UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. | Results of Operations and Financial Condition. |
On November 14, 2022, Calithera Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. A copy of this press release is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press Release, dated November 14, 2022 | |
104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Calithera Biosciences, Inc. | ||||||
Dated: November 14, 2022 | ||||||
By: | /s/ Susan M. Molineaux | |||||
Susan M. Molineaux | ||||||
President and Chief Executive Officer |
Exhibit 99.1
Calithera Biosciences Reports Third Quarter 2022 Financial Results and Business Update
Conference Call and Webcast Scheduled for 5:00 p.m. ET on Monday, November 14, 2022
SOUTH SAN FRANCISCO, Calif., November 14, 2022 (GLOBE NEWSWIRE) Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the third quarter ended September 30, 2022.
Earlier in the fourth quarter, we were very pleased to announce that we received FDA Fast Track designation for sapanisertib. This designation facilitates more frequent communication with the Agency, as well as a number of other benefits that could support our efforts to bring sapanisertib to patients in this area of high unmet need more quickly, said Susan Molineaux, PhD, president and chief executive officer of Calithera. Today we also share that we have experienced site activation delays on both our sapanisertib and mivavotinib trials, leading to slower than anticipated enrollment for both these programs. We expect initial data from these studies will not be available until mid-2023.
Third Quarter 2022 and Other Recent Highlights
| Received FDA Fast Track designation for sapanisertib (dual mTORC 1/2 inhibitor). In October, Calithera announced that sapanisertib has been granted Fast Track designation by the FDA for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors harbor the NRF2 mutation. Fast Track designation, which is designed to facilitate the development and expedite the review of therapeutic candidates with the potential to treat a serious or life-threatening condition where there is a major unmet medical need, provides a number of potential benefits including increased communication with the FDA, the ability to submit a marketing application on a rolling basis and the possibility of priority review. |
| Began enrolling patients in Phase 2 trial evaluating sapanisertib in sqNSCLC. In July 2022, the Company began enrolling patients in its phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated sqNSCLC. The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Calithera presented a trial-in-progress poster detailing the study design at the North American Conference on Lung Cancer in September 2022. |
| Continued patient enrollment activities in Phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June 2022, the Company began enrolling patients in its multicenter Phase 2 clinical trial (NCT05319028) evaluating mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL). The main objectives of the study are to confirm previously observed single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutation status and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate (as assessed by an independent radiology review committee) and safety. Details of the Phase 2 study design were presented in a trial-in-progress poster at the Pan Pacific Lymphoma Conference in July. |
| Continued to advance VPS4 program through lead optimization. Calithera continued to advance multiple vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B inhibitors through lead optimization and plans to share updates on this program by the end of 2022. |
Selected Third Quarter 2022 Financial Results
Cash and cash equivalents totaled $34.1 million at September 30, 2022. Based on its current operating plan, the Company expects it has sufficient cash to fund its operations into the second quarter of 2023. The Company is currently evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway.
Research and development expenses for the third quarter 2022 were $6.5 million, compared to $11.6 million in the same period prior year. The decrease of $5.1 million was primarily due to decreases in the telaglenastat and CB-280 programs and investments in early stage research, partially offset by increases in the sapanisertib and mivavotinib programs.
General and administrative expenses for the third quarter 2022 were $3.0 million, compared to $6.3 million in the same period prior year. The decrease of $3.3 million was primarily due to decreased personnel-related costs and legal expenses.
Net loss was $9.8 million for the three months ended September 30, 2022.
Conference Call Information
Calithera will host an update conference call today, Monday, November 14, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. 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 on Calitheras website for 30 days.
About Calithera
Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer, Calithera is advancing a robust pipeline of investigational, small-molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options.
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 the safety, tolerability and efficacy of Calitheras product candidates, the overall advancement of Calitheras product candidates in preclinical development and clinical trials, including the availability of initial data for the mivavotinib and sapanisertib trials by mid-2023, Calitheras ability to potentially initiate registrational studies in biomarker-specific populations in DLBC and relapsed or refractory squamous NSCLC, the expectation that VPS4 inhibitors will be well-tolerated and have strong single-agent activity in tumors with certain mutations, Calitheras plan to advance multiple VPS4 series through lead optimization and plan to share updates on this program by the end of the year, the unmet need in the treatment of patients with advanced disease, Calitheras expectation that cash and cash equivalents will be sufficient to meet its current operating plan into the second quarter of 2023 and whether Calithera will be able to enter into strategic collaborations or licensing agreements or sell certain programs and sufficiently extend its cash runway. 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 be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calitheras stock price. Additional information concerning these and other risk factors affecting Calitheras business can be found in Calitheras 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 Consolidated Statements of Operations Financial Data
(in thousands)
(unaudited)
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue: |
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License revenue |
$ | | $ | 6,750 | $ | | $ | 9,750 | ||||||||
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Total revenue |
| 6,750 | | 9,750 | ||||||||||||
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Operating expenses: |
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Research and development |
6,447 | 11,556 | 23,771 | 39,715 | ||||||||||||
General and administrative |
3,079 | 6,344 | 10,957 | 16,259 | ||||||||||||
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Total operating expenses |
9,526 | 17,900 | 34,728 | 55,974 | ||||||||||||
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Loss from operations |
(9,526 | ) | (11,150 | ) | (34,728 | ) | (46,224 | ) | ||||||||
Other income (expense): |
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Transaction costs allocable to warrant liabilities |
| | (475 | ) | | |||||||||||
Change in fair value of warrants liabilities |
(453 | ) | | 2,253 | | |||||||||||
Interest and other income (expense), net |
177 | (22 | ) | 236 | 346 | |||||||||||
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Other income (expense), net |
(276 | ) | (22 | ) | 2,014 | 346 | ||||||||||
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Net loss |
$ | (9,802 | ) | $ | (11,172 | ) | $ | (32,714 | ) | $ | (45,878 | ) | ||||
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Calithera Biosciences, Inc.
Selected Consolidated Balance Sheet Financial Data
(in thousands)
(unaudited)
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Balance Sheet Data: |
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Cash and cash equivalents |
$ | 34,068 | $ | 59,537 | ||||
Working capital |
25,465 | 47,446 | ||||||
Total assets |
37,083 | 64,756 | ||||||
Total liabilities |
10,695 | 15,672 | ||||||
Convertible preferred stock |
22,342 | 40,702 | ||||||
Accumulated deficit |
(505,680 | ) | (491,326 | ) | ||||
Total stockholders equity |
26,388 | 8,382 |
CONTACTS:
Stephanie Wong
ir@Calithera.com
650.870.1063
INVESTORS:
Burns McClellan
Lee Roth
212.213.0006
lroth@burnsmc.com
MEDIA:
Sam Brown, Inc.
Hannah Hurdle
805.338.4752
hannahhurdle@sambrown.com
Document and Entity Information |
Nov. 14, 2022 |
---|---|
Cover [Abstract] | |
Amendment Flag | false |
Entity Central Index Key | 0001496671 |
Document Type | 8-K |
Document Period End Date | Nov. 14, 2022 |
Entity Registrant Name | Calithera Biosciences, Inc. |
Entity Incorporation State Country Code | DE |
Entity File Number | 001-36644 |
Entity Tax Identification Number | 27-2366329 |
Entity Address, Address Line One | 343 Oyster Point Blvd. |
Entity Address, Address Line Two | Suite 200 |
Entity Address, City or Town | South San Francisco |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 94080 |
City Area Code | (650) |
Local Phone Number | 870-1000 |
Written Communications | false |
Soliciting Material | false |
Pre Commencement Tender Offer | false |
Pre Commencement Issuer Tender Offer | false |
Security 12b Title | Common Stock, 0.0001 par value |
Trading Symbol | CALA |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
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