On March 26, 2020 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the year ended December 31, 2019 and provided corporate milestones for 2020 (Press release, Pain Therapeutics, MAR 26, 2020, View Source [SID1234555876]).

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Net loss in full-year 2019 was $4.6 million, or $0.27 per share, compared to a net loss in 2018 of $6.6 million, or $0.61 per share. Net cash used in operations in full-year 2019 was $2.5 million. Cash and cash equivalents were $23.1 million as of December 31, 2019. Subsequently, Cassava Sciences received $3.6 million from the exercise of 2.9 million common stock warrants, increasing its net cash balance to more than $26 million at January 31, 2020. Net cash use in full-year 2020 is expected to be approximately $5 million.

"As we enter 2020, our financial considerations once again reflect a thoughtful balance between maintaining fiscal discipline and advancing our product candidates aimed at Alzheimer’s disease," said Eric Schoen, Chief Financial Officer.

"Our foundational strategy is to focus on the internal development of a first-in-class program aimed at Alzheimer’s disease and other neurodegenerative conditions," said Remi Barbier, President & CEO. "This emphasis on breakthrough innovations in neuroscience drives our actions and gives us the confidence to achieve our anticipated milestones for 2020 and beyond."

Anticipated Corporate Milestones for 2020
Cassava Sciences’ scientific approach for the treatment of Alzheimer’s disease is to improve both neurodegeneration and neuroinflammation with its lead investigational drug, PTI-125. The Company believes the ability to improve multiple vital functions in the brain represents a new, different and crucial approach to address Alzheimer’s disease. The Company is also developing SavaDx (formerly known as PTI-125Dx), an investigational diagnostic aimed at detecting Alzheimer’s disease with a simple blood test. The Company’s anticipated key milestone achievements for 2020 include:

Completion of patient enrollment for a Phase 2b study of PTI-125 in Alzheimer’s disease.
Status: completed and announced Q1 2020.

Biomarker analysis, statistical analysis and data analytics for the Phase 2b study.
Status: on-going.

Top-line results for the Phase 2b study.
Status: announcement expected approximately mid-2020.

Initiation of an open-label extension study of PTI-125 in Alzheimer’s disease.
Status: completed and announced Q1 2020.

Publication of prior clinical results with PTI-125 in a peer-reviewed journal.
Status: completed and announced Q1 2020.

Development of proprietary antibodies and other detection systems for SavaDx.
Status: announcement expected 2nd half 2020.

Initiation of a validation/disease specificity study of SavaDx.
Status: announcement expected 2nd half 2020.

Technical update of SavaDx at a major scientific conference.
Status: announcement expected approximately mid-2020.
Business Highlights 2019 to Date

Phase 2a Study of PTI-125

In September 2019, Cassava Sciences reported positive clinical results in Alzheimer’s disease with its lead drug candidate, PTI-125. In a first-in-patient, Phase 2a study funded by the National Institutes of Health (NIH), treatment with PTI-125 for 28 days significantly reduced biomarkers of disease pathology, neuroinflammation and neurodegeneration, consistent with years of basic research and pre-clinical data. Key biomarker results of the Phase 2a study include: total tau (T-tau) decreased 20% (p<0.001); phosphorylated tau (P-tau) decreased 34% (p<0.0001); neurofilament light chain (NfL), a marker for degeneration of axons, decreased 22% (p<0.0001); neurogranin, a marker for degeneration of dendrites, decreased 32% (p<0.0001); and neuroinflammatory marker YKL-40, an indicator of microglial activation, decreased 9% (p<0.0001). All evaluable patients showed a biomarker response to PTI-125. PTI-125 was safe and well-tolerated.

In December 2019, results of the Phase 2a study were presented as a late-breaking oral presentation at the CTAD Alzheimer’s Congress, a major international conference for researchers in the field of Alzheimer’s disease.

In February 2020, Phase 2a study results were published in The Journal of Prevention of Alzheimer’s Disease, a peer-reviewed clinical journal.
Phase 2b Study of PTI-125

In September 2019, Cassava Sciences announced the initiation of a Phase 2b confirmatory clinical study in Alzheimer’s patients, with funding provided by NIH. This blinded, randomized, placebo-controlled, multi-center, multi-dose research study is designed to evaluate the safety and tolerability of PTI-125, and its effects on biomarkers of disease. Study participants received PTI-125 100 mg, 50 mg or matching placebo, twice-daily, for 28 continuous days. The study was conducted in 9 U.S. clinical sites. The primary endpoint is improvements in levels of biomarkers of disease from baseline to Day 28.

In January 2020, Cassava Sciences announced the completion of patient enrollment for this Phase 2b study (N=64 patients with mild-to-moderate Alzheimer’s disease).

In February 2020, study participants received their final dose of treatment. In March 2020, study participants successfully underwent final, routine follow-ups. No issues were noted. Cerebrospinal fluid and plasma samples from study participants are being shipped to independent, third party labs for biomarker analysis. Biomarker analysis will be conducted under blinded conditions to avoid bias, meaning no one will know whether a test sample came from a subject who was on drug or placebo until the study is unblinded. Biomarker analysis, statistical analysis, data analytics and interpretation of results are expected to be conducted through approximately May 2020.

Cassava Sciences expects to announce top-line results for its Phase 2b study approximately mid-year 2020.
Open-Label Study of PTI-125

In March 2020, Cassava Sciences announced the initiation of an open-label, multi-center, extension study that will monitor the long-term safety and tolerability of PTI-125 at 100 mg twice-daily for 12 months. The target enrollment is approximately 100 patients with mild-to-moderate Alzheimer’s disease, including patients from prior studies of PTI-125. Study sites may initially slow the pace of patient enrollment to minimize any risks of exposing elderly patients to infectious disease during office visits.
SavaDx – detecting Alzheimer’s disease with a simple blood test

Cassava Sciences is continuing the development of proprietary antibodies and other detection systems for use with SavaDx. Assuming technical success with on-going efforts, the Company expects to initiate a validation/disease specificity study with SavaDx in the second half of 2020.

Cassava Sciences expects to present a technical update for SavaDx at a major scientific conference in 2020, assuming no health or transportation restrictions.
Financial Highlights

At December 31, 2019, cash and cash equivalents were $23.1 million, compared to $19.8 million at December 31, 2018, with no debt. The 2019 year-end cash balance included proceeds of $5.9 million from the exercise of 4.6 million common stock warrants.
In 2020, the Company received an additional $3.6 million in proceeds from exercise of warrants, bringing its cash balance in excess of $26.0 million at January 31, 2020.
The Company has approximately 24.7 million common shares outstanding as of March 26, 2020. Approximately 1.6 million warrants remain outstanding at March 26, 2020. Each warrant has an exercise price of $1.25 per share. All warrants expire February 2021.

Net cash used in operations during the year ended December 31, 2019 was $2.5 million, net of reimbursements received from NIH grant awards. Net cash use for full year 2020 is expected to be approximately $5.0 million, depending on the timing of clinical studies and other events.
Research and development expenses for the year ended December 31, 2019 were $1.6 million compared to $3.0 million for the same period in 2018, or a 47% decrease. While Phase 2 clinical program costs were higher in 2019, overall expense was reduced by greater NIH reimbursement as well as lower non-cash stock related compensation compared to the prior year.
We received reimbursements of $4.7 million in 2019 from research grant awards from NIH that we recorded as a reduction of research and development expense compared to $3.0 million in 2018.
Research and development expenses included non-cash stock related compensation costs of $0.5 million for the year ended December 31, 2019 and $1.0 million for the same period in 2018.

General and administrative expenses for the year ended December 31, 2019 were $3.4 million compared to $3.7 million for the same period in 2018, or an 8% decrease. This was due primarily to a decrease in non-cash stock-based compensation expense. General and administrative expenses included non-cash stock-based compensation costs of $0.8 million in the year ended December 31, 2019 compared to $1.4 million for the same period in 2018.
About PTI-125
Cassava Sciences’ lead therapeutic product candidate is for the treatment of Alzheimer’s disease. PTI-125 is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. PTI-125 seeks to simultaneously improve both neurodegeneration and neuroinflammation. The underlying science is published in peer-reviewed scientific journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry and Journal of Prevention of Alzheimer’s Disease. The Company is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older developed Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.2

On March 26, 2020 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported financial results for the three months and year ended December 31, 2019 and provided a corporate update (Press release, Aprea, MAR 26, 2020, View Source [SID1234555875]).

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Corporate Update:

The Company is conducting, supporting and planning multiple clinical trials of APR-246:

·Pivotal Phase 3 MDS Trial—The Company is currently enrolling a pivotal Phase 3 randomized, controlled trial evaluating APR-246 with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients. The trial has a target enrollment of 154 patients randomized in a 1:1 ratio to either the azacitidine control arm or to the APR-246 + azacitidine experimental arm, with a primary endpoint of CR rate. The Company had anticipated full enrollment in its Phase 3 trial in the first quarter of 2020 and as of March 25, 2020, the Company had enrolled 133 patients. The Company has observed a recent decrease in both patient screening and patient enrollment as a result of the recent coronavirus (COVID 19) pandemic. Together with its investigators and clinical sites, the Company is assessing the potential impact of the coronavirus pandemic on enrollment and the ability to maintain patients enrolled in the trial and the corresponding impact on the timing of the completion of the trial and subsequent availability of top-line data. The Company remains confident that it can complete the trial and have top-line data available before year end 2020.

·Phase 2 MDS/AML Post-Transplant Trial—The Company is currently enrolling its single-arm, open-label Phase 2 trial evaluating APR-246 with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant. The primary endpoint is relapse-free survival at 12 months. As of March 25, 2020, the Company had enrolled 11 patients in this trial. Target enrollment is 31 patients and the Company had anticipated full enrollment in the first half of 2020. Together with its investigators and clinical sites, the Company is assessing the potential impact of the coronavirus pandemic on the enrollment and the ability to maintain patients enrolled in this trial.

·Phase 1 AML Trial—Based on in vitro data evidencing synergistic activity between APR-246 and a Bcl-2 inhibitor, the Company is conducting a Phase 1 clinical trial in frontline and relapsed/refractory TP53 mutant AML assessing APR-246 with venetoclax with or without azacitidine. The primary endpoint is the composite rate of CR and CR with incomplete hematologic recovery, or CRi. The first patient was enrolled in 1Q 2020 and the Company completed enrollment of the first two safety cohorts of three patients each. Together with its investigators and clinical sites, the Company is assessing the potential impact of the coronavirus pandemic on the enrollment and the ability to maintain patients enrolled in this trial.

·Phase 1 NHL Trial—As further assessment of APR-246 in hematological malignancies, the Company has designed and plans to conduct a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) and mantle cell lymphoma (MCL) assessing APR-246 with venetoclax and rituximab, and APR-246 with ibrutinib. The Company is targeting the first patient to be enrolled in the second half of 2020.

·Phase 1/2 Solid Tumor Trial—Based on in vitro data evidencing synergistic activity between APR-246 and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and plans to conduct Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing APR-246 with anti-PD-1 therapy. The Company is targeting the first patient to be enrolled in the second half of 2020.

·APR-548 — The Company’s second product candidate, APR-548, is a next-generation p53 reactivator with the potential for oral administration. APR-548 is a unique analog of APR-246 and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has completed Investigational New Drug, or IND, enabling preclinical studies of APR-548. Final reports from these studies are pending and the Company is targeting the submission of an IND in the first half of 2020.

·APR-246 INN — The Company has secured eprenetapopt as the international nonproprietary name (INN) for APR-246.

Fourth Quarter Financial Results

·Cash and cash equivalents: As of December 31, 2019, Aprea had $130.1 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018. In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in net proceeds of approximately $86.9 million. The Company expects cash burn for 2020 to be between $35.0 million $40.0 million. The Company believes its cash and cash equivalents as of December 31, 2019 will be sufficient to meet its current projected operating requirements into 2023.

·Research and Development (R&D) expenses: R&D expenses were $8.0 million for the quarter ended December 31, 2019, compared to $4.4 million for the comparable period in 2018. The increase in R&D expenses was primarily related to the advancement of the Company’s lead product candidate, APR-246. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of APR-246 with azacytidine for frontline treatment of TP53 mutant MDS which is supported by two ongoing Phase 1b/2 investigator initiated trials, one in the U.S. and one in France, testing APR-246 with azacitidine as frontline treatment in TP53 mutant MDS and AML patients.

·General and Administrative (G&A) expenses: G&A expenses were $3.9 million for the quarter ended December 31, 2019, compared to $0.5 million for the comparable period in 2018. The increase in G&A expenses was primarily due to increased professional fees associated with operating as a public company, as well as increased personnel costs.

·Net loss: Net loss was $13.1 million, or $0.64 per share for the quarter ended December 31, 2019, compared to a net loss of $4.7 million, or $4.05 per share for the quarter ended December 31, 2018. Net loss for the year ended December 31, 2019 was $28.1 million, or $4.67 per share, compared to a net loss of $15.5 million, or $13.45 per share for the year ended December 31, 2018.

On March 26, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it has received a listing extension from the Staff of the Listing Qualifications Department of The Nasdaq Capital Market LLC (Nasdaq) (Press release, DelMar Pharmaceuticals, MAR 26, 2020, View Source [SID1234555874]). The extension grants the Company until September 21, 2020 to regain compliance with the $1.00 Minimum Bid Price requirement for continued listing on Nasdaq.

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As previously disclosed on a Form 8-K filed on September 27, 2019 with the U.S. Securities and Exchange Commission, on September 26, 2019, the Company received a written notice (the Initial Notice) from the Nasdaq Staff indicating that the Company was not in compliance with the $1.00 Minimum Bid Price requirement for continued listing on Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was afforded an initial period of 180 calendar days, or until March 24, 2020, to regain compliance. The Company was unable to regain compliance with the $1.00 Minimum Bid Price requirement, which required the Company to demonstrate compliance for a minimum of ten consecutive business days. Subsequently, on March 25, 2020, the Company received an additional written notice notifying that while the Company had not yet regained compliance with the $1.00 Minimum Bid Price requirement, the Nasdaq Staff has granted an additional extension of 180 calendar days to September 21, 2020 to regain compliance with the Minimum Bid Price requirement.

On March 26, 2020 Unum Therapeutics Inc. (NASDAQ: UMRX), a biopharmaceutical company focused on developing curative cell therapies for solid tumors, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided corporate updates (Press release, Unum Therapeutics, MAR 26, 2020, View Source [SID1234555873]).

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"We recently announced the conclusion of our Phase 1 ACTR707 programs and restructuring to prioritize our capabilities and resources towards advancing our preclinical program, BOXR1030, and BOXR platform aimed at discovering novel ‘bolt-on’ transgenes to help T cells survive longer and perform better in the solid tumor microenvironment," said Chuck Wilson Ph.D., President and Chief Executive Officer of Unum. "While taking steps internally to advance BOXR1030 and the BOXR platform given the broad potential we see to improve cell therapies in solid tumors, we are also taking steps to evaluate external opportunities as well and in this context, and with alignment from our Board of Directors, we are also actively seeking strategic alternatives to maximize shareholder value, including a sale or merger of the Company at this time."

Recent Program and Corporate Highlights

Announced plans to prioritize resources towards advancing its preclinical program, BOXR1030, for the treatment of solid tumor cancers: Unum’s BOXR1030 expresses a glypican-3 (GPC3) targeted CAR and incorporates the novel transgene glutamic-oxaloacetic transaminase 2 (GOT2) to improve T cell function in the solid tumor microenvironment by enhancing T cell metabolism. Unum has initiated formal preclinical development activities, including preclinical safety testing and GMP process development, to support filing an IND application for BOXR1030 in late 2020. As part of this effort, and to conserve resources for BOXR1030, Unum is concluding its ACTR707 clinical trials, including the Phase 1 trial (ATTCK-20-03) in combination with rituximab in relapsed/refractory non-Hodgkin lymphoma and the Phase 1 trial (ATTCK-34-01) in combination with trastuzumab to treat advanced HER2+ solid tumor cancers. Unum expects to continue to leverage its BOXR discovery platform, potentially in collaboration with partners, to create and develop new BOXR product candidates to address a broad range of solid tumor cancers.

Presented preclinical data for BOXR1030 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (November 6-10): BOXR1030 expresses a glypican-3 (GPC3) targeted chimeric antigen receptor (CAR) with the addition of the "bolt-on" transgene glutamic-oxaloacetic transaminase 2 (GOT2) to improve T cell function in the TME by enhancing T cell metabolism. As presented at the SITC (Free SITC Whitepaper) conference, expression of the GOT2 mitochondrial enzyme in BOXR1030 increased the production of key amino acids and metabolites, improved the anti-oxidant balance of T cells, and

prevented their dysfunction and exhaustion in preclinical studies using stringent animal xenograft models that simulate the TME. In vitro, BOXR1030 T cells were resistant to suppressive TME-like conditions, showing improved T cell proliferation under both hypoxic and low glucose conditions compared with control GPC3+ CAR-T cells. In vivo, BOXR1030 demonstrated superior activity compared to the control CAR-T with treated animals achieving complete tumor regressions under metabolically challenging conditions. Tumor infiltrating lymphocytes isolated from the tumors of treated animals revealed that BOXR1030 cells were more resistant to dysfunction, had fewer markers of exhaustion, and remained functional as compared to the control CAR-T cells.

Entered into a common stock purchase agreement for up to $25 million with Lincoln Park Capital Fund, LLC ("LPC"): Under the terms of the purchase agreement, Unum Therapeutics will have the sole discretion to direct LPC to purchase up to $25 million in shares of its common stock over the 36-month term of the agreement based on the market prices prevailing at the time of each sale to LPC. Unum Therapeutics controls the timing and amount of any future sales of its stock, subject to various limitations including those under the NASDAQ listing rules, and there is no upper limit as to the price per share that LPC may pay for future stock issuances under the purchase agreement. LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Unum Therapeutics’ common stock. Unum Therapeutics maintains the right to terminate the common stock purchase agreement at any time, at its discretion, without any additional cost or penalty.

Today announced plans to explore strategic options to maximize shareholder value. Following a review of its business, including the status of its development program, resources and capabilities, the Company has initiated a process to explore strategic alternatives focused on maximizing shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transaction. There can be no assurance that this process will result in any such transaction. Unum Therapeutics has not set a timetable for completion of this review process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.

Ladenburg Thalmann & Co. Inc. has been engaged to act as Unum Therapeutics’ strategic financial advisor during this process to explore and evaluate strategic alternatives to maximize shareholder value.

Fourth Quarter and Full Year 2019 Financial Results

Collaboration Revenue: Collaboration revenues were $15.3 million for the fourth quarter of 2019 and $22.5 million for the year ended December 31, 2019, compared to collaboration revenue of $3.8 million and $9.7 million, respectively, for the same periods of 2018. Collaboration revenue, which includes the

recognition of a portion of the upfront payment received as well as reimbursements of research and development costs attributed to the Seattle Genetics, Inc. collaboration agreement, increased during the fourth quarter of 2019 compared to the same period in 2018 as a result of the recognition of a significant portion of the upfront payment from Seattle Genetics, Inc., due to the suspension of the Phase 1 ATTCK-17-01 trial in November 2019. The collaboration agreement was subsequently terminated in January 2020.

R&D Expenses: Research and development expenses were $10.4 million for the fourth quarter of 2019 and $43.7 million for the year ended December 31, 2019, compared to $10.8 million and $38.3 million, respectively, for the same periods of 2018. Research and development expenses relate to costs for the Phase 1 trials and preclinical programs, as well as personnel-related costs to support these programs.

G&A Expenses: General and administration expenses were $2.7 million for the fourth quarter of 2019 and $11.0 million for the year ended December 31, 2019, compared to $2.0 million and $7.5 million, respectively, for the same periods of 2018. The increase is primarily related to increased headcount and personnel-related costs, as well as expenses required to operate as a public company.

Net Loss: Net income attributable to common stockholders was $2.3 million, or $0.07 per share, for the fourth quarter of 2019 and a net loss of $31.8 million, or ($1.04) per share, for the year ended December 31, 2019, compared to a net loss attributable to common stockholders of $8.6 million, or ($0.29) per share, and $34.5 million, or ($1.39) per share, respectively, for the same periods of 2018.

Cash and Cash Equivalents: As of December 31, 2019, Unum had cash and cash equivalents of $37.4 million. Unum believes that its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into mid-2021.

About Unum’s BOXR1030 and BOXR Platform

Unum’s BOXR1030 was discovered from its Bolt-on Chimeric (BOXR) platform that is designed to discover novel "bolt-on" transgenes to be co-expressed with CARs, a T-cell receptor, or ACTR, to help T cells survive longer and perform better in the solid tumor microenvironment. BOXR candidates consist of two main components: 1) a targeting receptor that directs the T cell to attack tumor cells, which may be a traditional CAR receptor, a T-cell receptor, or Unum’s ACTR receptor, and 2) a novel "bolt-on" transgene that improves the intrinsic function of the T cell. Once discovered, BOXR transgenes are designed to be incorporated into several different types of therapeutic T cells, including both ACTR T cells and CAR-T cells, to impart new functionality to T cells.

Unum’s first product candidate selected from the BOXR platform, BOXR1030, expresses GPC3+ targeted CAR and incorporates the bolt-on GOT2 transgene to improve T cell function in the solid tumor microenvironment (TME) by enhancing T cell metabolism. Preclinical data with BOXR1030 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2019. In preclinical studies, BOXR1030 T cells were resistant to suppressive TME-like conditions, showing improved T cell proliferation under both hypoxic and low glucose conditions compared with control GPC3+ CAR-T cells. In vivo, BOXR1030 demonstrated superior activity compared to the parental CAR-T with treated animals achieving complete tumor regressions. Tumor infiltrating lymphocytes isolated from the tumors of treated animals revealed that BOXR1030 cells were more resistant to dysfunction and had fewer markers of exhaustion as compared to the control CAR-T cells.

On March 26, 2020 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, 2019 (Press release, IntelGenx, MAR 26, 2020, View Source [SID1234555872]). 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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2019 Fourth Quarter Financial Highlights:

Revenue was $68,000, compared to $651,000 in the 2018 fourth quarter
Adjusted EBITDA was ($2.1 million), compared to ($2.0 million) in Q4-2018
2019 Full-Year Financial Highlights:

Revenue was $742,000, compared to $1.8 million in 2018
Net comprehensive loss was $10.3 million, compared to net comprehensive loss of $10.6 million in 2018
Adjusted EBITDA was ($8.5 million), compared to ($7.9 million) in 2018
Recent Highlights:

Closed an offering of 16,317,000 units (the "Units") at a price of C$0.50 per Unit for gross proceeds of C$8.2 million.
Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm Phase 2a ("BUENA") clinical trial in patients with mild to moderate Alzheimer’s Disease.
Announced that a cannabis-infused VersaFilm product has been finalized with its co-development partner, Tilray, Inc. (NASDAQ:TLRY) ("Tilray") and all manufacturing scale-up work has been successfully completed.
Signed a binding term sheet with Orivas for the commercialization of RIZAPORT pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway).
"There are several very near-term milestones that represent potential value inflection points for our Company," said Dr. Horst G. Zerbe, CEO of IntelGenx. "We are anticipating receipt of the U.S. Food and Drug Administration’s decision on our 505(b)(2) New Drug Application for RIZAPORT VersaFilm for the treatment of acute migraines later today. On the heels of that, we also expect to receive Health Canada’s requisite micro-processing license in the coming weeks, which will enable us to begin commercial production of cannabis-infused oral films for our partner, Tilray, with product sales expected to begin as soon as practicable thereafter. In addition, we are planning to resume enrollment for our Phase 2a BUENA trial at our Canadian sites under a Health Canada-approved dose increase and are looking forward to providing initial trial data as they become available."

Financial Results:

Total revenues for the three-month period ended December 31, 2019 amounted to $68,000, a decrease of $583,000 compared to $651,000 for the three-month period ended December 31, 2018. The change is mainly attributable to a decrease in R&D revenues of $583,000. Operating costs and expenses were $2.4 million for the fourth quarter 2019, versus $2.9 million for the corresponding three-month period of 2018. For Q4-2019, the Company had an operating loss of $2.4 million, compared to operating loss of $2.2 million for the comparable period of 2018.

Total revenues for the twelve-month period ended December 31, 2019 amounted to $742,000, compared to $1.8 million for the twelve-month period ended December 31, 2018. Operating costs and expenses were $10.3 million for the full year 2019, versus $10.8 million for the corresponding 12-month period of 2018. For the twelve-month period of 2019, the Company had an operating loss of $9.6 million, compared to an operating loss of $9.0 million for the comparable period of 2018. Net comprehensive loss was $10.3 million, or $0.11 per basic and diluted share, for the twelve-month period of 2019, compared to net comprehensive loss of $10.6 million, or $0.14 per basic and diluted share, for the comparable period of 2018.

As at December 31, 2019, the Company’s cash and short-term investments totalled $1.9 million, which did not include gross proceeds of C$8.2 million raised by the Company in its February 2020 equity offering.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2019, as well as its 2020 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Thursday, March 26, 2020 at 9:00 a.m. ET.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 fourth quarter and full year financial results on Friday, March 27, 2020 at 8:30 a.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5685777. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.