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Monopar Therapeutics Reports Fourth Quarter and Full-Year 2020 Financial Results and Recent Business Updates

On March 25, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported fourth quarter and full-year 2020 financial results and recent business updates (Press release, Monopar Therapeutics, MAR 25, 2021, View Source [SID1234577164]).

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Recent Business Updates

Lead Product Candidate Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
The U.S. Patent and Trademark Office (USPTO) allowed patent claims for Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential use of Validive in cancer patients beyond earlier allowed claims specifically for the prevention of oral mucositis in patients receiving CRT.
Camsirubicin

The Phase 2 clinical trial of camsirubicin is anticipated to commence enrollment in the second quarter of 2021. Monopar’s clinical development collaborator, Grupo Español de Investigación en Sarcomas (GEIS), will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).
The trial will begin with an open-label dose escalation "run-in" prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events.
The USPTO allowed patent claims covering compositions of matter (2-pyrrilino camsirubicin) for a novel family of camsirubicin analogs. This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar’s camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells which may enable use in cancer types beyond those treatable with camsirubicin.
MNPR-101 and Related Compounds

Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (i) IsoTherapeutics Group, LLC to develop and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (ii) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (iii) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the clinical development of uPRITs.
The European Journal of Cancer published a peer-reviewed preclinical study which shows the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection.
Results for the Fourth Quarter and Year Ended December 31, 2020 Compared to the Fourth Quarter and Year Ended December 31, 2019

Cash and Net Loss

Cash and cash equivalents as of December 31, 2020 were $16.7 million. Monopar anticipates that its current cash and cash equivalents, which includes an additional $10.9 million of net proceeds raised in the first quarter of 2021 under the Company’s Capital on Demand Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company’s planned operations at least through March 2022. Planned operations include funding and completing the Phase 2b portion of the Validive "VOICE" clinical trial and commencing of the Phase 3 portion; the funding of the run-in portion of the GEIS Phase 2 camsirubicin clinical trial; and continuation of the development of the COVID-19 uPRIT program along with other MNPR-101 related compounds. The Company plans to raise additional funds or engage a partner in the next 12 months to complete the VOICE clinical program and continue the GEIS camsirubicin clinical trial beyond the run-in phase.

Net loss for the fourth quarter of 2020 was $2.1 million or $0.19 per share compared to net loss of $1.2 million or $0.13 per share for the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $6.3 million or $0.58 per share compared to net loss of $4.2 million or $0.45 per share for the year ended December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2020 were $1.6 million compared to $0.6 million for the fourth quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses of $0.5 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.2 million for the VOICE clinical trial planning and manufacturing costs, and $0.3 million for R&D personnel salary and benefits.

R&D expenses for the year ended December 31, 2020 were $4.1 million compared to $2.0 million for the year ended December 31, 2019. This represents an increase of approximately $2.1 million primarily attributed to increases in expenses of $1.1 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.1 million for the VOICE clinical trial planning and manufacturing costs, and $0.9 million for R&D personnel salary and benefits.

General and Administrative (G&A) Expenses

G&A expenses for the fourth quarter of 2020 were $0.6 million, equal to $0.6 million for the fourth quarter of 2019.

G&A expenses for the year ended December 31, 2020 were $2.4 million, equal to $2.4 million for the year ended December 31, 2019.

Knight Therapeutics Reports Fourth Quarter and Year End 2020 Results

On March 25, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, reported financial results for its fourth quarter and year ended December 31, 2020 (Press release, Knight Therapeutics, MAR 25, 2021, View Source [SID1234577163]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2020 Highlights

Financials

Revenues were $199,519, an increase of $152,058 or 320% over prior year.
Gross margin was $81,690 or 41% compared to $26,918 or 57% in prior year.
Adjusted EBITDA1 was $16,837 compared to $2,827 in prior year.
Interest income generated of $14,322 a decrease of $9,220 or 39% over prior year.
Gain from strategic fund investments of $46,733, of which $16,644 was realized.
Adjusted earnings1 of $28,713, an increase of $2,714 or 10% over prior year.
Net income was $31,760 compared to net income of $18,033 in prior year.
Corporate Developments

Promoted Arvind Utchanah from VP Finance to CFO.
Appointed Janice Murray and Nicolás Sujoy on the Board of Directors.
Disposed of the shares of Medison Biotech (1995) Ltd. for a cash consideration of $77,000 and recorded a gain of $2,948.
Purchased 5,748,716 common shares at an average price of $6.40 per share through a Normal Course Issuer Bid ("NCIB").
Completed the tender offer process for an aggregate purchase price of $170,855 and achieved 99.9% ownership of Biotoscana Investments S.A. ("GBT").
Products

Launched Cresemba, indicated for the treatment of invasive aspergillosis and invasive mucormycosis, in Brazil.
Launched Karfib, indicated for relapsed or refractory multiple myeloma, in Argentina.
Received regulatory approval from Health Canada for Ibsrela for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").
Obtained the exclusive Canadian commercial rights of Trelstar, approved for the treatment of advanced prostate cancer.
Obtained regulatory approval for Lenvima and Halaven in Ecuador.
Received regulatory approval from Health Canada for Imvexxy and Bijuva.
Submitted a supplement to a New Drug Submission ("NDS") of Nerlynx for HER2-positive metastatic breast cancer.
Signed a new exclusive distribution agreement with Gilead for the continued commercialization of AmBisome in Brazil, effective January 1, 2021.
Strategic Investments

Disposed of 111,355 common shares of Profound Medical Inc. for total proceeds of $1,825.
Received US$5,000 for the full repayment of the strategic loan issued to Triumvira Immunologics Inc.
Amended strategic loan issued to Synergy CHC Corp. and loaned an additional US$2,500.
Received distributions of $29,128 from strategic fund investments and realized a gain of $16,644.
Key Subsequent Event

Purchased an additional 2,895,456 common shares at an average price of $5.25 per share through the NCIB.
Disposed of 315,600 common shares of Medexus Pharmaceuticals Inc. for total proceeds of $2,624.
Announced the Canadian commercial launch of Ibsrela for the treatment of IBS-C.
"The past year was a transformative year for Knight with the completion of the acquisition of GBT. Despite the challenges due to COVID-19, we continue to progress on integration, while advancing on our product portfolio in both Canada and Latin America. We have received regulatory approvals from Health Canada for Ibsrela, Imvexxy and Bijuva and received regulatory approvals for Lenvima and Halaven in Ecuador. We continue to focus on our mission to acquire, in-license, develop and commercialize innovative medicines and high-quality treatments to improve the health of patients in Latin America and Canada," said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc.

Immunocore Provides Business Update and Reports Full Year 2020 Financial Results

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]).

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.

Midatech Pharma PLC (“Midatech” or the “Company”) Non-binding Heads of Terms for MTX110 Co-development of MTX110 and
Unaudited Headline Results for the Year Ended 31 December 2020

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]).

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).

RiverVest Venture Partners Closes $275 Million Life Sciences Fund

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]).

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.