On March 17, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported that it has filed seven patent applications globally on a novel DNA-damaging agent with anticancer properties (Press release, Lantern Pharma, MAR 17, 2021, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-patents-on-novel-anti-cancer-agents [SID1234576799]). These patent applications include claims directed to a newly synthesized compound with promising in-vitro anticancer activity in a range of indications that are distinct from LP-184. This compound, newly designated as LP-284, is believed to act through mechanisms that are related to DNA-damage and DNA-repair inhibition in certain cancer cells.

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LP-284 is a small molecule drug candidate currently in preclinical development for certain cancers that have shown sensitivity to the compound. LP-284 is the stereoisomer (enantiomer) of LP-184 and has the potential for development as monotherapy and also as a synergistic agent in combination with other drugs. Stereoisomers can have differing and unique characteristics from one another and can be viewed as distinct pharmaceutical agents. These unique characteristics may allow LP-284 to also be considered for inclusion in Lantern Pharma’s antibody drug conjugate (ADC) program.

The individual stereoisomers of a biologically active molecule may often differ in potency, pharmacological action, metabolism, toxicity, and kinetics. This phenomenon applies to chiral anticancer agents such as LP-184 and LP-284. The enantiomers, which are different molecules, possess distinct cancer cell-killing activity. Due to these differences, we can expand the range of potential cancer indications that can be addressed by the Lantern portfolio. These differences can be better understood though the use of data-driven methodologies, such as large-scale genomic analysis and in-silico studies. Lantern expects to apply these insights to develop LP-284 in cancer indications that are different and complementary to those being targeted by LP-184.

"The insights and developments from our team are rapidly leading to new therapy opportunities in a targeted and cost-effective manner. The designation of LP-284 as a new drug candidate demonstrates our continued ability to efficiently advance and expand Lantern’s portfolio of targeted therapies," stated Panna Sharma, CEO & President of Lantern Pharma.

LP-284 will be advanced using Lantern’s proprietary RADR A.I. platform that leverages over 1.2 billion data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and biomarker signatures that correlate to drug response in cancers and in cancer patients.

Based on Lantern’s previously filed PCT ("Patent Cooperation Treaty") patent application, Lantern has filed national stage patent applications to seek protection for LP-284 in major market countries throughout the world. The national stage patent applications allow, if granted, for patent protection of LP-284. The filed, multi-national patent applications are directed to both the composition and manufacture of LP-284. Lantern previously licensed patents related to LP-184 from AF Chemicals, LLC. Lantern has also filed an additional 8 patent applications that include method and use claims directed to LP-184 in specific solid tumors and also in combination with other drug compounds in specific tumors. Lantern’s patent applications also include claims related to the manufacture of LP-184 in a fully synthetic manner.

"Our patent strategy will continue to be highly focused on protecting our insights and developmental pathways for our drug candidates on a global basis. These seven patent applications are consistent with our focus on becoming a leader in the global development of precision oncology therapies," said Mr. Sharma of Lantern Pharma.

On March 17, 2021 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported its financial and operational results for the fourth quarter and year ended December 31, 2020 (Press release, IMV, MAR 17, 2021, View Source [SID1234576795]).

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"Notwithstanding the challenges everyone faced in 2020, IMV’s commitment to provide effective and well-tolerated immunotherapies to patients with hard-to-treat cancer resulted in significant progress on multiple fronts with our lead compound, Maveropepimut-S, and with other DPX-based candidates," said Fred Ors, Chief Executive Officer at IMV Inc. "We see 2021 as a transformational year for IMV as we are advancing Maveropepimut-S in both relapsed, refractory DLBCL ("r/r DLBCL"), advanced recurrent ovarian cancer. Additionally, we now have encouraging early data in two other solid cancer indications. We continue to explore the power of our versatile delivery platform with new DPX-based cancer immunotherapies, like DPX-SurMAGE, a dual-targeted cancer immunotherapy that is expected to enter clinical trials later this year and DPX-BRAF that is currently evaluated in preclinical studies in animal models."

Clinical Program Updates

Maveropepimut-S: Phase 2 SPiReL Study in r/r DLBCL

As reported in May 2020, this Phase 2 study in r/r DLBCL met its primary efficacy endpoint. In December 2020, the study’s lead investigator, Neil Berinstein, MD, hematologist at Sunnybrook Health Sciences Center provided an update during a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In November 2020, Dr. Berinstein also presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting where he announced the discovery of a potential predictive biomarker.

In his presentation during the annual ASH (Free ASH Whitepaper) meeting, Dr. Neil Berinstein described the results from the SPiReL study:

In the PD-L1+ population (n=7), subjects
Have significantly higher median Progression Free Survival (PFS) of 230 days, compared to the PD-L1 negative subjects (70 days) with a p-value of 0.007, suggestive of a strong predictive biomarker for this treatment combination,
Demonstrated an objective response in six subjects, including three subjects who have completed one-year of study treatment,
Demonstrated an ORR and a DCR at both 85.7% in evaluable PD-L1+.
Peripheral blood was assessed for survivin-specific ELISpot responses in 15 subjects with available samples. All 3 subjects with a CR, and 3 of 4 subjects with a PR, had positive ELISpot responses, while only 1 subject with SD and 1 subject with PD demonstrated survivin-specific ELISpot response suggestive of an association between the clinical responses with the mechanism of action of DPX-Survivac.
Treatment was well tolerated. The majority of treatment-related adverse events were grade 1 and 2 severity. A majority of these were injection site reactions associated with the subcutaneous administration of DPX-Survivac.
Based on these results, IMV recently engaged with the FDA which provided productive feedback. The Company is working with Merck to finalize the protocol of the Phase 2b clinical study which is expected to begin in Q2 2021.

Maveropepimut-S: Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer

Top line data presented in December 2020 demonstrated clinically meaningful activity with long-lasting clinical benefits, and an excellent safety/tolerability profile.

15/19 (79%) evaluable subjects demonstrated disease control. Clinical responses were observed across platinum-sensitive, platinum-resistant, and platinum-refractory patients.
7/19 evaluable subjects (37%) achieved clinical benefit with partial/stable responses lasting > 6 months, and 5 subjects (26%) achieved clinical benefit with partial/stable responses lasting > 12 months.
Treatment was well-tolerated with the majority of adverse events being grade 1-2 reactions at the injection site.
IMV is currently analyzing translational data with the goal of better understanding the mechanism of action of Maveropepimut-S and identifying potential predictive biomarkers. Once the analysis of the translational data is completed, the Company will request a meeting with the FDA in the second half of the year to finalize the design of a Phase 2b trial.

Maveropepimut-S: Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The objective of this exploratory trial conducted in collaboration with Merck is to identify and select the best solid tumor opportunities for the combination of IMV’s T cell therapy with Merck’s anti PD-1 checkpoint inhibitor, Keytruda, and CPA. Recruitment in five cancer indications follows a Simon two-stage design and each indication has prespecified success thresholds defined by the expected effect of Keytruda as a monotherapy agent in that indication.

The combination therapy is evaluated in patients with metastatic bladder cancer, liver cancer (hepatocellular carcinoma, HCC), ovarian cancer (with and without CPA), non-small cell lung cancer (NSCLC), and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker. At the time of this update, 116 subjects were enrolled on the study and sufficient data was available for four of the five indications.

The combination therapy achieved the thresholds in two indications: metastatic bladder and MSI-H tumor cancers. IMV is pleased to announce that the combination therapy will be further evaluated in these two indications.
The combination therapy did not meet the prespecified criteria to progress to the next stage in NSCLC and ovarian cancer. The Company will discuss with its partner Merck to decide whether these indications should be further explored.
In the Hepatocellular Carcinoma (liver) HCC indication, IMV and its partner Merck have decided to adjust some of the enrollment criteria in order to accelerate enrollment rates. An update will be provided when the enrollment goal is met.
DPX-COVID-19: A DPX-Based Vaccine Against SARS-CoV-2

Due to the evolution of the regulatory landscape, the emergence of new variants and the regulatory approval of vaccines by a number of countries, the Company is currently conducting complementary preclinical studies, including evaluating the impact of new variants, and will provide an update once these preclinical studies are completed.

As the scientific community gains a better understanding of the duration of the protection induced by the current and soon-to-be approved vaccines, their efficacy against new emerging variants and the possible need to revaccinate, the Company’s goal is to generate sufficient clinical evidence supporting the claim that DPX-based vaccines, which have a different mechanism of action than traditional vaccines, can represent a compelling long-lasting solution to COVID-19 and to other future pandemics.

Once available, IMV intends to submit preclinical study results supporting the Phase 1/2 clinical trial in a peer-reviewed scientific journal.

2020 Operational Highlights

IMV strengthened its financial position in May 2020 with a private placement for gross proceeds of $25.1 million in addition to gross proceeds of $40.8 million (US $30 million) raised under its March and June At-The-Market facilities. This translates to cash and cash equivalents of $46.4 million at the end of the fiscal year.

Company appointed Andrew Hall, B.Med.Sci., M.Sc. as Chief Business Officer: Mr. Hall joined IMV in November 2020. He brings more than 20 years of executive experience in biopharmaceuticals and life sciences, and has spent his career focused on corporate and portfolio strategy, as well as business development and commercial operations with industry leaders such as Celgene, Merck, Schering-Plough, and Bristol-Meyers Squibb spearheading new product development, analytics and commercial strategy for immunology and inflammation, oncology, women’s health, cardiovascular portfolios and more.

Overview of Year-End 2020 Financial Results

As of December 31, 2021, the Company had cash and cash equivalents of $46.4 million and working capital of $45.5 million, compared with $14.1 million and $13.2 million, respectively as of December 31, 2019. The increase in cash primarily reflects proceeds from the $25.1 million private placement completed on May 7th, the 6,841,773 common shares issued for gross proceeds of $40.8 million (US$30 million) under its March and June At-The-Market facilities and $2.3 million from the exercise of 611,888 common share warrants. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations for at least the next 12 months.

Research and development expenses were $26.6 million for the year ended December 31, 2020 compared with $19.0 million for the year ended December 31, 2019. This increase of $7.6 million was mainly due to a rise in expenses related to the ongoing basket trial, personnel costs due to an increase in headcount, and pre-clinical development of DPX-COVID-19, which was offset by the increase in government assistance described below.

General and administrative expenses were $15.2 million for the year ended December 31, 2020 compared with $10.1 million for the year ended December 31, 2019. This increase was mainly attributable to an increase in insurance premium and, to a lesser extent, an increase in foreign exchange loss and non-cash deferred share unit compensation. These increases were partly offset by a decrease in travel costs due to COVID-19 travel restrictions and a decrease in non-cash stock backed compensation.

Government assistance totaled $6.7 million for fiscal 2020 compared with $2.4 million in fiscal 2019. This increase is mainly explained by various government grants for the development of DPX-COVID-19, reimbursed for eligible development expenditures incurred to date.

The net loss and comprehensive loss of $34.9 million ($0.58 per share) for the year ended December 31, 2020 was $7.5 million higher than the net loss and comprehensive loss for the year ended December 31, 2019 and can be further explained by a $5.1 million increase in general and administrative expenditures, a $7.6 million increase in research and development expenditures, partly offset by a $4.3 million increase in COVID-19 specific government funding.

As of March 16, 2021, the number of issued and outstanding common shares was 67,711,045 and a total of 4,997,282 stock options, warrants and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at View Source

All dollar amounts noted herein are denominated in Canadian dollars (unless otherwise noted herein).

2021 Expected Milestones

Maveropepimut-S

Q1 2021: Finalization of clinical protocol and collaboration agreement with partner for Phase 2B clinical trial in r/r DLBCL
Q2 2021: Translational and Biomarker analysis update for Ovarian cancer DeCidE1 trial
Q2 2021: Initiation of r/r DLBCL Phase 2B trial
H2 2021: Meeting with the FDA and final clinical design for a Phase 2B study in Advanced Recurrent Ovarian Cancer
H2 2021: Updated results for the basket trial.
DPX-SurMAGE

H2 2021: Initiation of a Phase 1 clinical study in bladder cancer.
DPX-COVID-19

Q2 2021: Submission of pre-clinical manuscript.
Conference Call and Webcast Information

Management will host a conference call and webcast today March 17, 2021 at 8:00 a.m. ET. Investment professionals are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 8998652. Other interested parties can access the live audio webcast at this link: View Source

On March 17, 2021 Helix BioPharma Corp. (TSX: "HBP"), a an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the fiscal second quarter ended January 31, 2021 (Press release, Helix BioPharma, MAR 17, 2021, View Source [SID1234576793]).

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OVERVIEW The Company reported a net loss and total comprehensive loss of $2,492,000 and $2,714,000 for the three and sixmonth periods ended January 31, 2021. For the three and six-month periods ended January 31, 2020, net loss and total comprehensive loss totalled $2,255,000 and $4,466,000, respectively. The net loss and total comprehensive loss for the three-month period ending January 31, 2021 included a net loss of $626,000 (2020-$nil) and for the sixmonth period ending January 31, 2021 a net gain of $1,536,000 (2020-$nil) as a result of the loss of control of a subsidiary and ultimately, a final tranche disposition on December 22, 2020 for gross proceeds of $2,308,000. Subsequent to the quarter ending January 31, 2021, BDO Canada LLP resigned as the Company’s auditors.

The Company has engaged Marcum LLP as its new auditors. Research and development Research and development expense for the three and six-month periods ended January 31, 2021 totalled $1,086,000 and $2,170,000, respectively, as compared to $1,588,000 and $3,099,000 respectively for the three and six-month periods ended January 31, 2020, respectively.

The reduction in research and development expenditures for both the three and six-month periods ended January 31, 2021 when compared to the prior year, is mainly the result of lower clinical study and intellectual property expenditures. 1 Lower clinical operation expenses are due to spending having occurred in the prior year related to the Company’s LDOS003 Phase II clinical study in Poland and the Ukraine which has since concluded but currently awaiting reporting. The Company’s new LDOS006 Phase Ib/II pancreatic clinical study in the U.S. was still in the early stages with U.S. FDA approval only having been received in August 2019 and enrollment having commenced in December 2019. COVID19 slowed down patient enrollment.

The Company has added a new study site on March 12, 2021 and expects to add a third site in a months’ time in order to increase the patient enrollment rate. Lower intellectual property maintenance costs are mainly the result of the Company reclaiming certain costs incurred on behalf of its former subsidiary as per agreement. Operating, general and administration Operating, general and administration expenses for the three and six-month periods ended January 31, 2021 totalled $818,000 and $2,121,000, respectively, as compared to $654,000 and $1,363,000 for the three and six-month periods ended January 31, 2020, respectively The increase in operating, general and administration expenditures for both the three and six-month periods ended January 31, 2021 when compared to the prior year, is mainly the result of higher stock-based compensation expense associated with the vesting of stock options that were granted to directors of the Company over their vesting period in addition to higher legal costs and auditor fees. The Company has been in discussions with various groups both in the U.S. and Canada and has been incurring additional legal and audit expenses as part of the Company’s objective to raise additional capital to qualify for a listing on a U.S. stock exchange such as NASDAQ.

LIQUIDITY AND CAPITAL RESOURCES The Company reported a net loss and total comprehensive loss of $2,492,000 for the three-month period ended January 31, 2021 (2020-$2,255,000) and $2,714,000 for the six-month period ended January 31, 2021 (2020-$4,466,000). As at January 31, 2021 the Company had working capital of $3,639,000, shareholders’ equity of $3,766,000 and a deficit of $183,230,000. As at July 31, 2020 the Company had working capital of $2,735,000, shareholders’ equity of $2,981,000, a deficit of $180,516,000.

The Company experienced a working capital deficiency throughout fiscal 2018 and 2019 until August 21, 2019 when the Company closed the first of a series of private placements with a more recent financing occurring in December 2020. During the quarter ended January 31, 2021, the Company completed two rounds of private placements for gross proceeds totalling $4,100,000. On December 22, 2020 the Company disposed its remaining interest in a subsidiary for gross proceeds of $2,308,000. The Company’s cash reserves of $4,098,000 as at January 31, 2021 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion.

Though the funds raised have assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, to be critical for its development needs.

The Company’s Interim Condensed Financial Statements (unaudited) and Management’s Discussion and Analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On March 17, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2020 (Press release, CTI BioPharma, MAR 17, 2021, View Source [SID1234576792]).

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"This past quarter, CTI has executed on the critical clinical, regulatory and commercial activities that will allow for the potential U.S. approval and commercial launch of pacritinib in 2021," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We continue to work diligently on our rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for pacritinib, for use in myelofibrosis patients with severe thrombocytopenia, and are on track to complete the submission before the end of this month. Pending priority review and approval by the FDA, we are planning to launch pacritinib in the United States by the end of the year. Over the last quarter, we have focused on the key pre-commercial activities that will enable a successful launch, including the recruitment of key leadership roles in marketing and sales, and the initiation of our disease awareness, market access, and field force strategies. We look forward to being able to provide pacritinib to myelofibrosis patients who are underserved by existing therapies."

Expected Milestones

Expected completion of rolling NDA submission for pacritinib in myelofibrosis patients with severe thrombocytopenia – Q1 2021
Expected FDA approval and U.S. commercial launch of pacritinib in myelofibrosis patients with severe thrombocytopenia – by end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – mid-2021
Fourth Quarter Financial Results

Operating loss was $14.8 million and $47.8 million for the three months and year ended December 31, 2020, respectively, as compared to an operating loss of $9.5 million and $40.7 million for the respective periods in 2019. The increase in operating loss for the three months ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from more extensive research and development activities. The increase in operating loss for the year ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from the recording of a full allowance against certain VAT receivables due to a reduced certainty of their collectability.

No revenues were recognized for the three months and year ended December 31, 2020 or for the three months ended December 31, 2019, as compared to revenues of $3.3 million recognized for the year ended December 31, 2019. License and contract revenues in 2019 resulted from royalty and other payments received from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and were related to the asset purchase agreement and transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.

Net loss for the three months ended December 31, 2020 was $15.0 million, or $0.20 for basic and diluted loss per share, as compared to a net loss of $8.2 million, or $0.14 for basic and diluted loss per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $52.5 million, or $0.74 for basic and diluted loss per share, as compared to a net loss of $40.0 million, or $0.69 for basic and diluted loss per share, for the same period in 2019.

As of December 31, 2020, cash, cash equivalents and short-term investments totaled $52.5 million, as compared to $33.7 million as of December 31, 2019. We expect our current cash, cash equivalents and short-term investments will enable us to fund our operations into the second quarter of 2021.

Conference Call and Webcast

CTI will host a conference call and webcast to review its fourth quarter 2020 financial results and provide an update on business activities today, March 17 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 9095063. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

About Myelofibrosis and Severe Thrombocytopenia

Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, creating a significant area of unmet medical need.

On March 17, 2021 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines,reported fourth quarter and full year 2020 financial results and operational progress (Press release, Codiak Biosciences, MAR 17, 2021, View Source [SID1234576791]).

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"The past year was tremendously productive for Codiak as we brought our first two programs into the clinic, the first ever engineered exosome therapeutic candidates to be tested in humans, and completed a successful initial public offering," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "The early data from our exoIL-12 program have provided validation of our approach and propel us into what we anticipate will be an exciting year ahead, with multiple data read-outs and the initiation of a third clinical program expected."

Fourth Quarter 2020 and Recent Highlights

Reported initial pharmacokinetic/pharmacodynamic and tolerability data from randomized, placebo-controlled healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and selected pharmacological dose and regimen to carry forward into assessment in patients with cutaneous T cell lymphoma (CTCL)
Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
Closed IPO in October 2020, raising $74.4 million in net proceeds
Published manuscript detailing the exoIL-12 preclinical program in Molecular Cancer Therapeutics
Published manuscript highlighting versatility of the engEx Platform in the online edition of Molecular Therapy
Closed follow-on public offering in February 2021, raising $62.0 million in net proceeds
Anticipated Milestones and Events

Late-breaking abstract poster presentation of the full pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Poster presentation of preclinical data from the exoASO-STAT6 program at the AACR (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected mid-2021
Investigational New Drug (IND) application filing for exoASO-STAT6 program to enable initiation of clinical trials anticipated during the second half of 2021
Biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients from exoIL-12 Phase 1 trial expected by year-end 2021
Fourth Quarter and Full Year 2020 Financial Results
Total revenues for the quarter ended December 31, 2020 were $1.6 million, compared to $0.2 million for the same period in 2019. Total revenues for the year ended December 31, 2020 were $2.9 million, compared to $0.4 million for the same period in 2019. These increases were primarily due to revenue recognized in connection with our collaboration with Sarepta Therapeutics.

Net loss for the quarter ended December 31, 2020 was $18.0 million, compared to a net loss of $21.6 million for the same period in 2019. Net loss for the year ended December 31, 2020 was $91.7 million, compared to a net loss of $78.0 million for the same period in 2019. Net loss for the quarter and year was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform.

Research and development expenses were $13.3 million for the quarter ended December 31, 2020 compared to $17.7 million for the same period in 2019. The decrease in research and development expenses was driven primarily by the timing of external manufacturing expenditures in the prior year.

Research and development expenses were $74.0 million for the year ended December 31, 2020 compared to $59.5 million for the same period in 2019. The year-over-year increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exoIL-12 and exoSTING clinical trials in September 2020.

General and administrative expenses were $5.9 million for the quarter ended December 31, 2020 compared to $4.3 million for the same period in 2019. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

General and administrative expenses were $19.9 million for the year ended December 31, 2020 compared to $21.0 million for the same period in 2019. The year-over-year decrease was primarily driven by a decrease in consulting, accounting and legal fees.

As of December 31, 2020, Codiak had cash and cash equivalents of approximately $88.9 million. Subsequent to year end, Codiak closed a public offering in February 2021, raising $62.0 million in net proceeds. Based on our current operating plan, we expect our cash and cash equivalents as of December 31, 2020, together with the net proceeds from our follow-on public offering in February 2021, will enable us to fund our operating expenses and capital expenditure requirements through the end of 2022.