On May 19, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the first quarter 2020 (Press release, Cue Biopharma, MAY 19, 2020, View Source [SID1234558278]).

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"We have successfully maintained momentum in meeting our business goals and clinical trial objectives for the first quarter and early second quarter of 2020, despite the rapid onset of COVID-19 and the many challenges it has presented," said Daniel Passeri, chief executive officer of Cue Biopharma. "I am grateful for the dedication of the Cue Biopharma team during this pandemic as we continue to work together and safely execute on our mission of bringing novel therapies to patients with serious diseases."

According to Kerri-Ann Millar, vice president of finance and principal financial and accounting officer of Cue Biopharma, "We successfully navigated the beginning of the pandemic and finished the first quarter of 2020 in a solid financial position which was further strengthened by the successful deployment of an ATM facility in April that enabled us to boost our cash position by an additional $34.3 million."

First-Quarter 2020 Financial Results

The Company reported collaboration revenue of approximately $0.9 million and $0.4 million for the three months ended March 31, 2020 and 2019, respectively.

Research and development expenses were $9.9 million and $8.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in research and development expenses of $1.5 million was primarily due to clinical trial costs related to our on-going CUE-101 mono-therapy trial that was initiated in the latter part of the third quarter of 2019. During the first quarter of 2020, we initiated the manufacturing of CUE-101 to supply our recently announced combination trial of CUE-101 with Merck’s KEYTRUDA which also contributed to the increase in research and development costs.

General and administrative expenses were $3.9 million and $3.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in general and administrative expense of $0.5 million was primarily due to an increase in stock-based compensation expense and legal and accounting fees incurred in the first quarter of 2020 as compared to the same period in 2019.

Recent News & Business Updates

Extended cash runway through an ATM equity offering sales agreement for aggregate proceeds of $34.3 million, net of commissions paid, with Stifel, who acted as sales agent. As of April 30, 2020, the Company had sold 1,824,901 shares of common stock under the sales agreement.

Completed our first analysis of clinical biomarker samples from the CUE-101 Phase 1 clinical trial and the early data provides favorable insights into clinical metrics that bolster our confidence in CUE-101 and our entire IL-2-based CUE-100 series.

Completed a clinical collaboration agreement with Merck in April 2020 to evaluate the combination of CUE-101 with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as a first-line therapy in patients with advanced HPV16+ head and neck cancer in a planned dose-escalation Phase 1 study to be called KEYNOTE-A78.

On May 19, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported financial results for the quarter ended March 31, 2020 (Press release, Ascendis Pharma, MAY 19, 2020, View Source [SID1234558277]).

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"We continue to execute on our vision to build a leading biopharma company. In addition to remaining on track to achieve our corporate milestones for 2020, we continue to expand our organization to support the planned global launch of our first commercial product, TransCon Growth Hormone," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We are preparing to submit our marketing application in the United States in the second quarter and have advanced the European submission now to be in the third quarter."

He continued, "Additionally, we recently reported positive top-line data from the fixed dose, blinded portion of PaTH Forward evaluating TransCon PTH. This portion of the phase 2 trial met its key objectives, marking a major potential advance in helping hypoparathyroidism patients who are in urgent need of an effective PTH replacement therapy. And, with the appointment of Jesper Høiland as Global Chief Commercial Officer, we have added significant commercial expertise related to our growth hormone and PTH product candidates."

Corporate Highlights & Progress

For TransCon hGH, an investigational long-acting prodrug of somatropin (human growth hormone or hGH), remain on track for planned submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second quarter, and a Marketing Authorisation Application (MAA) to the European Medicines Agency now in the third quarter, both for pediatric growth hormone deficiency (GHD).
Submitted an Investigational New Drug (IND) amendment to initiate the global, phase 3 foresiGHt Trial evaluating TransCon hGH in adults with GHD. Enrollment is expected to begin later this year.
Remain on track to initiate a phase 3 trial with TransCon hGH in pediatric GHD in Japan in the fourth quarter.
Received Orphan Drug Designation from the FDA for TransCon hGH as a treatment for GHD.
Announced positive top-line results from the four-week fixed dose, blinded portion of PaTH Forward, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH, an investigational long-acting prodrug of parathyroid hormone (PTH), in adult subjects with hypoparathyroidism. Data showed that within only four weeks TransCon PTH replaced the current standard of care for 82 percent of patients with hypoparathyroidism.
Remain on track to report six-month data from the open-label extension portion of the PaTH Forward Trial during the third quarter, and to initiate a global phase 3 trial of TransCon PTH in North America, Europe and Asia in the fourth quarter.
Remain on track to submit the first IND or equivalent in oncology in the fourth quarter for TransCon TLR7/8 Agonist.
Announced the appointment of Jesper Høiland as Global Chief Commercial Officer. Mr. Høiland has over 25 years of global senior leadership experience in biopharma, including over 20 years of global commercial experience in growth hormone.
Opened the company’s new facility in Redwood City, California to advance its pipeline of oncology programs.
Ended the first quarter 2020 with cash and cash equivalents of €534.4 million.
First Quarter 2020 Financial Results

For the first quarter, Ascendis Pharma reported a net loss of €63.3 million, or €1.32 per share (basic and diluted) compared to a net loss of €53.6 million, or €1.24 per share (basic and diluted) for the same period in 2019.

Revenue for the first quarter was €2.2 million compared to €5.4 million in the same quarter of 2019. The decrease was due to a lower amount of license and service revenue being recognized, partly offset by sale of clinical supply to Visen.

Research and development (R&D) costs for the first quarter were €57.5 million compared to €51.3 million during the same period in 2019. Higher R&D costs in 2020 reflect an increase in personnel-related costs, overhead costs allocated to R&D, and the continued progress in development of the company’s product candidates.

General and administrative expenses for the first quarter were €17.9 million compared to €10.4 million during the same period in 2019. The increase is primarily due to additional personnel-related costs, higher IT and facility costs, and continued build out of the company’s commercial capabilities.

As of March 31, 2020, Ascendis Pharma had cash and cash equivalents of €534.4 million compared to €598.1 million as of December 31, 2019. As of March 31, 2020, Ascendis Pharma had 47,985,837 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2020 financial results. Details include:

Date May 19, 2020
Time 4:30 p.m. ET
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 8295749
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

About Ascendis Pharma’s Pipeline

Ascendis Pharma currently has three product candidates in clinical development in rare endocrine diseases:

TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone or hGH) that releases somatropin with the identical amino acid sequence and size as daily growth hormone, in phase 3 development as a once-weekly treatment for growth hormone deficiency (GHD).
TransCon PTH, an investigational long-acting prodrug of parathyroid hormone (PTH) in phase 2 development as a once-daily replacement therapy for hypoparathyroidism (HP) designed to replace PTH at physiologic levels for 24 hours every day, and address both short-term symptoms and long-term complications of the disease.
TransCon CNP, an investigational long-acting prodrug of C-type natriuretic peptide (CNP) in phase 2 development as a therapy for children with achondroplasia (ACH), the most common form of dwarfism, for which there is no FDA-approved treatment. TransCon CNP is designed to provide continuous exposure of CNP at safe, therapeutic levels via a single, weekly subcutaneous dose.
Additionally, the company has established oncology as its second therapeutic area of focus and plans to submit an IND or equivalent in the fourth quarter of 2020 for its first oncology product candidate.

On May 15, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) reported that it has closed its previously announced non-brokered private placement financing by issuing a total of CAD$2,592,000 10% convertible debentures (Press release, ImmunoPrecise Antibodies, MAY 15, 2020, View Source [SID1234558275]).

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The debentures are unsecured, bear interest at a rate of ten percent (10%) per year, payable annually, and are due May 15, 2022 (which may be repaid early at the option of the Company). The principal amount of the debentures may be convertible, at the option of the holder, into units of the Company at a conversion price of CAD $0.85 per share.

The Company may force convert the principal amount of the debentures at CAD$0.85 per share if the average closing price is equal to or greater than CAD$1.50 for 20 trading days. In order to exercise this right, the Company must issue a news release announcing its intention to exercise this right within 10 business days after the end of the particular 20-day period.

Jennifer Bath, CEO of the Company, subscribed for $175,000 of debentures and Paul Andreola, a director of the Company, subscribed, directly and indirectly, for a total of $229,000 debentures. Participation by these insiders in the private placement is considered a related party transaction pursuant to Multilateral Instrument 61-101 — Protection of Minority Security Holders in Special Transactions. The Company is exempt from the requirements to obtain a formal valuation or minority shareholder approval in connection with the insider’s participation in the private placement in reliance of sections 5.5(a) and 5.7(a) of MI 61-101.

The securities are subject to restrictions on resale expiring on September 16, 2020. The Company paid finders cash commissions totalling $43,000.
Proceeds of the offering will be used to expand operations and sales in the United States, Canada and Europe and working capital purposes.
Resignation of Chief Technical Officer
Chip Wheelock has announced he is resigning as Chief Technical Officer effective immediately. The Board of Directors would like to thank Mr. Wheelock for all of his efforts.
On behalf of the Company.

On May 19, 2020 Vividion Therapeutics, a biotechnology company discovering and developing highly selective small molecule medicines that drug traditionally inaccessible targets, reported that it has entered into an exclusive worldwide option and license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to leverage its proteomics screening platform and proprietary small molecule library to target novel E3 ligases, as well as a range of oncology and immunology therapeutic targets. Roche has the exclusive right to license resulting compounds at different stages of development (Press release, Vividion Therapeutics, MAY 19, 2020, View Source [SID1234558274]).

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E3 ligases are an important class of proteins responsible for directing target proteins to the proteasome for degradation. Small molecules directed to novel E3 ligases with potentially differentiated properties, such as tissue-restricted bioactivity or stronger target recognition, have the potential to unlock a wide range of valuable therapeutic applications.

As part of the agreement, Vividion will be responsible for early drug discovery and pre-clinical development for selected programs. For a subset of such programs, Vividion has the right to conduct clinical development up to proof-of-concept with the option to share development costs and split U.S. profits and losses with Roche.

Vividion will receive $135 million in a cash upfront payment from Roche and is eligible to receive several billion dollars in payments based on the achievement of preclinical, development and commercial milestones, as well as royalties on sales of commercialized products resulting from the collaboration.

"We are thrilled to partner with Roche, marking the second major collaboration for Vividion focused on developing small molecule drugs against promising, untapped therapeutic targets," stated Dr. Diego Miralles, Chief Executive Officer of Vividion. "This collaboration with Roche will further expand a new pillar of our pipeline focused on leveraging distinct E3 ligases to bring cutting-edge treatments to patients in need."

"Our proprietary platform has demonstrated the ability to identify molecules that can drug challenging protein classes, such as transcription factors, adaptor proteins, and E3 ligases," stated Dr. Fred Aslan, President and Chief Business Officer of Vividion. "We look forward to discovering new therapies with Roche while simultaneously advancing our wholly owned pipeline."

"Partnering is a cornerstone of Roche’s research strategy to transform novel ideas into medicines. We are excited about Vividion’s approach to small molecule discovery and are looking forward to working with their team to discover potential new medicines for patients with cancer and immunological diseases," said James Sabry, Global Head of Roche Pharma Partnering

On May 19, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has entered into a research funding and option agreement ("the Agreement") with Scripps Research to advance the development of the XCART technology for B cell malignancies (Press release, Xenetic Biosciences, MAY 19, 2020, https://ir.xeneticbio.com/news/detail/92/xenetic-biosciences-inc-announces-research-and-development-collaboration-with-scripps-research-to-advance-xcarttm-platform [SID1234558271]).

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The XCART platform is a significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, and was originally developed by Scripps Research in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry. XCART is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells.

"We are thrilled to partner with Scripps Research to aid in the development of XCART. Not only are they a leading, world renowned research and development organization, but they are also one of the original developers of the XCART platform," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "We believe that the team at Scripps Research, given their deep knowledge and understanding of the XCART platform, is uniquely qualified to guide key aspects of our preclinical development program. They will also provide method development expertise as the program moves towards process development for clinical manufacturing. We expect this collaboration to be one of the integral elements in our strategy of leveraging academic and development partners to provide operational efficiencies as we drive XCART toward clinical manufacturing and ultimately first-in-human studies."

The XCART technology platform was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor ("BCR") on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor ("CAR"), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

"We are pleased to enter this agreement with Xenetic to participate in the preclinical development of the XCART platform. Our past experience with the technology will suit us well as we work closely with the Xenetic team to advance this platform for B cell malignancies," added Dr. Richard Lerner, Lita Annenberg Hazen Professor of Immunochemistry at Scripps Research.

Under the terms of the Scripps Research agreement, Xenetic will be granted an exclusive license to certain intellectual property arising from the research program in the field of B-cell malignancies, as well as an option to acquire rights and licenses to new intellectual property outside of that field. Xenetic is actively engaged in ongoing discussions to advance the development of XCART through additional collaborations with academic or development partners.