On February 16, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31st, 2020 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 16, 2021, View Source [SID1234579514]).

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"During the past few months, we have continued to accrue pre-clinical data for our lead platform asset, SON-1010. IL-12 has historically been a difficult target given the toxicities associated with its use," commented Pankaj Mohan, Ph.D., Founder and CEO. "To this end, we are increasingly more encouraged that our FHAB technology has the capacity to improve the therapeutic window of IL-12 and will help Sonnet position the SON-1010 asset as a potentially viable therapeutic candidate of significant value to patients and physicians."

First Quarter FY 2021 and Recent Corporate Updates
Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed a single- and multiple-dose non-human primate (NHP) study with SON-1010, the Company’s proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured using the Fully Human Albumin Binding (FHAB) platform. These two studies help to inform and de-risk the design of follow-on NHP studies needed to file an IND with the FDA. Importantly, the data demonstrated a well-tolerated agent with interferon-γ levels suggesting potent on-target activity. The Company will present additional data from the NHP studies at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting in April. The Company plans to file an IND and initiate Phase 1 clinical development in SON-1010 in the second half of 2021.

In SON-080 (low-dose recombinant fully human Interleukin 6, or IL-6), the Company is planning to file an IND and initiate Phase 1b/2a pilot efficacy clinical trials during the second half of 2021 for Chemotherapy Induced Peripheral Neuropathy (CIPN), followed by a Phase 1b/2a pilot efficacy trial for Diabetic Peripheral Neuropathy (SON-081) in 2022.

The previously announced letter of intent to negotiate a licensing agreement with New Life Therapeutics with respect to SON-080 and SON-081 continues on-track. The Company expects to finalize this agreement during the first quarter of 2021.

Sonnet is also developing SON-1210 (IL15-FHAB-IL12), the Company’s lead bispecific construct combining FHAB with fully human IL-12 and fully human Interleukin 15 (IL-15), for solid tumor indications, including colorectal cancer. An IND submission for SON-1210 is expected during the second half of 2021.

Fiscal 2021 First Quarter Ended December 31, 2020 Financial Results

Jay Cross, CFO, commented, "Our cash management strategies have been successful over the past quarter, but more importantly we have recently begun to draw from our ATM offering program, strengthening our balance sheet. With the ATM open, we also decided to close the share subscription facility."

As of December 31, 2020, Sonnet had $2.3 million cash on hand.
As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. As of today, the Company has sold 380,199 shares for net proceeds of $1.1 million to Sonnet.
All of the Company’s previously outstanding Series A and Series B warrants (except for approximately 42 thousand Series B warrants) have been exercised. The Company has 11.3 million Series C Warrants outstanding with an exercise price of $3.19 that will expire on October 16, 2025. In the event all the Series C Warrants were exercised for cash, the Company would receive up to an additional $36.1 million.
Research and development expenses were $3.9 million for the three months ended December 31, 2020, compared to $1.4 million for the three months ended December 31, 2019. The increase of $2.5 million was primarily due to the development of the cell line for IL12-FHAB and IL12-FHAB-IL15 manufacturing and increased costs for research and development activities due to the acquisition of Relief Therapeutics SA, including an increase in payroll and share-based compensation expense as the Company expanded its operations.
General and administrative expenses were $2.0 million for the three months ended December 31, 2020, compared to $1.1 million for the three months ended December 31, 2019. The increase of $0.9 million was primarily due to an increase in insurance expenses related to directors and officer’s insurance, and an increase in payroll and share-based compensation expense as the Company expanded its operations to support its overall business objectives.
The $20 million share subscription facility that was previously in place has been terminated.

On February 16, 2021 Artios Pharma ("Artios"), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, reported it is scheduled to participate in the following upcoming virtual conferences (Press release, Artios Pharma, FEB 16, 2021, View Source [SID1234578233]):

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LifeSci Partners Precision Oncology Day

17 February 2021

Niall Martin, Chief Executive Officer at Artios Pharma will present an overview of the company at 10.00am ET.

A replay of the presentation will be available to view after the conference on the Artios website.

10th Annual SVB Leerink Virtual Global Healthcare Conference

22 -26 February 2021

Niall Martin, Chief Executive Officer, Tania Dimitrova, Chief Business Officer, and Abid Ansari, Chief Financial Officer will participate in 1 x 1 meetings.

Barclays Healthcare Conference 2021

9 -11 March 2021

Tania Dimitrova, Chief Business Officer at Artios Pharma will present an overview of the company at 9.45am ET on Tuesday 9 March.

Niall Martin, Chief Executive Officer, Tania Dimitrova, Chief Business Officer, and Abid Ansari, Chief Financial Officer will participate in 1:1 meetings.

A replay of the presentation will be available to view after the conference on the Artios website.

On February 16, 2021 Cend Therapeutics, Inc., a clinical-stage biotech company, and Qilu Pharmaceutical, a major Chinese pharmaceutical company, reported that the companies have entered a Collaboration and License Agreement to develop and commercialize Cend’s investigational drug, CEND-1, in Greater China (Press release, CEND Therapeutics, FEB 16, 2021, View Source [SID1234575230]).

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Cend presented favorable clinical results at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) meeting September 2020 and is advancing into Phase 2 clinical trials in pancreatic cancer with CEND-1 in combination with gemcitabine and nab-paclitaxel. The Company is planning registration clinical trials in pancreatic cancer and will explore combinations with additional therapies, including immunotherapies, as well as expansion of its programs into additional solid tumor cancers.

"This partnership with Qilu will help us bring our treatment to patients with pancreatic and other solid tumor cancers in China. This collaboration will also speed global development to bring the treatment to market expeditiously. Qilu’s excellent development team and market position will position CEND-1 for success in China," commented David Slack, CEO of Cend.

"CEND-1 has generated encouraging clinical results in combination with standard of care chemotherapy for the treatment of pancreatic cancer, which remains a significant health issue in China. We are pleased to work with Cend to advance this program and explore broader potential applications for CEND-1," commented Oliver Kong, MD, Chief Medical Officer and Corporate Vice President of Qilu.

About the Qilu-Cend Partnership

In the Collaboration and License Agreement, Qilu will gain exclusive rights to CEND-1 in Greater China, including Taiwan, Hong Kong and Macau. Qilu will take on development as well as commercialization responsibilities within Greater China. Cend will continue to retain all rights outside of Greater China. Qilu will pay Cend an up-front license fee of US$10 million. Cend will be eligible to receive up to $225 million in milestones as well as tiered double digit royalties on product sales in the region.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumors by its affinity for alpha-v integrins, which are selectively expressed in tumors but not normally expressed in healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by protease expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors. CEND-1 has also been shown to further modify the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and to increase the number of cancer-fighting immune cells within the tumor, potentially enabling patients’ immune systems or immunotherapies to more effectively fight cancer.

On February 16, 2021 Centessa Pharmaceuticals ("Centessa") reported as a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated program (Press release, Centessa Pharmaceuticals, FEB 16, 2021, View Source [SID1234575227])s. Centessa’s asset-centric R&D model applied at scale has assembled best-in-class or first-in-class assets, each of which is led by specialized teams committed to accelerate development and reshape the traditional drug development process. The company was founded by Medicxi and raised $250 million in an oversubscribed Series A financing led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Wellington Management Company, BVF Partners L.P., EcoR1 Capital, Franklin Templeton, Logos Capital, Samsara BioCapital, LifeSci Venture Partners and an undisclosed U.S.-based, healthcare-focused fund.

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In conjunction with its launch, Centessa has completed the merger of 10 private biotech companies ("Centessa Subsidiaries") that will each continue to develop its assets with oversight from the Centessa management team. Each Centessa Subsidiary team is asset-focused, in that it prosecutes a single program or biological pathway, with leadership provided by subject matter experts who are given a high degree of autonomy to advance each program. With a singular focus on advancing exceptional science, combined with proprietary capabilities, including structure-based drug discovery and design, the subsidiary teams enable Centessa to potentially develop and deliver impactful medicines to patients.

"The vision of Centessa is to build a pharmaceutical company with a unique operational framework that aims to reduce some of the key R&D inefficiencies that classical pharmaceutical companies face because of structural constraints," said Francesco De Rubertis, Ph.D., Co-Founder and Partner at Medicxi and Chairman of the Centessa Pharmaceuticals Board of Directors. "Our operations will be driven by an asset-centric approach, whereby each Centessa Subsidiary is solely focused on the execution of its programs with oversight from the highly experienced Centessa management team. The ambition of applying asset centricity at scale is to be able to deliver life altering medicines to patients with improved efficiency by boosting R&D productivity."

Our Approach
Centessa brings together 10 companies from Medicxi’s portfolio with 15 high conviction programs led by experienced teams. Each Centessa Subsidiary is led by industry leaders and subject matter experts with deep experience directly related to key biological pathways that underpin the programs being advanced. These entrepreneurs who have catalyzed the creation of subsidiary companies will continue to advance novel science within the Centessa enterprise.

The Centessa Subsidiaries are comprised of ApcinteX, Capella BioScience, Janpix, LockBody, Morphogen-IX, Orexia Therapeutics, Palladio Biosciences, PearlRiver Bio, Pega-One and Z Factor. The current Centessa Pharmaceuticals portfolio consists of four clinical stage programs, including two that are in late-stage clinical development, and more than 10 additional programs spanning diseases with high unmet need across oncology, hematology, immunology, inflammation, neuroscience and rare diseases.

"With this first-of-its-kind model, we are bringing together programs with robust genetic and biological validation under one new pharmaceutical company that provides centralized resources to enable and empower asset-focused teams to advance highly impactful programs for patients," said Saurabh Saha, M.D., Ph.D., Centessa’s Chief Executive Officer. "This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions."

Centessa will have the flexibility to deploy capital by adhering to a "follow-the-data" philosophy and will support each Centessa Subsidiary with centralized capabilities that enable advancement of its respective programs. These include manufacturing, regulatory and operational support to enable and expedite scientific prosecution of programs by subsidiary teams. Each team is uniquely incentivized to expeditiously interrogate key scientific hypotheses.

Moncef Slaoui, Ph.D, Chief Scientific Officer, Advisor of Centessa added, "In creating Centessa, we have strategically assembled our subsidiary portfolio to include programs with strong biological validation, mechanistic diversification, and teams with proprietary capabilities and insights. This high-quality portfolio aims to deliver enhanced diversification, reduced risk and asymmetric upside with a view to withstanding the inherent low probability of success associated with drug development."

Meet the Team
The Centessa Pharmaceuticals management team consists of biotech and pharmaceutical industry leaders who oversee decisions related to capital allocation, development plans and strategic transactions in partnership with the Centessa Subsidiaries.

Saurabh Saha, M.D., Ph.D., former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, has been appointed as the company’s Chief Executive Officer and a member of the Board of Directors. In addition, Moncef Slaoui, Ph.D., former Chief Scientific Advisor of Operation Warp Speed, former Chairman of R&D at GlaxoSmithKline, and Partner at Medicxi, has been appointed as Chief Scientific Officer, Advisor.

The Centessa Board of Directors includes Francesco De Rubertis, Ph.D., Medicxi, who will serve as the company’s Chairman; Aaron Kantoff, Medicxi; Brett Zbar, M.D., General Atlantic; and Arjun Goyal, M.D., M.Phil., Vida Ventures.

"We believe Centessa represents a unique opportunity in our sector," said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic. "The high-quality science and entrepreneurial drive within each of the Centessa Subsidiaries, combined with this deeply experienced leadership team, has the potential to bring important medicines to patients with speed and efficiency."

"Centessa’s bold vision and unique operating model are supported by compelling clinical programs, strong data and a stellar team," said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director at Vida Ventures. "We believe Centessa’s approach can ultimately lead to impactful medicines that will benefit patients globally."

On February 16, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its fourth quarter and full year 2020 financial results on Thursday, February 25, 2021 before the U.S. financial markets open (Press release, Compugen, FEB 16, 2021, View Source [SID1234575160]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.