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.

On November 10, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2021 (Press release, VolitionRX, NOV 10, 2021, View Source [SID1234595101]). Volition management will host a conference call tomorrow, November 11 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"We have enjoyed an exciting quarter navigating the due diligence process and negotiations with three multi-national companies to advance term sheets for Nu.Q Vet licensing and distribution arrangements and anticipate signing a term sheet with one of those parties before the end of 2021," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also made progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with products."

Watch an interview with Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, Cameron Reynolds, President and Chief Executive Officer of Volition, and Terig Hughes, Chief Financial Officer of Volition: View Source

Company Highlights

Volition Veterinary

In advanced term sheet negotiations with three top global veterinary companies and anticipate signing a term sheet with one of those parties before the end of 2021.
Published two abstracts at the Veterinary Cancer Society Annual Conference including:
the first data published in relation to what will likely be the second Nu.Q Vet product, a disease monitoring tool, on track for a planned launch in 2022; and
the first study using Nu.Q Capture as an enrichment tool in the plasma of dogs with lymphoma.
Financial

Cash and cash equivalents as of September 30, 2021, totalled approximately $22.9 million compared with $19.4 million as of December 31, 2020.
Cash burn rate averaged approximately $1.7 million per month, lower than the rate during the previous two quarters and also below the Company’s expectations.
Net loss for the third quarter of 2021 was $7.2 million versus $5.6 million the prior quarter with this increase primarily due to non-cash items.
Personnel/ Operational

Dr. Gaetan Michel, Chief Operating Officer, has relocated to the U.S. and is tasked with expanding the team with roles expected to be filled in the quality, regulatory and manufacturing functions.
On November 1, Mr. Nick Plummer joined the Company as Group General Counsel.
Intellectual Property

27 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
82 granted patents (12 in the U.S., 14 in Europe and 56 rest of world).
82 patents pending.
Continued focus on filings during the third quarter of 2021 and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts continues to grow.
Year to date data for Nu.Q has been presented at four international conferences and Volition has collaborated on four clinical papers.
These publications are another very important step forward for the Company.
Clinical – NETosis including COVID-19

Volition believes the Nu.Q NETs assay will have wide applicability for monitoring diseases with a NETs component (such as COVID-19, influenza, sepsis, autoimmune diseases and cancer) and potentially to risk stratify patients for treatment selection.
Volition expects to register CE marks on its first NETs product, across multiple platforms including ELISA plate, automated beads and a proof of concept on very high throughput platform by the summer of 2022.
Volition intends to register the Nu.Q NETs product with a broad almost C-reactive protein (C.R.P.) style claim "for the detection and evaluation of infection, tissue injury, inflammatory disorders and diseases associated with NETosis".
Posters published this quarter (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
The Company has further large studies completed in COVID-19 and sepsis which are now awaiting the finalization of data and publication, as well as studies in other diseases in progress with results expected in the coming quarters.
Clinical – Cancer

The Company has completed preliminary analysis of the colorectal cancer studies (both asymptomatic and symptomatic populations) conducted with the National Taiwan University and has submitted these findings for presentation at a conference in early 2022.
The Company has completed preliminary analysis of the lung cancer study also conducted with the National Taiwan University and looks forward to reviewing the data with Professor Chen and his team ahead of publication either through a clinical paper or conference abstract.
Volition has also been in active and continuing negotiations in Asia this year in addition to platform development on its first human cancer launch in China.
Collection for the U.S. EDRN study restarted in June and enrolment has been slow but steady. The EDRN have diverted some efforts to drive recruitment and the Company anticipates study completion in the fourth quarter of 2022.
With regards to Volition’s U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
Given the pandemic delays in the larger NHL study (of 1500 subjects) the Company has taken the opportunity to alter the study protocol and are in the process of upgrading the platform to a high-throughput platform which will help facilitate an FDA compliant product. Consequently, Volition now expects this study to initiate recruitment in the first quarter of 2022 with study completion anticipated in 2023.
Upcoming Milestones

Volition expects to achieve the following milestones during the remainder of 2021 and beyond, pandemic permitting:

Drive revenue in the coming quarters in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet, with the aim of signing the first term sheet this year,
Processing samples at Silver One using its Nu.Q Discovery assays, and
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Third Quarter 2021 Financial Results and Business Update

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until November 25, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13725016.

On November 10, 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 inflammatory diseases and oncology, reported financial results for the third quarter and nine months ended September 30, 2021 (Press release, RAPT Therapeutics, NOV 10, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-third-quarter-2021-financial-results [SID1234595100]).

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"This has been an important year for RAPT as we advance the development of RPT193 in atopic dermatitis and FLX475 in cancer," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "In the third quarter, we presented additional incremental data for RPT193 at two separate dermatology meetings, allowing us to share our early positive data in atopic dermatitis with key members of the medical community. We are well positioned to advance RPT193 into Phase 2 clinical trials in atopic dermatitis and asthma in 2022. In addition, we have begun to focus development of FLX475 in key indications showing early promise, including EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer. Our goal is to report data from ongoing cohorts in the Phase 1/2 trial for FLX475 at a medical meeting in 2022."

Financial Results for the Third Quarter Ended September 30, 2021

Third Quarter ended September 30, 2021

Net loss for the third quarter of 2021 was $18.7 million, compared to $14.6 million for the third quarter of 2020.

Research and development expenses for the third quarter of 2021 were $15.7 million, compared to $12.9 million for the same period in 2020. This increase was primarily due to increased clinical trial costs for FLX475 and RPT193 and increases in stock-based compensation, personnel costs and facilities costs.

General and administrative expenses for the third quarter of 2021 were $3.8 million, compared to $3.2 million for the same period of 2020. The increase was primarily due to increases in stock-based compensation expense, insurance expense, personnel costs and facilities costs.

Nine Months Ended September 30, 2021

Net loss for the nine months ended September 30, 2021 was $51.3 million, compared to $40.2 million for the same period in 2020.

Research and development expenses for the nine months ended September 30, 2021 were $42.7 million, compared to $34.6 million for the same period in 2020. The increase was primarily due to increases in costs related to the clinical trials of FLX475 and RPT193, as well as increases in stock-based compensation, personnel expenses, facilities costs and laboratory supplies spend.

General and administrative expenses for the nine months ended September 30, 2021 were $11.5 million, compared to $9.3 million for the same period of 2020. The increase in general and administrative expenses was primarily due to increases in stock-based compensation expense, insurance expense and personnel costs.

As of September 30, 2021, the Company had cash and cash equivalents and marketable securities of $210.8 million.

On November 10, 2021 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate updates (Press release, Imago BioSciences, NOV 10, 2021, View Source [SID1234595099]).

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"Over the third quarter we have built upon the momentum of our recent initial public offering and concurrent private placement that resulted in gross proceeds of $174.6 million to advance our novel LSD1 inhibitor, bomedemstat (IMG-7289), for the treatment of hematologic diseases of the bone marrow. We are also pleased to have been added to the Russell 2000 Index in late September, which has driven greater market awareness of Imago," said Dr. Hugh Y. Rienhoff, Jr., M.D, Chief Executive Officer of Imago BioSciences. "We are thrilled to have completed enrollment in our Phase 2 trial of bomedemstat for the treatment of myelofibrosis and look forward to providing data updates on this Phase 2 trial, along with our Phase 2 trial of bomedemstat for the treatment of essential thrombocythemia this year."

Recent Corporate Developments and Pipeline Updates

Announced Oral Data Presentations at the Upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. In November 2021, Imago announced that two abstracts have been accepted for oral presentation at the ASH (Free ASH Whitepaper), to be held December 11-14, 2021: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Advanced Myelofibrosis"; and "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Essential Thrombocythemia (ET)".
Russell 2000 Index Inclusion: In September 2021, Imago announced its inclusion in the Russell 2000 Index as part of the Index’s quarterly IPO additions.
Granted Orphan Drug Designation for Bomedemstat in Essential Thrombocythemia (ET) from the European Medicines Agency (EMA): In July 2021, Imago announced that its lead asset, bomedemstat, was granted Orphan Drug Designation by the EMA for the treatment of ET. Under Orphan Drug Designation, bomedemstat potentially qualifies for incentives such as 10 years of market exclusivity, reduced fees for regulatory activities, and protocol assistance.
Successful Completion of Initial Public Offering (IPO): In July 2021, Imago completed an initial public offering and concurrent private placement with Pfizer resulting in gross proceeds of $174.6 million.
Third Quarter 2021 Financial Results

Cash and Cash Equivalents: As of September 30, 2021, Imago had cash, cash equivalents, restricted cash and short-term investments of $230.4 million.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2021 were $8.7 million (including stock-based compensation expense of $0.2 million) as compared to $3.6 million for the same period in 2020. The overall increase in R&D expenses was related to the continuation of the Phase 2 clinical studies in ET and MF, as well as startup costs for a Phase 2 extension study to accommodate those patients who wish to continue to receive bomedemstat, continued development of commercial material and material to support the ongoing and new clinical trials, and salaries and non-cash stock-based compensation expense for R&D employees as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2021 were $3.0 million (including stock-based compensation expense of $0.5 million) as compared to $0.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended September 30, 2021 was $11.7 million compared to $4.3 million for the same period in 2020.