1stOncology™: Cancer Intelligence Service – Page 9896 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Galera Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Accomplishments

On March 11, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, MAR 11, 2021, View Source [SID1234576507]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"In 2020, Galera presented positive interim data demonstrating that our dismutase mimetics have the potential to benefit the anti-cancer side of the therapeutic index of radiotherapy," said Mel Sorensen, M.D., President and CEO of Galera. "This encouraging interim data from our pilot placebo-controlled Phase 1/2 trial in patients with pancreatic cancer was presented at ASTRO in late 2020. We look forward to providing the final data readout from this trial in the second half of 2021 and advancing this regimen with the initiation of our Phase 2b GRECO-2 trial of GC4711 in combination with SBRT in patients with LAPC in the first half of 2021."

Dr. Sorensen continued, "We are excited for the year ahead, which we believe will be transformative for our company, with the topline data readout of our Phase 3 ROMAN trial. In anticipation, we continue our preparations for the commercial launch of avasopasem manganese."

Recent Corporate Highlights

Severe Oral Mucositis (SOM)

Continued enrollment in the Phase 3 ROMAN trial of avasopasem for the treatment of SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The Company remains on track to complete enrollment in the first half of 2021 and report topline data in the second half of 2021.
Completed enrollment in the Phase 2a EUSOM multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy. The Company remains on track to report topline data in the second half of 2021.
Locally Advanced Pancreatic Cancer (LAPC)

Presented positive interim data from the pilot placebo-controlled Phase 1/2 anti-cancer trial of avasopasem in combination with SBRT in patients with LAPC at the American Society for Radiation Oncology (ASTRO) virtual Annual Meeting in late 2020. Data on all patients through a minimum follow-up of three months demonstrated better tumor outcomes, including overall survival, with avasopasem compared to placebo. The Company plans to provide final data from this trial with at least one year of follow-up data on all patients in the second half of 2021.
Remain on track to initiate the Phase 2b GRECO-2 trial of GC4711, Galera’s second superoxide dismutase mimetic candidate, in combination with SBRT in patients with LAPC in the first half of 2021. GRECO-2 is a randomized, double-blind, placebo-controlled trial to evaluate the effect of 100 mg of GC4711 versus placebo in combination with SBRT on overall survival in patients with LAPC. The trial is expected to enroll approximately 160 patients.
Non-Small Cell Lung Cancer (NSCLC)

Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Phase 2 portion of GRECO-1 is randomized, double-blind, and placebo-controlled to evaluate the effect of 100 mg of GC4711 versus placebo. The Company continues to expect to report initial data in the first half of 2022.
Esophagitis

Continued enrollment in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company remains on track to report topline data in the first half of 2022.
Fourth Quarter 2020 Financial Highlights

Research and development expenses were $14.6 million in the fourth quarter of 2020, compared to $13.3 million for the same period in 2019. The increase was primarily attributable to avasopasem and GC4711 development costs, as well as higher employee-related costs due to increased headcount and share-based compensation expense. The increases were partially offset by decreased avasopasem and GC4711 preclinical spend.

General and administrative expenses were $4.3 million in the fourth quarter of 2020, compared to $2.9 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(20.1) million, or $(0.80) per share, for the fourth quarter of 2020, compared to a net loss of $(16.7) million, or $(1.31) per share, for the same period in 2019.

As of December 31, 2020, Galera had cash, cash equivalents and short-term investments of $72.8 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022. We expect to achieve these clinical enrollment milestones in the first half of 2021.
Full Year 2020 Financial Highlights

Research and development expenses were $54.8 million for the year ended December 31, 2020, compared to $42.3 million for the year ended December 31, 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a AESOP trial and the Phase 2a EUSOM trial, and manufacturing scale-up activities. In addition, employee-related costs also increased due to increased headcount and share-based compensation expense.
General and administrative expenses were $15.7 million for the year ended December 31, 2020, compared to $8.4 million for the year ended December 31, 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.
Galera reported a net loss of $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020, compared to a net loss of $(51.9) million, or $(16.31) per share, for the year ended December 31, 2019.

Enveric Biosciences Signs Definitive Agreement to Acquire Exclusive License for Novel Molecules from Diverse Biotech

On March 11, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has acquired an exclusive, perpetual license from Diverse Biotech, a biopharmaceutical company focused on developing new molecules for treating oncology and other debilitating diseases (Press release, Enveric Biosciences, MAR 11, 2021, View Source [SID1234576506]). Enveric plans to research and develop these new drugs with the goal of alleviating the side effects that cancer patients experience. Through the conjugation of cannabidiol (CBD) with existing, standard-of-care drugs via Diverse Biotech’s patented, advanced chemistry drug delivery platform, Enveric intends to expand its pipeline of development candidates that seek to deliver superior therapeutic outcomes for patients.

"This exclusive licensing agreement with Enveric aims to expand our CBD conjugate platform into oncology supportive care indications for the first time," said Brian Longstreet, Interim CEO, Diverse Biotech. "We believe that our collaboration has the potential to advance this science more efficiently, ultimately bringing therapies to market faster to help serve unmet medical needs in this large patient population."

As part of the agreement, Enveric will add to the Company’s list of target indications by obtaining five molecules, four of which are dermatology-focused and one that is pain-focused. Enveric will also gain access to Diverse Biotech’s scientists and formulators to help synthesize and validate these drugs, as the company moves through pre-clinical and clinical activities.

"This is an exclusive, novel way of bringing together CBD and well-known, existing compounds that hold promise to create a new, improved drug class," added David Johnson, Chairman and CEO, Enveric Biosciences. "As a patient-centric company, Enveric is constantly looking for new ways to eliminate or minimize cancer treatment side effects for patients in need. With its anti-inflammatory properties, CBD holds so much potential to help these patients, especially since status-quo treatments are not an adequate solution. We are confident that, with this impressive team of experts and Diverse Biotech’s conjugate technology platform, this relationship can help us to expand our potential treatment options for cancer patients who continue to suffer around the globe."

Mr. Johnson concluded, "Enveric has a clear focus to serve cancer patients’ supportive care needs with our current pipeline consisting of innovative early-stage formulations. We intend to continue to add to that portfolio by moving forward internal development initiatives and targeted external business opportunities. Our new molecules from Diverse Biotech provide us with more options to address these difficult indications while building on our IP portfolio and expanding our access to leading scientific talent."

MINISTRY OF HEALTH, LABOUR AND WELFARE GRANTS ORPHAN DRUG DESIGNATION IN JAPAN TO ANTI-CANCER AGENT LENVIMA® (LENVATINIB) WITH PROSPECTIVE INDICATION FOR UTERINE BODY CANCER

On March 11, 2021Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received orphan drug designation for LENVIMA (generic name: lenvatinib mesylate), the orally available multiple receptor kinase inhibitor discovered by Eisai, with a prospective indication for uterine body cancer, by the Ministry of Health, Labour and Welfare (MHLW) (Press release, Eisai, MAR 11, 2021, View Source [SID1234576505]).

In Japan, the estimated number of patients with uterine body cancer is approximately 30,000.1 It is estimated that in 2020, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease.2 It is considered that more than 90% of uterine body cancers occur in the endometrium.3

The pivotal Phase 3 Study 309/KEYNOTE-775 evaluated LENVIMA in combination with KEYTRUDA (generic name: pembrolizumab) in patients with advanced endometrial cancer (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen in Japan, the United States, Europe and other countries. In this study, LENVIMA plus KEYTRUDA met its dual primary endpoints, overall survival (OS) and progression-free survival (PFS), as well as its secondary efficacy endpoint of objective response rate (ORR). Currently, Eisai is preparing to submit an application for additional indications based on these results in various countries around the world including Japan.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA.

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of LENVIMA for cancer treatment, as it seeks to contribute addressing the diverse needs of, and increasing the benefits provided to, patients with cancer and their families.

C4 Therapeutics Reports Recent Business Highlights and Full Year 2020 Financial Results

On March 11, 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 year ended December 31, 2020 (Press release, C4 Therapeutics, MAR 11, 2021, View Source [SID1234576504]). In addition, C4T highlighted key anticipated 2021 milestones for its targeted protein degrader portfolio.

"C4T’s operational execution in 2020 provided the foundation for the recent progress with our lead program CFT7455, a highly potent, catalytic degrader of IKZF1/3, for the treatment of hematologic malignancies, culminating in the FDA’s clearance of our IND application," said Andrew Hirsch, chief executive officer at C4 Therapeutics. "We look forward to sharing CFT7455 pre-clinical data at AACR (Free AACR Whitepaper) and dosing patients in our inaugural clinical study in the coming months. In parallel, we continue to make good progress on our additional programs including BiDAC degraders targeting BRD9, BRAF and RET, positioning us to deliver four clinical-stage programs by year-end 2022."

ANTICIPATED 2021 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 such as multiple myeloma and various non-Hodgkin lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma. The trial will primarily investigate the 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 our 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 our 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

March 16, 2021 – C4T will participate in the Guggenheim Targeted Protein Degradation Day
April 10, 2021 – C4T will present pre-clinical data on CFT7455 in the late breaking mini-symposium at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper). CFT7455 is a novel, IKZF1/3 degrader that has demonstrated potent tumor regression in IMiD-resistant multiple myeloma xenograft models.
FOURTH QUARTER 2020 AND RECENT HIGHLIGHTS

Presented at the North American Protein Degradation Congress: In February 2021, Rhamy Zeid, Ph.D., director of target biology at C4T, delivered a presentation highlighting CFT8634, a novel degrader of the protein BRD9. This case study showcased C4T’s TORPEDO platform’s capabilities to enable the development of novel, selective, orally bioavailable degraders.
Received IND Clearance for CFT7455: In January 2021, the U.S. Food and Drug Administration (FDA) cleared C4T’s first IND application for its lead candidate, CFT7455, an orally bioavailable MonoDAC degrader targeting IKZF1/3 for the treatment of relapsed or refractory multiple myeloma and non-Hodgkin’s lymphomas.
Expanded Senior Leadership Team and Board of Directors: In January 2021, Kelly Schick was appointed chief people officer and Mayra Reyes-Armour, Ph.D. was appointed vice president of technical operations. Ms. Schick joined C4T from AMAG Pharmaceuticals, where she served as senior vice president, chief human resources officer and head of corporate engagement. Dr. Reyes-Armour joined C4T from Biogen, where she served as head of asset development and portfolio management operations. In addition, Glenn Dubin was reappointed as a member of the C4T Board of Directors, effective March 12, 2021. Mr. Dubin is the Principal of Dubin & Co., a private investment company based in New York, and a founder and former chair of the board of directors of the Robin Hood Foundation, a philanthropic organization in New York that applies investment principles to charitable giving.
Added to the Russell 2000 and Russell 3000 Indexes: C4T was added to the Russell 2000 and Russell 3000 Indexes as part of the Russell quarterly update, effective December 21, 2020. The Russell U.S. Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
FULL YEAR 2020 FINANCIAL RESULTS

Revenue: Total revenue for the year ended December 31, 2020 was $33.2 million, compared to $21.4 million for the year ended December 31, 2019. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico and increased by $11.8 million compared to the same period of 2019. The increase in revenue was primarily due to increased reimbursements from Biogen related to research activities and additional progress made on our targets under our collaboration agreements with Biogen and Roche.

Research and Development (R&D) Expense: R&D expense for the year ended December 31, 2020 was $78.4 million, compared to $48.1 million for the year ended December 31, 2019. The increase in R&D expense was primarily attributable to higher preclinical costs related to our lead programs, increased third-party chemistry and biology costs, and increased workforce expenses to support our growing clinical development activities.

General and Administrative (G&A) Expense: G&A expense for the year ended December 31, 2020 was $15.2 million, compared to $8.8 million for the year ended December 31, 2019. The increase in G&A expense was primarily attributable to higher professional fees and insurance costs resulting from our transition to a public company, as well as increased workforce expenses from our growing G&A function.

Net Loss and Net Loss per Share: Net loss for the year ended December 31, 2020 was $66.3 million, compared to $34.1 million for the year ended December 31, 2019. Net loss per share for the year ended December 31, 2020 was $5.83, compared to $31.03 for the year ended December 31, 2019. 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 (IPO) of 11,040,000 common shares in October 2020 and the resultant conversion of our outstanding redeemable convertible preferred stock to 30,355,379 shares of common stock. However, as these shares were outstanding as shares of common stock only in the fourth quarter of fiscal year 2020, the weighted-average equivalent impact of these shares for the full year in 2020 is approximately 25%. For the year ending December 31, 2021, the weighted-average shares outstanding will reflect the full number of shares issued in the IPO and the common shares issued upon the conversion of redeemable convertible preferred stock, representing a total of 41,395,379 shares, as the shares from these events will have been outstanding for the full year in 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2020 were $371.7 million, compared to $90.5 million as of December 31, 2019. The increase was primarily attributable to $191.2 million in net proceeds from our IPO completed on October 6, 2020, $145.5 million of net proceeds from our issuance of shares of Series B redeemable convertible preferred stock in June and July 2020, and $12.0 million of net proceeds from the issuance of long-term debt and a related warrant to purchase shares of Series B redeemable convertible preferred stock in June 2020. The increase resulting from these transactions was offset by net expenditures to fund our operations. We expect that our cash, cash equivalents and marketable securities as of December 31, 2020, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund our planned operating expenses and capital expenditures to the end of 2023.

BioXcel Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

On March 11, 2021 BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its quarterly results for the fourth quarter and full year ended December 31, 2020 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, MAR 11, 2021, View Source [SID1234576503]).

"Over the last 12 months, we have made significant progress with our leading neuroscience program, BXCL501, including reporting successful data readouts, submitting our first NDA, as well as advancing other potential indications," stated Vimal Mehta, Chief Executive Officer of BioXcel. "In addition to submitting our NDA for the acute treatment of schizophrenia and bipolar disorder related agitation, we also announced positive data from the TRANQUILITY Phase 1b/2 trial in dementia related agitation and will be discussing our plans for a pivotal Phase 3 program with the FDA in the second quarter of 2021. In parallel, we continue to evaluate BXCL501’s potential in a wide range of neuropsychiatric conditions with ongoing trials in opioid withdrawal symptoms and delirium related agitation. As we develop the commercial infrastructure needed to bring this potential candidate to market, we continue to execute on our clinical and corporate milestones, as well as leverage our unique AI platform to reach new patient populations where there are large unmet medical needs."

Dr. Mehta continued, "Moreover, our immuno-oncology candidate, BXCL701, has demonstrated encouraging signals of activity in difficult-to-treat tumors across both combination trials. We expect to report topline data from the ongoing trials in mid-2021, in hopes of further demonstrating this candidate’s potential at enhancing an individual’s innate immunity."

Fourth Quarter and Full Year 2020 and Recent Highlights

BXCL501-Neuroscience Program

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, designed for the treatment of agitation and opioid withdrawal symptoms. The Company believes BXCL501 may directly target a causal agitation mechanism.

BioXcel recently completed the rolling submission of its NDA to the FDA for BXCL501 for the acute treatment of schizophrenia and bipolar disorder related agitation. Leveraging the Company’s AI-based platform, BioXcel was able to develop this program from the first-in-human trial to NDA submission in just over 2 years.
The Company met the primary and secondary endpoints of the TRANQUILITY trial, a Phase 1b/2 trial of BXCL501 for the acute treatment of dementia related agitation. Topline results showed that BXCL501 was generally well tolerated, with statistically significant and clinically meaningful reductions in agitation achieved with both the 30 mcg and 60 mcg doses at 2 hours as measured by the PEC, PAS and Mod-CMAI scales. The end of Phase 2 meeting with the FDA is planned for Q2 2021, with the goal of initiating a registrational program in the H2 2021.
BioXcel has initiated a supplemental cohort investigating a 40 mcg dose of BXCL501 in 46 patients (1:1 randomization) as an expansion of TRANQUILITY to further inform its clinical development strategy.
The RELEASE study, a Phase 1b/2 trial of BXCL501 for the treatment of opioid withdrawal symptoms, is progressing on track, with the topline readout expected this month.
BioXcel has initiated the PLACIDITY trial, a Phase 2 trial of BXCL501 for the treatment of hospitalized patients with delirium related agitation. The Company expects to report topline results from this trial in Q1 2022.
BioXcel and its collaborators, the VA Connecticut Healthcare System and the Yale University Medical School, were awarded a grant by the U.S. Department of Defense’s ("DOD") Congressionally Directed Medical Research Programs ("CDMRP") to evaluate BXCL501 in patients suffering from post-traumatic stress disorder ("PTSD") related to alcohol and substance abuse disorder ("ASUD"). This will be the first time the Company is investigating BXCL501 as a potential chronic treatment.
The Company was issued U.S. patent No. 10,792,24 on October 6, 2020, which covers film formulations containing Dex and methods of treating agitation using such film formulations. The patent is expected to extend intellectual property ("IP") protection until 2039.
Commercial Highlights

Readiness initiatives for the potential launch of BXCL501 in schizophrenia and bipolar disorder related agitation continue to progress, including the infrastructure needed to support commercialization, the design of our sales force structure and size, as well as market research with both healthcare professionals and payers to inform launch strategy, communications and the BXCL501 value proposition.
The launch of our educational campaign on schizophrenia and bipolar disorder related agitation is planned for May 2021, in sync with Mental Health Awareness Month.
Medical Affairs Initiatives

Our Medical Science Liaison ("MSL") and Medical Manage Care ("MMC") teams are completing their training and will be deployed this month to begin scientific medical to medical exchange with healthcare professionals and payers, respectively.
Two abstracts on SERENITY I and II have been accepted for presentation at the American Psychiatric Association ("APA") Annual Meeting in May 2021.
BXCL701-Immuno-Oncology Program

BXCL701 is an orally-delivered small molecule, immunomodulator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent anti-tumor activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.

The Phase 2 efficacy portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA) for treatment emergent Neuroendocrine Prostate Cancer ("tNEPC") and castrate-resistant prostate cancer ("CRPC") is advancing, with topline results expected in mid-2021. In November 2020, interim data from this trial was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting ("SITC"), with an efficacy update presented last month at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
Preliminary efficacy data from the MD Anderson-led Phase 2 open label basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid tumors was presented at SITC (Free SITC Whitepaper). Topline results from the trial are expected in mid-2021.
In January, the FDA granted orphan drug designation to BXCL701 for the treatment of soft tissue sarcoma.
Corporate Highlights

BioXcel continues to integrate and evolve its neuroscience AI machine learning and drug development platform, focusing on symptoms resulting from stress-related behaviors. This platform led to the identification and rapid development of BXCL501, leading to the submission of its first NDA. The Company continues to leverage the platform to identify and develop new neuroscience programs.
In March 2021, June Bray was appointed to the Company’s Board of Directors. Ms. Bray brings over forty years of extensive U.S. and global regulatory experience across all therapeutics areas, including psychiatry and neurology.
In February 2021, Javier Rodriguez was appointed as Chief Legal Officer and Corporate Secretary of BioXcel. Mr. Rodriguez joins the Company with over 20 years of extensive strategic and legal experience within the biopharmaceutical industry.
Fourth Quarter and Full Year 2020 Financial Results

BioXcel reported a net loss of $21.1 million for the fourth quarter of 2020, compared to a net loss of $8.3 million for the same period in 2019. For the full year, BioXcel reported a net loss of $82.2 million, compared to a net loss of $33.0 million for the same period in 2019.

For the fourth quarter of 2020, research and development expenses were $11.4 million as compared to $6.5 million for the same period in 2019. The increase was primarily attributable to increased personnel, clinical trial and professional research costs primarily related to our BXCL501 studies.

Research and development expenses were $58.0 million for the full year 2020, as compared to $25.8 million for the same period in 2019. The increase for the year ended December 31, 2020 was generally attributable to increased clinical trial costs, compensation costs and professional research costs associated with BXCL501, as the Company continues to expand its clinical programs.

General and administrative expenses were $9.7 million for the fourth quarter of 2020, as compared to $1.9 million for the same period in 2019. The increase was primarily due to an increase in compensation costs related to the growth of BioXcel’s operations. Professional fees also increased primarily related to costs associated with preparation for the potential commercial launch of BXCL501.

General and administrative expenses were $24.3 million for full year 2020, as compared to $7.8 million for the same period in 2019. The increase was primarily due to the growth of BioXcel’s operations. Professional and consulting fees also increased due to the expansion of our corporate activities.

The fourth quarter 2020 results include approximately $6.6 million in non-cash stock-based compensation costs. For the full year, non-cash stock-based compensation costs totaled $14.6 million.

As of December 31, 2020, cash and cash equivalents totaled approximately $213.1 million.

Conference Call:

BioXcel will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BioXcel website at www.bioxceltherapeutics.com. The replay will be available through at least March 25, 2021.