– Initial safety and PK/PD data from Phase 1/2 study of exoSTING™ now expected in the fourth quarter of 2021 –
– Initial safety and efficacy data from Phase 1 trial of exoIL-12™ in CTCL anticipated by year-end –
– IND filing for third clinical program, exoASO™-STAT6, planned for 2H 2021 –
CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today reported second quarter 2021 financial results and operational progress.
“We continue to be intensely focused on execution of our two lead clinical programs, with plans to deliver near-term data readouts from both the exoSTING and exoIL-12 trials. We anticipate sharing safety data and a differentiating pharmacologic profile from initial dose escalation cohorts in the Phase 1/2 trial of exoSTING in the fourth quarter of 2021, and we expect to report initial safety, PK/PD and efficacy data from CTCL patients in the exoIL-12 Phase 1 trial by year end,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “We are also prosecuting multiple preclinical programs that together demonstrate the versatility of our platform and we look forward to filing an IND this year for our third engineered exosome therapeutic candidate, exoASO-STAT6 for the treatment of myeloid-rich cancers.”
Second Quarter 2021 and Recent Highlights
- Presented new preclinical data on exoAAV™, exoVACC™, exoASO-STAT6, and the ability of engineered exosomes to direct tropism at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting
- Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication
- Presented tolerability, pharmacokinetic (PK)/pharmacodynamic (PD) data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) Annual Meeting
- Appointed Jennifer Wheler, M.D., as Chief Medical Officer
- Added Anne-Virginie Eggimann, M.Sc., to Board of Directors
Anticipated Milestones and Events
- Initial safety, PK, and PD data from dose escalation cohorts 1-3 on the Phase 1/2 trial of exoSTING (CDK-002) in patients with advanced/metastatic solid tumors with injectable lesions expected in the fourth quarter of 2021
- IND filing for exoASO-STAT6 (CDK-004) anticipated during the second half of 2021
- Initial safety, PK/PD and efficacy data in CTCL patients from the Phase 1 trial of exoIL-12 (CDK-003) expected by year-end 2021
Second Quarter 2021 Financial Results
Total revenues for the quarter ended June 30, 2021, were $0.9 million, compared to $0.2 million for the same period in 2020. This increase was due to deferred revenue recognized from ongoing research and development collaborations.
Net loss for the quarter ended June 30, 2021, was $21.8 million, compared to a net loss of $15.9 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx™ Platform.
Research and development expenses were $15.4 million for the quarter ended June 30, 2021, compared to $11.6 million for the same period in 2020. The increase in research and development expenses was driven by an increase in engEx Platform expenses, partially offset by decreased manufacturing and preclinical costs as Codiak’s lead candidates progressed into the clinic during the second half of 2020.
General and administrative expenses were $6.9 million for the quarter ended June 30, 2021, compared to $4.4 million for the same period in 2020. The increase was driven primarily by an increase in general and administrative headcount to support our overall growth and our transition to becoming a public company.
As of June 30, 2021, Codiak had cash and cash equivalents of approximately $113.7 million.
About Codiak BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING and exoIL-12, including timing of release of data from clinical trials and the results of those trials, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of clinical trials, and statements regarding the capabilities and potential of Codiak’s engEx Platform and engineered exosomes generally. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Codiak’s Annual Report on Form 10-K for the quarter ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak’s subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.
CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, In thousands, except share and per share data)
| JUNE 30, 2021 | DECEMBER 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 113,681 | $ | 88,915 | ||||
| Prepaid expenses and other current assets | 5,641 | 4,843 | ||||||
| Total current assets | 119,322 | 93,758 | ||||||
| Property and equipment, net | 30,263 | 31,410 | ||||||
| Restricted cash, net of current portion | 4,170 | 4,170 | ||||||
| Operating right-of-use assets | 21,519 | 22,003 | ||||||
| Total assets | $ | 175,274 | $ | 151,341 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,782 | $ | 2,018 | ||||
| Accrued expenses | 7,689 | 8,870 | ||||||
| Deferred revenue | 9,117 | 5,281 | ||||||
| Operating lease liabilities | 2,333 | 1,482 | ||||||
| Total current liabilities | 20,921 | 17,651 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 41,746 | 57,416 | ||||||
| Note payable, net of discount | 25,230 | 24,960 | ||||||
| Operating lease liabilities, net of current portion | 35,306 | 36,540 | ||||||
| Other long-term liabilities | 207 | 207 | ||||||
| Total liabilities | 123,410 | 136,774 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.0001 par value; 150,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 22,272,975 and 18,787,579 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 372,069 | 302,655 | ||||||
| Accumulated deficit | (320,207 | ) | (288,090 | ) | ||||
| Total stockholders’ equity | 51,864 | 14,567 | ||||||
| Total liabilities and stockholders’ equity | $ | 175,274 | $ | 151,341 | ||||
CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited, in thousands, except share and per share data)
| THREE MONTHS ENDED JUNE 30, | SIX MONTHS ENDED JUNE 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue | $ | 890 | $ | 187 | $ | 14,081 | $ | 321 | ||||||||
| Total revenue | 890 | 187 | 14,081 | 321 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 15,419 | 11,622 | 31,969 | 30,013 | ||||||||||||
| General and administrative | 6,937 | 4,358 | 13,525 | 8,591 | ||||||||||||
| Total operating expenses | 22,356 | 15,980 | 45,494 | 38,604 | ||||||||||||
| Loss from operations | (21,466 | ) | (15,793 | ) | (31,413 | ) | (38,283 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (704 | ) | (294 | ) | (1,401 | ) | (589 | ) | ||||||||
| Interest income | 9 | 19 | 14 | 242 | ||||||||||||
| Other income | 352 | 155 | 683 | 215 | ||||||||||||
| Total other expense, net | (343 | ) | (120 | ) | (704 | ) | (132 | ) | ||||||||
| Net loss | $ | (21,809 | ) | $ | (15,913 | ) | $ | (32,117 | ) | $ | (38,415 | ) | ||||
| Cumulative dividends on redeemable convertible preferred stock | — | (3,420 | ) | — | (6,839 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (21,809 | ) | $ | (19,333 | ) | $ | (32,117 | ) | $ | (45,254 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.99 | ) | $ | (6.44 | ) | $ | (1.51 | ) | $ | (15.07 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 22,117,593 | 3,003,887 | 21,230,424 | 3,002,773 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (21,809 | ) | $ | (15,913 | ) | $ | (32,117 | ) | $ | (38,415 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on investments, net of tax of $0 | — | (2 | ) | — | (43 | ) | ||||||||||
| Total other comprehensive loss | — | (2 | ) | — | (43 | ) | ||||||||||
| Comprehensive loss | $ | (21,809 | ) | $ | (15,915 | ) | $ | (32,117 | ) | $ | (38,458 | ) | ||||