Calithera Biosciences, Inc. is a biopharmaceutical company that has been working to develop innovative precision oncology therapies. Founded in 2010, the company has faced its fair share of ups and downs, but has shown remarkable resilience in the face of adversity.

The company's early years were marked by a focus on developing its lead candidate, telaglenastat (CB-839), a glutaminase inhibitor for the treatment of non-small cell lung cancer. In 2021, however, the company announced the discontinuation of the phase 2 KEAPSAKE clinical trial for telaglenastat due to a lack of clinical benefit. This setback was a significant blow, but Calithera remained undeterred.

Company Background

Calithera Biosciences, Inc. was incorporated in the State of Delaware on March 9, 2010, as a fully-integrated, clinical stage precision oncology biopharmaceutical company. The company was co-founded by Dr. Susan Molineaux, who has served as the President and Chief Executive Officer since its inception. Dr. Molineaux brought valuable experience from her previous role as co-founder and CEO of Proteolix, Inc., another biopharmaceutical company.

Product Pipeline

Throughout its history, Calithera has built an impressive pipeline of product candidates. These include the dual TORC1/2 inhibitor sapanisertib (CB-228), the spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659), the CD73 inhibitor CB-708 (now ATG-37), and the arginase inhibitor CB-280 for the treatment of cystic fibrosis. Additionally, the company advanced an arginase inhibitor INCB001158, which was discovered by Calithera and subsequently developed by Incyte Corporation for oncology and hematology indications.

Sapanisertib (CB-228) was being evaluated in phase 2 trials for the treatment of NRF2-mutated squamous non-small cell lung cancer and in relapsed or refractory non-GCB DLBCL with enrichment of MYD88/CD79b mutated tumors. Mivavotinib (CB-659) was also in phase 2 development for the treatment of relapsed or refractory non-GCB DLBCL with enrichment of MYD88/CD79b mutated tumors.

The company also had a preclinical pipeline of synthetic lethality targets, with a focus on paralog genes.

Strategic Moves and Challenges

In the midst of these challenges, Calithera made a strategic move in 2021 to acquire the rights to two clinical-stage compounds, sapanisertib (CB-228) and mivavotinib (CB-659), from Takeda Pharmaceutical Company Limited. These assets were intended to diversify Calithera's pipeline and provide new avenues for growth. The acquisition came at a significant cost of $50.9 million, including an upfront payment of $10 million in cash and the issuance of 1 million shares of Calithera's Series A convertible preferred stock. The company recorded this acquisition as a charge to research and development expenses, as the assets acquired had no alternative future use at the time.

Unfortunately, the company's fortunes continued to wane, and on January 9, 2023, Calithera announced that its Board of Directors had unanimously approved a plan of dissolution, subject to stockholder approval. This decision came after the company's extensive consideration of potential strategic alternatives, but ultimately, the Board determined that winding down the company was the best course of action.

In connection with the Plan of Dissolution, Calithera began discontinuing all of its clinical programs and commenced reducing its workforce, which includes the planned termination of most employees by the end of the first quarter of 2023. The company is currently seeking to sell all of its clinical assets and programs.

Despite these challenges, Calithera's story is one of resilience and adaptability. The company has consistently sought to navigate the complex and ever-changing biopharmaceutical landscape, making strategic decisions to maximize value for its shareholders. Although the plan of dissolution represents a difficult outcome, it is a testament to Calithera's commitment to being responsible stewards of the resources entrusted to them.

Financials

From a financial perspective, Calithera has faced its fair share of struggles. As of December 31, 2022, the company had cash and cash equivalents of $25.5 million, down from $59.5 million at the end of 2021. This decline in cash is a direct result of the company's ongoing operations and the discontinuation of its clinical programs.

In terms of profitability, Calithera has consistently operated at a loss, with net losses of $39.7 million in 2022, $115.1 million in 2021, and $90.1 million in 2020. The company's operating expenses have been dominated by research and development, which accounted for $28.5 million, $53.5 million, and $71.0 million in 2022, 2021, and 2020, respectively.

For the year ended December 31, 2022, Calithera reported total revenue of $9.75 million, which was entirely comprised of license revenue. This revenue was primarily related to milestone payments received under the company's collaboration and license agreements.

Research and development expenses decreased significantly from $104.33 million in 2021 to $28.53 million in 2022, driven by a reduction in spending on the company's clinical programs, particularly the telaglenastat and CB-280 programs. General and administrative expenses also decreased from $20.85 million in 2021 to $13.54 million in 2022.

For the most recent quarter (Q4 2022), Calithera reported no revenue and a net loss of $6.94 million. The company did not report revenue for the most recent fiscal year or quarter, as it has discontinued all clinical programs and is in the process of winding down operations.

Liquidity

Calithera's cash flow situation has also been challenging, with the company reporting negative operating cash flows of $43.6 million, $66.3 million, and $84.3 million in 2022, 2021, and 2020, respectively. This persistent negative cash flow has been a significant burden on the company's liquidity.

Despite these financial woes, Calithera has continued to explore various strategic alternatives to create value for its shareholders. In 2022, the company raised $8.5 million in net proceeds from a public offering, and an additional $1.1 million from its at-the-market offering program. These funds have helped to extend the company's runway, but have not been sufficient to reverse its fortunes.

As of December 31, 2022, Calithera's financial position was as follows:

• Debt/Equity Ratio: 0.08
• Cash and Cash Equivalents: $25.45 million
• Current Ratio: 3.60
• Quick Ratio: 3.60

The company does not appear to have any credit facilities or lines of credit. Given its current financial position and the decision to pursue dissolution, Calithera has stated that its cash and cash equivalents will be insufficient to fund its operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern.

Conclusion

The announcement of the plan of dissolution, while a difficult decision, is a testament to Calithera's commitment to being transparent with its stakeholders and making responsible choices for the long-term viability of the company. The company is currently seeking to sell its remaining clinical assets and programs, and plans to distribute any remaining assets to its shareholders after satisfying its obligations.

In conclusion, Calithera Biosciences, Inc. has faced a challenging journey, navigating the ups and downs of the biopharmaceutical industry with resilience and adaptability. While the plan of dissolution represents a difficult outcome, the company's commitment to transparency and responsible decision-making is commendable. As Calithera winds down its operations, investors will be watching closely to see how the company's assets are monetized and how any remaining value is distributed to shareholders.