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.

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 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, reported financial results for the year ended December 31, 2019 and provided an update on anticipated clinical milestones (Press release, Aldeyra Therapeutics, MAR 12, 2020, View Source [SID1234555503]).

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"2019 was a year of continued momentum for our lead programs, as we reported statistically significant and clinical relevant data that underscored the potential of reproxalap as a first-line therapy in allergic conjunctivitis and dry eye disease, conditions that in the aggregate affect more than one billion people worldwide," stated Todd C. Brady, M.D., President and CEO of Aldeyra. "Reproxalap potentially represents a highly differentiated mechanism of action compared with existing therapies. We are excited about the market opportunities for reproxalap as we continue to advance towards the completion of clinical development."

Recent Highlights and Upcoming Milestones

Allergic Conjunctivitis: Aldeyra expects to complete the INVIGORATE Phase 3 clinical trial of topical ocular reproxalap in the second half of 2020. In 2019, Aldeyra announced achievement of the primary endpoint of the Phase 3 ALLEVIATE Trial in allergic conjunctivitis, as well as statistically significant reductions in ocular itching and redness in an allergen chamber clinical trial.

Dry Eye Disease: Based on the achievement of symptom endpoints in two well-controlled clinical trials, Aldeyra plans to meet with the U.S. Food and Drug Administration (FDA) prior to initiating Part 2 of the RENEW Trial, and plans to provide an update on future development in dry eye disease following FDA feedback, expected in the second half of 2020.

Proliferative Vitreoretinopathy (PVR): Aldeyra is currently enrolling patients in the GUARD Phase 3 Trial of ADX-2191, a novel anti-inflammatory and anti-proliferative agent for the prevention of PVR, a rare sight-threatening condition with no approved treatment. The GUARD Trial is a two-part, multi-center, randomized, controlled, adaptive clinical trial evaluating the efficacy of intravitreal injections of ADX-2191 versus standard-of-care for the prevention of PVR. The trial will compare recurrent retinal detachment rates over a 24-week period following surgical repair of retinal detachment due to PVR or open globe injury. Enrollment is currently expected to be completed in 2021.

Systemic Autoimmune Disease: A single and multiple ascending dose Phase 1 clinical trial has been completed for ADX-629, a novel orally administered RASP inhibitor in development for the treatment of systemic autoimmune disease and potentially other serious medical conditions. Top-line results are expected in the second quarter of this year. Initiation of Phase 2 clinical testing is planned for the second half of 2020.

Strategic Prioritization of Late-Stage Programs in Ocular Disease

In a separate news release issued earlier today, Aldeyra announced strategic prioritization of late-stage ocular disease programs in allergic conjunctivitis, dry eye disease, and proliferative vitreoretinopathy. In conjunction with the strategic prioritization, Aldeyra appointed ophthalmology drug development expert James A. Gow, M.D., as Senior Vice President of Clinical Development.

Aldeyra has elected to place on hold its clinical development of topical dermal reproxalap for the treatment of ichthyosis associated with Sjogren-Larsson Syndrome and ADX-1612 for the treatment of post-transplant lymphoproliferative disorder. The initiatives to prioritize the portfolio are expected to extend the company’s cash runway through the end of 2021.

Year Ended December 31, 2019 Financial Review

Aldeyra reported a net loss of $60.8 million for the year ended December 31, 2019, compared with a net loss of $38.9 million in 2018. Basic net loss per share was $2.24 for the year ended December 31, 2019, compared with $1.79 per share in 2018. Losses have resulted from the costs of Aldeyra’s clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses were approximately $44.4 million for the year ended December 31, 2019, compared with approximately $29.8 million for the year ended December 31, 2018. The increase of $14.6 million is primarily related to the increase in clinical and preclinical development and manufacturing costs; an increase in personnel costs; and non-cash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.

Acquired in-process research and development expenses were $6.6 million for the year ended December 31, 2019. Aldeyra did not have acquired in-process research and development expenses for the year ended December 31, 2018. The $6.6 million increase is related to the in-process research and development expenses associated with the January 2019 acquisition of Helio Vision.

General and administrative expenses were approximately $12.2 million for the year ended December 31, 2019, compared with $9.9 million for the year ended December 31, 2018. The increase of $2.3 million is primarily related to an increase in personnel costs and public company costs related to compliance with the Sarbanes-Oxley Act of 2002.

Total operating expenses were approximately $63.1 million for the year ended December 31, 2019, compared with total operating expenses of approximately $39.7 million for the year ended December 31, 2018.

Cash, cash equivalents, and marketable securities were $73.4 million as of December 31, 2019.

Conference Call & Webcast Information

Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its full-year 2019 financial results and provide a corporate update. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 9984588.

A live webcast of the conference call will also be available on the Investors Relations section of the Aldeyra Therapeutics website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

About Reproxalap

Reproxalap is a novel, small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease, and lead to activation of intracellular inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Topical ocular reproxalap has now been studied in more than 1,100 patients with no observed safety concerns reported; mild instillation site irritation is the most commonly reported adverse event in clinical trials.

About ADX-2191

ADX-2191, an intravitreal formulation of methotrexate, has received orphan drug and fast track designations from the FDA for the prevention of PVR. The observed clinical activity of ADX-2191 in patients with PVR is believed to be the result of down-regulation of aberrant retinal cell proliferation and activity, thereby leading to reduced retinal scarring that is characteristic of PVR. Aldeyra retains an exclusive license to certain patents related to the use of ADX-2191 for the prevention of PVR.