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.

On March 28, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported on its results for the fourth quarter and fiscal year ended December 31, 2020 (Press release, CytRx, MAR 25, 2021, View Source [SID1234577170]). In addition, CytRx highlighted developments pertaining to its licensing agreements with ImmunityBio, Inc. (NASDAQ: IBRX) ("ImmunityBio") and Orphazyme A/S (NASDAQ: ORPH) ("Orphazyme") as well as Centurion Biopharma. The Company’s 10-K has been filed with the U.S. Securities and Exchange Commission.

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Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:

"The past year was a transformative one for CytRx. We executed a strategic pivot that has positioned us to cut corporate costs, maintain a stable capital position, and nimbly manage our portfolio of licensing agreements and strategic assets. Our Board of Directors also took concrete steps to strengthen the Company’s corporate governance, including commencing a search for a new independent director with strong biotechnology experience. We are very excited about the year ahead now that Orphazyme is preparing for prospective regulatory approvals for arimoclomol in the treatment of Niemann-Pick disease Type C and ImmunityBio is expanding its scope of clinical trials involving aldoxorubicin to treat advanced-stage pancreatic cancer. In our view, CytRx has achieved robust momentum and operating tailwinds as fiscal year 2021 begins."

Fiscal Year 2020 Financial Overview

CytRx concluded the fiscal year ended December 31, 2020 with cash on hand of approximately $10 million, which management believes is sufficient to fund ongoing operations for the foreseeable future.
The Company recorded a net loss of $6.7 million for the fiscal year ended December 31, 2020, compared to a net loss of $7.2 million for the fiscal year ended December 31, 2019.
General and administrative expenses were $6 million for the fiscal year 2020, compared with $7.4 million in 2019. This sizable decrease was primarily due to a reduction in stock-based compensation expenses.
Research and development expenses were $0.8 million for the fiscal year, compared with $0.4 million for 2019. This was due to increased consulting expenditures related to the establishment of a regulatory plan and new strategic initiatives for Centurion Biopharma’s assets.
Based on a current projection of expenditures for fiscal year 2021, the Company’s monthly cash burn rate is estimated to be approximately $406,000 per month. This twelve-month estimate is down from a previous projection of approximately $423,000 per month at the close of the third quarter of fiscal year 2020.
Fiscal Year 2020 Highlights

Orphazyme Highlights

As previously disclosed, CytRx’s agreement with Orphazyme can deliver up to $120 million in potential milestone payments and future single- and double-digit royalties paid on sales of arimoclomol.
CytRx is positioned to receive up to $10 million in potential milestone payments in 2021 based on possible U.S. and European approvals for arimoclomol to treat Niemann-Pick disease Type C ("NPC").
In September 2020, Orphazyme announced that the U.S. Food and Drug Administration ("FDA") accepted, with Priority Review, its New Drug Application ("NDA") for arimoclomol for the treatment of NPC.
In November 2020, Orphazyme announced that it submitted a Marketing Authorisation Application ("MAA") to the European Medicines Agency ("EMA") for approval of arimoclomol in the treatment of NPC.
In early December 2020, Orphazyme announced the expansion of its U.S. presence and workforce ahead of potential FDA approval of arimoclomol in the treatment of NPC.
In addition to establishing its U.S. headquarters in Chicago, Orphazyme recruited more than 30 U.S. employees. Orphazyme also named three U.S. leaders to its global executive team.
In late December 2020, Orphazyme disclosed that the FDA extended its review period with a standard extension of three months in order to complete its NDA review. The updated Prescription Drug User Fee Act ("PDUFA") target action date is June 17, 2021.
Recently, Orphazyme announced the appointment of Christophe Bourdon as its new Chief Executive Officer, effective as of April 1, 2021.
As reported by Orphazyme, Mr. Bourdon has successfully launched a variety of products in demanding environments, making him an ideal individual to lead Orphazyme as it prepares for a potential commercial launch of arimoclomol.
He joins from Amgen, Inc., where he has held the role of Senior Vice President, General Manager for the U.S. Oncology Business. He was leading commercialization planning and execution for several products.
Previously, Mr. Bourdon was Senior Vice President of Europe, Middle East, Africa and Canada at Alexion Pharmaceuticals Inc. as the company launched two breakthrough ultra-orphan drugs and negotiated payor access across the United Kingdom, Germany, France, Italy and Canada. He holds an MBA from IMD business school (Switzerland) and a BA from ISG (France).
Recently, Orphazyme also announced MIPLYFFA as the global brand name for arimoclomol and expanded its NPC Early Access Program in the U.S. and opened similar programs in France and Germany.
ImmunityBio Highlights

As previously disclosed, CytRx’s agreement with ImmunityBio can deliver up to $343 million in potential milestones and future single- and double-digit royalties paid on sales of aldoxorubicin’s use for multiple tumor types.
This past summer, the Chief Executive Officer of ImmunityBio spoke about the successful experimental treatment delivered to former Senate Majority Leader Harry Reid for his stage IV pancreatic cancer. Former Nevada Senator Reid has described himself as being in "complete remission" after receiving experimental combination immunotherapy that included aldoxorubicin.
In October 2020, ImmunityBio and NantKwest, Inc. ("NantKwest") announced the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy, which includes aldoxorubicin, for locally advanced or metastatic pancreatic cancer (QUILT-88). The third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.
In December 2020, ImmunityBio and NantKwest announced their proposed merger and plans to create a leading immunotherapy and cell therapy company.
In their announcement, the companies noted the combination of ImmunityBio’s immunotherapy platforms – including aldoxorubicin – and NantKwest’s Natural Killer cell platform have already resulted in complete responses in aggressive and late-stage metastatic cancers.
In January 2021, ImmunityBio and NantKwest announced that their ongoing Phase 2 clinical trials of a novel combination immunotherapy – which includes aldoxorubicin – for locally advanced or metastatic pancreatic cancer had produced early indications of increased survival rates for patients with no other approved treatment options.
Interim results of the three-cohort trials, known as QUILT 88, showed median survival rates of more than double that of the historic rate in patients with advanced metastatic pancreatic cancer (for which no other FDA approved treatment exists).
Recently, ImmunityBio and NantKwest announced the closing of their merger, with ImmunityBio now trading on the NASDAQ under ticker symbol IBRX.
Additional Corporate Highlights

In August 2020, CytRx announced its plan to add a new independent member to its Board of Directors by no later than the one-year anniversary of the 2020 Annual Meeting of Shareholders. The Company has retained a leading recruitment firm to support the search process.
Throughout 2020, Mr. Kriegsman and Lead Director Louis Ignarro, PhD have pursued third-party financing and strategic partnership opportunities to advance pre-clinical and clinical studies for Centurion BioPharma’s high-potential assets.
Discussions with prospective partners and investors remain ongoing. There are no formal strategic financing updates to report at this time.
As of December 31, 2020, CytRx maintained federal and state net operating loss carryforwards – not subject to limitation under Section 382 of the Internal Revenue Code – of $258.3 million and $252.7 million, respectively, available to offset against future taxable income.
In February 2021, CytRx announced that it is now a part of the LD Micro Index (the "Index").
The Index is designed to give the most accurate representation of the intraday activity of microcap stocks in North America.
In March 2021, CytRx participated in the H.C. Wainwright Global Life Sciences Conference and the Virtual 33rd Annual ROTH Conference.
Mr. Kriegsman’s virtual presentation may be accessed on the News and Events page of the CytRx website.

On March 25, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the fourth quarter and full year ended December 31, 2020 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAR 25, 2021, View Source [SID1234577192]).

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"2020 was a pivotal year for Zentalis, marked by the advancement of our broad pipeline, multiple clinical and strategic collaborations, as well as successful public offerings," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "With the initiation of numerous studies at the end of 2020, our internally discovered candidates are now being investigated in a combined total of seven ongoing clinical trials, further exploring their potential to address a range of cancers. We believe our collaborations with global innovators in the biopharmaceutical and technology industries provide us with the resources needed to evaluate the full potential of our differentiated product candidates in the clinic as both monotherapies and in combinations."

Continued Dr. Sun, "Looking to the year ahead, we are strongly positioned to reach our upcoming milestones, starting with our late-breaker presentation discussing data from the Phase 1 portion of the Phase 1/2 monotherapy trial of ZN-c3 at AACR (Free AACR Whitepaper) in April. This readout, along with results from our other ongoing trials investigating ZN-c5, ZN-d5 and ZN-e4, is expected to deliver important insights into our clinical and regulatory strategies as we advance our objective of bringing improved therapies to cancer patients in need."

Program Highlights:

Zentalis initiated patient dosing in three combination and monotherapy clinical trials, which included a Phase 1b combination trial with ZN-c5 and abemaciclib (marketed as Verzenio by Eli Lilly) in ER+/HER2- advanced breast cancer, a Phase 1 combination dose escalation trial with ZN-c3 and chemotherapy in advanced ovarian cancer and a Phase 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin’s lymphoma. Each trial will assess the safety, tolerability and pharmacokinetics of the respective candidate.

In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will initially aim to validate Zentalis’ WEE1 inhibitor, ZN-c3, and its DNA damage response pathway in genetically distinct patient populations.

Three abstracts, including a late-breaker oral presentation on ZN-c3, were accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Zentalis expects to report clinical data from the Phase 1 portion of its Phase 1/2 monotherapy trial of ZN-c3 in advanced solid tumors.

Zentera Therapeutics, Zentalis’ majority-owned joint venture, submitted two IND applications in China for ZN-c5 and ZN-c3 in December 2020 and February 2021, respectively. A third IND application for ZN-d5 is expected to be submitted in 2021.
Corporate Highlights:

In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Marketable Securities Position: As of December 31, 2020, Zentalis had cash, cash equivalents and marketable securities of $338.5 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

Research and Development Expenses: Research and development expenses were $29.5 million in the fourth quarter of 2020, compared to $11.9 million for the same period in 2019. This increase of $17.6 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials investigating ZN-c5, ZN-c3 and ZN-d5 in 2020. In addition, in 2020 we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $10.2 million primarily due to $5.3 million of additional employee related costs, of which $2.6 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development, $1.6 million of facilities and other allocated overhead expenses, $3.0 million of consulting, supplies and outside services, and decreased federal grant reimbursements of $0.3 million.
Research and development expenses for the full year were $84.9 million, compared with $38.4 million in 2019.

General and Administrative Expenses: General and administrative expenses for the fourth quarter were $10.7 million, compared to $3.0 million for the same period in 2019. This increase of $7.7 million was primarily attributable to an increase of $7.3 million in employee-related costs, of which $5.1 million was driven by non-cash stock-based compensation from incentive grants issued during the year and increased headcount to support our growth. The remaining increase in spend was primarily driven by professional service fees for legal services of $0.6 million, consulting and other outside services of $0.7 million, and insurance costs of $0.6 million, which were offset by allocated overhead expenses.
General and administrative expenses for the full year were $33.9 million, compared with $8.5 million in 2019.

Net Loss: The Company’s net loss for the fourth quarter of 2020 was $40.4 million, compared to a net loss of $14.5 million for the same period in 2019.
The Company’s net loss for the full year 2020 was $118.5 million, compared to a net loss of $46.4 million for the same period in 2019.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

On March 25, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2020 (Press release, IntelGenx, MAR 25, 2021, View Source,%242.1%20million%20in%20Q4%2D2019. [SID1234577214]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2020 Fourth Quarter Financial Highlights:

Revenue was $790,000, compared to $68,000 in the 2019 fourth quarter.
Net comprehensive loss was $1.3 million, compared to $2.7 million in the 2019 fourth quarter.
Adjusted EBITDA loss was $754,000, compared to $2.1 million in Q4-2019.
2020 Full-Year Financial Highlights:

Revenue was $1.5 million, compared to $742,000 in 2019.
Net comprehensive loss was $7.1 million, compared to $10.3 million in 2019.
Adjusted EBITDA loss was $5.3 million, compared to $8.5 million in 2019.
Recent Developments:

Announced a strategic partnership with atai Life Sciences ("atai"), including a proposed equity investment by atai, positioning IntelGenx as a leader within the novel therapeutics field of psychedelics and providing the requisite financial resources to continue to advance its robust portfolio of other innovative pharmaceutical film product candidates towards commercialization.
The Company’s wholly owned subsidiary, IntelGex Corp., also received a $2.0 million secured loan from atai, of which $628,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal.
Received a Notice of Allowance for US Patent Application 16/110.737, entitled "Film Dosage Form with Extended Release Mucoadhesive Particle," covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
Filed a new provisional patent application at the United States Patent and Trademark Office entitled "High Loading Oral Film Formulation," which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm proprietary veterinary oral film technology.
Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp., the Company’s operating subsidiary.
Received its first purchase order from Heritage Cannabis Holdings, recently upsized from 50,000 to 75,000 CBD Filmstrips, pursuant to a definitive supply agreement.
"While we were pleased to see the positive impact of our performance improvement program continuing to be reflected in our financial results, it was the transformative partnership that we entered into with atai subsequent to year-end that truly served to validate our long-term growth strategy," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We are confident that this transaction is the best way forward to maximize value for our shareholders, and encourage them to vote "FOR" all related proposals at our Annual Meeting on May 11, 2021."

Financial Results:

Total revenues for the three-month period ended December 31, 202 amounted to $790,000, an increase of $722,000, or 1,062%, compared to $68,000 for the three-month period ended December 31, 2019. The change is mainly attributable to an increase in revenues from licensing agreements of $671,000 and an increase in R&D revenues of $51,000. Operating costs and expenses were $1.8 million for the fourth quarter of 2020, versus $2.4 million for the corresponding three-month period of 2019. For Q4-2020, the Company had an operating loss of $1.0 million, compared to operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $1.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2020, compared to net comprehensive loss of $2.7 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

Total revenues for the twelve-month period ended December 31, 2020 amounted to $1.5 million, representing an increase of $802,000, or 108% compared, to $742,000 for the year ended December 31, 2019. Operating costs and expenses were $7.8 million for the full year 2020, versus $10.3 million for the corresponding 12-month period of 2019. For the twelve-month period of 2020, the Company had an operating loss of $973,000, compared to an operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $7.1 million, or $0.07 per basic and diluted share, for the twelve-month period of 2020, compared to net comprehensive loss of $10.3 million, or $0.11 per basic and diluted share, for the comparable period of 2019.

As at December 31, 2020, the Company’s cash and short-term investments totalled $2.2 million, which did not include the $2.0 million secured loan granted to IntelGenx Corp. by atai in March 2021.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2012, as well as the 2021 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 25, 2021.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9174 (Canada and the United States) and (785) 424-1669 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On March 25, 2021 Immodulon Therapeutics reported that First patient enrolled in a phase I/II study for IMM-101 in limited metastatic pancreatic cancer patients at Erasmus University Medical Center (Press release, Immodulon Therapeutics, MAR 25, 2021, View Source [SID1234577114])

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Erasmus MC initiates recruitment for new investigator-sponsored phase I/II study to investigate the safety and efficacy of IMM-101 in limited metastatic pancreatic cancer

Uxbridge, UK – 25 March 2021 – Immodulon, the immuno-oncology company, is pleased to announce enrolment of the first patient in MEPANC-1, an investigator-sponsored, multi-centre, phase I/II, open label study in patients with limited metastatic (oligo-metastatic) pancreatic cancer. This study is being conducted in collaboration with Professor van Eijck and his team at the Erasmus University Medical Center Rotterdam ("Erasmus MC").

This study follows the initial collaborative study, LAPC-2, a phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer which has completed its recruitment and is nearing completion. MEPANC-1 is designed to enrol 100 eligible patients and evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy in patients with oligo-metastatic pancreatic cancer, who have either completed at least eight cycles of FOLFIRINOX or who could not tolerate FOLFIRINOX. The primary efficacy endpoint is one-year progression-free survival calculated from the start of the FOLFIRINOX regimen. The study was approved in December 2020 by the local Erasmus MC Medical Ethics Review Committee and the national Central Committee on Research Involving Human Subjects.

Professor Casper H J van Eijck, hepatobiliary surgeon and Professor in surgery, commented:
"We look forward to this new original study which has not been performed before in patients with limited metastatic pancreatic cancer. Since the recruitment in the LAPC-2 study was highly successful, we expect to include patients from all Dutch Pancreatic Cancer Group hospitals within the allocated time frame. We are pleased that Immodulon is providing us with the IMM-101 study drug again as well as their support. We hope that combining IMM-101’s positive effects on the immune system with those of radiotherapy will potentially lead to a major step forward in the search for new and effective treatments for pancreatic cancer."

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are extremely pleased to announce our continued collaboration with Professor van Eijck and his team at this Centre of Excellence for pancreatic cancer at Erasmus MC. The MEPANC-1 study is designed to complement the ongoing LAPC-2 study. Immodulon is dedicated and highly motivated to develop better therapies for pancreatic cancer, a vision that is strongly shared by Professor van Eijck and his team. Pancreatic cancer is a devasting disease and remains exceedingly challenging to treat effectively, despite the advances in other cancer treatments."

Dr. Cellia Habita, Chief Medical Officer of Immodulon, added:
"Professor van Eijck and his team are a fantastic group to collaborate with. The MEPANC-1 study recruited its first patient which is exciting news. We hope that IMM-101 may help to improve the prognosis for these patients."