- CB-839: First patient enrolled and dosed in combination with checkpoint modulator. In August 2016, we enrolled the first patient in a Phase 1/2 clinical trial assessing the safety and efficacy of CB-839, in combination with Opdivo® for the treatment of renal cell carcinoma (RCC), malignant melanoma and non-small cell lung cancer. The Phase 1/2 study will assess the safety, pharmacokinetics and pharmacodynamics of CB-839 and Opdivo®. The study will enroll patients with clear cell RCC who are naïve to checkpoint inhibitors, as well as clear cell RCC, melanoma, and non-small cell lung cancer patients who are receiving anti-PD-1 monotherapy as their current therapy without having a tumor response.
- CB-839: Data in renal cell carcinoma selected for oral presentation. In September, we announced that clinical data for CB-839 will be presented in a plenary session at the 28th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, November 29 to December 2, 2016 in Munich, Germany. The clinical presentation will be focused on data from Calithera's CB-839 Phase I RCC combination trial with everolimus.
- CB-839: Data in triple negative breast cancer selected for presentation. Clinical data for CB-839 will be presented at the San Antonio Breast Cancer Symposium in San Antonio, December 6 to 10, 2016 in San Antonio, Texas. The clinical presentation will be focused on data from Calithera's CB-839 Phase I triple negative breast cancer combination trial with paclitaxel.
- CB-1158: First patient dosed in a phase 1 study of our first-in-class inhibitor of the immuno-oncology target arginase. In September 2016, we announced dosing of the first patient in a Phase I clinical trial assessing the safety and efficacy of our drug candidate as a treatment for advanced solid tumors. Arginase is an enzyme in myeloid-derived suppressor cells (MDSCs), which prevents T-cell and natural killer (NK) cell activation in tumors.
- Board of Directors. In August 2016, Suzy Jones was appointed to our Board of Directors, and added to the Audit committee. Ms. Jones is currently Founder and Managing Partner of DNA Ink, a boutique life sciences advisory firm.
Based on the results for the first nine months of 2016 and our current expectations for the remainder of the year, we are raising our guidance and expect cash, cash equivalents and investments will be at least $50 million at the end of 2016.Conference Call Information Calithera will host its third quarter financial results and corporate update conference call today, November 9 th at 4:30 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and reference to conference ID 10450552. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay until our conference call to discuss financial results for its fourth quarter of 2016. About Calithera Biosciences Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera's lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells. Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body's cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is currently in a Phase I clinical trial. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera's receipt of clinical data from its clinical trials and Calithera's ability to recruit and enroll patients in its clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's Annual Report on Form 10-K for the year ended December 31, 2015, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
|Calithera Biosciences, Inc.|
|Selected Balance Sheets Financial Data|
|September 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||56,271||$||71,925|
|Total stockholders' equity||53,811||71,788|
|Calithera Biosciences, Inc.|
|Selected Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||6,313||$||6,752||$||21,155||$||17,915|
|General and administrative||2,319||2,198||7,575||6,776|
|Total operating expenses||8,632||8,950||28,730||24,691|
|Loss from operations||(8,632||)||(8,950||)||(28,730||)||(24,691||)|
|Interest income, net||88||50||246||115|
|Net loss per share, basic and diluted||$||(0.44||)||$||(0.49||)||$||(1.50||)||$||(1.36||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||19,507||18,105||18,963||18,005|