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]).

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"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.

On March 11, 2021 Exicure, Inc. (NASDAQ:XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported fourth quarter and full year financial results for the year ended December 31, 2020 and provided an update on corporate progress (Press release, Exicure, MAR 11, 2021, View Source [SID1234576539]).

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"We are pleased with our clinical and operational progress during 2020 and are grateful to our employees who have worked hard to lay the groundwork for a strong 2021," said David Giljohann, Ph.D., Chief Executive Officer of Exicure. "With the receipt of two Fast Track and an Orphan Drug Designation, we are advancing our cavrotolimod program, as well as expanding our pipeline of drug candidates targeting neurological indications such as Friedreich’s ataxia using our SNA platform," concluded Dr. Giljohann.

Corporate Progress

Key achievements during 2020 and recent developments include:

XCUR-FXN for Friedreich’s ataxia

Announced neurology pipeline expansion during virtual R&D day presentation in January 2021
Initiated IND-enabling studies for XCUR-FXN in December 2020
Cavrotolimod (AST-008) in Oncology

Granted Orphan Drug Designation from the FDA for cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC) in March 2021
Granted two Fast Track designations from FDA for cavrotolimod (AST-008) for MCC and cutaneous squamous cell carcinoma (CSCC), both in the advanced/metastatic setting after progression on anti-PD-1/PD-L1 antibodies in January 2021
Announced in December 2020 the issuance of two new U.S. patents and a new patent allowance covering cavrotolimod (AST-008) through 2034
Announced positive clinical data on cavrotolimod (AST-008) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting in November 2020
Announced promising interim results from ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) in September 2020
Announced first patient dosed in Phase 2 clinical trial of cavrotolimod (AST-008) in patients with MCC in June 2020
Corporate/Financial

Appointed Elizabeth Garofalo, M.D. and Andrew Sassine to the Board of Directors in March 2021
Appointed James Sulat to the Board of Directors in January 2021
Secured $25.0 million debt facility in October 2020
Moved into new corporate headquarters in Chicago, Illinois in July 2020
Added to the Russell 2000 Index in June 2020
Hired Douglas Feltner, M.D. as Chief Medical Officer in May 2020
Appointed Timothy Walbert as Chairman of the Board of Directors in April 2020
Pipeline Updates

Neurology

In the fourth quarter of 2020, Exicure initiated IND-enabling studies for XCUR-FXN, an SNA-based therapeutic candidate, for the treatment of Friedreich’s ataxia (FA). The Company expects to initiate a first-in-patient Phase 1b clinical trial in 2022. The Company is collaborating closely with the Friedreich’s Ataxia Research Alliance (FARA), a non-profit, charitable organization dedicated to accelerating research leading to treatments and a cure for FA, in the design and site selection of the Phase 1b clinical trial.
In January 2021, Exicure provided an update on its clinical pipeline across a number of rare neurodegenerative diseases of high unmet need and highlighted the advancement of two preclinical programs: one targeting SCN9A for neuropathic pain and the other targeting CLN3 for Batten Disease.
Immuno-oncology – cavrotolimod (AST-008)

Exicure is conducting a clinical trial in which cavrotolimod (AST-008) is being given in combination with pembrolizumab or cemiplimab for the treatment of locally advanced or metastatic MCC or CSCC, respectively, in patients with progression despite approved anti-PD-(L)1 therapy. In the Phase 2 portion of this trial, Exicure is planning to enroll two separate cohorts of patients with advanced or metastatic MCC or CSCC. Each cohort is expected to enroll up to 29 patients who have failed anti-PD-1/PD-L1, or programmed cell death protein 1/programmed death-ligand 1, therapy. In addition, the Company has added an exploratory cohort to include patients with melanoma who have progressed on PD-(L)1 therapy and MCC patients who do not qualify for the primary MCC cohort. As of February 23, 2021, 16 clinical sites were open for enrollment and 7 additional sites were pending activation. The Company expects to open up to 30 sites for the Phase 2 stage of the clinical trial by the end of 2021. In June 2020, the Company reported the dosing of the first patient in the MCC cohort of the clinical trial. As of February 23, 2021, 16 patients had been dosed in the Phase 2 portion of the clinical trial, including the primary and exploratory cohorts. As of February 23, 2021, 1 of 36 patients treated with cavrotolimod (AST-008) had experienced a treatment-related serious adverse event (SAE). In January 2021, Exicure was granted Fast Track designations by the FDA for cavrotolimod (AST-008) for two development programs. In March 2021, Exicure was granted Orphan Drug Designation for cavrotolimod (AST-008) for the treatment of patients with MCC.

In September 2020, Exicure reported that it had completed enrollment of the Phase 1b stage of the clinical trial for cavrotolimod (AST-008). The objectives of the Phase 1b dose-escalation stage of the clinical trial were to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of cavrotolimod (AST-008) alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose. The patients dosed in the Phase 1b stage included ten melanoma patients, five MCC patients, two CSCC patients, two head and neck squamous cell carcinoma patients and one leiomyosarcoma patient. At the time of enrollment, 85% of patients had experienced progressive disease while on anti-PD-1 antibody therapy.

The key results from the Phase 1b stage of the trial include:

Confirmed overall response rate (ORR) of 21% (4/19 patients) overall
Confirmed ORR of 33% (2/6 patients) in the highest dose cohort (32 mg), which was selected as the Phase 2 recommended dose
Overall responses occurred in two patients with advanced MCC and two patients with melanoma
Three of four responders were progressing on anti-PD-1 therapy at the time of enrollment
Responses were observed in 40% (2/5) of MCC patients enrolled in the study, including one complete response
2020 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and short-term investments were $82.1 million as of December 31, 2020, as compared to $94.1 million as of September 30, 2020.

Revenue: Revenue was $16.6 million for the year ended December 31, 2020, as compared to $1.3 million for the year ended December 31, 2019. The increase in revenue of $15.3 million for the year ended December 31, 2020 is primarily associated with the recognition of non-cash revenue in connection with the Company’s collaboration with AbbVie.

Research and Development (R&D) Expense: Research and development expenses were $32.1 million for the year ended December 31, 2020, as compared to $19.3 million for the year ended December 31, 2019. The Company continues to increase staffing in the R&D function, increasing headcount from 29 at December 31, 2019 to 54 at December 31, 2020 and the associated increase in hiring, in addition to growth in cavrotolimod (AST-008) clinical trial activities, has driven the Company’s increase in R&D costs. The associated increases in platform and discovery-related costs reflected increased preclinical R&D activities associated with the Company’s collaboration with AbbVie, increased costs related to XCUR-FXN, as well as other preclinical discovery work in neurology and ophthalmology, partially offset by the absence of a license fee of $3.8 million paid in 2019 to Northwestern University in connection with the receipt of the $25.0 million upfront payment from AbbVie.

General and Administrative (G&A) Expense: General and administrative expenses were $10.0 million for the year ended December 31, 2020, as compared with $8.6 million for the year ended December 31, 2019. The increase is mostly due to higher legal and accounting costs associated with operating as a public company, higher franchise tax costs and higher D&O insurance premium costs, partially offset by lower travel and related costs.

Net Loss: The Company had a net loss of $24.7 million for the year ended December 31, 2020 compared to a net loss of $26.3 million for the year ended December 31, 2019. The decrease in net loss was driven principally by higher revenue of $15.3 million associated with the Company’s collaboration with AbbVie, partially offset by the increases in R&D expenses and G&A expenses discussed above.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments, including amounts borrowed and available under the senior secured term loan with MidCap Financial Trust and Silicon Valley Bank, will be sufficient to fund its operations for at least 12 months.

COVID-19 Pandemic Update

With the global spread of the coronavirus disease, or COVID-19, pandemic, the Company continue to monitor closely the developments and take active measures to protect the health of its employees and their families, its communities, as well as clinical trial investigators, patients, and caregivers. The Company continues to monitor the impact that the COVID-19 pandemic is having on the clinical trial’s patient enrollment and safety, site initiation and study integrity. The Company has put in place and continue to maintain a variety of measures to mitigate the effects of COVID-19 and the top priority is to maintain patient safety and clinical trial continuity. During the third quarter of 2020 and through December 31, 2020, the Company observed delays in its enrollment plans and clinical trial site start-ups for the Phase 2 dose expansion phase of the trial. The Company believes the effects of the COVID-19 pandemic or its impact contributed to such delays. As a result, the Company has taken additional measures to increase the enrollment of patients, including frequent interaction with its clinical trial sites currently open as well as increasing the number of clinical trial sites that potentially are activated for this trial so that the Company may continue to enroll patients as initially planned, in accordance with related directives, orders and guidance from relevant health and safety authorities. However, these delays have caused the Company to lengthen clinical development timeline for cavrotolimod (AST-008), and it now expects to report overall response rate ("ORR") results in the first half of 2022 rather than by year end 2021 as previously guided in September 2020.

About Friedreich’s Ataxia (FA)

FA is a rare, degenerative, life-shortening neuro-muscular disorder that affects children and adults, and involves the loss of strength and coordination usually leading to wheelchair use, diminished vision, hearing and speech, scoliosis, increased risk of diabetes, and a life-threatening heart condition. There are no FDA-approved treatments. The Company estimates that approximately 13,000 patients across the United States, Europe, Canada and Australia are affected by FA.

On March 11, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the year ended December 31, 2020 and provided a business update (Press release, Nuvation Bio, MAR 11, 2021, View Source [SID1234576560]).

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"Nuvation Bio began a new chapter as a public company following the successful completion of our business combination with Panacea in February. With a strong cash position of approximately $830 million after transaction fees, as well as a recently expanded leadership team and employees dedicated to meaningfully improving the survival and quality of life for people with cancer, we are confident in our ability to advance our deep pipeline," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "Looking ahead, patient recruitment and dosing is ongoing in our Phase 1/2 study of NUV-422 in high-grade gliomas. As we recently announced, NUV-422has received the FDA’s Orphan Drug Designation for the treatment of malignant gliomas. We are also continuing to progress the rest of our portfolio of novel and mechanistically distinct therapies for solid and hematologic cancers. We expect to submit up to five additional Investigational New Drug applications with the U.S. Food and Drug Administration by 2026."

Recent Business Highlights

Debuted as publicly traded oncology company following the closing of a business combination with Panacea Acquisition Corp. In February 2021, Nuvation Bio announced the closing of its business combination with Panacea Acquisition Corp., a SPAC sponsored by EcoR1 Capital, and the commencement of trading shares of the combined company on the New York Stock Exchange (NYSE) under the ticker symbol "NUVB." Nuvation Bio’s total cash position at closing was approximately $830 million after transaction costs, including approximately $646 million held in Panacea’s trust account and received in concurrent private financings led by EcoR1 Capital, as well as 683 Capital, Ally Bridge Group, Avidity Partners, Deerfield Management Company, Irving Investors, Monashee Investment Management LLC, OrbiMed, Wellington Management and other existing Nuvation Bio shareholders including The Baupost Group, Boxer Capital of the Tavistock Group, Fidelity Management & Research Company, LLC, Omega Funds, Perceptive Advisors, Redmile Group and Surveyor Capital (a Citadel Company).

Initiated a Phase 1/2 study of NUV-422, the first of Nuvation’s six compounds to enter the clinic. In December 2020, Nuvation Bio commenced patient enrollment and dosing in the Phase 1/2 study of its lead investigational compound, NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation part of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion part of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022. The U.S. Food and Drug Administration (FDA) in March granted Orphan Drug Designation to NUV-422 for the treatment of malignant gliomas.

Expanded executive team with key appointments. In January 2021, Nuvation Bio appointed Lisa DeLuca as senior vice president, regulatory affairs. Ms. DeLuca brings more than 25 years of regulatory experience to Nuvation Bio and most recently led the regulatory team at Radius Health. In October 2020, Nuvation Bio appointed Jennifer Fox as chief financial officer to lead corporate strategy, business development, investor relations and corporate communications. Ms. Fox joined Nuvation Bio from Citigroup, where she most recently served as a managing director and co-head of the Healthcare Corporate and Investment Banking Group.
Full Year 2020 Financial Results
The following financial results for the year ended December 31, 2020 represent Nuvation Bio Inc. (now known as Nuvation Bio Operating Company Inc.) as a standalone private company, as its business combination with Panacea Acquisition Corp. closed on February 10, 2021. The financial results of Panacea Acquisition Corp. for the year ended December 31, 2020 will be reported in the Annual Report on Form 10-K to be filed by Nuvation Bio in March 2021. Nuvation Bio’s financial statements for the first quarter of 2021, to be reported in May 2021, and for subsequent periods will reflect the financial results of the combined public company.

Research and development expense for the year ended December 31, 2020 was $32.6 million compared to $25.1 million for the year ended December 31, 2019. General and administrative expense for 2020 was $10.9 million, compared to $7.0 million for 2019.

Net loss for 2020 was $41.7 million compared to $33.6 million for 2019.

On March 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it intends to offer shares of its common stock for sale in an underwritten public offering (Press release, Cyclacel, MAR 11, 2021, View Source [SID1234576590]). In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Cyclacel.

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Cyclacel intends to use the net proceeds from this offering to support the Company’s growth strategy and for working capital and general corporate purposes, including research and development expenses, and capital expenditures.

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the public offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-231923) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on June 21, 2019. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 11, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, RAPT Therapeutics, MAR 11, 2021, View Source [SID1234576455]).

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"In 2020, we achieved important advancements in clinical development for our two lead programs: FLX475 in oncology and RPT193 in inflammatory diseases," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "In November, we reported early evidence of clinical activity for FLX475, both as monotherapy and in combination with pembrolizumab, in multiple tumor types. These data helped us determine advancement of several cohorts in our multi-cohort, multi-indication Phase 1/2 trial. For RPT193, we continued enrolling our Phase 1b study of RPT193 in atopic dermatitis over the course of 2020 despite a brief pause early in the year because of the pandemic. Today, we are well positioned for key data readouts for both RPT193 and FLX475. We plan to report on the Phase 1b trial for RPT193 in the first half of 2021 and provide an update in the second half of 2021 on additional data generated with FLX475 in multiple cohorts that have sufficiently matured."

Financial Results for the Fourth Quarter and Year Ended December 31, 2020

Fourth Quarter Ended December 31, 2020
Net loss for the fourth quarter of 2020 was $12.7 million, compared to $13.2 million for the fourth quarter of 2019.

Research and development expenses for the fourth quarter of 2020 were $10.9 million, compared to $10.2 million for the same period in 2019 due to increased clinical trial costs for FLX475 and RPT193, increased personnel costs and stock-based compensation expense and an increase in preclinical program costs, offset by a decrease in laboratory supplies spend.

General and administrative expenses for the fourth quarter of 2020 were $3.5 million, compared to $2.6 million for the same period of 2019. The increase was primarily due to increases in stock-based compensation expense, personnel costs, legal and accounting fees and insurance expense, offset by a decrease in consulting costs.

Year Ended December 31, 2020
Net loss for the year ended December 31, 2020 was $52.9 million, compared to $43.0 million for the same period in 2019.

Research and development expenses for the year ended December 31, 2020 were $45.5 million, compared to $34.9 million for the same period in 2019. The increase was primarily due to an increase in clinical trial costs relating to FLX475 and RPT193, increased preclinical program costs as well as increases in stock-based compensation and personnel expenses, offset by decreases in lab supplies and travel costs.

General and administrative expenses for the year ended December 31, 2020 were $12.8 million, compared to $8.7 million for the same period of 2019. The increase in general and administrative expenses was primarily due to increases in stock-based compensation expense, personnel costs and costs associated with our public company status, offset by a decrease in professional fee and travel costs.

As of December 31, 2020, the Company had cash and cash equivalents and marketable securities of $111.5 million.