On March 25, 2021 Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported its results for the full year ended December 31, 2020 (Press release, Immunocore, MAR 25, 2021, View Source [SID1234577162]).

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2020 Highlights (including post-period)

Lead product candidate tebentafusp demonstrated superior overall survival (OS) in a Phase 3 randomized clinical trial in metastatic uveal melanoma (mUM) where the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71). Tebentafusp was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for unresectable or metastatic uveal melanoma, and the Company anticipates completion of the submission of a Biologics License Application (BLA) in the third quarter of 2021.

Continued development of ImmTAC (Immune mobilizing monoclonal T-cell receptors Against Cancer) clinical portfolio for multiple tumor types; IMC-C103C is currently in the dose escalation phase of a Phase 1 clinical trial in MAGE-A4 expressing solid tumors, with initial data expected to be presented in the second half of 2021; IMC-F106C is currently in a Phase 1 study in patients with PRAME-expressing solid tumors, with initial data expected to be presented mid-year 2022.

Dosing in a Phase 1 clinical trial for patients with chronic hepatitis B virus (HBV) is anticipated for mid-year 2021.

Cash position of $177 million as of December 31, 2020 with an additional $287 million in net proceeds raised from the Company’s initial public offering and a concurrent private placement in February 2021.

Bahija Jallal, Chief Executive Officer of Immunocore, said: "Reflecting on 2020, we have made great strides in the clinical advancement of TCR therapeutics. We believe the tebentafusp clinical data represent the first positive Phase 3 clinical trial for a TCR therapeutic and the first bispecific immune-oncology therapy with demonstrated overall survival advantage in any solid tumor. These results were a culmination of disciplined work by the Immunocore team and strong support by our investors. Our initial public offering in February enables us to accelerate the development of our pipeline of TCR therapeutics and the planned BLA submission of our lead candidate tebentafusp in patients with uveal melanoma, as well as begin early commercialization activities assuming regulatory approval."

Key Pipeline Updates

Tebentafusp

In November 2020, the Company announced tebentafusp achieved the primary endpoint of superior overall survival compared to investigator’s choice in a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to chemotherapy and other immunotherapies. The 378-patient study was unblinded by an independent data monitoring committee at the first pre-planned interim analysis when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Immunocore will be working with the FDA to facilitate complete submission of a BLA for tebentafusp in the third quarter of 2021, followed by Marketing Authorization Application submission to the European Medicines Agency (EMA).

In February 2021, tebentafusp was granted Breakthrough Therapy Designation by the FDA for unresectable or metastatic uveal melanoma. Additionally, in February 2021, the European Commission, upon recommendation of the EMA’s Committee for Orphan Medicinal Products (COMP) awarded tebentafusp Orphan Drug Designation for the treatment of uveal melanoma. Medicines that meet the EMA’s Orphan Drug Designation criteria qualify for several incentives, including ten years of market exclusivity, protocol assistance, and potentially reduced fees for regulatory activities.

In March 2021, the Company announced that Phase 3 data from IMCgp100-202 Phase 3 clinical trial would be the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR (Free AACR Whitepaper) Annual Meeting 2021 which will be held virtually on April 10, 2021.

Additional Clinical Programs

IMC-C103C – MAGE-A4

As of year-end 2020, 21 patients had been dosed in the dose escalation portion of the IMC-C103C Phase 1/2 clinical trial in patients with solid tumors. Early pharmacodynamics data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to present Phase 1 data from this trial in the second half of 2021.

The Company believes that IMC-C103C is the only clinical stage off-the-shelf therapy candidate in development against MAGE-A4—an X-chromosome-linked cancer/testis protein that is broadly expressed across a range of cancer indications, including non-small-cell lung cancer, among others. IMC-C103C is part of a co-development/co-promotion collaboration with Genentech under which Immunocore shares program costs and profits equally.

IMC-F106C – PRAME

As of year-end 2020, nine patients had been dosed in the dose escalation portion of the IMC-F106C Phase 1/2 clinical trial. The trial is designed to study the safety and preliminary activity of IMC-F106C as a monotherapy in patients with PRAME-expressing solid tumors. The Company plans to report initial Phase 1 data from this trial in mid-2022.

IMC-F106C is an ImmTAC targeting a PRAME derived peptide presented by HLA-A*02:01 and is the first off-the-shelf therapeutic targeting PRAME. PRAME has the highest expression frequency of all cancer/testis antigens across a range of solid and hematologic cancers, notably non-small-cell lung cancer, and its expression is generally identified as a poor prognostic feature. Immunocore retains full rights to IMC-F106C.

IMC-I109V – HBV

In August 2020, the Company announced the publication of novel therapeutic approach with the potential to provide a functional cure for chronic hepatitis B, in leading peer-reviewed journal, Hepatology. These data support on-target efficacy of the lead HBV ImmTAV against HBV-infected hepatocytes. The Company plans to initiate dosing in the single ascending dosing portion of the trial in mid-2021.

IMC-M113V – HIV

In 2020, the Company advanced IMC-M113V through GMP manufacturing and IND supporting pre-clinical studies for human immunosuppression virus (HIV). The Company’s HIV programs are funded by the Bill & Melinda Gates Foundation, and regulatory submission to enable clinical testing is anticipated in the second half of 2021.

GSK-01– NY-ESO

The GSK-01 NY-ESO Phase 1 dose escalation study to determine safety, and which is enrolling several different tumor types, is still ongoing. An expansion phase was planned to initiate once the Phase 1 dose escalation was complete. However, following a portfolio review, Immunocore, in collaboration with GSK, have jointly elected not to plan for or initiate the efficacy determining expansion phase of the trial. The expansion arm was planned to be conducted in synovial sarcoma, an ultra-rare disease which is already addressed by other assets in the Company’s portfolio including MAGE-A4 and PRAME. Consequently, GSK has forgone their option to acquire an exclusive license to the NY-ESO program and Immunocore will retain ownership of the asset. Immunocore plans to present the data from the Phase 1 study in 2022.

Corporate Updates

Fundraising and initial public offering on Nasdaq

In February 2021, the Company raised $312.1 million in aggregate financing and approximately $287 million in net proceeds from its initial public offering on Nasdaq of 11,426,280 American Depositary Shares (ADSs), including the exercise in full by the underwriters of their option to purchase an additional 1,490,384 ADSs, at an initial public offering price of $26.00 per ADS. In addition to the ADSs sold in the public offering, Immunocore announced the completion of the concurrent sale of an additional 576,923 ADSs at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15 million, in a private placement to the Bill & Melinda Gates Foundation.

In December 2020, the Company completed a $75 million Series C private financing round led by existing and new investors.

In November 2020, the Company closed a $100 million senior secured loan facility with Oxford Finance LLC.

In March 2020, the Company completed a $130 million Series B private financing round.

Financial Results

Cash and cash equivalents at December 31, 2020 totaled $177 million, before including the $287 million in net proceeds from the initial public offering and concurrent private placement in February 2021. This compared to $97 million at December 31, 2019.

Revenue for the year ended December 31, 2020 from collaboration agreements was £30.1 million compared to £25.7 million for the year ended December 31, 2019.

For the year ended December 31, 2020, our research and development expenses were £74.8 million compared to £100.0 million for the year ended December 31, 2019. For the year ended December 31, 2020, administrative expenses were £45.7 million, compared to £44.2 million for the year ended December 31, 2019. Our loss for the year ending December 31, 2020 was £74.1 million, compared to million £103.9 million for the year ended December 31, 2019.

The Company anticipates that its existing cash and cash equivalents, together with the net proceeds from its initial public offering and its debt facility, is sufficient to enable the Company to fund planned operating expenses and capital expenditure requirements through at the least the end of 2022.

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.