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.

On March 26, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the full year ended December 31, 2019 and provided a business update (Press release, Phio Pharmaceuticals, MAR 26, 2020, View Source [SID1234555871]).

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"Our progress in 2019, along with the bolstering of our balance sheet, now positions us to further unlock the value of our immuno-oncology programs based on our self-delivering RNAi (INTASYL) therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "With new data from animal studies becoming available, we look forward to continuing our R&D momentum in 2020, including the transition towards the clinical development stage of our lead candidate PH-762. We also continue to leverage our RNAi platform to establish research collaborations with leading companies and academic institutions. We recently announced a new collaboration and option agreement with Medigene AG, further building on our previously announced research collaboration with the Helmholtz Zentrum München to design and develop novel candidates in adoptive cell therapy."

Year in Review and Recent Corporate Updates

Pipeline

·Phio has developed a product platform based on our INTASYL technology that allows easy, precise, rapid and selective non-genetically modified programming of cells. It can be used to improve immune cells used in adoptive cell transfer (ACT therapy) and to reduce immunosuppression in the tumor microenvironment (TME). The use of INTASYL to improve ACT can be done ex vivo, during cell manufacturing. The direct therapeutic use of INTASYL compounds towards the TME can be done in vivo by local delivery to the tumor in the patient. Both applications of our INTASYL technology result in improved immunotherapy.

·Lead product candidate PH-762 is designed to elicit checkpoint blockade by inhibiting PD-1 receptor expression in T cells. Recent data developed in-house and with our collaborators, has shown that PH-762 can elicit PD-1 checkpoint blockade by silencing PD-1 receptor expression resulting in enhanced T cell activation and tumor cytotoxicity, and shows the potential of PH-762 in both ACT and TME applications. The Company expects that PH-762 can be ready to enter the clinic with a partner in ACT therapy in the second half of 2020, and for direct therapeutic use towards the TME through intra-tumoral injection in 2021.

·The Company’s next pipeline product, PH-804, is designed to silence the expression of the immune exhaustion target TIGIT by NK cells and T cells resulting in them becoming "weaponized." Phio has shown that reduction of TIGIT by PH-804 leads to an increase in the cytotoxic capacity of NK cells. In addition, in recent in vivo studies by the Company it was shown that intra-tumoral injections of a mouse version of PH-804 reduced the tumor growth in colorectal carcinoma tumor bearing mice. The Company is developing PH-804 with the aim to enter the clinic with a partner in ACT therapy in 2021.

R&D Collaborations

·Entered into a new collaboration and option agreement with Medigene AG ("Medigene") in relation to the previously announced research collaboration with the Helmholtz Zentrum München for the design and development of new targets based on Phio’s INTASYL platform for use in cancer immunotherapies.

·Expanded on a collaboration with the Karolinska Institutet to further develop self-delivering RNAi immunotherapies for treating solid tumors and build on the exciting results with several compounds in both T cells and NK cells developed under the previous agreement.

·Entered into a research collaboration with the Helmholtz Zentrum München for the design and development of new targets based on Phio’s INTASYL platform for use in cancer immunotherapies.

·Entered into a research collaboration with Carisma Therapeutics to evaluate the potential of Phio’s technology to enhance the immune function of Carisma’s chimeric antigen receptor macrophages (CAR-M) as a novel adoptive cell therapy for use in cancer treatment.

·Entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using our INTASYL in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord). The goal of the collaboration is to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety, resulting in further improvement of Glycostem’s cellular immunotherapies for the treatment of cancer patients.

Conference Presentations and Poster Exhibits

·Presented a corporate update at the Biotech Showcase 2020 in January 2020. The presentation highlighted the Company’s in vivo study result with PH-804. The in vivo studies showed that intra-tumoral injections of a mouse version of PH-804 reduced the tumor growth in colorectal carcinoma tumor bearing mice. This was shown to be correlated with the silencing of TIGIT messenger RNA expression and an increase in cytotoxic effector cells in the tumor micro-environment.

·Presented three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The presentation highlighted the Company’s proprietary INTASYL technology for "weaponizing" T cells against cancer reflecting internal work and the Company’s collaborations with Iovance Biotherapeutics and the Karolinska Institutet.

·Presented a poster "Feasibility and efficacy using self-delivering RNAi against TGFB1 to reduce TME immunosuppression" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019.

Organizational

·Appointed Gerrit Dispersyn, Dr. Med. Sc. as the Company’s President and Chief Executive Officer.

Financial Results

Cash Position

At December 31, 2019, the Company had cash of $6.9 million as compared with $14.9 million at December 31, 2018. This does not include the $9.74 million in gross proceeds the Company raised through two equity offerings completed in February 2020. The Company expects its cash will be sufficient to fund currently planned operations for at least the next 12 months.

Research and Development Expenses

Research and development expenses were approximately $4.3 million for the years ended December 31, 2019 and 2018, respectively. Research and development expenses were consistent year over year primarily as a result of a reduction in the Company’s legacy clinical trial-related expenses which ended in 2018; offset by increased use of third-party CROs to support preclinical immuno-oncology research efforts in 2019.

General and Administrative Expenses

General and administrative expenses were $4.7 million for the year ended December 31, 2019, compared to $3.2 million for the year ended December 31, 2018. The increase was primarily due to legal professional fees, recruiting fees related to employee hiring activities and increased proxy-related fees as a result of the Company’s annual and special stockholder meetings held in 2019.

Net Loss

Net loss was $8.9 million or $19.33 per share for the year ended December 31, 2019, compared with $7.4 million or $57.46 per share for the year ended December 31, 2018. The increase was primarily attributable to an increase in operating expenses, discussed above.