GlobeNewswire Inc | May 6, 2021 04:01PM EDT

May 06, 2021

Key clinical data from first in-human studies of engineered exosome therapeutic candidates, exoIL-12 and exoSTING, expected this year

Data from multiple preclinical programs to be presented at ASGCT 2021 showing broad potential applications for engineered exosomes

CAMBRIDGE, Mass., May 06, 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 first quarter 2021 financial results and operational progress.

We are making excellent progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx exosome engineering and manufacturing platform can harness exosomes as delivery vehicles for potent and selective therapeutics, not only in immuno-oncology, but potentially in vaccines, gene therapy and neuro-oncology/neurology as well, said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. We remain on track to deliver safety, biomarker and preliminary efficacy data from our exoIL-12 and exoSTING clinical programs in oncology and file an IND for our third program, exoASO-STAT6, later this year.

First Quarter 2021 and Recent Highlights

-- Reported positive Phase 1 results for exoIL-12 confirming local pharmacology and dose selection for safety and efficacy trial in patients with early-stage cutaneous T cell lymphoma (CTCL) -- Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors -- Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies -- Detailed versatility of Codiaks engExPlatform in manuscript published in Molecular Therapeutics, a Cell partner journal -- Presented pharmacokinetic/pharmacodynamic and tolerability 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, April 10-15 -- Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication

Anticipated Milestones and Events

-- Four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting on May 11, including new preclinical data on exoAAV, exoVACC, exoASO-STAT6, and the ability of engineered exosomes to direct tropism to neuronal cells of interest -- Safety, biomarker and preliminary pharmacodynamics and efficacy data from the exoSTING Phase 1/2 clinical trial in patients with solid tumors continue to be expected mid-2021, within the third quarter -- Investigational New Drug (IND) application filing for exoASO-STAT6 anticipated during the second half of 2021 to enable initiation of clinical trials -- Safety, biomarker and preliminary pharmacodynamics and efficacy data in CTCL patients from the exoIL-12 Phase 1 trial expected by year-end 2021

First Quarter 2021 Financial Results

Total revenues for the quarter ended March 31, 2021 were $13.2 million, compared to $0.1 million for the same period in 2020. This increase was primarily due to the mutual agreement between the Company and Jazz Pharmaceuticals to discontinue their work on exoASO-STAT3, one of five oncogene targets subject to the Collaboration and License Agreement by and between Codiak and Jazz Pharmaceuticals. The Company recognized the remaining $10.9 million in deferred revenue allocated to this target as revenue during the three months ended March 31, 2021.

Net loss for the quarter ended March 31, 2021 was $10.3 million, compared to a net loss of $22.5 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, offset in part by the $10.9 million in deferred revenue described above.

Research and development expenses were $16.6 million for the quarter ended March 31, 2021 compared to $18.4 million for the same period in 2020. The decrease in research and development expenses was driven primarily by lower manufacturing and preclinical costs as our lead assets progressed into the clinic during the second half of 2020.

General and administrative expenses were $6.6 million for the quarter ended March 31, 2021 compared to $4.2 million for the same period in 2020. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

As of March 31, 2021, Codiak had cash, cash equivalents, and marketable securities of approximately $130.3 million.

About Codiak BioSciencesCodiak 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 StatementsThis 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, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of its clinical program, and statements regarding the capabilities and potential of Codiaks engEx Platform and engineered exosomes generally. Any forward-looking statements in this press release are based on managements 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 Codiaks Annual Report on Form10-Kfor the quarter ended December31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiaks 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 (In thousands, except share and per share data)(unaudited)

MARCH31, DECEMBER31, 2021 2020Assets Current assets: Cash and cash equivalents $ 130,272 $ 88,915 Prepaid expenses and other current assets 4,405 4,843 Total current assets 134,677 93,758 Property and equipment, net 30,885 31,410 Restricted cash, net of current portion 4,170 4,170 Operating right-of-use assets 21,767 22,003 Total assets $ 191,499 $ 151,341 Liabilities and Stockholders? Equity Current liabilities: Accounts payable $ 2,162 $ 2,018 Accrued expenses 6,805 8,870 Deferred revenue 4,345 5,281 Operating lease liabilities 2,230 1,482 Total current liabilities 15,542 17,651 Long-term liabilities: Deferred revenue, net of current portion 46,008 57,416 Note payable, net of discount 25,095 24,960 Operating lease liabilities, net of current 35,931 36,540 portionOther long-term liabilities 207 207 Total liabilities 122,783 136,774 Commitments and contingencies Stockholders? equity: Common stock, $0.0001 par value; 150,000,000shares authorized as of March 31, 2021andDecember 31, 2020; 21,996,886 and 18,787,579 2 2 shares issued and outstanding as of March 31,2021 and December 31, 2020, respectivelyAdditional paid-in capital 367,112 302,655 Accumulated deficit (298,398 ) (288,090 )Total stockholders? equity 68,716 14,567 Total liabilities and stockholders? equity $ 191,499 $ 151,341

CODIAK BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share data)(unaudited)

THREE MONTHS ENDED MARCH31, 2021 2020 Revenue: Collaboration revenue $ 13,191 $ 134 Total revenue 13,191 134 Operating expenses: Research and development 16,550 18,391 General and administrative 6,588 4,233 Total operating expenses 23,138 22,624 Loss from operations (9,947 ) (22,490 )Other income (expense): Interest expense (698 ) (295 )Interest income 5 223 Other income 332 60 Total other expense, net (361 ) (12 )Net loss $ (10,308 ) $ (22,502 )Cumulative dividends on redeemable ? (3,419 )convertiblepreferred stockNet loss attributable to common stockholders $ (10,308 ) $ (25,921 )Net loss per share attributable to common $ (0.51 ) $ (8.64 )stockholders,basic and dilutedWeighted average common shares outstanding, 20,333,398 3,001,660 basic anddilutedComprehensive loss: Net loss $ (10,308 ) $ (22,502 )Other comprehensive loss: Unrealized loss on investments, net of tax of ? (41 )$0Total other comprehensive loss ? (41 )Comprehensive loss $ (10,308 ) $ (22,543 )



Investor Contact:Christopher TaylorVP, Investor Relations and Corporate CommunicationsT: 617-949-4220E: investor@codiakbio.com

Media Contact:Lindy DevereuxScient PRT: 646-515-5730E: media@codiakbio.com