.9% of the shares of OmniAb common stock outstanding, including the Earnout Shares in each case.

Advisors

Credit Suisse acted as lead financial and capital markets advisor to Ligand and OmniAb. Cowen, Stifel, SVB Securities and Truist Securities also acted as financial and capital markets advisors to Ligand and OmniAb, and CJS Securities, Craig-Hallum Capital Group LLC, H.C. Wainwright & Co. and Roth Capital Partners acted as advisors to Ligand and OmniAb. Latham & Watkins LLP served as legal counsel to Ligand and OmniAb Operations. Weil, Gotshal & Manges LLP served as legal counsel to APAC.

About OmniAb

OmniAb’s discovery platform provides pharmaceutical industry partners access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. We believe the OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.

On November 1, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, NOV 1, 2022, View Source [SID1234622673]).

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"INGREZZA continues to help more and more patients who suffer from tardive dyskinesia. With the submission of the sNDA of valbenazine for the treatment of chorea associated with Huntington Disease, we have the potential to help even more patients with our valbenazine franchise," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Our clinical programs continue to progress with multiple data readouts in 2023 including for crinecerfont in congenital adrenal hyperplasia and for NBI-‘352 in adult focal onset seizures. Additionally, we recently dosed our first patient in our lead muscarinic program for the treatment of schizophrenia. With a strong commercial and R&D presence, and an attractive financial profile, Neurocrine Biosciences is well positioned to be a leading neuroscience-focused company."

Third Quarter INGREZZA Net Product Sales and Commercial Highlights:
Net product sales were $376 million with total prescriptions (TRx) of approximately 68,600
Net product sales and TRx grew 31% and 32%, respectively, vs. third quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:
Third quarter 2022 GAAP net income and diluted earnings per share of $69 million and $0.69, respectively, compared with $23 million and $0.23, respectively, for third quarter 2021.
Third quarter 2022 non-GAAP net income and diluted earnings per share of $107 million and $1.08, respectively, compared with $63 million and $0.64, respectively, for third quarter 2021.
Differences in third quarter 2022 GAAP and non-GAAP operating expenses compared with third quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio
Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022
At September 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.2 billion.
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:
On November 1, 2022, we acquired Diurnal Group plc, or Diurnal, in an all-cash transaction, for an aggregate value of approximately £48.3 million GBP, or approximately $56 million USD. We believe the transaction presents an opportunity to accelerate the establishment of our clinical development and commercial capabilities in the United Kingdom to the benefit of patient communities and other stakeholders.

INGREZZA sales guidance for fiscal 2022 is based on recent trends and the anticipated benefit from our recently completed salesforce expansion. If new COVID-19 related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.
GAAP R&D guidance includes (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed. GAAP R&D guidance includes approximately $40 million of milestone expenses in connection with collaborations.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $60 million in R&D and $110 million in SG&A.
Based upon available Federal net operating losses and tax credits, the Company expects to begin making cash payments for Federal income tax beginning in the fourth quarter of 2022.

Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1881 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 1, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that financial results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 1, 2022, View Source [SID1234622672]).

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"With ORLADEYO on a trajectory to more than double sales in its second year of launch after a very strong first year, we continue to demonstrate that what we are offering HAE patients is unique and fills their need for a therapy that offers both low burden of disease and low burden of treatment. We believe that our ability to successfully pursue challenging targets like plasma kallikrein is just the start, and we expect we will bring rare disease patients many more oral therapies to offer these patients the unique treatment options they are waiting for," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

U.S. Launch

The total number of patients on paid therapy grew by nine percent in the third quarter.

New patient starts remained strong in the third quarter, in line with the running six quarter average.

The ORLADEYO prescriber base grew by 11 percent in the third quarter.

These strong underlying growth trends were masked by accelerated direct shipments requested by patients late in the second quarter in June prior to the July 4 holiday weekend, plus a negative out of period reimbursement-related charge that was accounted for in the third quarter.
ORLADEYO: Global Updates

In the third quarter, ORLADEYO was approved in Saudi Arabia. The company expects continued approvals and launches in additional countries.
"With the strong underlying growth fundamentals we continued to see from patients and physicians in the third quarter, and the further growth dynamics we expect to see in the fourth quarter, we are on track to more than double ORLADEYO revenue in 2022 compared to 2021," said Charlie Gayer, chief commercial officer of BioCryst.

Complement Program

BCX9930 – Oral, Twice-daily Factor D Inhibitor

On August 4, 2022, the company announced that the U.S. Food and Drug Administration (FDA) had lifted its partial clinical hold on the BCX9930 program and that the company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with paroxysmal nocturnal hemoglobinuria (PNH) and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).

Screening has begun for new patients to participate in the trials and the company expects to have data from approximately 15 newly-enrolled patients by the middle of 2023 to inform its decision to either fully invest in the pivotal program, or to discontinue the BCX9930 program.

BCX10013 – Oral, Once-daily Factor D Inhibitor with Best-in-class Potential

The company has begun a clinical program with BCX10013, a novel, potent and specific Factor D inhibitor, and expects to report preliminary data from healthy volunteers in the first quarter of 2023. The preclinical and early clinical profile from approximately 90 healthy volunteers to date suggests BCX10013 could have the properties of a once-daily oral therapy. A goal of the ongoing clinical program is to confirm this once-daily profile with healthy volunteer and patient data.

Additional Complement Targets

In addition to BCX9930 and BCX10013, which target the alternative pathway of complement, BioCryst is pursuing oral medicines directed at other targets across the classical, lectin and terminal pathways of the complement system. The goal of the company’s overall complement program is to advance several oral compounds across multiple pathways in the complement system to treat many complement-mediated diseases.
BCX9250 – Oral ALK-2 Inhibitor for Fibrodysplasia ossificans progressiva (FOP)

The company believes that patients with FOP, an ultra-rare disease, are likely to benefit from other oral ALK-2 inhibitors that currently are substantially ahead of BCX9250 in development. Considering the expectation that patients will be well-served by these other products, and the approximately $100 million in additional investment that would be required to advance BCX9250 to approval, the company is stopping the BCX9250 program and redirecting this investment to the other opportunities it has to serve patients with complement-mediated diseases.
Third Quarter 2022 Financial Results

For the three months ended September 30, 2022, total revenues were $75.8 million, compared to $41.0 million in the third quarter of 2021 (+85 percent year-over-year (y-o-y)). The increase was primarily due to $66.0 million in ORLADEYO net revenue in the third quarter of 2022.

Research and development expenses for the third quarter of 2022 increased to $52.7 million from $50.0 million in the third quarter of 2021 (+6 percent y-o-y), primarily due to additional investment in the HAE program and expenses for BCX9250 prior to its discontinuation, partially offset by reduced costs related to the BCX9930 studies.

Selling, general and administrative expenses for the third quarter of 2022 increased to $36.9 million, compared to $35.0 million in the third quarter of 2021 (+6 percent y-o-y). The increase was primarily due to increased investment to support the commercial launch of ORLADEYO.

Interest expense was $24.8 million in the third quarter of 2022, compared to $14.1 million in the third quarter of 2021 (+76 percent y-o-y). The increase was due to service on the royalty financings, which were completed in November 2021. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $6.5 million has been added in the third quarter of 2022 and $32.4 million since issuance, to the $200 million principal.

Net loss for the third quarter of 2022 was $42.5 million, or $0.23 per share, compared to a net loss of $58.8 million, or $0.33 per share, for the third quarter of 2021.

Cash, cash equivalents, restricted cash and investments totaled $462.6 million at September 30, 2022, compared to $203.9 million at September 30, 2021. Operating cash use for the third quarter of 2022 was $29.4 million.

Financial Outlook for 2022

Based on the strength of the ORLADEYO launch through the first three quarters of 2022, the company expects full year 2022 net ORLADEYO revenue to be $255 million.

Based on the reduced spending on the BCX9930 program in the first three quarters of the year, and lower than projected spending on the program for the remainder of the year, the company now expects operating expenses for full year 2022, not including non-cash stock compensation, to be between $365 million and $370 million.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 866-374-5140 for domestic callers and 404-400-0571 for international callers and using conference ID 28663801#. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A replay of the call will be available on the company website.

On November 1, 2022 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the company will release its third quarter 2022 financial results and provide a business update on Friday, November 11, 2022 at 8:00 am Eastern Time (Press release, Chemomab, NOV 1, 2022, View Source [SID1234622671]).

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During the event, Chemomab’s management team will review third quarter 2022 performance, discuss recent and upcoming developments and conduct a live question-and-answer session.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, November 11, 2022
Click this Webcast link to access the live webcast or replay.

The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call.

On November 1, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended September 30, 2022 (Press release, Bio-Techne, NOV 1, 2022, View Source [SID1234622670]). The quarterly dividend will be payable November 28, 2022, to all common shareholders of record on November 14, 2022. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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Bio-Techne also announced today that its board of directors has approved and declared a four-for-one split of Bio-Techne’s common stock in the form of a stock dividend to make stock ownership more accessible to employees and investors. Each stockholder of record on November 14, 2022 will receive a dividend of three additional shares of common stock for each then-held share, to be distributed after close of trading on November 29, 2022. Trading will begin on a stock split-adjusted basis on November 30, 2022.