On March 12, 2020 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, X4 Pharmaceuticals, MAR 12, 2020, View Source [SID1234555458]).

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"2019 was a remarkable year for X4, with significant achievements across the entire organization," said Paula Ragan, Ph.D., President and Chief Executive Officer of the Company. "We made important progress advancing our lead therapeutic candidate mavorixafor into pivotal Phase 3 development for patients with WHIM syndrome, while also initiating two proof-of-concept clinical trials in SCN and Waldenström’s, and strengthening both our leadership team and Board of Directors. We’re now well positioned for the years ahead as we focus on near-term clinical trial execution and prepare for key value creation events in our quest to bring new transformative therapies to patients with rare diseases."

Key 2019 Program Achievements and Upcoming Milestones

•Initiated Pivotal Phase 3 Clinical Trial of Mavorixafor for the Treatment of WHIM Syndrome – June 2019: The 4WHIM trial is a pivotal Phase 3 global clinical trial of mavorixafor for the treatment of WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease.
◦Top-line data from the trial are expected in the second half of 2021.
◦Company to hold Analyst Day, which will also be webcast, on April 7, 2020 to discuss strategic focus on WHIM.
◦Phase 2 open-label extension study data update expected in mid-2020.
•Received Orphan Drug Designation from the European Commission for Mavorixafor for the Treatment of WHIM Syndrome – July 2019
◦Received Scientific Advice from the European Medicines Agency to align the Phase 3 registration trial globally.
•Announced Positive Data from Phase 2a Trial of Mavorixafor in Clear Cell Renal Cell Carcinoma (ccRCC) Patients – September 2019: Data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) demonstrated that mavorixafor, in combination with axitinib yielded clinically meaningful improvements in median progression-free survival (mPFS) in a heavily pretreated advanced ccRCC patient population, and was generally well tolerated.

•Initiated Phase 1b Clinical Trial of Mavorixafor in Patients with Severe Congenital Neutropenia (SCN) – November 2019: The Phase 1b trial is a 14-day, proof-of-concept trial designed to assess the safety and tolerability of daily, oral mavorixafor in up to 45 patients with SCN and other selected congenital neutropenia disorders. The trial will evaluate the neutrophil response and genetic profiles in this patient population as an independent agent or in combination with granulocyte-colony stimulating factor (G-CSF).
◦Initial data from this trial are expected in the second half of 2020.
•Received Breakthrough Therapy Designation from U.S. FDA for Mavorixafor for the Treatment of WHIM Syndrome – November 2019: Highlighting the severity of the disease and the relevance of mavorixafor’s Phase 2 clinical trial data to support the drug’s role as a potential disease-modifying therapeutic option to this underserved patient population, Breakthrough Therapy Designation could expedite the development and regulatory review of mavorixafor.
•Initiated Phase 1b Clinical Trial of Mavorixafor in Combination with Ibrutinib in Patients with Waldenström’s Macroglobulinemia – December 2019: The Phase 1b multi-center, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of mavorixafor in combination with ibrutinib as well as to obtain certain efficacy signals in patients with Waldenström’s, a rare form of non-Hodgkin’s lymphoma, who have acquired a "gain of function" mutation in CXCR4 in addition to the MYD88 mutation, which is a hallmark of Waldenström’s.
◦Initial data from this trial are expected in the second half of 2020.
•Granted New Composition of Matter Patent by U.S. PTO for Mavorixafor – February 2020: Patent expected to provide exclusivity through 2038.

Key 2019 Corporate Highlights

•Shares of X4 Pharmaceuticals Began Trading on the Nasdaq Capital Market Under the Symbol "XFOR" — March 2019
•Completed Two Public Stock Offerings that Raised Gross Proceeds of $150.8 Million: The first offering was completed in April and the second offering was completed in November.
•Announced Multiple Development and Collaboration Agreements:
◦Announced Collaboration with The Leukemia & Lymphoma Society (LLS) – May 2019: Mavorixafor selected for LLS’ Therapy Acceleration Program (TAP), a strategic initiative creating an alliance to develop mavorixafor for patients with Waldenström’s macroglobulinemia.
◦Announced Partnership with Invitae to Provide No-Cost Genetic Testing to Patients – June 2019: The collaborative PATH4WARD program provides greater access to faster and earlier diagnosis for individuals who may carry genetic mutations known to be associated with WHIM syndrome and SCN.
◦Entered into Oncology Development and Commercialization Agreement with Abbisko for Mavorixafor in Greater China – July 2019: Provided Abbisko Therapeutics with the exclusive rights in China, Taiwan, Hong Kong, and Macau to develop and commercialize mavorixafor in combination with checkpoint inhibitors or other agents in solid tumor oncology indications.
•Strengthened Leadership Team and Board of Directors Throughout the Year: Appointed E. Lynne Kelley, M.D., as Chief Medical Officer and Murray W. Stewart, M.D., to Board of Directors in April 2019; appointed Renato Skerlj, Ph.D., as Senior Vice President of Research and Development and William E. Aliski to Board of Directors in September 2019; appointed Derek Meisner, J.D., as General Counsel in November 2019.

Financial Results

•Cash, Cash Equivalents & Restricted Cash: X4 had $128.1 million in cash, cash equivalents and restricted cash, as of December 31, 2019. We expect that our cash and cash equivalents will fund our operations into early 2022.
•Research and Development Expenses were $7.1 million for the fourth quarter of 2019, and $30.2 million for the year ended December 31, 2019, as compared to $4.7 million and $20.3 million for the comparable periods in 2018, respectively.
•General and Administrative Expenses were $3.9 million for the fourth quarter of 2019, and $17.6 million for the year ended December 31, 2019, as compared to $3.4 million and $8.7 million for the comparable periods in 2018, respectively.
•Net Loss: X4 reported a net loss of $10.8 million for the fourth quarter of 2019, and a net loss of $52.8 million for the year ended December 31, 2019, as compared to a net loss of $11.3 million and a net loss of $33.3 million for the comparable periods in 2018, respectively. Net loss of $52.8 million for the year ended December 31, 2019 includes $3.9 million of non-cash losses related to the sale of in-process research and development intangible assets.

Conference Call and Webcast
The Company will host a webcast and conference call to discuss its fourth quarter and full year 2019 results and provide an update on recent corporate activities today at 8:30 a.m. Eastern Time. The webcast will be accessible under "Events & Presentations" in the Investors page of the Company’s website at www.x4pharma.com. Individuals can participate in the conference call by dialing (866) 721-7655 (domestic) or (409) 216-0009 (international), followed by the conference ID: 3816258.

About Mavorixafor
Mavorixafor is an investigational, oral, targeted therapy that antagonizes the chemokine receptor CXCR4 via allosteric inhibition. The CXCR4 receptor plays a key role in enabling the trafficking of immune cells and effective immunosurveillance. Over-stimulation of CXCR4 results in various immune-system deficiencies. X4 Pharmaceuticals is currently investigating mavorixafor as a once-daily treatment in a global Phase 3 pivotal trial in patients with WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The FDA has granted Breakthrough Therapy Designation to mavorixafor for the treatment of WHIM syndrome. Mavorixafor is being developed in two proof-of-concept Phase 1b clinical trials – as monotherapy in patients with Severe Congenital Neutropenia (SCN), a group of rare blood disorders characterized by abnormally low levels of white blood cells, and in combination with ibrutinib in patients with Waldenström’s macroglobulinemia, a form of non-Hodgkin’s lymphoma, who have acquired mutations in the CXCR4 receptor.

On March 12, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 12, 2020, View Source [SID1234555487]).

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"In the fourth quarter of 2019, Harpoon closed a potentially transformational option and license transaction and expanded an existing discovery collaboration with AbbVie that further validates our proprietary TriTAC technology," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are expecting continued clinical milestone progress throughout 2020 with data updates for HPN424 potentially at ASCO (Free ASCO Whitepaper) and proof of concept data for HPN536 in the second half of the year."

Fourth Quarter 2019 Business Highlights and Other Recent Developments

In November, Harpoon and AbbVie announced an exclusive worldwide development and option agreement for HPN217, which targets BCMA. Under the terms of the development and option agreement, Harpoon granted to AbbVie an option to license worldwide exclusive rights to HPN217 for BCMA. AbbVie may exercise its option after completion of the Phase 1/2 clinical trial, which Harpoon expects to initiate in the first half of 2020. The development and option agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales, of which a $30 million upfront payment was received in December 2019 and up to $50 million for dosing the first patient in the HPN217 clinical trial, which we expect to occur in the first half of 2020.

In November 2019, Harpoon and AbbVie also announced the expansion of its existing discovery collaboration for up to six additional targets. The expanded discovery collaboration represents a deal transaction value of up to $1.86 billion, with an upfront payment of $20 million received in December 2019.

In October, Harpoon presented preclinical data on HPN328 for the treatment of small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston. The presentation demonstrated that HPN328 has the potential to be an efficacious, well-tolerated and convenient therapeutic for patients with DLL3-expressing malignancies. HPN328 was well-tolerated in cynomolgus monkeys at 1 and 10 mg/kg and pharmacokinetic data support the potential for once weekly dosing. Harpoon expects to initiate a Phase 1/2a trial in the second half of 2020.

Patient enrollment and dose escalation continues in the Phase 1 trial for HPN424 in metastatic castration resistant prostate cancer and the Phase 1/2a trial for HPN536, initially for ovarian cancer. Harpoon has submitted an abstract and to plans to present a clinical trial update with interim HPN424 results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting and plans to present preliminary data for HPN536 in second half of 2020.

Anticipated Milestones

HPN424 – present interim data from the dose escalation phase of our Phase 1 trial at ASCO (Free ASCO Whitepaper) 2020 and initiate expansion cohort in 2020

HPN536 – present interim data from Phase 1/2a trial in the second half of 2020

HPN217 – initiate Phase 1/2 trial in the first half of 2020

HPN328 – initiate Phase 1/2a trial in the second half of 2020

Fourth Quarter and Full Year 2019 Financial Results

Harpoon ended 2019 with $155.1 million in cash, cash equivalents and marketable securities compared to $89.5 million as of December 31, 2018. Net cash provided by financing activities for the year ended December 31, 2019 was $71.6 million, primarily comprised of approximately $70.7 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations. Net cash used in investing activities for the year ended December 31, 2019 was $69.3 million, primarily related to the purchase and maturities of marketable securities. Net cash used in operations for the year ended December 31,2019 was $2.9 million.

Revenue for the fourth quarter ended December 31, 2019 was $2.2 million compared to $1.1 million for the fourth quarter ended December 31, 2018. Revenue for the year ended December 31, 2019 was $5.8 million, compared to $4.8 million for the prior year. The increase in revenue for both comparative periods was primarily due to collaboration and license revenue recognized from the upfront payment under the Development and Option Agreement with AbbVie, which occurred during the fourth quarter of 2019. During both the fourth quarter and year ended December 31, 2019, revenue primarily consisted of the revenue recognized related to research and development services performed under the Collaboration Agreement and the Development and Option Agreement with AbbVie.

Research and development expense for the fourth quarter ended December 31, 2019 was $12.2 million compared to $8.7 million for the fourth quarter ended December 31, 2018. R&D expense for the year ended December 31, 2019 was $41.6 million, compared to $26.4 million for the prior year. The increases over both comparative periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expenses for the quarter ended December 31, 2019 was $4.4 million compared to $2.2 million for the quarter ended December 31, 2018. General and administrative

expenses for the year ended December 31, 2019 were $22.4 million, compared to $6.1 million for the prior year. The increases over both comparative periods were due to higher expenses primarily related to legal fees associated with ongoing Maverick litigation, consulting and accounting services, an increase in headcount, and other professional services to support our ongoing operations as a public company.

Net loss for the fourth quarter ended December 31, 2019 was $14.3 million compared to $9.7 million for the fourth quarter ended December 31, 2018. Net loss for the year ended December 31, 2019 was $55.6 million, compared to $27.4 million for the prior year.

Conference Call Information

Harpoon will host a conference call and live audio webcast this afternoon at 1:30 p.m. PT / 4:30 p.m. ET to discuss the fourth quarter and full year 2019 financial results and provide a corporate update. The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-261-0624 for international callers and using conference ID: 5468929. A live webcast of the call will be available online from the investor relations section of the Harpoon Therapeutics website at View Source

An archived replay of the webcast will be available on Harpoon Therapeutics’ website shortly after the conference call.

On March 12, 2020 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, reported financial results for the fourth quarter and year ended December 31, 2019, provided an overview of recent achievements, and highlighted key milestones for 2020 (Press release, Tetraphase, MAR 12, 2020, View Source [SID1234555502]).

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"We made significant progress throughout 2019, ending the year with $3.6 million in XERAVA net sales for the full year and a quarter-to-quarter net revenue increase in the fourth quarter of 2019 of 49.3%. Our sales consist solely of actual use and not stocking retail or other channels," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "We believe XERAVA is a critically important new addition to the hospital antibiotic armamentarium, and we remain committed to increasing formulary uptake and reaching all of our targeted accounts. The reorganization efforts we undertook in 2019 to create a streamlined organization singularly focused on the commercialization of XERAVA, including the elimination of our research and development function, are central to the success of our mission. With two recently completed equity offerings in November 2019 and January 2020 adding to our balance sheet, we are now in a stronger financial position to execute on our goals."

Key Milestones for 2020

Complete 143 formulary reviews for XERAVA by mid-year
Continue pulling through appropriate utilization at the 1,200 hospitals at which XERAVA is on formulary or available
Continue double-digit quarter over quarter growth for XERAVA
Create additional opportunities in TIER 2 and TIER 3 Accounts
Out-license pipeline assets and enter into arrangements for commercialization of XERAVA in Europe and Latin America
Filing by Everest Medicines for regulatory approval of XERAVA for complicated intra-abdominal infections in China in the fourth quarter of 2020
Fourth Quarter and Recent Highlights

Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage

The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date and $3.6 million in XERAVA sales for the full-year 2019. XERAVA sales for 2018 were $178,000. Tetraphase’s salesforce is now focusing on bringing XERAVA to both Tier 1 as well as Tier 2 institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be strong, with reorder rates as high as 67% for all accounts and approximately 77% within the Tier 1 account segment. XERAVA is on formulary or available at more than 1,200 accounts and approximately 143 formulary reviews are pending or planned to take place over the next six months.
Completed Two Equity Financings Totaling Net Proceeds of $23.0 Million

In January 2020, the Company completed a private placement with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated gross proceeds of approximately $10 million. In addition, the Company concurrently completed a registered direct offering with certain healthcare-focused institutional investors, priced at-the-market, that generated gross proceeds of approximately $7.5 million. The net proceeds from the concurrent January 2020 private placement and registered direct offering were approximately $15.9 million.

In November 2019, the Company completed a registered direct offering with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated net proceeds of approximately $7.1 million.

The Company issued warrants in connection with all of the financings listed above.
Fourth Quarter and Full-Year 2019 Financial Results

As of December 31, 2019, Tetraphase had cash and cash equivalents of $21.2 million and 3.5 million shares outstanding. Subsequent to the end of the fourth quarter, the Company raised an additional $15.9 million in net proceeds via an equity offering. The Company expects that its cash and cash equivalents, including the equity proceeds and its expected revenue, will be sufficient to fund operations into the first quarter of 2021.

For the fourth quarter of 2019, Tetraphase reported a net loss of $11.4 million, or $2.75 per share, compared to a net loss of $21.5 million, or $8.00 per share, for the same period in 2018, driven by both increased product revenues and lower operating expenses. For the year ended December 31, 2019, Tetraphase reported a net loss of $70.1 million, or $22.85 per share, compared to a net loss of $72.2 million, or $27.48 per share, for the same period in 2018.

Total revenues were $1.7 million for the fourth quarter of 2019, of which $1.5 million was from sales of XERAVA, compared to $4.3 million for the same period in 2018, of which $178,000 was from sales of XERAVA. Total revenues were $7.4 million for the year ended December 31, 2019, of which $3.6 million was from sales of XERAVA, compared to $18.9 million for the same period in 2018, of which $178,000 was from sales of XERAVA. Total revenues for the fourth quarter and year ended December 31, 2019 consisted of XERAVA product revenue, license and collaboration revenue from the Company’s relationship with Everest Medicines and government contract revenue. The primary driver of the year over year decrease in revenue was a reduction in the up front and regulatory milestones received from the Company’s relationship with Everest Medicines and the wind down of its government awards and grants and the related revenue.

Research and development (R&D) expenses for the fourth quarter of 2019 were $2.5 million, compared to $10.7 million for the same period in 2018. R&D expenses for the year ended December 31, 2019 were $22.8 million, compared to $54.9 million for the same period in 2018. The significant year over year decrease in R&D expenses was driven by the completion of XERAVA development and our corporate reorganization in June 2019, which included the cessation of development of our pipeline candidates.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $9.3 million, compared to $14.7 million for the same period in 2018. SG&A expenses for the year ended December 31, 2019 were $49.0 million, compared to $37.1 million for the same period in 2018. The decrease in fourth quarter 2019 SG&A expenses compared to fourth quarter 2018 SG&A expenses was driven by our 2019 corporate reorganization and by up-front Xerava launch expenses incurred in the fourth quarter of 2018. The increase in full year 2019 SG&A expenses compared to full year 2018 SG&A expenses was driven primarily by a full year of commercial and medical affairs expenses in 2019 following the fourth quarter 2018 launch of Xerava.

About XERAVATM

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVATM Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

On March 12, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported that it will release fourth quarter 2019 financial and operating results on Thursday, March 19, 2020 after the close of the U.S. financial markets and will host a conference call and webcast that day at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results and corporate developments (Press release, Biolase Technology, MAR 12, 2020, View Source [SID1234555519]).

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-353-6461. For international participants outside the U.S./Canada, the dial-in number is 334-323-0501. For all callers, refer to the Conference ID 7830999. To access the live webcast, go to BIOLASE Investor Events Page.

An audio archive of the webcast will be available for 30 days on the Investors section of the BIOLASE website.

On March 12, 2020 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA) reported on March 11, 2020 its financial and operational results for the fourth quarter and year ended December 31, 2019 (Press release, Idera Pharmaceuticals, MAR 12, 2020, View Source [SID1234555459]).

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"In 2019, we made great progress with ILLUMINATE-301, our registrational trial of tilsotolimod in combination with ipilimumab in anti-PD-1 refractory patients with advanced melanoma. This was the result of outstanding focus and dedication across our organization and enabled us to finish enrollment in the first quarter of 2020, earlier than anticipated. It also positions us to have initial data from the trial early next year," stated Vincent Milano, Idera’s Chief Executive Officer. "2019 was also notable for our progress in taking tilsotolimod beyond melanoma through both our collaboration in squamous cell carcinoma of the head and neck and through our ILLUMINATE-206 trial, which we initiated in the microsatellite stable colorectal cancer cohort."

ILLUMINATE (tilsotolimod) Clinical Development Update

ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma:

·Primary endpoint family of ORR per RECIST v1.1 and overall survival (OS);
·Trial initiated in March 2018;
·Enrollment completed in March 2020; and
·ORR and other preliminary data expected in Q1 2021.

ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors:

·Trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort;

·Initial safety run-in cohort of 10 patients with MSS-CRC fully enrolled; and
·Preliminary data from this cohort expected in Q2 2020.

ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with anti-PD-1 refractory advanced melanoma:

·Enrollment completed in February 2019 at tilsotolimod 8 mg with ipilimumab; and
·Final top-line results from the ILLUMINATE-204 trial, to include ORR, median OS, duration of response (DOR), and safety, are expected to be released in Q2 2020.

Corporate Updates

Since September 30, 2019, the following corporate updates were announced:

·Received new U.S. Patent for tilsotolimod, providing exclusivity through September 2037 when tilsotolimod is used with certain checkpoint inhibitors.
·Entered into private placement financing of up to $97.7 million, with $10.1 million received in December 2019 from initial proceeds and option fees.
·Dr. Jonathan Yingling departed Idera as its Chief Scientific Officer effective January 31, 2020.

Financial Results

Fourth Quarter Results

Revenue in the fourth quarter of 2019 and 2018 was nominal. Research and development expenses for the three months ended December 31, 2019 totaled $8.4 million compared to $8.9 million for the same period in 2018. General and administrative expense for the three months ended December 31, 2019, totaled $3.4 million compared to $3.6 million for the same period in 2018.

Additionally, during the fourth quarter of 2019 the Company recorded $0.6 million and $11.0 million of non-cash warrant revaluation expense and non-cash future tranche right revaluation expense, respectively. These expenses were related to a private placement transaction consummated pursuant to a Securities Purchase Agreement, dated as of December 23, 2019, by and between us and certain institutional investors, whereby the Company sold shares of Series B1 convertible preferred stock and warrants to purchase common stock for $3.9 million and received an upfront option fee of approximately $6.2 million related to certain rights provided to such institutional investors to purchase shares of Series B2, Series B3, and Series B4 convertible preferred stock and warrants to purchase common stock in future tranches, subject to shareholder approval to increase authorized shares. The 2019 period also included non-cash deemed dividends of approximately $28.0 million, increasing net loss attributable to common stockholders, related to the transaction.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2019, was $51.3 million, or $1.76 per basic and diluted share, compared to net loss applicable to common stockholders of $12.2 million, or $0.45 per basic and diluted share, for the same period in 2018. Net loss applicable to common stockholders excluding non-cash expense of approximately $11.6 million and deemed dividends of approximately $28.0 million related to the Securities Purchase Agreement for the three months ended December 31, 2019 was $11.7 million, or $0.40 per basic and diluted share.

Full Year Results

Revenue for the year ended December 31, 2019, was $1.5 million compared to revenue of $0.7 million for the same period in 2018. Research and development expenses for the year ended December 31, 2019, totaled $34.9 million compared to $41.8 million for the same period in 2018. General and administrative expenses for the year ended December 31, 2019, totaled $12.5 million compared to $15.4 million for the same period in 2018. Merger-related costs, net for the year ended December 31, 2018, totaled $1.2 million. No such costs were incurred during 2019. Restructuring costs for the year ended December 31, 2019, totaled $0.2 million compared to $3.1 million for the same period in 2018 and related to our decision in July 2018 to wind-down our discovery operations.

The 2019 period also included $0.6 million and $11.0 million of non-cash warrant revaluation expense and non-cash future tranche right revaluation expense, respectively, as well as non-cash deemed dividends of approximately $28.0 million, increasing net loss attributable to common stockholders, as further discussed above under fourth quarter results.

As a result of the factors above, net loss applicable to common stockholders for the year ended December 31, 2019, was $84.6 million or $2.96 per basic and diluted share, compared to net loss applicable to common stockholders of $59.9 million, or $2.25 per basic and diluted share, for the same period in 2018. Net loss applicable to common stockholders excluding non-cash expense of approximately $11.6 million and deemed dividends of approximately $28.0 million related to the Securities Purchase Agreement for the three months ended December 31, 2019 was $45.0 million, or $1.57 per basic and diluted share.

As of December 31, 2019, our cash, cash equivalents, and short-term investments totaled $42.8 million, which includes a $6.2 million contingently refundable option fee received in connection with the December 2019 private placement transaction, discussed above. We currently anticipate that, based on our current operating plan, our current cash, cash equivalents, and short-term investments, excluding the $6.2 million contingently refundable option fee, will fund our operations into the first quarter of 2021.