GlobeNewswire Inc | Nov 19, 2020 04:05PM EST

November 19, 2020

Human clinical testing now underway with Codiaks first two candidates, exoIL-12 and exoSTING

Initial safety results and preliminary systemic exposure/pharmacokinetics of exoIL-12 in healthy volunteers anticipated YE 2020 -

Biomarker, safety and clinical outcome results in cancer patients anticipated mid-2021 for both exoSTING and exoIL-12

CAMBRIDGE, Mass., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics, today reported third quarter 2020 financial results and operational progress.

Codiak was founded to realize the potential of engineered exosomes as a new and important class of biologic medicines for the treatment of a broad range of diseases, said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. The creativity, expertise, and execution of our team has enabled us to bring the fields first two engineered exosome candidates into the clinic and we are on track to initiate a third clinical program next year. The recent successful completion of our initial public offering provides additional funding to progress our development programs, invest in our platform and sustain the positive momentum we have built.

Third Quarter 2020 and Recent Highlights

-- Closed initial public offering (IPO) in October 2020, raising $74.4 million in net proceeds -- Initiated healthy volunteer dosing of exoIL-12 in a Phase 1 clinical trial designed to transition into patients with cutaneous T cell lymphoma (CTCL) -- Initiated subject dosing in a 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 -- Presented preclinical data on exoIL-12 and the engEx Platform at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) -- Expanded executive team with addition of Yalonda Howze as Executive Vice President, Chief Legal Officer -- Welcomed Jason Haddock to the Board of Directors and as Audit Committee Chairman

Anticipated Milestones and Events

-- Initial safety, tolerability and systemic exposure/pharmacokinetics data from the healthy volunteer portion of the exoIL-12 Phase 1 clinical trial are expected by year-end, with biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients expected by mid-2021 -- Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected by mid-2021 -- Evercore ISI HEALTHCONx Virtual Conference, December 2, 2020

Third Quarter 2020 Financial ResultsTotal revenues for the quarter ended September 30, 2020 were $1.0 million, compared to $0.2 million for the same period in 2019. This increase was primarily due to an increase in collaboration revenue driven primarily by activities in connection with the collaboration with Sarepta.

Net loss for the quarter ended September 30, 2020 was $35.3 million, compared to a net loss of $20.7 million for the same period in 2019. Net loss for the quarter ended September 30, 2020 was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform. The current quarter net loss was inclusive of a $15.0 million milestone payment to Kayla Therapeutics in connection with dosing of the first patient in the Phase 1/2 clinical trial of exoSTING.

Research and development expenses were $30.7 million for the quarter ended September 30, 2020 compared to $16.5 million for the same period in 2019. The increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exo-IL12 and exoSTING clinical trials in September 2020.

General and administrative expenses were $5.3 million for the quarter ended September 30, 2020 compared to $4.8 million for the same period in 2019. The increase was primarily driven by an increase in consulting and legal fees, personnel costs, and other administrative expenses in anticipation of operating as a public company.

As of September 30, 2020, Codiak had cash, cash equivalents, and marketable securities of $48.3 million. In October 2020, the completion of the IPO resulted in net proceeds of $74.4 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 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 Quarterly Report on Form10-Qfor the quarter ended September30, 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.

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

Investor ContactChristine LabareeEvergreen CommunicationsT: 650-600-1697E: investor@codiakbio.com

CODIAK BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data)(Unaudited)

SEPTEMBER30, DECEMBER31, 2020 2019Assets Current assets: Cash and cash equivalents $ 48,339 $ 10,316 Investments ? 73,065 Restricted cash ? 367 Prepaid expenses and other current assets 4,022 10,370 Total current assets 52,361 94,118 Property and equipment, net 31,544 17,626 Restricted cash, net of current portion 4,170 4,170 Operating lease right-of-use assets 22,226 ? Other non-current assets 50 48 Total assets $ 110,351 $ 115,962 Liabilities, Redeemable Convertible Preferred Stock and Stockholders? DeficitCurrent liabilities: Accounts payable $ 2,488 $ 2,381 Accrued expenses 23,858 15,818 Deferred revenue 6,268 742 Deferred rent ? 814 Operating lease liabilities 1,778 ? Total current liabilities 34,392 19,755 Long-term liabilities: Deferred revenue, net of current portion 58,069 54,870 Note payable, net of discount 24,825 9,572 Deferred rent, net of current portion ? 9,814 Operating lease liabilities, net of current 37,102 ? portionTotal liabilities 154,388 94,011 Commitments and contingencies (Note 10) Series A redeemable convertible preferredstock, $0.0001 par value; 33,200,000 sharesauthorized as of September 30, 2020 andDecember 31, 2019; 33,200,000 shares issuedand 46,162 44,169 outstanding as of September 30, 2020 andDecember 31, 2019; liquidation value as ofSeptember30, 2020 and December 31, 2019 of $46,162and $44,169, respectivelySeries B redeemable convertible preferredstock, $0.0001 par value; 21,400,000 sharesauthorized as of September 30, 2020 andDecember 31, 2019; 20,583,328 and 20,520,828sharesissued and outstanding as of September 30, 84,769 81,108 2020 and December 31, 2019, respectively;liquidationvalue as of September 30, 2020 and December31, 2019 of $84,769 and $80,874,respectivelySeries C redeemable convertible preferredstock, $0.0001 par value; 20,204,100 sharesauthorized as of September 30, 2020 andDecember 31, 2019; 20,204,079 shares issuedand 94,102 89,507 outstanding as of September 30, 2020 andDecember 31, 2019; liquidation value as ofSeptember30, 2020 and December 31, 2019 of $94,102and $89,507, respectivelyStockholders? deficit: Common stock, $0.0001 par value; 150,000,000shares authorized as of September 30, 2020and 120,000,000 shares authorized as ofDecember 31, 2019; 3,195,355 and 2,997,040 ? ? sharesissued and outstanding as of September 30,2020 and December 31, 2019, respectivelyAdditional paid-in capital 1,063 2 Accumulated other comprehensive income ? 43 Accumulated deficit (270,133 ) (192,878 )Total stockholders? deficit (269,070 ) (192,833 )Total liabilities, redeemable convertible $ 110,351 $ 115,962 preferred stock and stockholders? deficit

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

THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER30, SEPTEMBER30, 2020 2019 2020 2019 Revenue: Collaboration $ 954 $ 151 $ 1,275 $ 238 revenueTotal revenue 954 151 1,275 238 Operating expenses:Research and 30,640 16,546 60,653 41,794 developmentGeneral and 5,342 4,835 13,933 16,786 administrativeTotal operating 35,982 21,381 74,586 58,580 expensesLoss from (35,028 ) (21,230 ) (73,311 ) (58,342 )operationsOther income (expense):Interest income 4 344 246 1,145 Interest (607 ) (3 ) (1,196 ) (3 )expenseOther income 338 226 553 878 Total otherincome (265 ) 567 (397 ) 2,020 (expense), netNet loss $ (35,293 ) $ (20,663 ) $ (73,708 ) $ (56,322 )Cumulativedividends onredeemable (3,457 ) (3,454 ) (10,296 ) (10,247 )convertiblepreferred stockNet lossattributable to $ (38,750 ) $ (24,117 ) $ (84,004 ) $ (66,569 )commonstockholdersNet loss pershareattributable tocommon $ (12.83 ) $ (8.05 ) $ (27.92 ) $ (22.29 )stockholders,basic anddilutedWeightedaverage commonshares 3,020,055 2,995,917 3,008,576 2,986,889 outstanding,basic anddilutedComprehensive income (loss):Net loss $ (35,293 ) $ (20,663 ) $ (73,708 ) $ (56,322 )Othercomprehensive income (loss):Unrealized gain(loss) oninvestments, ? (8 ) (43 ) 72 net of tax of$0Total othercomprehensive ? (8 ) (43 ) 72 income (loss)Comprehensive $ (35,293 ) $ (20,671 ) $ (73,751 ) $ (56,250 )loss