On March 25, 2021 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio‐delivery and biodistribution of medicines, reported the Company has agreed non‐binding Heads of Terms for the co‐development of MTX110 and its unaudited headline results for the year ended 31 December 2020 (Press release, Midatech Pharma, MAR 25, 2021, View Source [SID1234577158]).

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MTX110 ‐ Non‐binding Heads of Terms
On 26 January 2021, the Company announced that it was engaged in tentative discussions with a third party around the potential co‐development of MTX110. These discussions have now advanced and a non‐binding Heads of Terms has been agreed.

The Heads of Terms envisage that, if the deal progresses to definitive agreements, the Company would expect to receive a modest upfront payment upon execution, success‐based development and sales milestones and royalties typical for a licensing agreement with products in a similar stage of development. R&D expenses would be assumed by the two parties with the apportionment to be agreed based on their respective territories. There can be no assurance on the timing for concluding these discussions nor any assurance that the parties will enter into definitive agreements. Further announcements will be made in due course, as appropriate.

Unaudited 2020 Headline Results
In March 2020, the Company announced a strategic review of its operations which led to the termination of further in‐house development of MTD201, closure of its Spanish subsidiary, Midatech Pharma España SL ("MPE"), and the MTD201 dedicated manufacturing facilities in Bilbao, Spain.

The closure of MPE resulted in an immediate halving of the Company’s cash burn rate and significant savings in R&D and administrative expenses going forward. Included in the unaudited headline results for 2020 are R&D expenses and administrative costs of £2.8 million and £1.1 million, respectively, in respect of MPE.

Also in connection with the termination of MTD201, the Company has recognised a non‐cash impairment loss in 2020 for in‐process development of £9.3 million and goodwill of £2.3 million. In addition, in connection with the purported termination of the Company’s licence for panobinostat from Secura Bio, Inc. in June 2020, the Company has recognised a non‐cash impairment of an intangible asset relating to the licence agreement of £0.8 million as of 31 December 2020.

Midatech’s headline unaudited results, including MPE, for the year ended 31 December 2020 compared with the prior yearare as follows:

Year ended 31 December

The Company expects to publish its audited results for the year ended 31 December 2020 by the end of April 2021.

The Company’s consolidated financial statements for the financial year ended 31 December 2020 (the "Period") are not yet available and our independent registered public accounting firm, Mazars LLP, has not completed its audit of the consolidated financial statements for the Period. The Company’s expectations with respect to its unaudited results for the Period are based upon management estimates. The estimates set forth in this announcement were prepared based upon a number of assumptions, estimates and business decisions that are inherently subject to significant business and economic conditions and competitive uncertainties and contingencies, many of which are beyond the Company’s control. This summary is not meant to be a comprehensive statement of Midatech’s unaudited financial results for the Period and the actual results may differ from these estimates.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

On March 25, 2021 RiverVest Venture Partners, a leading venture capital firm, reported the closing of its RiverVest Venture Fund V, L.P. ("Fund V"), with $275 million of capital commitments in an oversubscribed fundraise. Fund V brings the firm’s total assets under management to more than $1.6 billion (Press release, RiverVest Venture Partners, MAR 25, 2021, View Source [SID1234577157]).

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RiverVest invests in early-stage biopharma and medical device companies addressing significant unmet medical needs and has delivered consistently strong results to investors. Fund V is RiverVest’s largest fund to date, reflecting commitments from a wide range of institutional investors, as well as family offices and individual investors. Fund V’s limited partners include most major investors from earlier RiverVest funds and several new institutional investors, enabled by the larger fund size.

"With RiverVest Venture Fund V, we will continue our investment strategy grounded in close collaboration with entrepreneurs and academic investigators to develop products for the most pressing challenges patients face today," said Jay Schmelter, RiverVest’s co-founder and managing director. "Fund V’s larger size will enable RiverVest to participate more fully in later equity rounds of portfolio companies which have the greatest potential."

RiverVest has a 20-year track record of success. Of the 55 companies in which RiverVest has invested, 18 have been successfully sold and eight have gone public, including Allakos (NASDAQ: ALLK), Mirum Pharmaceuticals (NASDAQ: MIRM) and most recently Spruce Biosciences (NASDAQ: SPRB) in October 2020. Having founded 15 companies to date, RiverVest is adept at founding companies with technology that originates from academic labs or that has been spun out from larger companies. RiverVest joins syndicates with peer venture firms globally to propel early-stage companies.

Today, there are at least 27 commercial products treating patients and many in development from companies in which RiverVest has invested. They include drugs such as Lokelma, a treatment for hyperkalemia, a life-threatening condition caused by elevated potassium levels, developed by ZS Pharma and commercialized by AstraZeneca in 2018, and medical devices such as the Supera stent, used to treat peripheral artery disease, developed by IDEV Technologies and acquired by Abbott in 2013.

"RiverVest approaches each investment in our concentrated portfolio with high conviction," said Schmelter. "Working as a team, we aggressively identify and create investment opportunities, we are thorough in our due diligence, and we aim to provide our portfolio companies collaborative scientific, operational, financial and business development expertise."

With its disciplined investment approach, RiverVest will continue to create value for patients, entrepreneurs and investors. Headquartered in St. Louis and with offices in San Diego and Cleveland, RiverVest is at the intersection of outstanding medical research universities and flourishing innovation ecosystems, reviewing a diverse opportunity set and investing nationally.

On March 25, 2021 Anaveon, a clinical stage, immuno-oncology company, reported that its Clinical Trial Application (CTA) has been accepted by the Spanish Agency of Medicines and Medical Devices (AEMPS) to conduct a Phase I/II study evaluating the safety and clinical activity of its lead product, ANV419, as a monotherapy in advanced solid tumors (Press release, Anaveon, MAR 25, 2021, View Source [SID1234577156]). The Company will initiate the first two arms of a multi part, first-in-human dose finding study, with the expectation of enrolling the first patient in Q2 2021.

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"Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for Anaveon," said Dr Christoph Bucher, Chief Medical Officer of Anaveon. "Our lead program is a powerful and selective interleukin-2 (IL-2) agonist that is designed to overcome known challenges with tolerability and selectivity of human IL-2, which, if approved, could have wide applicability in a range of cancer indications, as well as in combination with other therapeutics."

ANV419 is a novel IL-2/anti-IL-2 fusion protein with preferential signaling through the IL-2 beta/gamma receptor. It has antibody-like pharmacology, behaviour and stability and selectively stimulates the proliferation of CD8 T cells and NK cells without promoting the expansion of Regulatory T cells (Tregs). In non-human primate studies, ANV419 demonstrated excellent tolerability, a highly favorable safety profile and pharmacokinetics with strong in-vivo expansion of NK and CD8 T cells but not Tregs. No significant changes in body weight or blood pressure were seen at any dose during the entire study period and no signs of capillary leak syndrome were observed.

Anaveon was founded in December 2017 by Andreas Katopodis, previously Director at the Autoimmunity, Transplantation & Inflammation Group at the Novartis Institutes for BioMedical Research and Onur Boyman, Professor and Chair in the Department of Immunology at the University of Zurich. The Company is developing selective IL-2 Receptor Agonists, which have the potential to therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Activated T-cells are able to attack tumors and, consistent with this approach, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer; however, due to lack of specificity, human IL-2 has severe, dose-limiting side effects and a short half-life that requires frequent infusions. The lead compound, ANV419, is designed to preferentially signal through the IL-2 beta/gamma receptor and therefore overcome known challenges of human IL-2. This novel type of therapeutic, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

On March 25, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the year ended December 31, 2020 (Press release, Can-Fite BioPharma, MAR 25, 2021, View Source [SID1234577155]).

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Clinical Developments and Corporate Highlights Include:

Cash Infusion of $5 Million – During the first quarter of 2021, Can-Fite received $2.75 million in February and March 2021 through warrant exercises and $2.25 million in an upfront payment in March 2021 from a new distribution agreement with Ewopharma.

Out-licensing Deal Worth $42.7 Million with Ewopharma – Can-Fite signed its latest out-licensing agreement with Swiss-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland. Can-Fite received $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales.

Phase II COVID-19 Study Enrolling Patients – Can-Fite is enrolling 40 patients in its Phase II study under a U.S. Food and Drug Administration (FDA) approved protocol in patients hospitalized with moderate to severe COVID-19. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson twice daily or placebo, and treated for up to 28 days.

Phase III Psoriasis Study Continues to Enroll Based on Positive Interim Analysis – In October 2020, the Independent Data Monitoring Committee for Can-Fite’s Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis reviewed the blinded study data and recommended the Company continue to enroll patients. The majority of costs associated with the Phase III Comfort study have been previously paid.

Phase IIb NASH Study Expected to Commence Q4 2021 – Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint, Can-Fite is working closely with top Key Opinion Leaders in liver disease to complete its study design for a Phase IIb study. Can-Fite expects to commence the study before the end of 2021.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has reached agreements with the U.S. FDA and the European Medicines Agency on the protocol of a pivotal Phase III study for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Should the study meet its efficacy endpoint and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients.

"2020 was a pivotal year for Can-Fite as we demonstrated a robust clinical proof of concept for both Piclidenoson and Namodenoson," stated Can-Fite CEO Dr. Pnina Fishman. "We advanced our pipeline and are firmly focused on Psoriasis, NASH, Advanced Liver Cancer, and COVID-19. We continue to collaborate with distribution and out-licensing partners in select territories, thereby securing distribution for our drugs upon approval and generating revenues through upfront money and milestone payments. We are excited to potentially deliver on additional significant milestones in 2021."

Financial Results

Revenues for the year ended December 31, 2020 were $0.76 million, a decrease of $1.27 million, or 63%, compared to $2.03 million for the year ended December 31, 2019. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the year ended December 31, 2020 were $11.95 million, an increase of $0.98 million, or 8.9%, compared to $10.97 million for the year ended December 31, 2019. Research and developments expenses for the year ended 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis. We expect that the research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $2.95 million for the year ended December 31, 2020 a decrease of $0.11 million, or 3.6%, compared to $3.06 million for the year ended December 31, 2019. The decrease is primarily due to the decrease in professional services and travel expenses which was partly offset by an increase in salaries and related benefits and insurance expenses. We expect that general and administrative expenses will remain at the same level through 2021.

Financial expense, net for the year ended December 31, 2020 aggregated $0.3 million compared to $0.6 million for the year ended December 31, 2019. The decrease in financial expense, net was mainly due to a decrease in the revaluation of our short-term investment.

Net loss for the year ended December 31, 2020 was $14.44 million compared with a net loss of $12.62 million for the year ended December 31, 2019. The increase in net loss for the year ended December 31, 2020 was primarily attributable to a decrease in revenues in 2020 and an increase in research and development expenses which were partly offset by a decrease in finance expenses, net.

As of December 31, 2020, Can-Fite had cash and cash equivalents of $8.26 million as compared to $2.69 million at December 31, 2019. The increase in cash during the year ended December 31, 2020 is due to an aggregate of $17.68 million in net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April, and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity of $12.06 million.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.

On March 25, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Corvus Pharmaceuticals, MAR 25, 2021, View Source [SID1234577154]).

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"In 2020, we made considerable progress expanding our technology platform to address COVID-19 and other infectious diseases. As a result, we have extended our product development strategy with the initiation of a Phase 3 study of CPI-006 for COVID-19. In a recently completed Phase 1 study, CPI-006 induced robust and prolonged anti-SARS-CoV-2 antibody responses," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "During the year we also co-founded Angel Pharmaceuticals, a new biopharma company in China that is positioned to develop our product candidates in the rapidly growing Chinese market and potentially accelerate our global product development capability. Angel’s first clinical program is expected to kick off with the initiation of a Phase 2 study of CPI-818 for peripheral T cell lymphoma in China. Along with our planned Phase 2 study to evaluate ciforadenant in first-line renal cancer as a triplet combination with pembrolizumab and a tyrosine kinase inhibitor, we are excited to have three mid-to-late stage programs that may provide catalysts for the Company in the near-term."

2021 Key Areas of Focus
Corvus is focused on several potential transformational opportunities in its pipeline in 2021, headlined by the execution of its global Phase 3 study of CPI-006 in COVID-19. The Company is also efficiently advancing its other clinical programs, CPI-818 and ciforadenant, along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

CPI-006 Phase 3 Study for COVID-19

In February 2021, the Company initiated a Phase 3 registration clinical trial of CPI-006, an anti-CD73 B cell activating antibody, for the treatment of hospitalized patients with mild-to-moderate COVID-19. This randomized, double-blind trial is planned to enroll up to 1,000 patients, who will be randomized into one of three arms and receive either 1.0 mg/kg or 2.0 mg/kg of CPI-006, or placebo. The primary endpoint of the study is the proportion of patients that progress to requiring mechanical ventilation or death within 28 days of dosing. The study will be conducted in the United States, Europe, Latin America and South Africa and will include an interim safety and futility analysis. The Company expects to complete enrollment in the study in the fourth quarter 2021.
Results from the Phase 1 dose escalation (0.3 to 5.0 mg/kg) clinical trial of CPI-006 in 29 hospitalized patients with COVID-19 showed that patients developed sustained high titers of polyclonal anti-SARS-CoV-2 antibodies. As of March 4, 2021, all the patients in the study were discharged from the hospital in a median of three days and no patients progressed to requiring mechanical ventilation. The results from the Phase 1 study were presented in the "Hot Topic Symposium: COVID-19 and Cancer" session at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2020.
CPI-818 Phase 2 Study for PTCL in Partnership with Angel Pharmaceuticals

The Company expects that a global Phase 2 trial of CPI-818, a small molecule ITK inhibitor, for the treatment of refractory peripheral T cell lymphoma (PTCL) will be initiated in partnership with Angel Pharmaceuticals.
Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As of March 4, 2021, of seven patients with PTCL, there has been one complete response lasting over 15 months and one partial response lasting for over five months; both responses are ongoing. The interim data was presented at the 62ND American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2020.
Angel Pharmaceuticals is a new China-based biopharmaceutical company co-founded by Corvus in October 2020. Angel licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – CPI-006, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. The formation of Angel is expected to provide Corvus with clinical study synergies and accelerated timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol. Corvus currently holds a 49.7% ownership position in Angel Pharmaceuticals, excluding 7% of Angel’s equity reserved for issuance under the Angel employee stock ownership plan.
Ciforadenant Phase 2 Study for Front Line RCC

The Company plans to initiate a Phase 2 trial of ciforadenant, a small molecule antagonist of the adenosine A2A receptor, in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and lenvatinib. The study is planned to be conducted in collaboration with the Kidney Cancer Consortium, is expected to enroll approximately 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies indicate adenosine may be a cause of resistance to current therapies with anti PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the adenosine gene signature.
Financial Results

As of December 31, 2020, Corvus had cash, cash equivalents and marketable securities totaling $44.3 million. This compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019. The cash and investment balance at December 31, 2020 does not include net proceeds of $31.8 million received on February 17, 2021 from the company’s follow-on equity offering with institutional investors. Corvus expects full year 2021 net cash used in operating activities to be between $46 million and $48 million.

Research and development expenses for the three months and full year ended December 31, 2020 totaled $7.2 million and $31.8 million, respectively, compared to $8.9 million and $38.0 million for the same periods in 2019. In the fourth quarter of 2020, the decrease of $1.7 million was primarily due to lower outside costs for ciforadenant and CPI-818 and a decrease in personnel costs, partially offset by an increase in outside costs for CPI-006. For the full year 2020, the decrease of $6.1 million was primarily due to lower outside costs for ciforadenant and CPI-818 and a decrease in personnel and related costs, partially offset by an increase in outside costs for CPI-006.

Gain on deconsolidation of $37.5 million and loss from equity method investment of $0.2 million for the three months and full year ended December 31, 2020 are both the result of the Angel Pharmaceuticals transaction described above.

Net income for the three months ended December 31, 2020 was $27.1 million and net loss for the year ended December 31, 2020 was $6.0 million compared to a net loss of $11.0 million and $46.7 million for the same periods in 2019. Total stock compensation expense for the three months and year ended December 31, 2020 was $1.2 million and $5.7 million, respectively, compared to $1.7 million and $7.3 million for the same periods in 2019.