On May 13, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2021 and provided recent business highlights (Press release, iTeos Therapeutics, MAY 13, 2021, View Source [SID1234580038]).

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"Our current clinical strategy includes six studies for our two clinical programs in different indications and combinations that are expected to provide meaningful readouts before the end of 2022. In addition to our recent EOS-448 Phase 1 data presentation at AACR (Free AACR Whitepaper), we also continue to advance our adenosine A2A receptor antagonist, inupadenant, and we look forward to reporting updated data with evidence that expression of the A2A receptor in tumor biopsy samples is associated with anti-tumor benefit at the upcoming ASCO (Free ASCO Whitepaper) meeting in June," said Michel Detheux, PhD, president and chief executive officer of iTeos. "In addition to this progress across our two lead programs, we also remain committed to our ongoing discovery efforts to identify and advance new novel product candidates that could expand our pipeline and continue to serve our mission to improve the lives of people with cancer."

Program Highlights

EOS-448: EOS-448 is an IgG1 antibody with the ability to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through a multifaceted mechanism.

The company presented initial clinical and safety data from the monotherapy dose escalation part of the Phase 1 trial in adult patients with advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021. These preliminary data showed the drug was well-tolerated across dose levels, caused depletion of TIGIT-expressing Treg cells in the blood, providing evidence of target and FcyR engagement, and had encouraging signs of anti-cancer activity.

The company plans to advance EOS-448 into combination trials in both checkpoint-naïve and resistant patients in mid-2021. These Phase 1b trials will assess the safety of EOS-448 in combination with pembrolizumab and with iTeos’ novel agent inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) in patients with multiple myeloma.
Inupadenant (EOS-850): Designed as a highly selective small molecule antagonist of the adenosine A2A receptor. Inupadenant is currently in an open-label multi-arm Phase 1/2a clinical trial in adult patients with advanced solid tumors.

iTeos is currently enrolling patients in three distinct cohorts in its Phase 1/2a clinical trial as both as a single agent and in combination. The initial cohort is evaluating inupadenant as a monotherapy in prostate cancer, and the second cohort is evaluating the safety of inupadenant in combination with pembrolizumab in patients with solid tumors with planned expansions in prostate cancer and melanoma. The final cohort is evaluating inupadenant in combination with chemotherapy in patients with triple-negative breast cancer.

iTeos plans to report updated single-agent data, including results from tumor biopsy analyses as part of an e-poster at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held virtually June 4-8, 2021. The abstract will be available on Wednesday, May 19th at 5:00 p.m. ET, and the e-poster will be available for on-demand viewing starting on Friday, June 4 at 9:00 a.m. ET.

Abstract Title: Phase 1 trial of the adenosine A2A receptor antagonist inupadenant (EOS-850): Update on tolerability, and antitumor activity potentially associated with the expression of the A2A receptor within the tumor.
Abstract Number: 2562
Preclinical programs: iTeos continues to progress research programs focused on additional targets that address additional pathways of immunosuppression and complement the mechanism of action of A2AR and TIGIT programs. iTeos expects to nominate an additional product candidate for Investigational New Drug-enabling studies before the end of 2021.

Upcoming Events

Corporate presentation at the Jefferies Healthcare Conference, June 1-4, 2021
Present on inupadenant in an e-poster at the ASCO (Free ASCO Whitepaper) Annual Meeting, June 4-8, 2021
Corporate presentation at the Citi European Healthcare Conference, June 15-16, 2021
First Quarter 2021 Financial Results

Cash Position: The Company had cash and cash equivalents of $321.4 million as of March 31, 2021, compared to $147.7 million as of March 31, 2020. This cash balance provides a runway into 2023.
Research and Development (R&D) Expenses: R&D expenses were $11.6 million for the quarter ended March 31, 2021, compared to $5.8 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for inupadenant and EOS-448 and increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended March 31, 2021, compared to $2.4 million for the same quarter of 2020. The increase was primarily due to increased headcount and professional fees and other costs associated with becoming a publicly traded company.
Net Loss: Net loss attributable to common shareholders was $13.5 million, or a net loss of $0.39 per basic and diluted share, for the quarter ended March 31, 2021, as compared to $6.5 million, or a net loss of $25.53 per basic and diluted share, for the same quarter of 2020.
Conference Call Details:
iTeos Therapeutics will host a conference call and webcast today, Thursday, May 13th, at 4:30 p.m. ET. To access the live event, please dial the numbers and reference the conference ID listed below. A live audio webcast of the event will also be accessible from the Events page of the Company’s website at View Source archived webcast will be available approximately two hours after the completion of the event and for 30 days following the call.

On May 13, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Decibel Therapeutics, MAY 13, 2021, View Source [SID1234585162]).

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"The start of 2021 marked a pivotal time for Decibel as we successfully closed our upsized IPO. With this strong financial foundation, we are in a position to further advance our exciting pipeline of clinical, preclinical and discovery programs with the overarching goal of bringing the privileges of hearing and balance to people in need. In early 2021, we announced encouraging preclinical results on our lead gene therapy program, DB-OTO, for the treatment of people with otoferlin deficiency. We also established a critical cGMP manufacturing and development relationship with Catalent," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Beyond DB-OTO, we remain encouraged by the progress in our gene therapy programs for congenital, monogenic hearing loss and look forward to announcing the program target for our AAV.104 program in 2021."

Company Highlights

Closed Second Tranche of Series D Financing and Upsized Initial Public Offering: In February 2021, Decibel completed its Series D financing, closing the second tranche and receiving net proceeds of $27.4 million. Additionally, Decibel completed its Initial Public Offering (IPO) of 7,662,000 shares of common stock at a public offering price of $18.00 per share. Net proceeds from the offering, after deducting underwriting discounts and offering expenses, were approximately $124.8 million.
Pipeline Progress

Gene Therapies for Congenital, Monogenic Hearing Loss

Continued Development of Lead Gene Therapy Program, DB-OTO, for Otoferlin (OTOF): In February 2021, Decibel established manufacturing capabilities for its lead gene therapy product candidate, DB-OTO. Under the new agreement, Catalent will provide Decibel with cGMP manufacturing and process and analytical development of DB-OTO.
Presented New Preclinical Data on DB-OTO and Surgical Approach at the 44th Annual Association for Research in Otolaryngology Conference (ARO) and the Annual Scientific and Technology Conference of the American Auditory Society: In the first quarter of 2021, Decibel presented new preclinical findings to support the development of DB-OTO. Presentations highlighted data demonstrating that the Company’s proprietary dual vector technology and cell-selective promoter enabled expression of OTOF in hair cells and durably restored hearing in mice and drove highly selective expression of a reporter gene in hair cells of non-human primates across the cochlear length.
On Track for DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) and/or a Clinical Trials Application (CTA) in Europe and initiate a Phase 1/2 clinical trial for DB-OTO in pediatric patients with congenital hearing loss in 2022.
Preclinical Pipeline Expansion Continues: Decibel expects to announce the program target for its AAV.104 discovery program in patients with autosomal recessive hearing disorders in 2021.
Gene Therapies for Hair Cell Regeneration

Preclinical Pipeline Expansion Continues: Decibel continues to advance DB-ATO and AAV.201, its gene therapy programs for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy, and its gene therapy program to regenerate hair cells in the cochlea for the treatment of sensorineural hearing loss. Based on findings from recently completed behavioral studies of DB-ATO, the Company did not see sufficient functional recovery to continue to move DB-ATO to development candidate in 2021. The Company plans to announce the program target for AAV.201 in 2022.
Otoprotection Therapeutic

Updated Timeline to Report Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss: The reporting of interim results from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss is now expected in the first half of 2022 due to continued impact of the COVID-19 pandemic on the pace of patient recruitment in the United States. Due to COVID-19 restrictions, sites in the United States have been delayed in recruiting, but are now open and actively recruiting for the trial, along with the active sites in Australia.
First Quarter 2021 Financial Results:

Cash Position: As of March 31, 2021, cash, cash equivalents and available-for-sale securities were $191.1 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was due to the sale of the Company’s Series D convertible preferred stock and common stock in the Company’s IPO completed in February 2021.
Research and Development Expenses: Research and development expenses were $6.0 million for the first quarter of 2021, compared to $7.4 million for the first quarter of 2020. The decrease in research and development expenses for the first quarter of 2021 was primarily due to $1.8 million decrease in personnel-related costs due to reduced headcount, driven primarily by a reduction-in-force conducted in January 2020 and a $0.8 million decrease in expenses incurred for our DB-020 program driven by decreased activity as a result of delays due to the COVID-19 pandemic, partially offset by an increase of $1.2 million in other indirect research and development expenses.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the first quarter of 2021, compared to $4.2 million for the same period in 2020. The increase in general and administrative expenses for the first quarter of 2021 was primarily attributable to $1.0 million increase in professional fees, driven primarily by expenses related to consulting, accounting advisory and audit services incurred as a result of becoming a public company in February 2021.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.

On May 13, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, reported financial results for the quarter ended March 31, 2021 (Press release, Ikena Oncology, MAY 13, 2021, View Source [SID1234579852]).

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"This first quarter marked important milestones for Ikena, both with our entrance into the public markets and the advances we have made across our pipeline. We continued to progress our clinical development programs and our lead targeted oncology program is on track for an IND submission in the second half of the year," said Mark Manfredi, PhD, President & Chief Executive Officer of Ikena. "We are thrilled that through our IPO, we brought in new long-term partners and deepened our relationships with our current investors. The funding, along with a dedicated and passionate team, are propelling us towards our mission of bringing novel targeted cancer therapies to patients."

Recent Business Highlights and Corporate Update

Financial and Corporate

In March 2021, Ikena completed a successful initial public offering (IPO), raising $143.8 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, and listed on The Nasdaq Global Market. The IPO followed the closing of a Series B crossover financing of $120 million in gross proceeds in December 2020.
In April 2021, Maria Koehler, MD, PhD, current Chief Medical Officer of Repare Therapeutics, Inc. (NASDAQ: RPTX), was appointed to the Ikena Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she contributed to the strategic direction of the oncology portfolio.
Development Pipeline

IK-930: IND-enabling studies are ongoing for Ikena’s lead targeted oncology program, IK-930, a potent, selective and well tolerated oral small molecule TEAD inhibitor in the Hippo signaling pathway. In preclinical studies, IK-930 demonstrated anti-tumor activity in Hippo pathway-driven cancer models and synergy with EGFR inhibition and MEK inhibition.
ERK5 Inhibitor: Lead optimization is ongoing for Ikena’s ERK5 inhibitor program which is being developed for the treatment of KRAS mutant tumors. Ikena’s ERK5 tool molecule inhibitor has shown single agent and synergistic anti-tumor activity with MEK inhibition in preclinical models of KRAS mutant pancreatic cancer and lung adenocarcinoma.
IK-175: The ongoing Phase 1b clinical trial with IK-175, Ikena’s AHR antagonist, continues to enroll patients in the monotherapy dose expansion arm. In addition, the first patient was recently dosed in the dose escalation combination arm which consists of IK-175 with nivolumab in patients with bladder cancer, including patients with AHR-activated tumors.
IK-412: IND-enabling studies are currently ongoing for IK-412, a novel enzymatic therapeutic designed to lower levels of kynurenine, an immunosuppressive metabolite in the tumor microenvironment. IK-412 has demonstrated profound and durable kynurenine depletion in preclinical models.
IK-007: The ongoing Phase 1b clinical trial continues to enroll patients with advanced or progressive microsatellite stable colorectal cancer (MSS-CRC) with IK-007 in combination with pembrolizumab. The clinical trial is enriching for patients that have high urinary prostaglandin E metabolite (PGEM) biomarker.
Milestones and Key Priorities for 2021

Complete IND-enabling studies for TEAD inhibitor, IK-930, and submit IND application to FDA during the second half of 2021.
Nominate ERK5 inhibitor development candidate and initiate IND-enabling studies in the second half of 2021.
Complete IND-enabling studies for kynurenine degrading enzyme, IK-412, and submit IND to FDA during the second half of 2021.
Complete enrollment into the Phase 1b study of EP4 antagonist IK-007 in combination with pembrolizumab in patients with advanced or progressive MSS-CRC.
First Quarter 2021 Financial Results

As of March 31, 2021, the Company had cash and cash equivalents totaling $281.0 million, which will fund operations through 2023. Net cash used in operations was $13.2 million for the first quarter of 2021 compared to $9.9 million for the first quarter of 2020.

Research and development expenses for the first quarter 2021 were $10.0 million, compared to $7.9 million for the first quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, on-going IND-enabling studies and manufacturing development costs for IK-142, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount.

General and administrative expenses for the first quarter were $3.2 million, compared to $2.5 million for the first quarter 2020. The increase in G&A expense were primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our transition to becoming a public company.

Net loss for the first quarter 2021 was $9.7 million, compared to $6.9 million for the first quarter 2020, driven predominantly by increase in research and development expenses.

On May 13, 2021 Eli Lilly and Company (NYSE: LLY) will participate in the UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 (Press release, Eli Lilly, MAY 13, 2021, View Source [SID1234579903]). Anat Ashkenazi, senior vice president and chief financial officer, will participate in a virtual fireside chat at 10:00 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 13, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, reported financial results for the first quarter of 2021 (Press release, Inhibrx, MAY 13, 2021, View Source [SID1234579919]).

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"This past quarter, we continued to make significant progress advancing our clinical programs and are on track to deliver data from all four programs later this year," said the Company’s Chief Executive Officer, Mark Lappe. "April 2021 marked 11 years of Inhibrx dedicated to developing novel, best-in-class therapeutics for the treatment of cancer and rare diseases, and we remain strongly encouraged that we will deliver on our mission."

Financial Results

Cash and Cash Equivalents. As of March 31, 2021, Inhibrx had cash and cash equivalents of $108.0 million, compared to $128.7 million as of December 31, 2020.
R&D Expense. Research and development expenses were $16.4 million during the first quarter of 2021, compared to $17.0 million during the first quarter of 2020. This overall decrease was primarily due to the timing of work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, offset in part by an increase in headcount and personnel-related costs due to the continued expansion of its organization.
G&A Expense. General and administrative expenses were $3.0 million during the first quarter of 2021, compared to $1.5 million during the first quarter of 2020. This increase was primarily due to an increase in personnel-related costs and other expenses associated with operating as a public company.
Net Loss. Net loss was $19.3 million during the first quarter of 2021, or $0.51 per share, compared to $20.1 million during the first quarter of 2020, or $1.11 per share.
About the Inhibrx sdAb Platform

Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.