On November 10, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter and year-to-date for the period ended September 30, 2021 (Press release, Navidea Biopharmaceuticals, NOV 10, 2021, View Source [SID1234595107]).

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Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "During this time of transition in our leadership, we remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can execute on our business plan and fulfill the vision we have for Navidea."

Third Quarter 2021 Highlights and Subsequent Events

Submitted draft Clinical Study Report to the U.S. Food and Drug Administration ("FDA") for the Company’s completed NAV3-31 Phase 2b study in Rheumatoid Arthritis ("RA") as part of the briefing package for an End-of-Phase 2 Type B meeting.
Held an End-of-Phase 2 Type B meeting with the FDA to discuss the Company’s ongoing program in RA and advancement to the pivotal Phase 3 trial September 1, 2021 via conference call.
Opened a third site for enrollment in the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Enrollment is ongoing and biopsy specimens are in the process of analysis.
Nearly completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Arm 1 is 4 subjects from completion and Arm 2 is fully enrolled.
Completed enrollment and imaging data analysis in the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
Appointed Alexander L. Cappello and John K. Scott, Jr. to the Board of Directors. Mr. Scott is the Company’s largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
Appointed Thomas F. Farb and Agnieszka Winkler to the Board of Directors. Mr. Farb has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally, and Ms. Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies.
Appointed Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea. Dr. Mikhail brings more than 30 years of experience in the pharmaceutical industry and a track record of achievement in research and development ("R&D") and international regulatory affairs at large multinational research-based pharmaceutical companies.
Jed A. Latkin resigned as Chief Executive Officer, Chief Financial Officer and Chief Operating Officer of the Company and as a member of the Company’s Board of Directors. The Company’s Board of Directors has established an Executive Leadership Committee to lead the Company on an interim basis while its next CEO is identified. The Executive Leadership Committee includes Michael Rosol, Ph.D., the Company’s Senior Vice President and Chief Medical Officer; Erika Eves, the Company’s Vice President of Finance and Administration; and Jeffrey Smith, the Company’s Vice President of Operations. The Executive Leadership Committee will work with a newly established Board Oversight Committee, consisting of independent directors Alexander Cappello, Thomas Farb and John K. Scott, Jr.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have had a constructive dialogue with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the NAV3-33 Phase 3 study, and we continue to prepare for initiation of this trial. We also have active enrollment in the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and have near full enrollment in the NAV3-35 normative database study. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the third quarter of 2021 were $96,000, compared to $268,000 for the same period in 2020. Total net revenues for the first nine months of 2021 were $481,000, compared to $695,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs and the partial recovery of debts previously written off in 2015.
R&D expenses for the third quarter of 2021 were $1.0 million, compared to $1.4 million in the same period in 2020. R&D expenses for the first nine months of 2021 were $3.8 million, compared to $3.7 million in the same period in 2020. The net increase during the year to date was primarily due to net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs. The net increase in research and development expenses also included increased regulatory consulting and general office expenses offset by decreased employee compensation including incentive-based awards.
Selling, general and administrative ("SG&A") expenses for the third quarter of 2021 were $1.5 million, compared to $1.8 million in the same period in 2020. SG&A expenses for the first nine months of 2021 were $5.1 million, compared to $4.9 million in the same period in 2020. The net increase during the year to date was primarily due to increased consulting services related to preparation for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased travel costs, increased European license fees, increased general office expenses, and a loss on the third quarter 2021 abandonment of certain intellectual property, offset by decreased legal and professional services, decreased investor relations costs, decreased facilities costs and decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the third quarter of 2021 was $2.4 million, or $0.08 per share, compared to $3.3 million, or $0.13 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the first nine months of 2021 was $8.1 million, or $0.28 per share, compared to $8.4 million, or $0.37 per share, for the same period in 2020.
Navidea ended the third quarter of 2021 with $7.2 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. As noted in the Company’s press release dated November 3, 2021, questions will not be taken during the conference call. Previously-submitted questions will be read aloud and answered during the Q&A portion of the conference call, and we may also respond to questions on an individual basis or by posting answers on our website after the call.

A live audio webcast of the conference call will be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 10, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, reported its cash position as of September 30, 2021 and its revenues for the first nine months of 2021 (Press release, Inventiva Pharma, NOV 10, 2021, View Source [SID1234595106]).

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Cash Position

As of September 30, 2021, Inventiva’s cash and cash equivalents stood at €105.7 million, compared to €93.6 million as of June 30, 2021 and €105.72 million as of December 31, 2020.

Net cash used in operating activities amounted to €31.6 million for the first nine months of 2021 compared to (€19.4) million for the same period in 2020. R&D expenses for the first nine months of 2021 were up by 88% compared to the same period in 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH, and to a lesser extent, by the increase of general and administrative expenses (G&A) expenses (+ 51%) resulting from Inventiva’s dual listing status.

Net cash generated from financing activities for the first nine months of 2021 amounted to €23.9 million, mainly due to the sale of $30 million in gross proceeds of the Company’s ordinary shares in the form American Depositary Shares ("ADS") on September 23, 2021. The sale was made through the Company’s At-The-Market (ATM) program established on August 2, 2021, to existing and new specialized institutional investors. For the same period in 2020, net cash generated from financing activities amounted to €111.6 million, driven by: the issuance of €15 million (gross proceeds) of ordinary shares to certain existing investors in the Company, the entry into €10 million in French state-guaranteed credit agreements with a syndicate of French banks, and the receipt of €94.9 million3 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020.

Over the third quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million.

Considering its current R&D and clinical development programs and excluding additional financial resources that may originate from funding activities, Inventiva’s cash runway will allow the Company to fund its operations through the first quarter of 2023.

Revenues

The Company’s revenues for the first nine months of 2021 amounted to €0.2 million, as compared to €0.3 million for the same period in 2020. As part of its collaboration with AbbVie in auto-immune diseases, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant planned before the end of 2021.

Update on the Phase II clinical trial with lanifibranor in patients with NAFLD and T2D

The Phase II investigator-initiated clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2D) is progressing and Professor Cusi is recruiting the last patients of the trial. However, given the current status of recruitment, the publication of the results is now expected for the second half of 2022, rather than the first half of 2022 as previously communicated.

Next key milestones expected

Webcast with Key Opinion Leaders from the AASLD The Liver Meeting 2021 hosted by Inventiva – scheduled on November 19, 2021
Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for November 2021
Activation of first clinical sites for Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and T2D – planned for the first half of 2022
Last Patient First Visit of the NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the second half of 2022
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of NAFLD in patients with T2D – planned for the second half of 2022
Strategy update on the development of odiparcil – planned for 2022
Upcoming investor conference participation

Stifel Healthcare Conference 2021 – November 16-17, 2021
Jefferies 2021 London Healthcare Conference – November 16-18, 2021
J.P. Morgan Healthcare Conference 2022 – January 10-13, 2021
Upcoming scientific conference presentations

AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

Full-Year 2021 Revenues and cash position: Monday, February 14, 2022 (after U.S. market close)

On November 10, 2021 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT, MXCN), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported third quarter ended September 30, 2021 financial results (Press release, MaxCyte, NOV 10, 2021, View Source [SID1234595105]).

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Third Quarter and Recent Highlights

Total revenue was $10.1 million in the third quarter of 2021, representing 50% growth compared to the same period in 2020.
Excluding Strategic Platform License (SPL) Program-related revenue, revenue from cell therapy customers was $6.2 million for the third quarter, an increase of 38% compared to the same period in 2020.
SPL Program-related revenue was $2.0 million in the third quarter — the highest SPL Program-related revenue we have received in any quarter to-date — as compared to $0.3 million for the same period in 2020.
Revenue from drug discovery customers was $1.9 million in the third quarter, a decrease of 5% compared to the same period in 2020, but up sequentially from the second quarter of 2021.
With the addition of Myeloid Therapeutics, Inc., Celularity, Inc., Sana Biotechnology, Inc., and Nkarta, Inc. signed year-to-date, the total number of SPLs now stands at 15.
"We are pleased to report very strong third quarter results driven by ongoing strength in sales to cell therapy customers and robust SPL Program-related revenue." said Doug Doerfler, President and CEO of MaxCyte.

"We continue to expand our customer base and increase the number of strategic partnerships, now with 15 SPL agreements in place following the announcement of our agreement with Nkarta in early November. The vast majority of our SPL agreements enable MaxCyte to participate in pre-commercial milestones and post-commercial sales-based payments on SPL-related Programs. We remain bullish around the potential for our SPL partnerships to generate meaningful revenue for the business over the next 12 to 18 months and beyond as our partners continue to see clinical success.

We are also making important and strategic investments in our business, expanding our marketing, R&D and product development capabilities, launching innovative solutions to drive future growth, bolstering our leading internal and field-based cell engineering expertise, expanding our manufacturing capabilities as our customers move closer to commercialization, and adding strong talent across all facets of our business."

"Overall, MaxCyte remains well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

Third Quarter Financial Results

Total revenue for the third quarter of 2021 was $10.1 million, compared to $6.8 million in the third quarter of 2020, representing growth of 50%. Sales to cell therapy customers, across both instruments and single use disposables, were collectively up 38% compared to the same period last year.

Success in recognizing revenue from our SPL Programs was also a primary source of strength in the quarter. The Company recognized $2.0 million in SPL Program-related revenue in the quarter (comprised of pre-commercial milestone revenues) as compared to $0.3 million in SPL Program-related revenue in the third quarter of 2020.

Gross profit for the third quarter of 2021 was $9.2 million (91% gross margin), compared to $6.0 million (89% gross margin) in the same period of the prior year. The increase in gross margin was driven by the higher SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the third quarter of 2021 were $11.6 million, compared to operating expenses of $8.9 million in the third quarter of 2020. The overall increase in operating expense was principally driven by a $3.4 million increase in compensation expense associated with increased headcount and higher stock-based compensation (principally due to stock-price appreciation), as well as a $1.2 million increase in legal, public company and professional service expenses.

Partially offsetting this expense growth was a $2.5 million decline in CARMA-related expenses compared with the same period last year. As of March 2021, all pre-clinical and clinical activities related to the CARMA platform were substantially completed.

Third quarter 2021 net loss was ($2.7) million compared to net loss of ($3.1) million for the same period in 2020.

Total cash, cash equivalents and short-term investments were $255.9 million as of September 30, 2021.

Preliminary 2021 Revenue

We are updating our revenue projection for fiscal year 2021. We now expect to achieve at least $33.0 million in revenue for fiscal year 2021, up from our prior guidance of greater than $30 million in revenue for the year.

Executive Leadership Addition

James Lovgren has joined MaxCyte as Senior Vice President of Global Marketing. Mr. Lovgren brings deep experience in cell therapy to the role, where he will help grow adoption of the MaxCyte ExPERT platform in cellular-based research and next-generation drug development. Most recently, Mr. Lovgren served as Vice President at Berkeley Lights, where he was responsible for cell therapy strategy, including product development and marketing. Previously, he served as General Manager at Thermo Fisher Scientific in the cell and gene therapy business, overseeing the launch of several strategic products. He also held leadership positions at Minerva Biotechnologies, ORGN3N and Life Technologies. Mr. Lovgren earned his master’s degree in business administration at North Carolina State University and his bachelor’s degree in biology at University of North Florida.

Webcast and Conference Call Details

MaxCyte will host a conference call today, November 10, 2021, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers or (918) 922-6914 for international callers, followed by Conference ID: 5098687. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Form 10-Q

MaxCyte expects to file its Quarterly Report on Form 10-Q for the period ended September 30, 2021 with the SEC on November 10, 2021. When filed, a copy of the Form 10-Q will be available on the SEC’s website at www.sec.gov and will also be available under the "SEC filings" page of the Investors section of the Company’s website, View Source

On November 10, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported third quarter 2021 financial results (Press release, Relay Therapeutics, NOV 10, 2021, View Source [SID1234595104]).

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"It’s been a very productive year at Relay Therapeutics. We have delivered on all of our key goals set out at our IPO in July 2020 and have proven our ability to effectively advance our clinical trials, having recently disclosed interim clinical data for RLY-4008. Not only do the clinical data validate our Dynamo platform and approach, but they also suggest RLY-4008 is a highly selective FGFR2 inhibitor that has the potential to address a significant unmet medical need," said Sanjiv Patel, M.D., president and chief executive officer. "Our other programs continue to progress, with RLY-2608, the first of our PI3Kα franchise, on path to begin a first-in-human study in the first half of 2022. We will continue to focus on execution for the remainder of 2021 and into 2022, and are confident our recent financing will provide the capital needed to push multiple programs through the clinic while maintaining a robust preclinical pipeline."

Recent Corporate Highlights

Presented interim clinical data for RLY-4008 in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma and other solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 8, 2021 that suggest RLY-4008 is a highly selective FGFR2 inhibitor demonstrating robust inhibition of FGFR2 regardless of alteration or tumor type while not being limited by off-target toxicities
Announced the Company anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021
Shared preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 7, 2021 that support RLY-2608 as the first known allosteric pan-mutant selective inhibitor of PI3Kα
Additional preclinical data for RLY-2608 in combination with standard of care medicines, fulvestrant (estrogen receptor inhibitor) and/or abemaciclib (CDK 4/6 inhibitor), will be presented at the San Antonio Breast Cancer Symposium
Presentation Title: RLY-2608: the first allosteric mutant- and isoform-selective inhibitor of PI3Kα, is efficacious as a single agent and drives regressions in combination with standard of care therapies in PIK3CA mutant breast cancer models
Presentation Time: Poster Session 5, December 10, 2021, 7:00 a.m. – 8:30 a.m. CT
Successfully raised $402 million of gross proceeds in an underwritten follow-on public offering
Third Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents and investments totaled approximately $616.5 million, which excludes the gross proceeds of $402 million from the Company’s recent public offering, compared to $678.1 million as of December 31, 2020. The Company expects its current cash and cash equivalents, together with the net proceeds from its recent public offering, will be sufficient to fund its current operating plan at least into 2025.

R&D Expenses: Research and development expenses were $45.0 million for the third quarter of 2021, as compared to $24.4 million for the third quarter of 2020. The increase of $20.6 million was primarily due to $8.9 million related to pre-clinical development candidates and $9.6 million of additional employee related costs and expenses attributable to clinical development activities.

G&A Expenses: General and administrative expenses were $14.7 million for the third quarter of 2021, as compared to $12.2 million for the third quarter of 2020. The increase of $2.5 million was primarily due to $1.3 million of increased personnel costs and $0.7 million of other general and administrative expenses.

Net Loss: Net loss was $60.8 million for the third quarter of 2021, or a net loss per share of $0.66, as compared to a net loss of $36.1 million for the third quarter of 2020, or a net loss per share of $3.00.

On November 10, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage 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 third quarter of 2021 (Press release, C4 Therapeutics, NOV 10, 2021, View Source [SID1234595103]).

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"In recent months, C4T has built momentum across our portfolio of highly potent targeted protein degraders by continuing to enroll patients in our CFT7455 Phase 1/2 clinical trial and successfully nominating our next development candidate, CFT1946, a BRAF V600X degrader for the treatment of V600 mutant solid tumors" said Andrew Hirsch, chief executive officer of C4 Therapeutics. "We remain on track to achieve our remaining 2021 milestones, including IND submission for CFT8634 and advancing our EGFR and BRAF degraders towards the clinic. Our strong balance sheet and commitment to bringing innovative treatments to patients keep us on track to deliver clinical data for CFT7455 next year and achieve four clinical programs by end of 2022."

THIRD QUARTER 2021 AND RECENT BUSINESS HIGHLIGHTS

CFT7455: CFT7455 is an orally bioavailable MonoDAC degrader targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin’s lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma.

Accepted to Present at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition: Jesus G. Berdeja, M.D., director, multiple myeloma research at Sarah Cannon Research Institute, will present a trial-in-progress poster titled "A Phase 1 Study of CFT7455, a Novel Degrader of IKZF1/3, in Multiple Myeloma and Non-Hodgkin Lymphoma" at the ASH (Free ASH Whitepaper) Annual Meeting at 5:30 p.m. ET on Saturday, December 11, 2021. The November online supplemental issue of Blood also features the abstract.
Received Orphan Drug Designation: In August 2021, the U.S. Food and Drug Administration granted Orphan Drug Designation to CFT7455 for the treatment of multiple myeloma.
CFT8634: CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Presented at the 4th Annual Targeted Protein Degradation Summit: In October 2021, C4T delivered a presentation describing the multiparameter optimization of a series of BRD9 degraders, which led to the identification of a degrader with a sufficient intravenous pharmacokinetic (PK) profile to enable in vivo proof-of-concept studies. This work served as a launching point for further optimization and eventually led to the discovery of CFT8634, an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.
CFT8919: CFT8919 is a potent and selective BiDAC degrader of EGFR L858R for the treatment of non-small cell lung cancer (NSCLC).

Presented at the 4th Annual Targeted Protein Degradation Summit: In October 2021, C4T delivered an encore presentation of the Company’s June presentation at the Keystone Symposium on targeted protein degradation. The presentation included pre-clinical data demonstrating CFT8919 is active in in vitro and in vivo models of acquired resistance to approved EGFR inhibitors which harbor resistance-causing secondary mutations in EGFR.
CFT1946: CFT1946 is an orally bioavailable, mutant-selective BiDAC degrader targeting BRAF V600X.

Nominated CFT1946 for Clinical Development: In August 2021, C4T and Roche selected CFT1946, a mutant-selective degrader of BRAF V600X active preclinically in the setting of acquired resistance to BRAF inhibitors, as a development candidate. C4T has initiated IND-enabling activities for CFT1946.
Regained Rights to BRAF Program from Roche: In November 2021, C4T and Roche mutually agreed to terminate their agreement solely with respect to the BRAF target, allowing C4T to advance CFT1946 and any other BRAF degraders independently from Roche. There is no impact to cash runway guidance as a result of this change. With this mutual agreement, C4T wholly owns the BRAF program and no longer has future financial obligations to Roche related to this program.
Research and Development Activities

Pre-clinical Research Paper Published in ACS Chemical Biology: In September 2021, ACS Chemical Biology featured a scientific publication from C4T titled, "Structural Characterization of Degrader-Induced Ternary Complexes Using Hydrogen–Deuterium Exchange Mass Spectrometry (HDX-MS) and Computational Modeling: Implications for Structure-Based Design." The publication describes the potential utility of HDX-MS to provide rapidly accessible structural insights into degrader-induced protein–protein interfaces in solution, and supports predictive capabilities of the TORPEDO platform.
UPCOMING KEY MILESTONES

C4T continues to advance its portfolio and is on-track to achieve four clinical programs by year-end 2022. To achieve this objective, C4T is focused on accomplishing the following activities:

Advance its CFT7455 program and share safety and efficacy data at a medical meeting in 2022.
Submit an IND application for CFT8634 by year-end 2021.
Submit an IND application for CFT8919 in mid-2022.
Submit an IND application for CFT1946 in 2022.
Continue lead optimization activities for the RET program through 2021.
UPCOMING EVENTS

November 18, 2021 – C4T will participate in the Jefferies Global Healthcare Conference.
December 2, 2021 – C4T will participate in the Evercore ISI 4th Annual HealthCONx Conference.
December 11-14, 2021 – C4T will participate in the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, including the presentation of a trial-in-progress poster for CFT7455.
THIRD QUARTER 2021 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2021 was $8.5 million, compared to $8.4 million for the third quarter of 2020. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico.

Research and Development (R&D) Expense: R&D expense for the third quarter of 2021 was $24.3 million, compared to $23.9 million for the third quarter of 2020. The increase in R&D expense was primarily attributable to higher pre-clinical costs related to our lead programs, and increased workforce expenses to support continued clinical development activities for CFT7455.

General and Administrative (G&A) Expense: G&A expense for the third quarter of 2021 was $8.5 million, compared to $2.9 million for the third quarter of 2020. The increase in G&A expense was primarily attributable to an increase in stock-based compensation expense, which was driven by new stock option grants and a higher fair value of those stock options, as well as higher professional fees and insurance costs resulting from our transition to a public company.

Net Loss and Net Loss per Share: Net loss for the third quarter of 2021 was $24.7 million, compared to $21.8 million for the third quarter of 2020. Net loss per share for the third quarter of 2021 was $0.51, compared to $17.55 for the third quarter of 2020. The decrease in net loss per share, despite the increase in net loss, was driven by a significant increase in the weighted-average number of shares outstanding. This increase in shares outstanding was caused by our initial public offering of 11,040,000 common shares in October 2020 and the resultant conversion of then outstanding shares of redeemable convertible preferred stock into 30,355,379 shares of common stock, together with our issuance of 4,887,500 shares of common stock upon the closing of our follow-on offering in June 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of September 30, 2021 were $480.3 million, compared to $371.7 million as of December 31, 2020. The change in cash was primarily driven by net proceeds from our June 2021 follow-on offering of $169.5 million, offset by expenditures to fund operations. C4T expects that our cash, cash equivalents and marketable securities as of September 30, 2021, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures for at least the next 24 months.