On March 31, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported it is initiating a Dose Response in-vivo Study in mice; results to be included as part of the Product Package to be submitted to the U.S. Food and Drug Administration along with a Pre-IND meeting request (Press release, Cannabics Pharmaceuticals, MAR 31, 2021, View Source [SID1234577461]).

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The Dose Response Study comes in light of previously reported results indicating a 33% reduction in tumor volume and a 35% prolonged survival rate in mice inoculated with human colorectal cancer cells and exposed to Cannabics RCC-33.

Eyal Barad Cannabics Pharmaceuticals co-founder and CEO said: "the entire Cannabics team is filled with enthusiasm as we see our own formula having such promising results on animals. Our priority and attention is in advancing RCC-33 down the clinical and regulatory pathway in a timely and efficient manner to be potentially become a part of the standard of care and treatment regimen for colorectal cancer patients."

On March 31, 2021 Tyra Biosciences, a biotech company targeting acquired resistance in oncology with purpose-built drugs, reported the closing of a $106 million Series B financing to accelerate and expand its in-house drug discovery platform, SNÅP, and to advance its pipeline of novel, small molecule therapies into the clinic.

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The financing is led by new investor Nextech Invest and includes participation from Cormorant Asset Management, BVF Partners, L.P., Janus Henderson Investors, and Logos, as well as returning investors Alta Partners, RA Capital, Boxer Capital of Tavistock Group, and Canaan. Melissa McCracken, Ph.D. from Nextech Invest will join the TYRA Board of Directors.

"We warmly welcome Melissa to our Board of Directors, and the addition of top-tier crossover investors to our strong financing syndicate," said Todd Harris, Founder and Chief Executive Officer of Tyra Biosciences. "At Tyra, we are driven to overcome the desperation faced by patients in the moment their therapy stops working. This financing enables the acceleration and expansion of our mission to deliver therapies that are purpose-built for each new acquired resistance, so that for patients living with cancer, there is always a new hope."

With this raise, TYRA also announces the expansion of its executive leadership team, including:
— Hiroomi Tada, MD, Ph.D., Chief Medical Officer
— Piyush Patel, Ph.D., Chief Development Officer; and
— Robert L. Hudkins, Ph.D., promoted to Chief Technology Officer.

"Tyra has assembled a dynamic and experienced team that is bringing unprecedented speed, clarity, and focus to structure-based drug discovery through purposeful process optimization and prioritization of real-world, empirical data," said Dr. McCracken, Principal at Nextech Invest. "I am pleased to join the Board of Directors at Tyra, which is well positioned to deliver on their vision of accelerating the development of new therapies targeting acquired resistance in oncology."

TYRA’s in-house discovery engine, SNÅP, enhances traditional structure-based drug discovery through the generation of rapid and sequential "structural SNÅPshots" that enable the empirical (observational) evaluation of atomic-level interactions between drug and target.

"At Tyra, we’ve built in-house tools and expertise to shorten the timeline for generating crystal structures, deep cellular profiles, and data from in vivo models to days rather than weeks," said Robert Hudkins, Ph.D., Chief Technology Officer at Tyra Biosciences. "This vast amount of empirical data forms comprehensive ‘structural SNÅPshots’ that we use to refine molecular designs down to the tenth of an angstrom on a weekly cycle."

The first drug candidates developed using the SNÅP platform are expected to be nominated for development in 2021 and advance to the clinic in 2022.

"The rigor, fidelity, and speed of the SNÅP platform drives rapid discovery cycles towards novel drug candidates differentiated through achieving precise structural fit to their targets," said Hiroomi Tada, MD, Ph.D., Chief Medical Officer at Tyra Biosciences. "I am excited to join Tyra at this early stage to ensure that this ethos is extended to our approach to clinical development as we relentlessly advance new therapies for patients."

On March 31, 2021 Cancer Genetics, Inc. (the "Company" or "CGI") (Nasdaq: CGIX), an emerging leader in novel drug discovery techniques, and StemoniX, Inc. ("StemoniX"), a company empowering the discovery of new medicines through the convergence of novel human biology and software technologies, reported their recently approved transaction has closed, and in connection with the merger, Cancer Genetics, Inc. was renamed Vyant Bio, Inc. ("Vyant Bio") effective March 30, 2021 (Press release, Cancer Genetics, MAR 31, 2021, View Source [SID1234577445]). StemoniX will operate as a wholly-owned subsidiary of the Company.

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Vyant Bio will be traded on the Nasdaq under the symbol VYNT beginning on March 31, 2021. The name and ticker change will align the Company’s strategic focus on the creation of a leading biotechnology and drug discovery platform business.

Vyant Bio is now positioned to integrate human-powered scientific and technology-based systems with years of preclinical experience to de-risk and accelerate discovery and development of preclinical and clinical pipelines for biopharma partners as well as for the Company’s proprietary pipeline. The merger of the two companies represents a bold new chapter in drug discovery, creating a unique platform using in vivo, in vitro, and in silico technologies to identify repurposed and novel therapeutics to fight diseases in neurology, oncology, and cardiology.

The merger has attracted highly experienced board and management team members who share a vision of creating world-class capabilities. Management teams from both companies will join forces for Vyant Bio, led by health science veteran Jay Roberts, who will serve as Chief Executive Officer, innovation thought-leader Ping Yeh, Vyant Bio’s new Chief Innovation Officer, and Andrew LaFrence, incoming Chief Financial Officer, an accomplished public company financial executive and former KPMG audit partner.

"Vyant Bio will now jumpstart an exciting clinical pipeline of therapeutics from its Drug Discovery Engine for purposes of out-licensing to partners worldwide," stated Jay Roberts. "We worked tirelessly throughout 2020 and Q1 2021 to identify and complete this merger with StemoniX and are very excited to bring the best of these two companies together in a shared culture and vision for the future – to create safer and more effective therapeutics and meaningful shareholder value."

"We are very pleased to be announcing the new name and branding initiative. Vyant Bio was created as it represents a vital, vibrant, innovative new force in drug discovery, derived from the French words "vie" and "avant" – together, they represent our mission to transform lives with new treatments derived from leading-edge science and technology. We believe the combined companies create a new path for innovation, with a human-powered approach that will de-risk and accelerate decision making to more rapidly bring important therapeutics to patients," said Ping Yeh.

Under the terms of the merger agreement, the Company will issue an aggregate of 17,977,272 shares of its common stock to the former holders of StemoniX common stock, preferred stock, convertible notes and certain warrants. It will also issue options to purchase an aggregate of 893,179 shares of Common Stock to the holders of StemoniX options and warrants expiring in 2026 to purchase 143,890 shares of Common Stock to the holder of a StemoniX warrant.

Immediately after the merger, there were approximately 28,984,458 million shares of Common Stock of the Company outstanding.

H.C. Wainwright & Co. acted as financial advisor to Cancer Genetics, Inc., and Lowenstein Sandler LLP served as legal counsel to Cancer Genetics. Roth Capital Partners and Northland Capital Markets acted as financial advisors to StemoniX, and Taft Stettinius & Hollister LLP served as legal counsel to StemoniX.

A Current Report on Form 8-K containing more detailed information regarding the merger transaction will be filed with the Securities and Exchange Commission.

On March 31, 2021 Gracell Biotechnologies Inc. (NASDAQ:GRCL)("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the company has entered into a Manufacturing Service Agreement (MSA) with Lonza (SIX:LONN) for clinical manufacturing of Gracell’s FasTCAR-enabled CAR-T cell product candidates in the U.S (Press release, Gracell Biotechnologies, MAR 31, 2021, View Source [SID1234577462]).

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Gracell is advancing its innovative CAR-T pipeline globally for difficult-to-treat cancers, including its lead program for GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma. This autologous CAR-T product candidate is manufactured on Gracell’s proprietary FasTCAR technology platform, which significantly reduces the manufacturing time from an industry norm of two to six weeks down to next day. Gracell will leverage Lonza’s integrated services in CAR-T manufacturing and establish state of the art cGMP process, a critical component of Gracell’s IND enabling clinical development programs.

"Gracell has developed some highly innovative CAR-T manufacturing platforms, including our FasTCAR platform enabling next day manufacturing of autologous CAR-T products. With Lonza’s experience in CAR-T therapy manufacturing and excellent reputation, they are an ideal strategic collaborator for advancing our pioneering, proprietary FasTCAR platform globally," stated Dr. William Wei Cao, Chief Executive Officer of Gracell. Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, added, "We are pleased to enter into this collaboration with Lonza and are currently building our international presence, including clinical operations to advance our product candidates and bring them to more patients globally. We are hoping to expand our programs in close collaboration with Lonza’s capabilities. In addition, we look forward to a strategic relationship with Lonza to support IND-filing and clinical manufacturing in the U.S."

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

On March 31, 2021 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, reported financial results and for the year ended December 31, 2020 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 31, 2021, View Source [SID1234577489]).

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"Despite the challenging landscape presented by the ongoing pandemic, this past year has been one of continued execution for Mereo, and I believe that 2020 was a highly successful and exciting year for the Company," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "We were able to further strengthen our partnering portfolio with licensing agreements for setrusumab and navicixizumab, with significant milestone payments tied to each deal. Our internal pipeline has continued to progress with etigilimab currently in a Phase 1b/2 basket study and alvelestat in a Phase 2 POC study for patients with AATD as well as a Phase 1 study in patients with COVID-19. Since the beginning of 2020, we successfully raised a total of $183 million (£138 million) through a combination of private placements, convertible loan notes and most recently a public offering in February 2021. The proceeds from these financing events, coupled with the upfront payments under the setrusumab and navicixizumab licensing agreements, will fund the continued advancement of our clinical programs and allow us to continue focusing on execution of our clinical and operational development strategies. As we look toward 2021, I believe that the Company is well positioned to deliver on multiple milestones and build upon the momentum we generated in 2020 as we continue to advance to our goal of becoming a leading biopharmaceutical company developing innovative therapeutics to improve outcomes for patients with rare diseases and select oncology indications."

Recent Product Highlights and Developments

Etigilimab (OMP-313M32)

Initiated Phase 1b/2 basket study in combination with an anti-PD-1 in a range of tumor types
Initial data expected second half 2021
Alvelestat (MPH-966)

Ongoing Phase 2 trial in 165 patients with AATD
Data expected in late 2021
Initiated Phase 1 study for the treatment of COVID-19 – data expected second half 2021
Setrusumab (BPS-804)

Rare pediatric disease designation in September 2020
Announced partnership with Ultragenyx for the development of setrusumab for the treatment of patients with OI in December 2020
Navicixizumab (OMP-305B83)

In January 2020 completed a global license agreement with OncXerna Therapeutics (formerly Oncologie, Inc.) for the further development and commercialization of navicixizumab.
Corporate Updates

Strengthened Management team

John Lewicki, PhD appointed Chief Scientific Officer, and Ann Kapoun, PhD appointed SVP Translational R&D, June 2020
Christine Fox appointed Chief Financial Officer, and Heidi Petersen appointed SVP Regulatory Affairs, October 2020
Suba Krishnan, M.D. appointed Senior Vice President of Clinical Development, November 2020
Delisted From AIM

Officially delisted from the AIM market of the London Stock Exchange on December 18, 2020
The Company’s American Depositary Shares ("ADSs") remain listed, and are only tradeable on Nasdaq
Upcoming Events

Needham Healthcare Conference, April 12-15, 2021
Jefferies Healthcare Conference, June 1-4, 2021
Full Year 2020 Financial Results

Full year 2020 research and development expenses were £16.3 million, compared to £23.6 million in 2019. R&D expenses relating to setrusumab decreased by £6.0 million, or 44%. The decrease was driven primarily by the completion of the adult Phase 2b study which reported top-line data in November 2019, with a further update in January 2020. Following the licensing and collaboration agreement with Ultragenyx, future ongoing development costs for setrusumab are expected to decrease significantly. R&D expenses relating to alvelestat remained consistent, reflecting the ongoing Phase 2 proof-of-concept study. R&D expenses relating to leflutrozole decreased by £1.0 million, or 88%, due to the completion of the Phase 2b study in 2019 and limited activity in 2020 following the completion of the study. Similarly, there were no ongoing studies for acumapimod in 2020 and this resulted in a decrease in R&D expenses for acumapimod of £0.3 million, or 72%. Partially offsetting the decrease, R&D expenses relating to etigilimab increased by £0.3 million, or 34%. The increase was driven primarily by the costs associated with preparing for the open label Phase 1b/2 basket study in combination with an anti-PD-1 in a range of tumor types. We expect the costs related to the etigilimab program to increase significantly in 2021.

Administrative expenses increased by £5.3 million, or 33%, from £15.9 million in 2019 to £21.2 million in 2020. The increase was primarily due to incremental legal and professional fees associated with various transactions during the year. Professional and legal fees increased from £1.7 million to £6.9 million in 2019 and 2020, respectively. The increase reflects transaction costs associated with the June 2020 Private Placement and the cancellation of admission of our ordinary shares to trading on the AIM market of London Stock Exchange in December 2020, along with higher costs associated with the Nasdaq listing and managing a larger business in two jurisdictions following the acquisition of Mereo BioPharma 5, partially offset by intellectual property related costs as a result of lower activity associated with setrusumab. Employee-related costs increased by £1.5 million to £7.3 million in 2020 primarily due to the expansion of our management team in 2020 compared to 2019. Premises-related costs increased by £1.7 million in 2020 primarily due to transaction costs associated with renegotiation of our office lease in Redwood City. This was partially offset by a gain on lease modification of £0.9 million. Offsetting these increases were lower travel-related costs, which decreased by £0.5 million from 2019 due to COVID-19 travel restrictions.

Net loss attributable to equity holders for the year 2020 was £163.6 million, compared to a net loss of £34.8 million in 2019, reflecting an operating loss of £37.6 million, a loss of £109.8 million due to changes in the fair value of financial instruments and a £10.9 million loss on disposal of intangible assets.

Total ordinary shares outstanding at December 31, 2020 were approximately 339 million shares. Total ADSs outstanding at December 31, 2020 were approximately 67.7 million, with each ADS representing five ordinary shares of the Company.

Cash and short-term deposits totaled £23.5 million as of December 31, 2020. Mereo anticipates that its current cash and short-term deposits, which includes the upfront payment received under the collaboration and license agreement with Ultragenyx and our recently completed public offering in February 2021, will extend the Company’s runway into 2024.