On August 3, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will virtually participate in the following investor conferences in August (Press release, CytomX Therapeutics, AUG 3, 2022, View Source [SID1234617407]).

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BTIG Biotechnology Conference 2022
Date: Tuesday, August 9, 2022

2022 Wedbush PacGrow Healthcare Virtual Conference
Date: Wednesday, August 10, 2022
Panel Discussion: 2:20 p.m. ET

A live webcast of the Wedbush panel discussion will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On August 3, 2022 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the second quarter ended June 30, 2022 (Press release, Vanda Pharmaceuticals, AUG 3, 2022, View Source [SID1234617426]).

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"During the second quarter we made significant progress towards commercializing our products and improving access to HETLIOZ for patients with Non-24," said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. "We advanced our clinical pipeline, with significant clinical milestones expected in the coming quarters, and we are preparing our NDA for tradipitant in gastroparesis and our sNDA for HETLIOZ in insomnia."

Financial Highlights

Second Quarter of 2022

Total net product sales from HETLIOZ and Fanapt were $64.4 million in the second quarter of 2022, a 5% decrease compared to $67.9 million in the second quarter of 2021.

HETLIOZ net product sales were $41.2 million in the second quarter of 2022, a 7% decrease compared to $44.5 million in the second quarter of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.

Fanapt net product sales were $23.2 million in the second quarter of 2022, a 1% decrease compared to $23.4 million in the second quarter of 2021.

Net income was $2.6 million in the second quarter of 2022 compared to $9.7 million in the second quarter of 2021.
First Six Months of 2022

Total net product sales from HETLIOZ and Fanapt were $124.6 million in the first six months of 2022, a 5% decrease compared to $130.6 million in the first six months of 2021.

HETLIOZ net product sales were $78.2 million in the first six months of 2022, a 7% decrease compared to $83.9 million in the first six months of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.

Fanapt net product sales were $46.4 million in the first six months of 2022, a 1% decrease compared to $46.7 million in the first six months of 2021.

Net loss was $3.9 million in the first six months of 2022 compared to net income of $18.3 million in the first six months of 2021.

Cash, cash equivalents and marketable securities (Cash) was $440.9 million as of June 30, 2022, representing an increase to Cash of $44.4 million compared to June 30, 2021.
Key Operational Highlights

HETLIOZ (tasimelteon)

Clinical trials for HETLIOZ in delayed sleep phase disorder (DSPD) and sleep disturbances in autism spectrum disorder (ASD) are currently enrolling patients.

Vanda is preparing for the submission of a supplemental New Drug Application (sNDA) for HETLIOZ in the treatment of insomnia.

Since November 2021, more than 15 states have revised or agreed to revise their Medicaid prior authorization criteria to broaden access to HETLIOZ for patients with Non-24 and patients with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).

In July 2022, an Administrative Law Judge struck down a Medicare Part D plan policy that blocked HETLIOZ coverage for sighted Non-24 patients. Vanda intends to advocate with other Part D plans to challenge similar policies and improve HETLIOZ access for Non-24 patients.

In January 2022, Vanda settled its HETLIOZ patent litigation against one of the Abbreviated New Drug Application (ANDA) defendants. The trial for the consolidated lawsuit against the remaining defendants was held in March 2022. A decision is expected from the court by the end of 2022.
Tradipitant

Vanda is continuing to conduct an open-label safety study for tradipitant in gastroparesis and continues to receive requests from patients seeking access to tradipitant through the Expanded Access program that has multiple patients who have taken tradipitant for more than a year.

Vanda recently held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned New Drug Application (NDA) submission for tradipitant in the short-term treatment of nausea in gastroparesis. Vanda is preparing for the submission of the NDA for this indication.

The Phase III study of tradipitant in the treatment of motion sickness is approximately 30% enrolled.
Fanapt (iloperidone)

Enrollment of the Phase III clinical study of Fanapt in acute manic episodes in patients with bipolar disorder is close to being fully enrolled. The study is a placebo controlled four-week evaluation of approximately 400 patients at sites in the U.S. and Europe. Results are expected by the end of 2022.
VQW-765

The Phase II clinical study of a single-dose treatment of VQW-765 to alleviate social/performance anxiety is fully enrolled. Results are expected by the end of 2022.
GAAP Financial Results

Net income was $2.6 million in the second quarter of 2022 compared to net income of $9.7 million in the second quarter of 2021. Diluted net income per share was $0.05 in the second quarter of 2022 compared to diluted net income per share of $0.17 in the second quarter of 2021.

Net loss was $3.9 million in the first six months of 2022 compared to net income of $18.3 million in the first six months of 2021. Diluted net loss per share was $0.07 in the first six months of 2022 compared to diluted net income per share of $0.32 in the first six months of 2021.

2022 Financial Guidance

Conference Call

Vanda has scheduled a conference call for today, Wednesday, August 3, 2022, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2022 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 4304469. A replay of the call will be available on Wednesday, August 3, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, August 10, 2022 at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 4304469.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

On August 3, 2022 Advanced Proteome Therapeutics Corporation (TSXV: APC) (FSE: 0E81) ("APC" or the "Company") reported that the United States Patent and Trademark Office has issued a patent to its US subsidiary, Advanced Proteome Therapeutics Inc. ("APTI") (Press release, Advanced Proteome Therapeutics, AUG 3, 2022, View Source [SID1234622591]).

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On August 2, 2022, APTI was issued U.S. Patent No. 11,400,165 titled ‘Composition and method for modifying polypeptides’. The patent covers highly site-selective antibody conjugate compositions produced with APTI’s two-step conjugation technology including the half-product of the first step and final antibody-drug conjugate (ADC) product of the second step. The claims broadly cover antibodies as a class and different classes of payloads including toxins, drugs and chelators. The patent term, including patent term adjustment, is expected to extend into November 2039. This is the first patent issued under US patent application 16/180,960. APTI is continuing to pursue expanded claims and additional patents within the initial application in order to create additional layers of intellectual property protection.

Dr. Benjamin Krantz, President and CEO of APTI commented, "The issuance of this patent is a critical milestone for APTI. The patent provides market exclusivity to highly site-selective ADC compositions that are created with our two-step antibody conjugation approach. This protection greatly enhances our ability to monetize our invention and increases our attractiveness to potential collaborators. This is another step forward in our 2022 plan and I look forward to other successes in the near future."

On August 3, 2022 GSK plc (LSE/NYSE: GSK) reported that its wholly owned subsidiary, GSK Finance (No.3) plc, is offering to repurchase for cash any and all of its outstanding Exchangeable Senior Notes due 2023 (CUSIP No. 36259 RAA0) (Press release, GlaxoSmithKline, AUG 3, 2022, View Source [SID1234617325]).

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Pursuant to the offer, each holder may require the notes’ issuer to repurchase all or part of such holder’s notes at a price equal to 100% of principal amount. Holders may exercise their right to require the repurchase of notes through 5:00 p.m. ET on 16 September, 2022. As of the date of this notice, approximately $280 million aggregate principal amount of the notes is outstanding.

The offer to repurchase is being made on the terms and subject to the conditions set forth in the indenture governing the notes and the notice of offer to repurchase that has been delivered to holders of the notes. This press release is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell the notes or any other securities.

On August 3, 2022 Aeterna Zentaris Inc. (Nasdaq: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the second quarter ended June 30, 2022 and recent highlights (Press release, AEterna Zentaris, AUG 3, 2022, View Source [SID1234617357]).

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"Throughout the quarter, we continued to execute against our strategic priorities," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "As we look ahead, we are laser focused on building on the positive momentum we’ve achieved across our therapeutics, diagnostics and vaccine development pipelines, all with an eye towards generating value in the near and long term for our valued stakeholders."

Recent Highlights

Announced that licensing partner, Consilient Health, launched Ghryvelin (macimorelin) for diagnosing adult growth hormone deficiency (AGHD) in Europe;
Achieved proof-of-concept for the treatment of neuromyelitis optica spectrum disorder (NMOSD) with AIM Biologicals program in animal experiments; and
Entered into a research and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane, Australia, to advance the development of macimorelin as a potential therapeutic for the treatment of Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig’s Disease).
Results of operations for the three-month period ended June 30, 2022
All amounts in this press release are in U.S. dollars unless otherwise noted.

For the three-month period ended June 30, 2022, we reported a consolidated net loss of ($4.2 million), or ($0.87) net loss per common share (basic), as compared with a consolidated net loss of ($2.1) million, or ($0.43) net loss per common share (basic) for the three-month period ended June 30, 2021. The $2.1 million increase in net loss is primarily due to an increase of $0.7 million in total operating costs, $1.8 million decline in total revenues and offset by favorable foreign currency exchange rates of $0.4 million.

Revenues

Our total revenue for the three-month period ended June 30, 2022 was ($0.2) million as compared with $1.6 million for the same period in 2021, representing a decline of $1.8 million. The 2022 revenue was comprised of ($0.2) million in licensing revenue (2021 – $0.5 million), ($0.1) million in development revenue (2021 – $1.0), $0.03 million in supply chain revenue (2021 – $0.04 million), $0.02 million in royalty income (2021 – $0.2 million).

Our negative revenue balances for the quarter are driven by revenue reversals associated with the DETECT project. Using management’s best estimate, we determined the additional overall costs associated with the project and its effect on the accounting treatment from a revenue recognition perspective. These additional costs are attributed to the Ukraine/Russia conflict and its delays on the project, reducing the amount of revenue recordable within the quarter.
Operating expenses

Our total operating expense for the three-month period ended June 30, 2022 was $4.5 million as compared with $3.7 million for the same period in 2021, representing an increase of $0.8 million. This increase arose primarily from a $0.6 increase research and development, $0.2 million increase in general and administrative expenses.
Net finance (costs) income

Our net finance (costs) for the three-month period ended June 30, 2022 was $0.5 million as compared with net finance income of $0.1 million for the same period in 2021, representing an increase in net finance income of $0.4 million.
The Company had $58.2 million cash and cash equivalents at June 30, 2022 (December 31, 2021 – 65.3 million).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the second quarter, as well as the Company’s unaudited consolidated interim financial statements as of June 30, 2022, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

Nasdaq Update

The Company is pleased to announce that, on August 3, 2022, the Company received notice of compliance from Nasdaq (the Compliance Notice), confirming the Company’s continued listing on Nasdaq. As previously announced to shareholders, notwithstanding the successful completion of the Company’s share consolidation on July 21, 2022, due to the timing of the share consolidation, the Company did not meet the Minimum Bid Requirement that required the Company’s common shares to trade above $1.00 per share for a minimum of ten trading days on or before July 25, 2022. As a result of this technical non-compliance, the Company had received notice of delisting on July 28, 2022. The Compliance Notice confirms that the Company is currently in compliance with those Nasdaq listing requirements.