On May 13, 2021 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported its financial results for the quarter ended March 31, 2021 and provided a business update (Press release, Sellas Life Sciences, MAY 13, 2021, View Source [SID1234579934]).

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"Under our exclusive license agreement with 3D Medicines for the development and commercialization of galinpepimut-S (GPS) in Greater China, we advanced the technology transfer to 3D Medicines during the first quarter of 2021. In February, our progress triggered a milestone payment of $1.0 million. This achieved milestone is the first of milestone payments that have the potential to total $194.5 million over the life of the agreement. In addition to the $1.0 million payment, we further strengthened our balance sheet during the first quarter with approximately $3.0 million in net proceeds from warrant exercises," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "During the quarter, we continued to progress our GPS clinical program with the activation of additional clinical sites in the United States, and also preparations for opening clinical sites and enrolling patients in European countries, for our Phase 3 REGAL study of GPS in patients with acute myeloid leukemia (AML). Screening and enrollment of patients for the REGAL study is ongoing in the United States."

Pipeline Updates:

Galinpepimut-S (GPS)

During the first quarter of 2021, SELLAS triggered and received a milestone payment in the amount of $1.0 million related to the completion of a technology transfer plan under its license agreement with 3D Medicines.

In April 2021, the Company received National Ethics Committee approval in Greece for the Phase 3 REGAL study in patients with AML. The Company expects to activate sites and begin enrolling patients in France, Germany and Greece by the end of the second quarter of 2021.
Nelipepimut-S (NPS)

In January 2021, the data safety monitoring board for the ongoing investigator sponsored study of NPS plus trastuzumab in high risk HER2 3+ breast cancer patients recommended that, given the small size of the study and in order to preserve the statistical power of the study, the primary analysis of the study be completed upon the completion of three years of follow-up on every patient or until more events are collected. The Company expects the primary analysis in this study to be completed by the end of 2021.

In February 2021, the subgroup analysis of the cohort of patients with triple negative breast cancer (TNBC) from the Phase 2b investigator-sponsored study of NPS plus trastuzumab in HER2 low-expressing breast cancer patients was published in the peer-reviewed journal Clinical Immunology. As previously reported, the subset analysis identified significant improvement in 36-month disease-free survival between NPS (n=55) and placebo (n=44) in TNBC.
Corporate Highlights for the First Quarter 2021:

The Company received approximately $3.0 million in net proceeds from the exercise of common stock warrants.
Financial Results for the First Quarter 2021:

Licensing revenue: During the first quarter of 2021 the Company recorded $5.7 million of licensing revenue which consists of the recognition of revenue from the upfront license fee received from 3D Medicines in 2020 and the milestone payment received in the first quarter of 2021 from the achievement of a milestone under the Company’s license agreement with 3D Medicines. The Company did not record any licensing revenue for the first quarter of 2020.

R&D Expenses: Research and development expenses for the first quarter of 2021 were $4.3 million, as compared to $1.9 million for the first quarter of 2020. The increase was primarily due to a ramp up of the manufacture of clinical trial materials and registration batches of GPS, a technology transfer to a new contract manufacturer, and clinical drug supply purchase costs in the European Union in preparation for opening sites and enrolling patients in European Union countries.

G&A Expenses: General and administrative expenses for the first quarter of 2021 were $3.6 million, as compared to $2.2 million for the first quarter of 2020. The increase was primarily due to amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement as well as an increase in legal fees.

Net Loss: Net loss attributable to common stockholders was $2.4 million for the first quarter of 2021, or a basic and diluted loss per share attributable to common stockholders of $0.16, as compared to a net loss attributable to common stockholders of $4.2 million for the first quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66.

Cash Position: As of March 31, 2021, cash and cash equivalents totaled approximately $28 million.

On May 13, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported business highlights and financial results for the first quarter of 2021 (Press release, C4 Therapeutics, MAY 13, 2021, View Source [SID1234579933]).

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"C4T continues to build momentum following FDA clearance of our IND application for our lead candidate, CFT7455, a MonoDAC protein degrader for the treatment of hematologic malignancies," said Andrew Hirsch, chief executive officer at C4 Therapeutics. "After presenting compelling preclinical data for CFT7455 in multiple myeloma at AACR (Free AACR Whitepaper), we are excited to share our preclinical work in non-Hodgkin’s lymphoma at the upcoming ICML meeting. Our team has also successfully completed site initiation activities to enable patient enrollment in our CFT7455 Phase 1/2 clinical trial and we are on track to begin dosing patients this quarter. In tandem, we continue to invest in our TORPEDO platform and advance our emerging pipeline with the goal of delivering four clinical-stage programs by year-end 2022. This includes submission of our second IND application to the FDA for CFT8634, a BiDAC protein degrader targeting BRD9 for synovial sarcoma and SMARCB1-deleted tumors, which is anticipated by year-end 2021."

FIRST QUARTER 2021 AND RECENT HIGHLIGHTS

Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021: In April 2021, C4T presented preclinical data for CFT7455, C4T’s lead MonoDAC degrader, targeting IKZF1/3 for the treatment of hematologic malignancies. The in vitro results presented confirmed that treatment with CFT7455 results in deep, rapid degradation of IKZF1/3 proteins, generating apoptotic cell death. In mouse xenograft models of IMiD-insensitive multiple myeloma, preclinical data further established CFT7455 as a highly potent, catalytic degrader of IKZF1/3, capable of generating anti-tumor activity as a single agent and in combination with dexamethasone. These results, which support clinical evaluation of CFT7455 in multiple myeloma and other hematologic malignancies, were delivered as a late-breaking oral presentation during the first session of the AACR (Free AACR Whitepaper) Annual Meeting 2021.
Secured IND Clearance for CFT7455: In January 2021, the U.S. Food and Drug Administration (FDA) cleared C4T’s first investigational new drug (IND) application for CFT7455 for the treatment of relapsed or refractory multiple myeloma and non-Hodgkin’s lymphomas.
UPCOMING KEY MILESTONES

Initiate a Phase 1/2 clinical trial for CFT7455 in 1H 2021. The Phase 1/2 clinical trial will be an open-label, two-part dose escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies, including multiple myeloma and various non-Hodgkin’s lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. The trial will primarily assess safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455.
Submit an IND application for CFT8634 in 2H 2021. CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
Advance the BRAF program into IND-enabling studies in 2021. The objective of the BRAF program is to develop an orally bioavailable BiDAC degrader targeting BRAF V600E mutations for the treatment of genetically defined solid tumors, including locally advanced or metastatic melanoma and non-small cell lung cancer (NSCLC). The BRAF program is partnered with Roche.
Advance the RET program into IND-enabling studies in 2021. The objective of the RET program is to develop an orally bioavailable BiDAC degrader targeting genetically altered RET for the treatment of solid tumors, including relapsed or refractory NSCLC and sporadic medullary thyroid cancers that are resistant to RET inhibitors.
UPCOMING EVENTS

May 26, 2021 – C4T will participate in the UBS Global Healthcare Conference
June 1, 2021 – C4T will participate in the Jefferies Healthcare Conference
June 18-22, 2021 – C4T will present pre-clinical data on CFT7455 in non-Hodgkin’s lymphoma at the 16th Annual ICML meeting. CFT7455 is a novel, IKZF1/3 MonoDAC degrader that has demonstrated potent tumor regression in a spectrum of NHL xenograft models.
FIRST QUARTER 2021 FINANCIAL RESULTS

Revenue: Total revenue for the first quarter of 2021 was $7.4 million, compared to $6.8 million for the first quarter of 2020. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The increase in revenue was primarily due to additional progress made on our targets under the Biogen collaboration agreement.

Research and Development (R&D) Expense: R&D expense for the first quarter of 2021 was $20.5 million, compared to $16.3 million for the first quarter of 2020. The increase in R&D expense was primarily attributable to higher preclinical costs related to our lead programs and increased workforce expenses to support our growing clinical development activities for CFT7455.

General and Administrative (G&A) Expense: G&A expense for the first quarter of 2021 was $7.4 million, compared to $2.8 million for the first quarter of 2020. The increase in G&A expense was primarily attributable to workforce expenses related to our growing G&A functions, principally stock-based compensation expense related to new stock option grants and an increase in the fair value of our common stock, and higher professional fees and insurance costs resulting from our transition to a public company.

Net Loss and Net Loss per Share: Net loss for the first quarter of 2021 was $21.0 million, compared to $11.9 million for the first quarter of 2020. Net loss per share for the first quarter of 2021 was $0.49, compared to $9.59 for the first quarter of 2020. The decrease in net loss per share despite the increase in net loss was driven by a significant increase in the weighted-average shares outstanding caused by our initial public offering of 11,040,000 common shares in October 2020 and the resultant conversion of our then outstanding shares of redeemable convertible preferred stock into 30,355,379 shares of common stock.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2021 were $346.0 million, compared to $371.7 million as of December 31, 2020. The change in cash was primarily driven by expenditures to fund operations. We expect that our cash, cash equivalents and marketable securities as of March 31, 2021, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund our existing operating plan to the end of 2023.

On May 13, 2021 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Terns Pharmaceuticals, MAY 13, 2021, View Source [SID1234579932]).

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"Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive endpoints, including MRI-PDFF (proton density fat fraction), a marker of steatosis, as well as ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are markers of fibrosis and/or inflammation linked to clinical outcomes and histological improvements in chronic liver diseases," said Senthil Sundaram, CEO at Terns. "In March, we initiated our first clinical trial of TERN-501 and look forward to announcing top-line data in the second half of 2021 that we hope will provide clinical confirmation of its high metabolic stability and differentiated pharmacokinetic profile."

Recent Developments and Anticipated 2021 Milestones
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

Completed patient enrollment in the Phase 2a LIFT study in NASH patients in January 2021
Expecting top-line data from the Phase 2a LIFT study in June 2021
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial in March 2021
Expecting top-line data from the ongoing Phase 1 trial in 2H21
Composition of matter claims allowed by USPTO
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Expecting to initiate dosing in 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22
GLP1-R: Oral, small-molecule receptor agonist

Expecting to nominate a final candidate in 2H21 for further development
Strengthened balance sheet

Completed an oversubscribed and upsized $147 million initial public offering in February 2021
Cash and equivalents support operations into 2024
Terns also announced today that Erin Quirk, M.D., will assume the position of Head of Research & Development, in addition to President and Chief Medical Officer, effective immediately. Weidong Zhong, Ph.D. will be leaving his position as Chief Scientific Officer and board member, effective as of July 2, 2021. In the interim, Dr. Zhong will continue to support Dr. Quirk to ensure a smooth transition.

Mr. Sundaram continued, "On behalf of our board and our entire team, I would like to thank Weidong for all of the contributions he made in founding Terns but also in successfully building and advancing our diverse NASH pipeline. At the same time, we are pleased to expand Erin’s title in recognition of her ongoing role in leading our research, development and manufacturing teams, which she has done since 2020. With Erin’s leadership, I am confident that we are well positioned to continue to advance our current and future pipeline candidates through all stages of research and development."

First Quarter Financial Results

Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $195.6 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these will be sufficient to fund its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended March 31, 2021, as compared with $7.2 million for the quarter ended March 31, 2020.
General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2021, as compared with $2.2 million for the quarter ended March 31, 2020.
Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2021, as compared with $9.2 million for the quarter ended March 31, 2020.

On May 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Silverback Therapeutics, MAY 13, 2021, View Source [SID1234579931]).

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"In our first quarter as a public company, our team continues to execute on Silverback’s mission to bring tissue-targeted therapies to patients in need," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are on track to report interim clinical data for SBT6050 in the second half of this year, and we are equally excited about the progress and preclinical data emerging from SBT6290 and SBT8230, highlighting the broad applicability of our ImmunoTAC platform."

Recent Highlights

SBT6050 (HER2-TLR8 ImmunoTAC) continues to advance through monotherapy and pembrolizumab combination dose escalation arms of the Phase 1/1b clinical study. Silverback is on track to deliver interim clinical data from the monotherapy dose escalation arm of the study in the second half of 2021.
GLP toxicology studies have commenced for SBT6290 (Nectin4-TLR8 ImmunoTAC), with an IND submission anticipated in the fourth quarter of 2021. Dosing has been initiated in the GLP toxicology study and GMP manufacturing of the Phase 1 clinical supply is underway. In April 2021, Silverback presented data at the American Association of Cancer Research Annual Meeting 2021. These preclinical data showed that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with CMC activities underway. GLP toxicology studies are expected to commence in the first quarter of 2022.
Appointed Maria Koehler, M.D., Ph.D. to Board of Directors. In March 2021, Silverback appointed Dr. Koehler, M.D., Ph.D. to its board of directors, bringing more than 20 years of clinical development leadership experience.
First Quarter Financial Results

For the first quarter ended March 31, 2021, Silverback reported a net loss of $18.9 million, compared to a net loss of $5.3 million for the comparable period in 2020. Net loss for the first quarter of 2021 included non-cash stock-based compensation expense of $4.3 million compared to $47,000 for the same period in 2020.

Research and development expenses for the first quarter ended March 31, 2021 were $12.2 million, compared to $4.4 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, into preclinical development and the continued development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advances.

General and administrative expenses for the first quarter ended March 31, 2021 were $6.6 million, compared to $0.8 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2020, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of March 31, 2021, Silverback reported cash and cash equivalents of $374.2 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.

On May 13, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, MAY 13, 2021, View Source [SID1234579930]).

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"We continue to focus on advancing our novel pipeline and are pleased to have initiated the emricasan study for treatment of mild symptomatic COVID-19 patients and are on track to initiate the HST-003 study for knee cartilage repair in the second quarter of 2021," said Richard W. Pascoe, President and Chief Executive Officer. We also welcomed Dr. Susan Windham-Bannister and Rochelle Fuhrmann to our Board of Directors. Both Sue and Rochelle bring to our board relevant industry experience with respective expertise in strategic growth and financial management, which will serve Histogen well. Looking forward, we will continue to focus on the initiation and execution of the HST-003 study, delivering top-line results of the emricasan COVID-19 trial, and completing our evaluation of the clinical development plans for the HST 001 program."

Highlights from the First Quarter Ended March 31, 2021 and Business Updates

HST-001 – In February 2021, we announced the final results from the week 26 assessments of our study of HST-001 for the treatment of androgenic alopecia in men. These results supported that HST-001 was shown to be safe and well tolerated as compared to placebo with no reports of serious adverse events but did not achieve statistical significance at week 26 as compared to placebo. Additional observations at week 26 included that 84% of patients treated with HST-001, as compared to baseline, demonstrated a statistically significant change in total hairs (terminal and vellus) within the target area (TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography system. We are currently evaluating our clinical development plans for the HST-001 program and expect to complete our evaluation in the second quarter of 2021.

HST-003 – In March 2021, we announced that the U.S. Food and Drug Administration ("FDA") confirmed that we can proceed with the initiation of our planned Phase 1/2 clinical study of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. We anticipate enrollment to commence in the second quarter of 2021. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD.

Emricasan – In March 2021, we, in collaboration with our partner Amerimmune, announced dosing the first patient in the Phase 1 study of emricasan for the treatment of mild symptomatic COVID-19 patients. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool. We, along with our partner Amerimmune, expect top-line data to be available in the second quarter of 2021.

Appointed Dr. Susan Windham-Bannister and Rochelle Furhmann to the board of directors – In March 2021, we continued to strengthen and diversify our board with the appointment of Dr. Windham-Bannister and Rochelle Fuhrmann. Dr. Windham-Bannister is an internationally recognized expert in innovation, market access and market optimization strategies. She has been recognized by Biosphere as one of the "10 Most Prominent African American Science Leaders," the Boston Globe as one of the "10 Most Influential Women in Biotech," by Boston Magazine as one of the "50 Most Powerful Women in Boston" and is the President of the National Board of Directors of the Association for Women in Science (AWIS). Dr. Windham-Bannister currently serves as Managing Partner of Biomedical Innovation Advisors LLC, which she founded with Dr. Harvey Lodish, co-founder of Genzyme, and member of the Whitehead Institute, MIT. She also serves as the President and CEO of Biomedical Growth Strategies, LLC. Ms. Fuhrmann currently serves as the Vice President Audit and Enterprise Risk Management at Becton Dickinson (BD). In 2016, Ms. Fuhrmann helped establish the BD Foundation, and she presently serves as Treasurer and as a member of its Board of Trustees. She joined BD in July 2015 as Senior Vice President and Chief Financial Officer, BD Life Sciences. Prior to joining BD, Rochelle held various positions responsible for the management of financial functions, including accounting and financial reporting, investor relations, corporate finance, risk management and treasury, primarily in the pharmaceutical industry with companies such as Amneal Pharmaceuticals and Warner Chilcott plc. She previously served as a member of the Board of Directors of Concordia International Corp. and held the position of Audit Committee Chairperson for three years.

Financings – In January 2021, we received $14 million of gross proceeds from an S-1 offering and as of March 31, 2021, an incremental $6.8 million of gross proceeds from the exercise of warrants associated with the January 2021 public offering.
First Quarter 2021 Financial Highlights

First Quarter Ended March 31, 2021 and 2020

Product and Service Revenues in the first quarter of 2021, revenue decreased 56% to $0.4 million from $1.0 million in the first quarter of 2020. The decrease is primarily related to revenue recognized during the first quarter of 2020 associated with the Allergan License Agreement amendments offset by first quarter 2021 revenue related to the final supply of cell conditioned medium ("CCM") to Allergan under the Allergan License Agreements.

Cost of revenues for the three months ended March 31, 2021 and 2020 were $0.2 million and $0.3 million, respectively. The cost of product revenue during the first quarter of 2021 is related to the final supply of CCM sold to Allergan as compared to $0.2 million of scrapped inventory and $0.1 million of costs associated with professional services during the first quarter of 2020.

Research and development expenses for the three months ended March 31, 2021 and 2020 were $2.2 million and $1.4 million, respectively. The net increase of $0.8 million for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to increases in expanded development costs of our product candidates partially offset by $0.2 million in qualifying reimbursable expenses in connection with the Department of Defense grant and increases in personnel related expenses.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were $2.3 million and $1.2 million, respectively. The $1.1 million increase for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to incremental costs related to the transition from a private to a public exchange traded entity, such as legal, accounting and insurance fees and increases in personnel related expenses.

Cash and cash equivalents as of March 31, 2021 were $21.7 million. We believe that Histogen’s existing cash and cash equivalents and cash inflow from operations will be sufficient to meet its anticipated cash needs through the second quarter of 2022.