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Equillium Reports Second Quarter 2021 Financial Results and Provides Clinical Development Update

On August 10, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2021, and provided an update on its clinical programs (Press release, Equillium, AUG 10, 2021, View Source [SID1234586229]).

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"The second quarter of the year was highlighted by positive data from our Phase 1b EQUATE study in acute graft-versus-host disease," said Bruce Steel, chief executive officer at Equillium. "These data were critical for achieving a positive outcome from our End-of-Phase 1 meeting with the FDA and accelerating our plans to immediately advance to a single, pivotal Phase 3 clinical study. This strategy, if successful, may position itolizumab to become the first approved therapy to treat patients with acute graft-versus-host disease in the first-line setting."

Corporate & Clinical Highlights Since Beginning of Q2 2021:

Announced positive topline results from the EQUATE study in first-line treatment of acute graft-versus-host disease presented at the 2021 Virtual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and plans to initiate a Phase 3 pivotal study following an End-of-Phase 1 meeting with the FDA
Itolizumab continues to demonstrate favorable safety and efficacy profile
Rapid and durable complete responses resulted in clinically meaningful reduction in corticosteroid use
Data support clinical advancement of itolizumab in first-line treatment of aGVHD
Presented multiple posters at the 104th annual meeting of the American Association of Immunologists; research highlighted:
Itolizumab’s novel mechanism of action and its effect on modulating T cell responses through inhibition of the CD6-ALCAM pathway
Development of a pharmacodynamic biomarker assay to monitor target engagement and fate of CD6 on T cells in patients treated with itolizumab
Upcoming Catalysts:

EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis) expected 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma expected 2H 2021
Initiate pivotal study in first-line aGVHD expected Q4 2021
Second Quarter 2021 Financial Results

Research and development (R&D) expenses for the second quarter of 2021 were $6.0 million, compared with $3.9 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount, an increase in clinical development expenses primarily related to the EQUATE and EQUALISE studies, as well as greater consulting, overhead, and non-clinical research expenses.

General and administrative (G&A) expenses for the second quarter of 2021 were $2.9 million, compared with $2.7 million for the same period in 2020. The increase was driven by greater employee compensation and benefits primarily related to increased headcount, partially offset by a decrease in non-cash stock-based compensation mainly due to retention option grants issued to certain officers and directors in the second quarter of 2020.

Net loss for the second quarter of 2021 was $9.2 million, or $(0.31) per basic and diluted share, compared with a net loss of $6.5 million, or $(0.37) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to greater operating expenses.

Cash used in operations for the second quarter of 2021 was $7.0 million compared to $7.9 million in the first quarter of 2021.

Cash, cash equivalents and short-term investments totaled $97.6 million as of June 30, 2021, compared to $104.1 million as of March 31, 2021. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into 2023.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

CohBar Reports Second Quarter 2021
Financial Results and Provides Business Update

On August 10, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the second quarter ended June 30, 2021 (Press release, CohBar, AUG 10, 2021, View Source [SID1234586228]).

"Our positive CB4211 topline data announcement today marks an important milestone in our path towards demonstrating the full potential of our novel therapeutic platform sourced from the mitochondrial genome," stated Dr. Joseph Sarret, Chief Executive Officer. "In parallel with our ongoing analysis of the promising data from the CB4211 study, we are diligently working to enable CB5138-3 to enter the clinic next year for the treatment of idiopathic pulmonary fibrosis. This is an exciting time for the company as we look forward to continued progress in the development of product candidates designed to address serious unmet medical needs."

Second Quarter 2021 and Recent Highlights

Announced Positive Topline Data from the Phase 1a/1b Study of CB4211 Being Developed for the Treatment of Nonalcoholic Steatohepatitis (NASH) and Obesity: Today, the company announced topline results from the multi-center, randomized, double-blind, placebo-controlled Phase 1a/1b clinical study of CB4211, under development for NASH and obesity. The study met its primary endpoints as CB4211 was well-tolerated and appeared safe with no serious adverse events. The evaluation of the exploratory endpoints showed robust and statistically significant improvements in key biomarkers of liver damage, ALT and AST, and in glucose levels in the CB4211 group compared to placebo. There was a trend towards lower body weight in the CB4211 group after four weeks of treatment.
Appointed Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director: In April, the company announced the appointment of Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director. Dr. Sarret is a seasoned executive with a track record of success in biotechnology.
Second Quarter 2021 Financial Highlights

Cash and Investments: CohBar had cash and investments of $13.8 million as of June 30, 2021, compared to $21 million as of December 31, 2020. The cash burn for the quarter ended June 30, 2021, was approximately $4.6 million.
R&D Expenses: Research and development expenses were $2.6 million for the three months ended June 30, 2021, compared to $1.5 million in the prior year quarter. The increase in research and development expenses was primarily due to the investment in the company’s research programs focused on the continued development of its peptides, and an increase in clinical trial costs due to the timing of those expenses, partially offset by a decrease in stock based compensations costs.
G&A Expenses: General and administrative expenses were $2.6 million for the three months ended June 30, 2021, compared to $1.4 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher compensation and stock-based compensation costs and increased D&O insurance premiums.
Net Loss: For the three months ended June 30, 2021, net loss, which included $1.0 million of non-cash expenses, was $5.2 million, or $0.08 per basic and diluted share. For the three months ended June 30, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.1 million, or $0.09 per basic and diluted share.
Second Quarter Investor Call:

Please visit View Source and enter password CWBR, or
Go to www.cohbar.com and click on CohBar Q2 2021 Investor Presentation at the top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Zoom approximately 10 minutes prior to its start. Please note, no audio will be available through Zoom.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 10, 2021, through 11:59 p.m. Eastern Time on August 31, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 10159293. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

Marker Therapeutics Reports Second Quarter 2021 Operating and Financial Results

On August 10, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the second quarter ended June 30, 2021 (Press release, TapImmune, AUG 10, 2021, View Source [SID1234586227]).

"Marker accomplished a number of strategic goals and clinical milestones this quarter, including completing the safety lead-in portion of our Company-sponsored Phase 2 trial investigating Marker’s MultiTAA-specific T cell therapy in post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are now enrolling patients as well as activating additional clinical sites in the main portion of the trial. In parallel, we opened a new in-house cGMP manufacturing facility in Houston and recently announced that the facility is fully operational. We look forward to manufacturing study drug at the new facility next quarter, which we expect will yield quality product, reduce manufacturing costs and expand patient access to Marker’s MultiTAA-specific T cell therapies."

PROGRAM UPDATES

In June 2021, Marker completed the six-patient safety lead-in portion of the Company’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML.
The Company continues to enroll patients in the main portion of the trial and activate clinical sites across the U.S. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.
BUSINESS UPDATES

Marker recently announced that the Company’s new cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport, is fully operational. The facility will manufacture Marker’s MultiTAA-specific T cell products for the Company’s Phase 2 AML trial as well as future hematological and solid tumor trials, in addition to producing the potential commercial supply of any approved products.
ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

Complete enrollment of 20 patients in main portion of Phase 2 trial in Q4 2021
Topline readout of Group 2 (active disease) in Q1 2022
Manufacturing Milestones

Manufacture MT-401 at Marker’s new cGMP facility for Phase 2 AML trial in Q3 2021
SECOND QUARTER 2021 FINANCIAL RESULTS

Cash Position and Guidance: At June 30, 2021, Marker had cash and cash equivalents of $57.2 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $7.4 million for the quarter ended June 30, 2021 compared to $4.3 million for the quarter ended June 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.6 million for the quarter ended June 30, 2021 compared to $2.5 million for the quarter ended June 30, 2020.
Net Loss: Marker reported a net loss of $10.9 million for the quarter ended June 30, 2021, compared to a net loss of $6.3 million for the quarter ended June 30, 2020.

Janux Therapeutics Reports Second Quarter 2021 Financial Results

On August 10, 2021 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing novel T cell engager immunotherapies based on its TRACTr platform technology, reported financial results for the quarter ended June 30, 2021 (Press release, Janux Therapeutics, AUG 10, 2021, View Source [SID1234586226]).

"With the successful completions of a Series B financing and IPO this past quarter, we are well-capitalized to advance our novel TRACTr platform technology and next-generation T cell engager immunotherapies, with the potential to improve the treatment of cancer," said David Campbell, Ph.D., President and CEO of Janux. "Janux has also significantly strengthened the organization with key hires to our senior management team. These team members bring invaluable expertise and decades of drug development experience, specifically in T cell therapeutics, to propel our broad preclinical pipeline toward the clinic."

Recent Business Highlights:

TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers for PSMA, EGFR, TROP2, and its costimulatory bispecific TRACIr program remain on track as they move through preclinical development. Janux continues to expect to submit at least two Investigational New Drug (IND) applications by the end of 2022.
Strengthened management team with appointment of Shahram Salek-Ardakani, Ph.D., as Chief Scientific Officer, and Wayne Godfrey, M.D., as Chief Medical Officer. Dr. Salek-Ardakani brings more than 20 years of experience as a scientific leader and drug developer in multiple disease areas, most recently serving as the Senior Director of Cancer Immunology at Pfizer, Inc., where he was responsible for formulating first-in-class discovery programs and platform initiatives to implement Pfizer’s T cell targeted therapeutics strategy. Dr. Godfrey brings more than 25 years of drug development, clinical strategy, and research experience in cancer immunology and immunotherapy at leading pharmaceutical and biotechnology companies, most recently serving as the Vice President of Clinical Development at IGM Biosciences, Inc., where he led the global clinical development of IGM’s emerging pipeline of proprietary bispecific T cell engaging IgM antibodies.
Completed Series B financing and initial public offering (IPO). In April 2021, Janux completed a Series B financing, raising gross proceeds of $125.0 million. In June 2021, Janux completed an initial public offering, selling 13,110,000 shares of its common stock at a price to the public of $17.00 per share, for aggregate gross proceeds of $222.9 million (before deducting underwriting discounts and commissions and offering costs).
Second Quarter 2021 Financial Highlights:

Cash and cash equivalents and short-term investments: As of June 30, 2021, Janux reported cash and cash equivalents and short-term investments of $394.2 million, compared to $7.8 million at December 31, 2020.
Research and development expenses: Research and development expenses for the quarter ended June 30, 2021 were $4.7 million, compared to $0.7 million for the comparable period in 2020. The increase in research and development expenses in 2021 was primarily attributable to the development of the TRACTr platform technology and programs. Janux also incurred additional personnel-related expenses, including stock-based compensation, as operations grew in support of program advances.
General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2021 were $2.0 million, compared to $0.4 million for the same period in 2020. The increase in general and administrative expenses was primarily attributable to an increase in personnel-related expenses including stock-based compensation, due to increased headcount in 2021. The increase in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses, as Janux now operates as a public company.
Net loss: For the quarter ended June 30, 2021, Janux reported a net loss of $6.2 million, compared to a net loss of $2.5 million for the comparable period in 2020.

Crinetics Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 10, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Crinetics Pharmaceuticals, AUG 10, 2021, View Source [SID1234586225]).

"We’ve seen advancements across our pipeline over the past months, with the commencement of dosing in the Phase 3 PATHFNDR-1 trial of paltusotine in acromegaly and the announcement of data from CRN04894’s Phase 1 program," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "This program continues to follow the blueprint of paltusotine’s success, as early clinical data have provided proof-of-concept by demonstrating the dose-dependent and clinically-significant pharmacodynamic effects of CRN04894 on a well validated hormonal biomarker. We are also mirroring this approach with our somatostatin receptor type 5 agonist, CRN04777, and remain on track to report data from the single-ascending dose cohorts of the ongoing Phase 1 trial in September."

Dr. Struthers continued, "Looking forward, our strong financial foundation and talented team of in-house endocrinology experts leaves us well positioned to execute on our corporate and clinical objectives. Through the continued advancement of our pipeline, we aim to solidify our position as a leader in the design and development of novel small molecule drugs for endocrine diseases."

SECOND QUARTER AND SUBSEQUENT HIGHLIGHTS
Reported positive data from single-ascending dose (SAD) cohorts of first-in-human study of CRN04894. In August 2021, Crinetics announced positive data from the SAD cohorts of an ongoing Phase 1 study of its ACTH antagonist, CRN04894. Preliminary data provided evidence of clinically relevant cortisol suppression. CRN04894 demonstrated dose-dependent reductions in basal cortisol levels as well as suppression of cortisol following ACTH challenge. In addition, the data suggests that CRN04894 was orally bioavailable and demonstrated dose-proportional pharmacokinetics. CRN04894 was well-tolerated, and all adverse events were considered mild. The data is supportive of proceeding to the multiple-ascending dose cohorts of the Phase 1 study and additional data is expected in the fourth quarter of 2021.
Commenced dosing in Phase 3 PATHFNDR-1 study. In June 2021, Crinetics announced that the first patient had been dosed in PATHFNDR-1, one of two planned Phase 3 trials assessing the safety and efficacy of once-daily oral paltusotine that together will evaluate paltusotine in a wide cross section of acromegaly patients. Topline data from PATHFNDR-1 is expected to be available in 2023.
Strengthened balance sheet with successful common stock offerings. In April 2021, Crinetics completed an underwritten follow-on offering and raised gross proceeds of approximately $75.0 million and in August 2021, Crinetics entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 851,306 shares at $17.62 per share, raising gross proceeds of $15.0 million.
Appointed Garlan Adams as General Counsel. In June 2021, Crinetics strengthened its leadership team with the appointment of Ms. Adams to the newly created role of General Counsel. Ms. Adams brings more than two decades of experience managing legal and compliance matters associated with the development and commercialization of innovative pharmaceutical and biotechnology products.

SECOND QUARTER 2021 FINANCIAL RESULTS
Research and development expenses were $20.5 million for the three months ended June 30, 2021, compared to $12.6 million for the same period in 2020. The increase was primarily due to an increase in personnel costs of $3.0 million, of which stock-based compensation was $1.1 million, and increased spending on manufacturing and development activities of $4.1 million associated with our clinical and nonclinical activities for paltusotine and our other clinical and preclinical programs.
General and administrative expenses were $5.6 million for the three months ended June 30, 2021, compared to $4.3 million for the same period in 2020. The increase was primarily due to additional personnel costs of $0.8 million, of which stock-based compensation was $0.6 million.
Net loss for the three months ended June 30, 2021 was $26.1 million, compared to a net loss of $16.5 million for the three months ended June 30, 2020.
Unrestricted cash, cash equivalents and investments totaled $203.8 million as of June 30, 2021, compared to $170.9 million as of December 31, 2020. The increase was attributable to the $72.6 million net proceeds from the common stock offering completed in April.
As of July 31, 2021, the company had 38,563,660 common shares outstanding.