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Pulmatrix, Inc. Announces 1-for-20 Reverse Stock Split

On February 24, 2022 Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM) a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported a 1-for-20 reverse split of its common stock, to be effective as of 4:05 p.m. Eastern Time on February 28, 2022 (Press release, Pulmatrix, FEB 24, 2022, View Source,-Inc-Announces-1-for-20-Reverse-Stock-Split [SID1234608983]). The Company’s common stock is expected to trade on the Nasdaq Capital Market on a split-adjusted-basis when the market opens on March 1, 2022.

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At the special meeting of stockholders held on February 10, 2022, the Company’s stockholders authorized the Board of Directors (the "Board") to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio in the range of 1-for-2 to 1-for-20, with the ratio within such range to be determined at the discretion of the Board and included in a public announcement. On February 15, 2022, the Board approved the implementation of the reverse stock split at a ratio of 1-for-20 (the "Reverse Split") with the timing described above, which will reduce the number of outstanding shares of the Company’s common stock from approximately 65,965,730 million shares to 3,298,301 million shares. The number of authorized shares of the Company’s common stock will remain at 200,000,000. No fractional shares will be issued following the Reverse Split.

Upon effectiveness, the Reverse Split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the Reverse Split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be appropriately adjusted to give effect to the Reverse Split.

The Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol "PULM." The new CUSIP number for the common stock following the Reverse Split is 74584P301.

VStock Transfer, LLC, the Company’s transfer agent, will be acting as exchange agent for the Reverse Split. Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form will have their positions automatically adjusted to reflect the Reverse Split and do not need to take any action in connection with the Reverse Split, subject to brokers’ particular processes. For those stockholders holding physical stock certificates, VStock Transfer, LLC will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. VStock Transfer, LLC can be reached at (212) 828-8436.

The Company is completing the Reverse Split in order to increase the trading price of its common stock to meet the minimum per share bid price requirement for continued listing on The Nasdaq Capital Market. The Company believes increasing the trading price of its common stock may make its common stock more attractive to a broader range of investors. Accordingly, the Company believes that the Reverse Split is in its stockholders’ best interests.

Additional information about the Reverse Split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on December 30, 2021, a copy of which is also available at or at under the SEC Filings tab located on the Investors page.

Primmune Therapeutics to Participate in the 12th Annual Biocom Global Life Science Partnering Conference

On February 24, 2022 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system to treat cancers and viral diseases, reported that Charles McDermott, President and Chief Executive Officer of Primmune, will present at the 12th Annual Global Life Science Partnering Conference, presented by Biocom California, which will be held Feb. 22 to 24 in San Diego (Press release, Primmune Therapeutics, FEB 24, 2022, View Source [SID1234608982]).

12th Annual Global Life Science Partnering Conference

Date: Thursday, February 24
Time: 11:15 a.m. PT

More information about the conference can be found here.

Personalis Reports Fourth Quarter and Full Year 2021 Financial Results

On February 24, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Personalis, FEB 24, 2022, View Source [SID1234608981]).

Fourth Quarter and Recent Highlights

Reported quarterly revenue of $20.7 million in the fourth quarter of 2021 compared with $20.2 million in the fourth quarter of 2020, a 3% increase
Revenue from biopharma and other customers, excluding the VA MVP (as defined below), of $15.4 million in the fourth quarter of 2021 compared with $7.6 million in the fourth quarter of 2020, a 102% increase and a record quarter; revenue from biopharma and other customers includes revenue from Natera at $5.8 million in the fourth quarter of 2021; revenue from biopharma customers excluding Natera at $9.6 million for the fourth quarter of 2021, a 26% increase compared with the fourth quarter of 2020
Revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $5.3 million in the fourth quarter of 2021 compared with $12.6 million in the fourth quarter of 2020, a decrease of 58%
Launched tumor-informed liquid biopsy assay, NeXT PersonalTM in December 2021; NeXT Personal is designed to deliver industry leading molecular residual disease (MRD) sensitivity down to approximately 1 part-per-million, which is expected to enable earlier detection across a broader set of cancers with low mutational burden and low-shedding cancers
Received first customer order for NeXT Personal in the first quarter of 2022 from a top global pharmaceutical company
Announced a collaboration with the Moores Cancer Center at UC San Diego Health, a National Cancer Institute-designated Comprehensive Cancer Center, to support clinical diagnostic testing in patients with advanced solid tumors and hematological malignancies
Added Olivia Bloom to the Personalis Board of Directors and Audit Committee effective March 1, 2022; Ms. Bloom is a certified public accountant and currently serves as Executive Vice President and Chief Financial Officer of Geron Corporation
Cash, cash equivalents, and short-term investments were $287.1 million as of December 31, 2021
Full Year 2021 Highlights

Reported annual revenue of $85.5 million for the full year of 2021 compared with $78.6 million for the full year of 2020, a 9% increase
Revenue from biopharma and other customers of $39.8 million for the full year of 2021 compared with $22.5 million for the full year of 2020, a 77% increase; revenue from biopharma and other customers includes revenue from Natera of $8.6 million for the full year of 2021; revenue from biopharma customers excluding Natera of $31.2 million for the full year of 2021, a 39% increase
Revenue from the VA MVP of $45.7 million for the full year of 2021 compared with $56.2 million for the full year of 2020, a decrease of 19%; VA MVP unfulfilled orders were approximately $7.6 million at December 31, 2021 and remaining unfulfilled orders are expected to be recognized as revenue from the first quarter through the third quarter of 2022, depending upon sample receipt volume and timing from the VA MVP
"I’m pleased to report that revenue for our oncology business exceeded $15 million in the fourth quarter of 2021 and was nearly $40 million for the full year 2021 and grew 77% over 2020, reflecting consistent execution on our growth initiatives. Customer orders were once again significantly above revenue for both the fourth quarter and full year of 2021. Accordingly, we expect our oncology revenue to grow by more than 50% in 2022 over 2021," said John West, Chief Executive Officer of Personalis. "In addition, we recently received our first customer order for NeXT Personal, our MRD liquid biopsy offering, from a large global pharmaceutical company. We expect NeXT Personal to be an important growth driver for both biopharma and diagnostic test revenue."

Fourth Quarter 2021 Financial Results

Revenue was $20.7 million in the three months ended December 31, 2021
Gross margin was 38.7% in the three months ended December 31, 2021
Operating expenses were $28.2 million in the three months ended December 31, 2021
Net loss was $20.2 million in the three months ended December 31, 2021 and net loss per share was $0.45 based on a weighted-average basic and diluted share count of 44.8 million
Cash, cash equivalents, and short-term investments were $287.1 million as of December 31, 2021
Full Year 2021 Financial Results

Revenue was $85.5 million for the year ended December 31, 2021
Gross margin was 37.0% for the year ended December 31, 2021
Operating expenses were $97.0 million for the year ended December 31, 2021
Net loss was $65.2 million for the year ended December 31, 2021 and net loss per share was $1.49 based on a weighted-average basic and diluted share count of 43.9 million
Full Year 2022 Outlook

Personalis expects the following for the full year of 2022:

Total company revenue is expected to be approximately $67.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be approximately $60.0 million, an increase of 51% compared with 2021
Net loss is expected to be in the range of $110.0 million to $115.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2021 financial results after market close on Thursday, February 24, 2022 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 6877026. The live webinar can be accessed at View Source

OPKO Health Reports 2021 Fourth Quarter Business Highlights and Financial Results

On February 24, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended December 31, 2021 (Press release, Opko Health, FEB 24, 2022, View Source [SID1234608980]).

Business Highlights

Business highlights for the fourth quarter of 2021 and subsequent weeks include the following:

NGENLA (somatrogon) injection granted regulatory approvals in Europe, Japan, Australia and Canada for pediatric growth hormone deficiency. NGENLA is a once-weekly, long-acting recombinant human growth hormone for the long-term treatment of growth hormone deficiency (GHD) in pediatric patients. NGENLA has been approved in the European Union, including Iceland, Norway and Liechtenstein, Japan, Australia and Canada. Under the worldwide agreement with Pfizer Inc., OPKO is eligible to receive a milestone payment after regulatory approvals and pricing determinations are obtained in major markets outside of the U.S. NGENLA became commercially available in Canada to patients with pediatric growth hormone deficiency on February 16, 2022, the product’s first commercial launch.

In the U.S., the Food and Drug Administration (FDA) issued a Complete Response Letter for the Biologics License Application for somatrogon. Pfizer is evaluating the FDA’s comments and intends to work with the Agency to determine an appropriate path forward in the U.S.

RAYALDEE launched in Germany by OPKO’s licensee, Vifor Fresenius Medical Care Renal Pharma (VFMCRP). VFMCRP has initiated the commercial launch of RAYALDEE (extended-release calcifediol) in Germany, the first launch of RAYALDEE outside the U.S. VFMCRP is OPKO’s commercial partner for RAYALDEE in Europe and selected markets outside the U.S. The sales kick-off in Germany began with presentations from several nephrology key opinion leaders. VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch the product in additional markets.

Topline results reported from a Phase 2 clinical trial evaluating RAYALDEE as a treatment for symptomatic COVID-19 outpatients. Topline data indicate that improving vitamin D status with oral RAYALDEE results in earlier resolution of respiratory symptoms associated with mild-to-moderate COVID-19. A preprint manuscript summarizing the topline results is available on medRxiv. This manuscript is currently under review for publication in a peer-reviewed medical journal. We plan to discuss potential next steps with the FDA.

Definitive agreement signed for Sema4 Holdings Corp. (Sema4) to acquire GeneDx, Inc., a leader in genomic testing and analysis. Upon completion of the transaction, OPKO anticipates Sema4 and GeneDx will be one of the largest and most advanced providers of genomic clinical testing in the U.S., with a projected $350 million in pro forma 2022 revenue. Under the terms of the agreement, Sema4 will acquire GeneDx for an upfront payment of $150 million in cash plus 80 million shares of Sema4 common stock, with up to an additional $150 million in revenue-based milestones over the next two years (payable in cash or Sema4 shares at Sema4’s discretion). Based on the closing price of Sema4’s common stock on January 14, 2022, the total upfront consideration is approximately $473 million and the total aggregate consideration including potential milestones is approximately $623 million. As part of the transaction, Sema4 also entered into definitive agreements for a $200 million private placement of Sema4 stock from a syndicate of institutional investors, including Pfizer. The acquisition and the private placement are expected to close in the second quarter of 2022, subject to customary closing conditions including approval by Sema4 stockholders.

BioReference Laboratories (BRL) processed approximately 2.7 million COVID-19 PCR tests in the fourth quarter of 2021 versus 2.2 million in the third quarter of 2021. Demand for COVID-19 PCR tests increased significantly due to the Omicron variant beginning late in the fourth quarter of 2021 and continuing into the first quarter of 2022.

In December 2021, BRL announced a collaboration with MVP Health Care (MVP) to offer MVP’s members medically necessary COVID-19 testing, bloodwork and other diagnostic tests in the comfort of their homes. MVP, the first insurer in New York and Vermont to offer this service, is utilizing Scarlet Health, BRL’s seamlessly integrated digital platform that provides specimen collection for laboratory diagnostic services conducted by a Scarlet Health professional in a patient’s home or office.

FDA approved the Premarket Approval Application (PMA) of the 4Kscore Test. This test is approved for use in men aged 45 years and older who have not had a prior prostate biopsy or are biopsy negative and have an age-specific abnormal total prostate specific antigen (PSA) and/or abnormal digital rectal exam. The 4Kscore Test in the intended use population, when used in conjunction with other clinical factors and patient preferences, can contribute to a properly informed decision as to whether or not to proceed with a prostate biopsy. The regulatory approval provides further validation of the 4Kscore Test as an important diagnostic tool and should assist in expanding reimbursement coverage.
Fourth Quarter Financial Results

Consolidated: Consolidated total revenues for the fourth quarter of 2021 were $401.3 million compared with $494.6 million for the comparable period of 2020. Operating loss for the fourth quarter of 2021 was $63.1 million compared with operating income of $49.3 million for the comparable period of 2020. Net loss for the fourth quarter of 2021 was $73.8 million, or $0.11 per share, compared with net income of $32.3 million, or $0.05 per diluted share, for the comparable period of 2020. Operating loss for the fourth quarter of 2021 included non-recurring legal expenses, as well as expenses related to the GeneDx transaction.

Diagnostics: Revenue from services in the fourth quarter of 2021 were to $362.8 million compared to $457.9 million in the prior-year period, primarily due to a decrease in COVID-19 testing volume. Total costs and expenses were $381.4 million in the fourth quarter of 2021 compared to $388.0 million in the fourth quarter of 2020, resulting in an operating loss of $18.6 million compared to operating income of $69.9 million in the 2020 period. The lower operating income is primarily due to a decline in COVID-19 test volume and increased investment in BRL’s base business and digital health activities, principally related to Scarlet. Included in the fourth quarter 2021 results were revenue of $33.1 million and costs and expenses of $43.4 million at GeneDx compared with revenue of $20.3 million and costs and expenses of $36.6 million for the fourth quarter of 2020.

Pharmaceuticals: Revenue from products in the fourth quarter of 2021 increased nearly 15% to $35.3 million compared to $30.8 million in the fourth quarter of 2020, with the increase primarily attributable to the accelerating growth of OPKO’s international pharmaceutical businesses. Revenue from sales of RAYALDEE in the fourth quarter of 2021 was $7.7 million compared to $10.1 million in the prior-year period. Sales of RAYALDEE were negatively impacted by challenges in onboarding new patients due to the COVID-19 pandemic. Revenue from the transfer of intellectual property was $3.3 million in the fourth quarter of 2021 compared to $5.9 million in the 2020 period. Total costs and expenses were $53.3 million in the fourth quarter of 2021 compared to $45.7 million in the prior-year period, reflecting an increase in the cost of product revenue at OPKO’s international operating companies related to higher sales and ongoing expenses for the somatrogon program to support open-label extension studies, as well as the preparation of applications for marketing approvals. Operating loss was $14.8 million in the fourth quarter of 2021 compared to an operating loss of $9.0 million in the fourth quarter of 2020.

Cash and equivalents: Cash, cash equivalents and marketable securities were $134.7 million as of December 31, 2021. In addition, the Company has $64.8 million available under its line of credit with JP Morgan.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss fourth quarter financial results and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are requested to pre-register for the conference call using the link here. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 4489338.

To access the live call via webcast, please click on the link OPKO 4Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 4Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 4489338.

Iveric Bio Reports Fourth Quarter and Full Year 2021 Operational Highlights and Financial Results

On February 24, 2022 -IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the fourth quarter and full year ended December 31, 2021 and provided a general business update (Press release, Ophthotech, FEB 24, 2022, View Source [SID1234608979]).

"In 2021, we successfully achieved a number of major milestones that we believe have laid the groundwork for 2022 to be a banner year for Iveric Bio," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We continue to focus on execution as evidenced by GATHER2, our second Phase 3 clinical trial for Zimura (avacincaptad pegol), a novel complement inhibitor, for the treatment of geographic atrophy (GA), which continues to exceed expectations with a 12-month injection fidelity rate target of greater than 90%, despite a global pandemic. We are excited to be more than 84% complete with year one of the trial, based on the number of scheduled patient visits. We look forward to sharing topline GATHER2 data in the second half of this year, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis."

"This is a pivotal time for the Company as we continue our internal efforts to prepare for a potential filing of a New Drug Application (NDA) for Zimura for the treatment of GA," stated Pravin U. Dugel, MD, President of Iveric Bio. "We continue to gain momentum in building out our medical affairs and commercial infrastructure as we prepare for the potential launch of Zimura in the US. We plan to initiate a Phase 3 clinical trial studying Zimura in patients with intermediate AMD during the second half of this year. We are pursuing additional lifecycle initiatives, including evaluating multiple sustained-release delivery technologies for Zimura. Further, the U.S. Patent and Trademark Office (USPTO) recently allowed claims for a patent covering methods of treating GA with Zimura, an important addition to our intellectual property portfolio."

Therapeutics Programs Targeting Geographic Atrophy (GA) and other Stages of Age-Related Macular Degeneration (AMD)

Zimura (avacincaptad pegol): Complement C5 Inhibitor

In February 2022, the USPTO allowed claims for methods of using Zimura for the treatment of GA. The patent, when issued, is expected to expire in 2034.
In February 2022, results from a post-hoc analysis that evaluated various GA growth parameters to explore the rate of disease progression within various regions in the fovea in a subset of patients from GATHER1, the Company’s Phase 3 clinical trial for the treatment of Zimura in GA, were presented at the Angiogenesis, Exudation and Degeneration conference. Consistent with the overall results of GATHER1, in the new analysis a reduction in lesion growth in five standardized regions surrounding and including the central foveal area was observed for patients receiving Zimura 2 mg as compared to patients receiving sham over a period of 18 months. We believe the preservation of the central fovea region that was observed in this post-hoc analysis has the potential to be a corollary to a functional benefit.
In July 2021, the Company announced the completion of patient enrollment in GATHER2, four months ahead of the Company’s original schedule.
In July 2021, the Company received a written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2. The agreement further solidifies the Company’s plans to file an NDA with the FDA for marketing approval of Zimura for GA, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months. Zimura met its pre-specified primary efficacy endpoint at 12 months with statistical significance in the previously completed GATHER1 pivotal clinical trial.
In June 2021, the Company announced data from post-hoc analyses from the GATHER1 trial, in which the Company evaluated the progression of incomplete Retinal Pigment Epithelial and Outer Retinal Atrophy (iRORA) to complete Retinal Pigment Epithelial and Outer Retinal Atrophy (cRORA) and the progression of drusen to iRORA or cRORA, in patients receiving Zimura 2 mg as compared to patients in the corresponding sham group. Based on the Company’s hypothesis regarding complement inhibition as a mechanism of action to treat AMD and the results of the analyses, the Company plans to initiate a Phase 3 clinical trial studying Zimura in patients with intermediate AMD in the second half of 2022. The development strategy in this indication is subject to regulatory feedback, which the Company plans to obtain before initiating this trial.
Patient enrollment in STAR, the Company’s Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, is ongoing. The results of this trial are expected after the topline results of GATHER2.
IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor

In 2021, the Company initiated a number of preclinical tolerability and pharmacokinetic studies for IC-500. The Company anticipates that the start of IND-enabling toxicology studies for IC-500 will be later than originally planned, primarily due to the limited availability of study slots at contract research organizations in the wake of the COVID-19 pandemic. The Company expects to submit an investigational new drug application (IND) to the FDA for IC-500 during mid-2023.
Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

As the Company focuses its efforts and resources on the development and potential commercialization of Zimura, the Company is exploring potential collaborations for the future development and potential commercialization of IC-100, the Company’s product candidate for Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200, the Company’s product candidate for BEST1-Related IRDs.
In the second half of 2021, the Company transitioned the Stargardt Disease (ABCA4) and USH2A minigene research programs from the University of Massachusetts Medical School (UMMS) to the Company with plans to continue these programs internally. The Company has established a laboratory for continuing the work on its minigene research programs and other preclinical ocular research activities.
Corporate Updates

The Company expanded its Board of Directors and management by adding a number of industry leaders:

Christine Ann Miller, a pharmaceutical veteran, joined the Company’s board of directors in January 2022.
Tony Gibney joined the Company as Executive Vice President and Chief Business and Strategy Officer in December 2021. Mr. Gibney is an experienced biotechnology executive and former investment banker.
Christopher Simms joined the Company as Senior Vice President and Chief Commercial Officer in August 2021. Mr. Simms has commercial leadership experience in retina, ophthalmology, and optometry.
In October 2021, the Company raised approximately $163 million in net proceeds in an underwritten public offering of its common stock. In July 2021, the Company raised approximately $108 million in net proceeds in an underwritten public offering of its common stock.

Fourth Quarter and Year Ended 2021 Operational Update and 2022 Cash Guidance

As of December 31, 2021, the Company had approximately $381.7 million in cash, cash equivalents and marketable securities.
The Company estimates its year-end 2022 cash, cash equivalents and marketable securities will range between $215 million and $225 million. The Company also estimates that its cash, cash equivalents and available for sale securities will be sufficient to fund its planned capital expenditure requirements and operating expenses through at least mid-2024. These estimates are based on the Company’s current business plan, including the continuation of its ongoing clinical development programs for Zimura in GA and STGD1 and the initiation of an intermediate AMD clinical trial, preparation and potential filing of an NDA and a MAA for Zimura in GA, continuing preparations for potential commercial launch of Zimura in GA, investing in sustained release delivery technologies for Zimura, and the advancement of its IC-500 development program. Excluded from these estimates are any potential approval or sales milestones payable to Archemix Corp. or any potential expenses for actual commercial launch of Zimura, such as associated sales force expenses, any additional expenditures related to potentially studying Zimura in indications outside of GA, STGD1 and intermediate AMD, or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue.
2021 Q4 Financial Highlights

R&D Expenses: Research and development expenses were $25.1 million for the quarter ended December 31, 2021, compared to $17.5 million for the same period in 2020. For the year ended December 31, 2021, research and development expenses were $85.1 million compared to $62.8 million for the same period in 2020. Research and development expenses increased year over year primarily due to the commencement and completion of patient enrollment for the GATHER2 clinical trial, increased manufacturing activities for Zimura and increases in personnel costs, including share-based compensation associated with additional research and development staffing. This increase in costs was partially offset by decreases in costs associated with the Company’s gene therapy programs.
G&A Expenses: General and administrative expenses were $8.0 million for the quarter ended December 31, 2021 and for the same period in 2020. For the year ended December 31, 2021, general and administration expenses were $29.7 million, compared to $26.0 million for the same period in 2020. General and administration expenses increased year over year primarily due to an increase in external costs, including legal and consulting costs associated with litigation, pre-commercialization activities and other administrative costs necessary to support the Company’s operations.
Income Tax Benefit: The Company recorded no income tax benefit for the three months ended December 31, 2021 and 2020 and the year ended December 31, 2021. Income tax benefit of $3.7 million for the year ended December 31, 2020, was recognized to reflect a favorable settlement of a state corporate income tax audit.
Net Loss: The Company reported a net loss for the quarter ended December 31, 2021 of $33.0 million, or ($0.29) per diluted share, compared to a net loss of $25.4 million, or $(0.27) per diluted share, for the same period in 2020. For the year ended December 31, 2021, the Company reported a net loss of $114.5 million or ($1.12) per diluted share, compared to a net loss of $84.5 million or ($1.14) for the same period in 2020.
Conference Call/Web Cast Information
Iveric Bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for February 24, 2022 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 8865993. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 1-877-344-7529 (USA Toll Free), passcode 8000837.