On May 5, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Protara Therapeutics, MAY 5, 2022, View Source [SID1234613680]).

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"The recent commencement of patient dosing in the Phase 1 ADVANCED-1 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) marked an important step toward our goal of bringing a much needed, novel therapeutic option to this underserved population," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Beyond NMIBC, we are encouraged to have recently held a meeting with the U.S. Food and Drug Administration (FDA), where we received preliminary guidance regarding a development path for TARA-002 in lymphatic malformations (LMs). We are currently planning to initiate a Phase 2 clinical trial in this indication subject to alignment with FDA on a clinical trial protocol. We also remain very engaged with the LMs treating community as we work to design a clinical study that will further progress our program for this rare pediatric indication that currently lacks any FDA-approved therapies."

Recent Highlights

TARA-002 in NMIBC

In March 2022, the Company announced that the first patient was dosed in its Phase 1 ADVANCED-1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of NMIBC.
TARA-002 in LMs

The Company continues to engage with the Vaccines and Related Products Division of the FDA and recently received preliminary guidance regarding a potential development path for TARA-002 in LMs. The Company is planning to initiate a Phase 2 clinical trial of TARA-002 in this indication subject to alignment with the agency on a clinical trial protocol.
IV Choline Chloride in Intestinal Failure Associated Liver Disease (IFALD)

Protara’s prospective study to enhance understanding of the incidence of IFALD in patients dependent on parenteral nutrition remains ongoing. The Company expects to use results from the prospective study, as well as its previously completed retrospective study, to inform next steps for the IV Choline Chloride development program.
With respect to the IV Choline Chloride program, in April 2022, the U.S. Patent and Trademark Office issued to the Company a patent claiming a sterile aqueous choline salt composition with a term expiring in 2041. The Company expects such patent to be listed in the FDA’s "Orange Book" in the event of the FDA’s approval of the Company’s IV Choline Chloride product candidate.
First Quarter 2022 Financial Results

As of March 31, 2022, cash, cash equivalents and restricted cash were $118.5 million. The Company expects its current cash and cash equivalents will be sufficient to fund its planned operations into mid-2024.
Research and development (R&D) expenses for the first quarter of 2022 decreased to $5.3 million from $7.0 million during the first quarter of 2021. The decreased R&D expenses were primarily due to decreases in manufacturing and non-clinical expenses associated with TARA-002.
General and administrative expenses for the first quarter of 2022 decreased to $5.6 million from $6.5 million for the prior year period. The decrease was primarily due to decreases in stock-based compensation.
For the first quarter of 2022, Protara reported a net loss of $10.8 million, or $0.96 per share, compared with a net loss of $13.5 million, or $1.20 per share, for the same period in 2021. Net loss for the first quarter of 2022 included approximately $1.9 million of stock-based compensation expenses.
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully demonstrated manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Lymphatic Malformations (LMs)

LMs are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of 3 years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

About IV Choline Chloride and Intestinal Failure-associated Liver Disease (IFALD)

IV Choline Chloride is an investigational, intravenous (IV) phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition (PN) who have IFALD. Choline is a known important substrate for phospholipids that are critical for healthy liver function. Because PN patients cannot sufficiently absorb adequate levels of choline and no available PN formulations contain sufficient amounts of choline to correct this deficiency, PN patients often experience a prolonged progression to hepatic failure and death, with the only known intervention being a dual small bowel/liver transplant. If approved, IV Choline Chloride would be the first approved therapy for IFALD. It has been granted Orphan Drug Designations (ODDs) by the FDA for the treatment of IFALD and the prevention of choline deficiency in PN patients.

On May 5, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and first quarter 2022 financial results (Press release, Avalo Therapeutics, MAY 5, 2022, View Source [SID1234613679]).

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"The first quarter has been highly productive for the Avalo Therapeutics team. We executed our pipeline prioritization plan and right-sized the organization needed to deliver what we think will provide the greatest value for our shareholders," said Dr. Garry Neil, Chief Executive Officer of Avalo Therapeutics. "We remain focused on driving our highest value programs forward to meet our timelines. These include our Phase 2 clinical trial of AVTX-002 in NEA and our pivotal trial of ATX-803 in LAD II. We have now initiated both programs, and we expect to dose our first patients in both studies in the second quarter, keeping the programs on track to meet our year-end data release milestones."

Business Update

The Company executed a reduction in workforce in March to align with its previously announced, focused pipeline. With these changes, the Company believes it will achieve substantial cost savings over time while creating a more appropriately sized workforce needed to successfully achieve the Company’s 2022 objectives, most notably obtaining and releasing data for its Phase 2 clinical trial of AVTX-002 in NEA and pivotal trial of AVTX-803 in LAD II. Headcount was reduced by approximately one third from December 31, 2021.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
NEA: The Company has initiated its Phase 2 randomized, double-blind, placebo-controlled clinical trial evaluating AVTX-002 in 80 patients with poorly controlled NEA. Top-line data from the trial are expected in the fourth quarter of 2022.
IBD: The Company continues to consider initiating a randomized, double-blind, placebo-controlled clinical study in moderate-to-severe refractory patients in inflammatory bowel disease (IBD).

AVTX-007: Anti-IL-18 mAb targeting adult-onset Still’s disease (AOSD).

AOSD: The Company is evaluating AVTX-007 in a multicenter, Phase 1b study in 12 refractory or steroid-dependent patients with AOSD in two cohorts. Management is currently reviewing preliminary data and the path forward related to this indication. Top-line data are currently expected in 2023, which is subject to change and refinement pending finalization of the review.
AVTX-800 programs (AVTX-801 and AVTX-803): Monosaccharide therapies for two congenital disorders of glycosylation (CDGs): leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG) and PGM1-CDG.
LAD II: The Company has initiated a single-center (U.S.), double-blind (followed by an open-label extension) pivotal study of AVTX-803 in patients with LAD II. Data from this pivotal trial are expected in the fourth quarter of 2022.
PGM1-CDG: Avalo and the study sponsor remain in dialogue with the U.S. Food and Drug Administration (FDA) to align on a suitable clinical study design for AVTX-801 (PGM1-CDG). Pivotal trial data are expected in 2023. Avalo is currently working with the study sponsor to refine milestone timing.
First Quarter 2022 Financial Update:

As of March 31, 2022, Avalo had $38.5 million in cash and cash equivalents, representing a $16.1 million decrease as compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development.

Total operating expenses decreased $9.0 million for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021. The decrease was mainly driven by a $15.6 million decrease in research and development expenses. The decrease in research and development expenses was due to: 1) a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat; and 2) a $5.6 million reduction due to specific timing of manufacturing and clinical trial activities.

The decrease in operating expenses was partially offset by $3.1 million of severance expense and $4.3 million of non-cash stock-based compensation expense recognized in the first quarter of 2022 due to headcount reductions from the pipeline prioritization plan and the termination of employees prior to such plan. Most of these expenses were general and administrative, and they were the primary driver of the increase in general and administrative expenses period over period. The Company expects salary related expenses to decrease beginning in the second quarter as a result of the headcount reductions. The net loss and change in net loss was largely driven by operating expenses.

(a) The condensed consolidated balance sheets as of March 31, 2022 and December 31, 2021 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

(a) The unaudited condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On May 5, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported its first quarter 2022 financial results and provides pipeline updates (Press release, Arbutus Biopharma, MAY 5, 2022, View Source [SID1234613678]).

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"In the first quarter of 2022, we continued to advance our efforts to develop a functional cure for hepatitis B and to develop novel treatment options for coronavirus infections, including SARS-CoV-2," said William Collier, Arbutus’ President and Chief Executive Officer. "We are on-track to achieve our goal of reporting data later this year from four clinical trials with chronically infected HBV patients being treated with either AB-729, our RNAi therapeutic, or AB-836, our next generation oral capsid inhibitor. Furthermore, our IND-enabling studies with our oral PD-L1 inhibitor, AB-101, and our oral RNA destabilizer, AB-161, are moving forward and we expect these to be completed in the second half of 2022. Additionally, we have had seven abstracts accepted at the EASL International Liver Congress, which include some of these data."

Mr. Collier continued, "With respect to our research efforts to develop a nsp5 main protease (Mpro) and nsp12 viral polymerase for SARS-CoV-2 and future coronavirus outbreaks, we are on-track to initiate IND-enabling studies for a nsp5 Mpro candidate later this year. Lead optimization activities are continuing for a nsp12 viral polymerase candidate. Financially, we are well-positioned to continue advancing all our current clinical programs through important data milestones with a projected cash runway into the second quarter of 2024."

Anticipated Milestones in 2022:

Dose first patient in the AB-729-202 Phase 2a clinical trial evaluating AB-729, in combination with VTP-300, Vaccitech plc’s (Vaccitech) therapeutic vaccine and nucleos(t)ide analogue therapy (NA), in cHBV patients in the first half of 2022.
Present new on-treatment data as well as long-term off-treatment data for cHBV patients in the AB-729-001 clinical trial at a medical conference later this year.
Report initial data from the AB-729-201 Phase 2a clinical trial evaluating AB-729 in combination with ongoing NA therapy and short courses of PEG-IFNα-2a in cHBV patients in the second half of 2022.
Report initial data from the Phase 2a clinical trial evaluating AB-729 in combination with vebicorvir (VBR), Assembly Biosciences, Inc.’s (Assembly) lead HBV core inhibitor (capsid inhibitor), and an NA in cHBV patients in the second half of 2022.
Report data set from the AB-836-001 clinical trial evaluating multiple doses of AB-836 in cHBV patients in the first half of 2022.
Complete IND-enabling studies for two oral compounds (PD-L1 inhibitor, AB-101 and RNA destabilizer, AB-161) to treat HBV in the second half of 2022.
Advance an oral compound that inhibits the SARS-CoV-2 nsp5 main protease into IND enabling studies in the second half of 2022.
Continue to explore a potential oncology indication with our oral PD-L1 program.
Financial Results

Cash, Cash Equivalents and Investments

As of March 31, 2022, the Company had cash, cash equivalents and investments in marketable securities of $221.8 million, as compared to $191.0 million as of December 31, 2021.

During the three months ended March 31, 2022, the Company received a $40.0 million (net of withholding taxes) upfront payment from Qilu Pharmaceutical Co., Ltd. ("Qilu") related to a technology transfer and license agreement for AB-729 in greater China, $15.0 million of gross proceeds from Qilu’s equity investment and $0.3 million of net proceeds from the issuance of common shares under Arbutus’s "at-the-market" offering program. These cash inflows were partially offset by $23.4 million of cash used in operations. The Company expects a net cash burn between $90 to $95 million in 2022, not including the $55 million of proceeds received from Qilu, and believes its cash runway will be sufficient to fund operations into the second quarter of 2024.

Revenue

Revenues were $12.6 million for the three months ended March 31, 2022 compared to $2.1 million for the same period in 2021. The increase of $10.5 million was due primarily to $9.6 million of revenue recognition from the Company’s license agreement with Qilu based on employee labor hours expended by the Company during the first quarter of 2022 to perform its manufacturing obligations under the license agreement.

Net Loss

For the three months ended March 31, 2022, the Company’s net loss attributable to common shares was $15.8 million, or a loss of $0.11 per basic and diluted common share, as compared to a net loss attributable to common shares of $19.6 million, or a loss of $0.21 per basic and diluted common share, for the three months ended March 31, 2021. Net loss attributable to common shares for the three months ended March 31, 2021 included $3.2 million of non-cash expense for the accrual coupon on the Company’s convertible preferred shares, which converted into 22.8 million common shares in October 2021.

Operating Expenses

Research and development expenses were $18.5 million for the three months ended March 31, 2022 compared to $13.8 million for the same period in 2021. The increase of $4.7 million was due primarily to an increase in expenses related to the Company’s multiple, ongoing AB-729 Phase 2a clinical trials, including its collaborations with Assembly and Vaccitech, an increase in expenses for its ongoing AB-836-001 clinical trial, and an increase in expenses for its early stage development programs, including AB-101 and AB-161. General and administrative expenses were $4.9 million for the three months ended March 31, 2022 compared to $3.9 million for the same period in 2021. This increase was due primarily to increases in professional fees, employee compensation and non-cash stock-based compensation expense.

Outstanding Shares

As of March 31, 2022, the Company had approximately 148.7 million common shares issued and outstanding, as well as approximately 15.7 million stock options outstanding. Roivant Sciences Ltd. owned approximately 26% of the Company’s outstanding common shares as of March 31, 2022.

COVID-19 Impact

The COVID-19 pandemic has resulted in and will likely continue to result in significant disruptions to businesses. Measures implemented around the world in attempts to slow the spread of COVID-19 have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, including shortages and delays in the supply chain and prohibitions in certain countries on enrolling subjects and patients in new clinical trials. While we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will materially impact our plans and timelines in the future.

On May 5, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Thursday, May 12, 2022 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the first quarter ended March 31, 2022 (Press release, Navidea Biopharmaceuticals, MAY 5, 2022, View Source [SID1234613677]).

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Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On May 5, 2022 eyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, reported recent corporate highlights and financial results for the quarter ended March 31, 2022 (Press release, Aldeyra Therapeutics, MAY 5, 2022, View Source [SID1234613676]).

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"Consistent with our planned completion this quarter of clinical development for reproxalap in dry eye disease and the recently announced demonstration of clinical activity of ADX-629 in three inflammatory diseases, we are delivering on our strategy to expand our RASP platform from the front of the eye to systemic disease, including clinical trials in ethanol toxicity, chronic cough, minimal change disease, and Sjögren-Larsson Syndrome," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Additionally, we continue to advance our intravitreal drug platform for the treatment of rare retinal diseases, highlighted by Phase 3 clinical trial results in proliferative vitreoretinopathy and Phase 2 clinical trial results in retinitis pigmentosa expected in the second half of this year."

Recent Corporate Highlights

Completed Enrollment in the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease. Aldeyra completed enrollment in the Phase 3 TRANQUILITY-2 Trial of 0.25% reproxalap ophthalmic solution in patients with dry eye disease. The primary endpoints of the TRANQUILITY-2 Trial are Schirmer test on the first day of dosing and ocular redness on the second day of dosing during exposure to a dry eye chamber. In a Phase 2 clinical trial and in the Phase 3 TRANQUILITY Trial announced last year, reproxalap demonstrated statistically significant superiority over vehicle in ocular redness and Schirmer test, respectively.
Reported Positive Top-Line Data and Announced New Indications for ADX-629. At its Research & Development Day in March, Aldeyra reported positive top-line data from Phase 2 proof-of-concept trials of ADX-629, a first-in-class orally administered RASP modulator, suggesting broad-based activity across a number of biomarker and clinical endpoints. Accordingly, Aldeyra announced the advancement of ADX-629 to Phase 2 clinical trials in four new indications: ethanol toxicity, chronic cough, minimal change disease, and Sjögren-Larsson Syndrome.
Initiated Phase 2 Clinical Trials of ADX-629 in Ethanol Toxicity and Chronic Cough. Patient enrollment has begun in the Phase 2 clinical trials of ADX-629 in ethanol toxicity and chronic cough. Up to 10% of adults in the U.S. abuse ethanol, which when done chronically can lead to the development of liver disease. Chronic cough, defined as a cough that lasts eight weeks or longer in adults, affects an estimated 13 million adults in the U.S., and up to approximately 10% of people worldwide.
Dry Eye Disease Clinical Data Presented at 2022 ASCRS Annual Meeting. Edward J. Holland, M.D., Professor of Ophthalmology at the University of Cincinnati, presented results from the run-in cohort of the Phase 3 TRANQUILITY Trial of reproxalap in dry eye disease at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The TRANQUILITY run-in cohort demonstrated statistical superiority of reproxalap over vehicle in ocular redness during exposure to a dry eye chamber and in symptom scores after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones

Dry Eye Disease: Results from the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease are expected in the second quarter of 2022, followed by a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration, pending the outcome of TRANQUILITY-2 and enrollment in the 12-month safety trial of reproxalap in dry eye disease patients. Aldeyra is continuing to review data from the completed TRANQUILITY Trial to finalize analytical plans for the TRANQUILITY-2 results.
Allergic Conjunctivitis: Results from the Phase 3 INVIGORATE-2 allergen chamber trial of reproxalap in allergic conjunctivitis are expected in 2023. INVIGORATE-2 is a randomized, double-masked, crossover trial substantially similar in design to INVIGORATE, which demonstrated statistically significant superiority of reproxalap over vehicle for the primary endpoint of ocular itching and the key secondary endpoint of ocular redness.
Retinal Disease: Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in proliferative vitreoretinopathy, and from the Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa, are expected in the second half of 2022.
Systemic Disease: Results from the Phase 2 clinical trial of ADX-629 in ethanol toxicity are expected in the second half of 2022, and results from the Phase 2 clinical trials of ADX-629 in chronic cough, minimal change disease, and Sjögren-Larsson Syndrome are expected in 2023.
First-Quarter 2022 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2022 were $216.9 million. Based on its current operating plan, Aldeyra believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submissions; initial commercialization of reproxalap, if approved; and continued development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.

Net loss for the three months ended March 31, 2022 was $16.8 million, or $0.29 per share, compared with a net loss of $11.3 million, or $0.25 per share, for the comparable period of 2021. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses for the three months ended March 31, 2022 were $12.2 million, compared with $7.7 million for the same period in 2021. The increase of $4.5 million is primarily related to increases in clinical research and development expenditures.

General and administrative expenses for the three months ended March 31, 2022 were $4.2 million, compared with $3.1 million for the same period in 2021. The increase of $1.1 million is primarily due to increases in consulting expenditures.

Total operating expenses for the three months ended March 31, 2022 were $16.5 million, compared with total operating expenses of $10.8 million for the same period in 2021.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss recent corporate highlights and financial results for the quarter ended March 31, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 742862. Please dial in at least 10 minutes prior to the start time.

A live webcast of the conference call can be accessed via the Investors & Media page of Aldeyra’s website at View Source After the live webcast, the event will remain archived on the website for 90 days