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SCYNEXIS Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 16, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the second quarter ended on June 30, 2021 and provided an update on recent clinical and corporate developments (Press release, Scynexis, AUG 16, 2021, View Source [SID1234586646]).

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"We are not slowing down after our June 1, 2021 approval of BREXAFEMME, the first FDA-approved indication from our ibrexafungerp franchise," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Our commercial team has been deployed to the field to call on their healthcare provider (HCP) customers to communicate the differentiating features and benefits of BREXAFEMME. We also continue to engage in an active dialogue with payers to establish coverage. While it is still too early to assess external demand for BREXAFEMME, I am extremely proud of our team for their strong execution which we believe will translate to more tangible results to drive shareholder value in the next quarter. In addition, our clinical development team remains focused on advancing ibrexafungerp for life-threatening invasive fungal infections in the hospital setting, including work on the new intravenous (IV) formulation currently in Phase 1."

BREXAFEMME Commercial Update

BREXAFEMME (ibrexafungerp tablets) is now FDA-approved. On June 1, 2021 the New Drug Application (NDA) for BREXAFEMME was approved by the FDA, becoming the first drug from a novel antifungal class (triterpenoid) in more than 20 years. BREXAFEMME was also granted a five-year exclusivity extension under the GAIN Act for a total of 10 years of regulatory exclusivity and is also protected by a composition-of-matter patent until 2035.

BREXAFEMME launch update. On June 29, 2021 SCYNEXIS hosted a virtual investor event to outline plans for the commercial launch of BREXAFEMME which began in August. BREXAFEMME is now available at pharmacies and the entire SCYNEXIS sales team is in the field actively engaging HCPs. An Early Experience Program was successfully implemented with key HCPs in July, confirming the need for a new treatment option and their willingness to prescribe BREXAFEMME. The Pharmacy and Therapeutic (P&T) review process with payers continues to rapidly progress with numerous P&T meetings already scheduled.
Ibrexafungerp Clinical Update

Enrollment is complete in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC), for which there is no approved therapy in the U.S. SCYNEXIS expects last-patient/last-visit by the end of 2021 with top-line results and a supplemental NDA submission anticipated in the first half of 2022 with a potential approval in late 2022.

Dosing is ongoing in Phase 1 testing of the liposomal IV formulation of ibrexafungerp. Based on promising pre-clinical data of the company’s liposomal IV formulation of ibrexafungerp, SCYNEXIS is conducting a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the IV liposomal formulation of ibrexafungerp in healthy subjects. The study is being conducted in South Africa and dosing began in March 2021.

Ibrexafungerp Phase 3 data were presented at a key medical conference, reporting efficacy in non-albicans Candida (NAC) and patients with severe vulvovaginal candidiasis infections. On April 30, 2021 SCYNEXIS presented posters on two data sets from SCYNEXIS’ Phase 3 VANISH program demonstrating the therapeutic potential of ibrexafungerp at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting that took place virtually from April 30 – May 2, 2021. The data highlighted ibrexafungerp’s strong activity in treating patients with NAC, which was comparable to that of the total patient population enrolled in the trial. Additionally, ibrexafungerp showed activity in patients with severe VVC, and may provide a treatment alternative where currently available therapies may not be satisfactory.

Key findings from interim data analyses of SCYNEXIS’s ongoing refractory invasive fungal infections (rIFI) program, which is comprised of two open-label Phase 3 studies (FURI and CARES), were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). On July 12, 2021 presentations examining positive data from the third interim analysis of the FURI study and first interim analysis of the CARES study, showed oral ibrexafungerp’s ability to treat severe fungal infections in the hospital setting. An analysis by an independent data review committee of 33 patients from the Phase 3 FURI study evaluating ibrexafungerp for the treatment of patients with refractory fungal disease found that 23 patients (70%) achieved clinical improvement, defined as complete or partial response. Seven patients (21%) maintained stable disease and 0 patients (0%) progressed. Three patients (9%) were considered as indeterminate. The first interim analysis of the CARES study showed strong clinical activity of oral ibrexafungerp in patients with invasive candidiasis and candidemia due to Candida auris, a high-mortality infection classified by Centers for Disease Control and Prevention as an urgent threat to public health, with eight out of 10 patients (80%) experiencing a complete response. The results support continued enrollment in both open-label Phase 3 studies, with potential future submissions under the LPAD regulatory pathway.
Corporate Developments

In May 2021, SCYNEXIS entered into an agreement with a third party to sell a portion of its unused New Jersey Net Operating Loss (NOL) and research and development credits for approximately $4.1 million.
In May 2021, SCYNEXIS entered into a Loan Agreement with Hercules Capital, Inc. and Silicon Valley Bank for an aggregate principal amount of $60 million. Under the terms of the Loan Agreement, SCYNEXIS received an initial tranche of $20 million from the lenders on the closing date and received an additional $10 million upon FDA approval of ibrexafungerp for the treatment of vaginal yeast infections. Subsequent cash injections will be available upon achieving certain milestones.
In May 2021, SCYNEXIS announced the appointment of Christine Coyne as Chief Commercial Officer. She brings to the team deep anti-infective commercial expertise across hospital and community settings.
Second Quarter 2021 Financial Results

Cash and cash equivalents totaled $112.4 million on June 30, 2021, compared to $93.0 million in cash, and cash equivalents on December 31, 2020. Based upon its existing operating plan, the company believes that its existing cash and cash equivalents, the sale of a portion of its New Jersey NOLs, and the anticipated sales of BREXAFEMME will enable SCYNEXIS to fund its operating requirements into 2023.

Research and Development expense for the three months ended June 30, 2021 decreased to $4.7 million from $8.5 million for the three months ended June 30, 2020. The decrease of $3.8 million, or 44%, for the three months ended June 30, 2021, was primarily driven by a decrease of $1.5 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $1.4 million in clinical development expense, a decrease of $0.3 million in preclinical expense, a decrease of $0.2 million in regulatory expense, and a net decrease in other research and development expense of $0.4 million.

Selling, General & Administrative expense for the three months ended June 30, 2021 increased to $12.8 million from $3.4 million for the three months ended June 30, 2020. The increase of $9.4 million, or 281%, for the three months ended June 30, 2021 was primarily driven by a $5.8 million increase in commercial related expense associated with the ongoing commercialization of BREXAFEMME, an increase of $1.1 million in salary related costs, an increase of $1.0 million in medical affairs expense, an increase of $0.8 million in expense associated with increased information technology costs, and a net increase of $0.7 million in other selling, general and administrative expense.

Total other income was $15.0 million for the three months ended June 30, 2021, compared to total other income of $2.3 million for the three months ended June 30, 2020. During the three months ended June 30, 2021 and 2020, SCYNEXIS recognized non-cash gain of $15.3 million and $3.6 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended June 30, 2021 and 2020, recognized non-cash gains of $0.5 million and $0.7 million on the fair value adjustment of the derivative liabilities, respectively.

Net income for the three months ended June 30, 2021 was $1.7 million, or $0.06 per basic and ($0.22) per diluted share, compared to a net loss of $6.4 million, or ($0.64) per basic and diluted share for the three months ended June 30, 2020.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The New Drug Application (NDA) for BREXAFEMME (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

Vaccinex Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 16, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Vaccinex, AUG 16, 2021, View Source [SID1234586645]).

"During the second quarter and subsequent period, we achieved significant milestones by initiating clinical trials in both Alzheimer’s disease (AD) and metastatic head and neck cancer (HNSCC). We believe that successfully advancing these programs will demonstrate the versatility of pepinemab’s mechanism of action in serious diseases in which SEMA4D overexpression is implicated," stated Maurice Zauderer, Ph.D., president and chief executive officer.

"With respect to our Huntington’s disease (HD) program, we believe the results of our completed Phase 2 SIGNAL study support potential cognitive benefit of treatment with pepinemab. 1) treatment with pepinemab significantly improved cognition as reflected in the HD-Cognitive Assessment Battery Composite score (p=0.007). 2) Patients demonstrated significant improvement (p=0.029) in a measure of apathy severity that has previously been reported to correlate with cognition in HD as well as in Alzheimer’s and Parkinson’s disease. 3) FDG-PET, a measure of brain metabolic activity, indicated significant positive treatment effect in the majority of brain regions examined in patients with HD. Multiple clinical studies in AD have shown that decline in FDG-PET correlates with cognitive decline and FDG-PET is accepted as a biomarker of clinical progression in AD. As previously indicated, we are actively engaged in partnering discussions to initiate a definitive Phase 3 study in HD.

Pepinemab Clinical Updates:

Alzheimer’s Disease. We announced activation of clinical sites and dosing of the first patient in our Phase 1/2 clinical trial of pepinemab in Alzheimer’s disease. This program is funded in part by a $3 million award from the Alzheimer’s Drug Discovery Foundation as well as a $750,000 development grant from the Alzheimer’s Association under its 2020 "Part the Cloud" program.

This randomized, placebo-controlled, multi-center study is expected to enroll at least 40 subjects across 13 U.S. trial sites. We anticipate topline data in late 2022 or early 2023.
Head and Neck Cancer. Subsequent to the end of the first quarter, Vaccinex announced that it initiated screening to enroll patients in its Phase 2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in metastatic head and neck cancer.

Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is strong rationale for development in this indication.

The study is expected to enroll up to 65 subjects across 18 U.S. trial sites and is designed to assess whether combination therapy can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival. Vaccinex anticipates early data from this study in second half of 2022.
Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" studies in colorectal, pancreatic, head and neck cancer and melanoma.
Other Second Quarter and Recent Accomplishments:

Elizabeth Evans, PhD, Senior Vice President and Chief Operating Officer, chaired a panel and Q&A session, entitled, Targeting glial cell activation for treatment of neurodegenerative disease at the XV European Meeting on Glial Cells in Health and Disease, which was held July 5-9. Dr. Evans shared a presentation and an accompanying poster describing the mechanism of action of pepinemab and findings from the Company’s Phase 2 clinical trial of pepinemab in Huntington’s Disease as well as the design of the now active Phase 1b/2a clinical trial of pepinemab in Alzheimer’s Disease.
Vaccinex announced the publication of results from the CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal Clinical Cancer Research. The paper presents data showing that pepinemab is clinically active when combined with BAVENCIO, a checkpoint inhibitor, and was well tolerated with no major safety signals identified. The combination appeared to halt or reverse tumor progression (partial response or stable disease) in select patients with primary or acquired resistance to anti-PD-1/L1 therapy.
Upcoming Anticipated Milestones:

H2 2022 – Meaningful data from open label head and neck cancer trial
Late 2022/Early 2023 – Topline data from randomized Alzheimer’s trial
Financial Results for the Three Months Ended June 30, 2021:

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2021 were $4.1 million as compared to $4.6 million for the comparable period in 2020.

General and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2021 were $1.6 million as compared to $1.9 million for the comparable period in 2020.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2021 were $22.4 million, as compared to $10.6 million as of December 31, 2020.

Sonnet BioTherapeutics Provides Fiscal Year 2021 Third Quarter Business and Earnings Update

On August 16, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended June 30th , 2021 and provided a business update (Press release, Sonnet BioTherapeutics, AUG 16, 2021, View Source [SID1234586644]).

"Throughout the quarter, we’ve continued to make several advancements towards the clinic with our proprietary Fully Human Albumin Binding (F H AB) pipeline assets, and our partnered product" commented Pankaj Mohan, Ph.D., Founder and CEO. "We are progressing our SON-1010 (F H AB-IL12) and SON-080 (Low-dose IL-6) programs, with IND applications on track to be filed with the FDA for both before the end of 2021, with an additional IND for SON-1210 (IL12-F H AB-IL15) during the first half of 2022. We remain confident that the ability to deliver a therapeutic payload in a more targeted manner than traditional, wild-type cytokines has the potential to result in greater efficacy with an improved toxicity profile."

"We are pleased with our ongoing financing strategy, which is designed to provide the company with the funding necessary to advance our R&D activities and to grow the company beyond 2021," commented Jay Cross, CFO.

FY 2021 Third Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

In May 2021, Sonnet entered into a license agreement with New Life Therapeutics, granting exclusive licenses to develop and commercialize SON-080 for the prevention, treatment, or palliation of diabetic peripheral neuropathy in certain territories in Asia.

In June 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,028,166 entitled "Albumin Domain Fusion Proteins" that covers Sonnet’s F H AB technology. The patent also includes therapeutic fusion proteins that utilize F H AB for tumor targeting and retention, thereby providing extended pharmacokinetics.

In June 2021, Sonnet executed its final issuance of shares of its common stock under the At-the-Market Sales Agreement, pursuant to which the Company executed issuances of an aggregate of 7,454,238 Shares for aggregate gross proceeds of $15,874,999.

FY 2021 Third Quarter Ended June 30, 2021 Financial Results

As of June 30, 2021, Sonnet had $6.0 million cash on hand.
Research and development expenses were $3.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020. The increase of $1.4 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15 and increased costs for research and development activities due to the acquisition of Relief and an increase in payroll and share-based compensation expense as operations are expanded.
General and administrative expenses were $2.4 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020. The decrease of $0.1 million was primarily due to a $0.9 million decrease in professional fees and transaction-related fees associated with the closing of the merger, offset by an increase in payroll and share-based compensation expense of $0.7 million to support expanded operations.

HiberCell Expands Translational Oncology Toolbox by Acquiring Genuity Science, Inc.

On August 16, 2021 HiberCell, a clinical stage biotechnology company developing therapeutics to treat cancer relapse and metastasis, reported the acquisition of Genuity Science, Inc., a life science technology company that provides world-leading genomics and multi-omic analytics bolstered by an advanced artificial intelligence (AI) and machine learning (ML) platform to illuminate the underlying cause of cancer and other diseases (Press release, HiberCell, AUG 16, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-expands-translational-oncology-toolbox-by-acquiring-genuity-science-inc [SID1234586643]). Together, the combined company will strategically apply AI and ML to accelerate and advance fast its pipeline with a focus on overcoming the foundational barriers that prevent patients from living longer, cancer-free lives. The stock acquisition of the Genuity Science business provides HiberCell with approximately $100 million in cash, as well as the existing partnership agreements with Ionis and AbbVie. It is expected that future earnouts of these partnerships will support HiberCell’s growth as a clinical stage biotechnology company.

Under the terms of the agreement, Genuity Science, Inc., and its two wholly owned subsidiaries, Genuity Science (Iceland) ehf and Genuity Sciences (Ireland) Limited, will become a wholly owned subsidiary of HiberCell. This acquisition builds on HiberCell’s translational oncology efforts by adding a world-leading human genomics analytic technology and computational platform, along with high-quality genomic, multi-omic, and deeply characterized phenotype datasets in cancer, cardiometabolic, autoimmune, and neurological disorders. HiberCell will also expand its executive leadership team with the addition of Tom Chittenden as Chief Technology Officer, Jeff Gulcher as Chief Scientific Officer of Genomics, and Hákon Guðbjartsson as Chief Informatics Officer. These important additions bolster HiberCell’s leadership team, which has decades of experience in oncology drug discovery and development.

"Our therapeutic programs have been identified through mechanistic insight into the role of the adaptive stress phenotype in cancer patients," said Alan Rigby, Ph.D., Co-Founder and Chief Executive Officer of HiberCell. "Genuity’s hybrid AI and ML platform, which has successfully identified and validated novel molecular pathways in disease initiation and progression, is well positioned to further our understanding of the stress phenotype and its role in cancer progression."

The combined company brings together powerful tools that will enhance the company’s probability of clinical success through an in-depth analysis of clinical samples, a validation of pharmacodynamic biomarkers, and a deeper understanding of the responsive phenotype in patients. The combined company will also leverage the multi-omic AI/ML capabilities to exhaustively compare primary tumor biology with paired metastatic lesions to better identify the targets and mechanisms that drive metastatic disease.

"We believe pairing HiberCell’s success in advancing differentiated oncology medicines into the clinic with Genuity’s advanced technologies in genomic research and one-of-a-kind AI/ML platform will break new ground for what is possible in cancer drug discovery," said Hannes Smarason, current CEO and Co-Founder of Genuity Science.

"Since forming HiberCell, we have been building our clinical pipeline and research programs using proprietary datasets," said Rigby. "The integration of Genuity’s AI/ML tools uniquely positions HiberCell at the forefront of computational technology and drug development. We believe this acquisition jump starts a deeper mechanistic understanding of the relationship between the adaptive stress phenotype and cancer, while simultaneously allowing us to identify novel precision oncology targets. Applying these computational capabilities to our existing proprietary clinical dataset and material from treatment resistant, relapse, and metastatic disease cohorts will further guide our mechanistic insight."

For more information about HiberCell’s pipeline, visit the website at www.HiberCell.com

Protalix BioTherapeutics Reports Second Quarter 2021 Financial Results and Financial and Business Update

On August 16, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2021 and provided a financial and business update (Press release, Protalix, AUG 16, 2021, View Source [SID1234586642]).

"We continue to work closely with the FDA to address the issues raised in the Complete Response Letter received in April for PRX-102 for the proposed treatment of adult patients with Fabry disease," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We look forward to the meeting with the FDA, which has been scheduled for September 9, 2021. In addition, we strengthened our balance sheet by entering into definitive agreements with a majority of our institutional note holders relating to exchanges by such note holders of a total of $54.65 million principal amount of our outstanding 7.50% Senior Secured Convertible Notes due 2021 for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024, $25.90 million in cash and accrued and unpaid interest through the closing date. We plan to close the exchanges as soon as practicable. This transaction will allow us the use of our cash resources to continue to realize the PRX-102 potential and advance our early-stage pipeline. We are grateful for the continued support from our team members and external partners and look forward to a productive finish to 2021."

2021 Second Quarter and Recent Business Update

Regulatory Updates

On April 28, 2021, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa, or PRX-102, for the proposed treatment of adult patients with Fabry disease. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package.
On August 2, 2021, the Company announced that a Type A meeting request was submitted to the FDA to discuss the CRL dated April 27, 2021 regarding the BLA for PRX-102 for the proposed treatment of adult patients with Fabry disease. The FDA has scheduled the Type A meeting for September 9, 2021.
Clinical Advancements

On June 2, 2021, the Company, together with Chiesi, announced initial top-line results from an interim analysis of the phase III BALANCE clinical trial, a study designed to evaluate the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme).
Based on the interim analysis of the 12-month data generated from the BALANCE study, and in combination with previously reported positive data from the phase III BRIGHT and BRIDGE clinical trials of PRX-102, Protalix and Chiesi intend to submit a Marketing Authorization Application (MAA) to the European Medicines Agency for the review of PRX-102 for the proposed treatment of Fabry disease, subject to a positive meeting with the EMA rapporteur.
Corporate & Financial Developments

On August 12, 2021, the Company entered into definitive agreements relating to exchanges of an aggregate of $54.65 million principal amount of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the "Exchange Notes"), $25.90 million in cash and accrued and unpaid interest through the closing date. The exchanges are expected to close as soon as practicable, subject to satisfaction of certain closing conditions. At closing, we will have reduced our debt by $28.75 million and effectively extended the maturity for substantially all of the remaining debt from 2021 until 2024. The support and willingness of our note holders to extend the maturity underscores their confidence in our core technology and expanding pipeline.
On May 13, 2021, the Company and Chiesi entered into a binding term sheet pursuant to which they amended the two exclusive license and supply agreements for PRX-102 in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter in exchange for a $25.0 million reduction in a longer-term regulatory milestone payment in the Ex-U.S. Exclusive License and Supply Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company and Chiesi also agreed to negotiate certain manufacturing related matters. The $10.0 million payment was received in June 2021.
On July 2, 2021, the Company entered into an ATM Sales Agreement with H.C. Wainwright & Co., LLC (the agent) whereby the Company may sell, from time-to-time, shares of its common stock through the agent up to an aggregate offering price of $20.0 million. Upon execution of the sales agreement, the Company terminated the ATM Equity Offering Sales Agreement it had previously entered into with BofA Securities, Inc.
Second Quarter 2021 Financial Highlights

The Company recorded revenues from selling goods of $3.2 million during the three months ended June 30, 2021, a decrease of $0.4 million, or 11%, compared to revenues of $3.6 million for the same period of 2020.
Revenues from license and R&D services for the three months ended June 30, 2021 were $3.2 million, a decrease of $4.1 million, or 56%, compared to $7.3 million for the same period of 2020. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease resulted primarily from an updated costs estimation throughout the trials until completion in the amount of $4.1 million and from revenues recognized in connection with the progress of the Company’s clinical trials that have been completed during 2020.
Cost of goods sold for the three months ended June 30, 2021 was $4.7 million, an increase of $2.9 million, or 161%, compared to $1.8 million for the same period in 2020. The increase in cost of goods sold was primarily the result of certain one-time manufacturing costs incurred while preparing for the then anticipated FDA approval of the PRX-102 BLA.
Research and development expenses for the three months ended June 30, 2021 were $7.7 million, a decrease of $1.5 million, or 16%, compared to $9.2 million for the same period of 2020. The decrease was primarily the result of the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the BALANCE study. The Company expects research and development expenses to continue to be its primary expense as it enters into more advanced stages of preclinical and clinical trials for certain of its product candidates.
Selling, general and administrative expenses for the three months ended June 30, 2021 were $3.2 million, an increase of $1.0 million, or 45%, compared to $2.2 million for the same period in 2020. The increase resulted primarily from an increase in corporate costs related to insurance and funding.
Financial expenses, net were $2.1 million for the three months ended June 30, 2021 and $1.9 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in the amortization of debt issuance costs and debt discount.
Cash, cash equivalents and short-term bank deposits were approximately $76.9 million at June 30, 2021.
Net loss for the three months ended June 30, 2021 was approximately $11.2 million, or $0.25 per share, basic and diluted, compared to a net loss of $4.2 million, or $0.13 per share, basic and diluted, for the same period in 2020.
Conference Call and Webcast Information

The Company will host a conference call today, August 16, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source

Webcast Link: View Source

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.