On March 31, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported financial results for the year ended December 31, 2021 (Press release, IO Biotech, MAR 31, 2022, View Source [SID1234611294]).

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"The past year has been a transformative period for IO Biotech, during which we made substantial progress developing our promising pipeline," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "We believe our platform and product candidates may represent a paradigm shift in the management of cancer, and that they have the potential to become cornerstones of treatment regimens for multiple solid tumors. The publication of the compelling high response rate data from the Phase 1/2 MM1636 melanoma trial in Nature Medicine supports the potential of IO102-IO103 in this patient population. Clinical updates from this study will be presented at the AACR (Free AACR Whitepaper) meeting next month. Although we are experiencing longer than expected lead times in clinical trial site activation and patient enrollment, we look forward to progressing this lead asset in the ongoing global Phase 3 trial. We will be providing an update during the middle of this year on the anticipated timing of receiving interim data from this trial. With a solid balance sheet as a result of our successful capital raises and initial public offering in 2021, we were able to debut as a public company with a substantial cash runway to carry us through multiple data readouts into mid-2024."

Highlights from 2021 & Recent Weeks

Announced the publication of clinical data in Nature Medicine from the Phase 1/2 MM1636 study of IO102-IO103 in combination with nivolumab in metastatic melanoma; updated data cut as of December 1, 2021 including multiple sub-group analyses to be presented for the first time at AACR (Free AACR Whitepaper) 2022
Initiated clinical collaboration with Merck to evaluate IO102-IO103 with KEYTRUDA (pembrolizumab) as first-line treatment of advanced melanoma patients in a Phase 3 trial
Initiated clinical collaboration with Merck to evaluate IO102-IO103 in combination with KEYTRUDA (pembrolizumab) as first-line treatment of metastatic solid tumors in a Phase 2 multi-cohort basket trial
Began patient recruitment for global Phase 3 combination trial with our lead asset IO102-IO103 and KEYTRUDA (pembrolizumab) as first-line treatment in advanced melanoma
Strengthened leadership team and Board of Directors, and expanded the Company’s global footprint
Raised $253 million in new capital investment in 2021; debuted as a public company on the Nasdaq exchange November 2021
2021 Financial Results

Net loss was $67.9 million for the year ended December 31, 2021 compared to $12.0 million for the prior year period. The increase in net loss was primarily related to an increase in research and development and general and administrative expenses, as well as increase in other expense primarily related to an increase in the fair value adjustments on preferred stock tranche of $26.5 million.
Research and development expenses were $30.2 million for the year ended December 31, 2021, compared to $8.5 million for the prior year period. The increase of $21.7 million was primarily related to an increase in costs for clinical trial-related activities for our IO102-IO103 product candidate, including the completion of our Phase 1/2 clinical studies, of $9.8 million, which includes $2.9 million in one-time costs triggered by our IPO, an increase in chemistry, manufacturing and control, or CMC, activities of $5.0 million as well as an increase in personnel costs of $5.4 million primarily related to an increase in headcount and related recruiting cost.
General and administrative expenses were $11.1 million for the year ended December 31, 2021, compared to $1.7 million for the prior year period. The increase of $9.4 million was primarily related to an increase in professional services of $3.1 million related primarily to corporate legal fees and audit and tax fees and other consulting costs in support of our growth as well as an increase in personnel costs of $2.4 million primarily related to an increase in headcount and related recruiting costs and an increase in consultants, insurance and other costs of $3.8 million.
Cash and cash equivalents of $211.5 million at December 31, 2021; cash runway sufficient to support operations through multiple data readouts into mid-2024.
About the MM1636 Clinical Trial

The MM1636 trial (ClinicalTrials.gov: NCT03047928), an investigator-initiated trial at the Copenhagen University Hospital, Herlev, enrolled 30 patients with metastatic melanoma. In this Phase 1/2 clinical trial, patients received the multi-antigen immunotherapeutic, IO102-IO103, in combination with the anti-programmed death 1 (PD-1) antibody nivolumab as first line treatment. Patients were treated with nivolumab every second week as long as there was a clinical benefit or no adverse events prohibiting further treatment. IO102-IO103 was given from the start of administration of nivolumab and every second week for the first six weeks and thereafter, every fourth week for 41 weeks. The trial objectives were to assess safety, immune response in blood and biopsies as well as efficacy.

About the IOB-013 / KN-D18 Clinical Trial

IOB-013 / KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

On March 31, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the fourth quarter and year ended December 31, 2021 (Press release, Idera Pharmaceuticals, MAR 31, 2022, View Source [SID1234611293]).

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"We are actively identifying and evaluating new development or commercial-stage assets for Idera’s portfolio while we continue to preserve cash," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, we have asked JMP Securities LLC, our current partner and advisor on business development activities, to expand their current scope of work beyond acquisition or in-licensing opportunities to include additional strategic alternatives for the Company."

Fourth Quarter Financial Results

Our cash position as of December 31, 2021 was $32.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the March 31, 2022 filing date of the Annual Report Form 10-K.

Research and development expenses for the three months ended December 31, 2021 totaled $2.1 million, compared to $5.1 million for the same period in 2020. General and administrative expense for the three months ended December 31, 2021 totaled $2.0 million, compared to $2.9 million for the same period in 2020.

Additionally, during the three months ended December 31, 2020, we recorded $3.2 million and $65.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended December 31, 2021, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2021 was $4.1 million or $0.08 per basic and diluted share compared to net loss applicable to common stockholders of $76.7 million or $2.11 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $68.6 million for the three months ended December 31, 2020 related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.1 million.

Full Year Results

Research and development expenses for the year ended December 31, 2021 totaled $16.4 million compared to $24.8 million for the same period in 2020. General and administrative expenses for the year ended December 31, 2021 totaled $10.0 million compared to $11.9 million for the same period in 2020. Restructuring costs for the year ended December 30, 2021 totaled approximately $1.3 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such restructuring costs were incurred during 2020.

Additionally, during the year ended December 31, 2021 we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the termination of securities issued in connection with our December 2019 private placement transaction in the first quarter of 2021. The losses of non-cash warrant revaluation and non-cash future tranche right revaluation were $3.7 million and $72.4 million, respectively, for the same period in 2020.

As a result of the factors above, net income applicable to common stockholders for the year ended December 31, 2021 was $96.9 million or $1.97 per basic share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per basic share for 2020. On a diluted basis, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million or $0.58 per diluted share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per diluted share for 2020.

Excluding the non-cash gain of approximately $125.8 million related to the termination of securities issued in connection with the December 2019 private placement transaction in the first quarter of 2021, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million. Excluding the non-cash loss of approximately $76.1 million related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders for the year ended December 31, 2020 was $36.6 million.

On March 31, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the fourth quarter and full year of 2021 (Press release, Pulse Biosciences, MAR 31, 2022, View Source [SID1234611292]).

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Company Updates

Implemented changes to commercial leadership, salesforce and strategy, to focus on increasing commercial clinic utilization and over near-term reducing emphasis on new system sales.

Appointed two medical technology industry veterans to commercial leadership positions; Kevin Danahy to the newly created role of Chief Commercial Officer and Joe Talarico as Vice-President of North American Sales.

Initiated operating expense reduction programs, including workforce reductions, expected to lower costs by approximately 20% from the current run rate, resulting in expected 2022 operating expenses in line with 2021.

Achieved fourth quarter 2021 revenue of $844 thousand and full year 2021 revenue of $1.4 million.

Completed the first three commercial sales of CellFX Systems, two in the fourth quarter of 2021 and one in the first quarter of 2022.

Transitioned 17 Controlled Launch Program participants to commercial use in the fourth quarter and expect an additional 10 participants to transition in the first quarter, resulting in 39 total commercial conversions at the end of the first quarter.

20 clinics remain in the Controlled Launch program after a total of 11 clinics have opted out at the end of Q1.

FDA meeting expected in Q2 2022 to discuss Additional Information letter regarding the sebaceous hyperplasia 510(k).

"2021 included a number of milestones for Pulse Biosciences, including regulatory approvals in the U.S., Europe, Canada and Australia, onboarding 70 Controlled Launch Program participants, the transition of 29 clinics to commercial use, and sales of our first two commercial CellFX Systems," said Darrin Uecker, President and CEO of Pulse Biosciences. "In 2022, our focus is on increasing utilization at commercial clinics to develop CellFX reference centers for the benign lesion market under new commercial leadership. At the same time, we will remain focused on expanding the CellFX System’s indications for use in dermatology and beyond."

Fourth Quarter 2021 Results

Revenue for the three months ended December 31, 2021 was $844 thousand. System revenue for the three months ended December 31, 2021 was $699 thousand, with approximately $600 thousand recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the three months ended December 31, 2021 was $145 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the three months ended December 31, 2021 was ($0.4) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the three months ended December 31, 2021 was ($0.3) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the three months ended December 31, 2021 were $15.0 million, compared to $13.8 million for the prior year period. Non-GAAP operating expenses for the three months ended December 31, 2021 were $11.2 million, compared to $11.1 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities offset by uncapitalized manufacturing operations costs now recorded in cost of revenue.

GAAP net loss for the three months ended December 31, 2021 was ($15.4) million compared to ($13.8) million for the three months ended December 31, 2020. Non-GAAP net loss for the three months ended December 31, 2021, was ($11.5) million compared to ($11.1) million for the three months ended December 31, 2020.

Full Year 2021 Results

Revenue for the full year of 2021 was $1.4 million. System revenue for the full year of 2021 was $1.2 million including $1.1 million recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the full year of 2021 was $229 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the full year of 2021 was ($0.6) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the full year of 2021 was ($0.4) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the full year of 2021 were $62.5 million, compared to $50.0 million for 2020. Non-GAAP operating expenses for the full year of 2021 were $46.9 million, compared to $38.8 million for the same period in 2020. The year-over-year increase in operating expenses was driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities and investments to expand use of the CellFX System outside dermatology.

GAAP net loss for the full year of 2021 was ($63.7) million compared to ($49.9) million for 2020. Non-GAAP net loss for the full year of 2021, was ($47.9) million compared to ($38.7) million for 2020.

Cash, cash equivalents and investments totaled $28.6 million as of December 31, 2021 compared to $20.5 million as of December 31, 2020 and $42.0 million as of September 30, 2021. Cash used in the fourth quarter of 2021 totaled $13.4 million compared to $9.2 million used in the same period in the prior year and $13.8 million used in the third quarter of 2021. Excluding net proceeds from equity offerings, cash used in the full year of 2021 totaled $52.9 compared to $34.9 million used in 2020.

* Gross loss is calculated as total revenues less cost of revenues.

Reconciliations of GAAP to non-GAAP operating expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, March 31, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

On March 31, 2022 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, reported financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 31, 2022, View Source [SID1234611291]).

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"During 2021, we continued to execute on all fronts and made substantial progress across our pipeline. We further advanced our etigilimab anti-TIGIT program, reporting highly promising interim data from the ongoing ACTIVATE Phase 1b/2 study and expanded our research to include clear-cell ovarian cancer through our partnership with Cancer Focus Fund and MD Anderson," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "In addition, we reported positive data from multiple studies of alvelestat, which also received orphan drug designation for the treatment of AATD. We ended the year well positioned for further success in 2022, with a strong balance sheet supported by the proceeds of our public offering early last year. Following our accomplishments in 2021, we look forward to our upcoming catalysts in 2022."

Highlights from 2021 and Recent Developments

Etigilimab (MPH-313)

Reported interim data in Q4 2021 from ACTIVATE Phase 1b/2 open label study of etigilimab anti-TIGIT antibody in combination with nivolumab in solid tumors
Based on analysis of 15 patients in the efficacy analysis set with a minimum of one scan to-date or clinical progression, those receiving the etigilimab / nivolumab combination have achieved one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical and uveal melanoma
Well tolerated with a favorable safety profile
Ongoing Phase 1b/2 basket combination study continues to enroll well
Update on additional patients and durability of initial responses expected in Q2 2022
Alvelestat (MPH-966)

Received orphan designation from the FDA for the treatment of AATD
Held an R&D Day update on the alvelestat programs in Q1 2022, including in the ongoing Phase 2 trial which enrolled 99 patients with AATD
Data expected in early Q2 2022
Reported positive bio-marker data from investigator-sponsored Phase 1b/2 study of alvelestat in patients with BOS following hematopoietic stem cell transplantation
Reported positive top-line results from Phase 1b/2 trial in hospitalized patients with COVID-19 respiratory disease; Alvelestat, on top of standard of care, resulted in a more rapid time to improvement in WHO Disease Severity score in the first 5-7 days compared to placebo plus standard of care.
Corporate Updates

Partnerships

Announced partnership with the Cancer Focus Fund supporting a Phase 1b/2 clinical study of etigilimab in combination with nivolumab in clear cell ovarian cancer to be conducted at The University of Texas MD Anderson Cancer Center
Ultragenyx expects to enroll the first patient in the Phase 2/3 study of setrusumab in 5–25 year-olds with osteogenesis imperfecta in 1H 2022
Public Offering of American Depositary Shares

Public offering gross proceeds of $115.1 million in Q1 2021
Strengthened Board of Directors

Pierre Jacquet, M.D., Ph.D. appointed to Board of Directors, September 2021
Anne Hyland appointed to Board of Directors, March 2022
Full Year 2021 Financial Results
Revenue was £36.5 million in 2021, representing the upfront payment under the licensing and collaboration agreement with Ultragenyx in January 2021 for the development and commercialization of setrusumab for OI.

Full year 2021 research and development expenses were £23.6 million, compared to £16.3 million in 2020, an increase of £7.2 million, or 44%. R&D expenses relating to etigilimab increased by £12.5 million. The increase was due to the costs associated with commencement of the open label Phase 1b/2 basket study in combination with nivolumab in a range of tumor types. R&D expenses relating to alvelestat increased £0.6 million, or 13%, primarily related to the ongoing Phase 2 proof-of-concept study. Partially offsetting the increases, R&D expenses relating to setrusumab and navicixizumab decreased by £4.1 million and £1.7 million, respectively. The decrease related to setrusumab was primarily driven by the licensing and collaboration agreement with Ultragenyx, under which Ultragenyx will fund global development of the program, and the decrease related to navicixizumab was driven by the global out-licensing agreement with OncXerna for the development and commercialization of navicixizumab.

Administrative expenses decreased by £5.3 million, or 25%, from £21.2 million in 2020 to £15.9 million in 2021. The decrease was primarily driven by a £4.0 million reduction in legal and professional fees in 2021, reflecting lower activity and related transaction costs in 2021 compared to 2020. Premises-related costs decreased by £1.3 million in 2021 primarily due to one-off transaction costs in 2020 associated with renegotiation of our office lease in Redwood City.

Net profit attributable to equity holders for the year 2021 was a net profit of £12.7 million, compared to a net loss of £163.6 million in 2020, reflecting an operating loss of £20.9 million and a gain of £40.0 million, due to changes in the fair value of financial instruments resulting from an unrealized gain on warrants.

Total ordinary shares outstanding at December 31, 2021 were approximately 585 million. Total ADSs outstanding at December 31, 2021 were approximately 116.5 million, with each ADS representing five ordinary shares of the Company.

Cash and short-term deposits totaled £94.3 million at December 31, 2021.

On March 31, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the fourth quarter and year ended December 31, 2021 (Press release, Idera Pharmaceuticals, MAR 31, 2022, View Source [SID1234611290]).

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"We are actively identifying and evaluating new development or commercial-stage assets for Idera’s portfolio while we continue to preserve cash," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, we have asked JMP Securities, a Citizens Company, our current partner and advisor on business development activities, to expand their current scope of work beyond acquisition or in-licensing opportunities to include additional strategic alternatives for the Company."

Fourth Quarter Financial Results
Our cash position as of December 31, 2021 was $32.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the March 31, 2022 filing date of the Annual Report Form 10-K.

Research and development expenses for the three months ended December 31, 2021 totaled $2.1 million, compared to $5.1 million for the same period in 2020. General and administrative expense for the three months ended December 31, 2021 totaled $2.0 million, compared to $2.9 million for the same period in 2020.

Additionally, during the three months ended December 31, 2020, we recorded $3.2 million and $65.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended December 31, 2021, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2021 was $4.1 million or $0.08 per basic and diluted share compared to net loss applicable to common stockholders of $76.7 million or $2.11 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $68.6 million for the three months ended December 31, 2020 related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.1 million.

Full Year Results
Research and development expenses for the year ended December 31, 2021 totaled $16.4 million compared to $24.8 million for the same period in 2020. General and administrative expenses for the year ended December 31, 2021 totaled $10.0 million compared to $11.9 million for the same period in 2020. Restructuring costs for the year ended December 30, 2021 totaled approximately $1.3 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such restructuring costs were incurred during 2020.

Additionally, during the year ended December 31, 2021 we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the termination of securities issued in connection with our December 2019 private placement transaction in the first quarter of 2021. The losses of non-cash warrant revaluation and non-cash future tranche right revaluation were $3.7 million and $72.4 million, respectively, for the same period in 2020.

As a result of the factors above, net income applicable to common stockholders for the year ended December 31, 2021 was $96.9 million or $1.97 per basic share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per basic share for 2020. On a diluted basis, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million or $0.58 per diluted share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per diluted share for 2020.

Excluding the non-cash gain of approximately $125.8 million related to the termination of securities issued in connection with the December 2019 private placement transaction in the first quarter of 2021, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million. Excluding the non-cash loss of approximately $76.1 million related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders for the year ended December 31, 2020 was $36.6 million.