On March 10, 2022 Shorla Pharma reported that Our new name is better suited to our mission of re-thinking, re-imagining, and improving on existing, proven oncology treatments (Press release, Shorla Pharma, MAR 10, 2022, View Source;utm_medium=rss&utm_campaign=company-name-change-shorla-pharma-is-now-shorla-oncology [SID1234610027]). Shorla Oncology remains committed to the field of oncology and bringing our products to patients in need.

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On March 10, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX) (Press release, Erasca, MAR 10, 2022, View Source [SID1234639380]).

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This agreement will support the ongoing Phase 1b/2 HERKULES-3 trial, a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in various combinations, including with the BRAF inhibitor encorafenib (BRAFTOVI) and cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). Erasca will sponsor the study, and Lilly will supply cetuximab at no cost. The two companies will form a joint committee to review the clinical trial results.

"We are grateful to Lilly for their collaboration as we explore the therapeutic potential of adding ERAS-007, our intermittently-dosed ERK1/2 inhibitor, to the current standard of care regimen for this patient population," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We expect the long-term benefits seen with current standard of care may be limited due to resistance mechanisms, particularly through MAPK reactivation. ERAS-007 inhibits the terminal node of the MAPK pathway and, based on preclinical models, offers more robust inhibition of MAPK reactivation over MEK and other ERK inhibitors. Additionally, ERAS-007’s pharmacokinetic and tolerability profile positions it well for combinations."

There are approximately 180,000 people, representing approximately 10% of all patients with CRC globally, who have BRAF V600E mutations. The combination of encorafenib plus cetuximab significantly improved overall survival in patients with mCRC with a BRAF V600E mutation compared to the control arm. Those clinical results also showed that 20% of patients experience an objective response and half of these responses last more than four months. Therefore, emergence of resistance is a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E CRC.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of our MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

On March 10, 2022 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 fourth quarter and year ended December 31, 2021 (Press release, RAPT Therapeutics, MAR 10, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-fourth-quarter-and-year-end-2021 [SID1234609864]).

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"2021 was a significant year for RAPT, with progress in both of our lead programs," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "We reported positive results for RPT193 from our Phase 1b clinical trial in atopic dermatitis and are excited about RPT193’s potential as a safe, once-daily oral drug for multiple inflammatory diseases. Based on those promising data, we plan to initiate a Phase 2b clinical trial of RPT193 in atopic dermatitis in the first half of 2022, as well as a Phase 2a trial in asthma in the second half of the year. For FLX475, we are continuing development in several indications including EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer. We plan to provide an update on FLX475 in 2022 when we have data that are sufficiently mature from the ongoing cohorts."

Financial Results for the Fourth Quarter and Year Ended December 31, 2021

Fourth Quarter Ended December 31, 2021

Net loss for the fourth quarter of 2021 was $17.9 million, compared to $12.7 million for the fourth quarter of 2020.

Research and development expenses for the fourth quarter of 2021 were $14.3 million, compared to $10.9 million for the same period in 2020. The increase in research and development expenses was primarily due to higher costs for the FLX475 and RPT193 clinical trials, personnel, facilities and laboratory supplies, partially offset by a decrease in stock-based compensation expense.

General and administrative expenses for the fourth quarter of 2021 were $4.5 million, compared to $3.5 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increases in professional fees, personnel costs and insurance expenses, partially offset by a decrease in stock-based compensation expense.

Year Ended December 31, 2021

Net loss for the year ended December 31, 2021 was $69.2 million, compared to $52.9 million for the same period in 2020.

Research and development expenses for the year ended December 31, 2021 were $57.0 million, compared to $45.5 million for the same period in 2020. The increase in research and development expenses was primarily due to higher costs for the FLX475 and RPT193 clinical trials, personnel, facilities, stock-based compensation expense and laboratory supplies.

General and administrative expenses for the year ended December 31, 2021 were $16.0 million, compared to $12.8 million for the same period of 2020. The increase in general and administrative expenses was primarily due to increases in professional fees, insurance expense, personnel costs and stock-based compensation expense.

As of December 31, 2021, the Company had cash, cash equivalents and marketable securities of $189.7 million.

On March 10, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported the company will participate and be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 10, 2022, View Source [SID1234609880]):

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Roth Capital Partners 34th Annual Conference
Date: March 15, 2022
Time: 10:00 am PT / 1:00 pm ET
Format: Fireside chat and available for 1×1 investor meetings

Oppenheimer 32nd Annual Healthcare Conference
Date: March 16, 2022
Time: 3:20 pm ET
Format: Virtual presentation and available for 1×1 investor meetings
Webcast: To register, click on the link HERE
A replay of the Oppenheimer presentation will be available on the Investor page of the company website.

On March 10, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported the Company will release its fourth quarter and full year 2021 financial results before the market opens on Thursday, March 17, 2022 (Press release, Synlogic, MAR 10, 2022, View Source [SID1234609896]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 1719849. Participants may access the live webcast in the "Events Calendar" of the Investors & Media section of the website. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.