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Earnings Conference Call Q1 FYE2020 6 February 2020

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Page 1: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Earnings Conference CallQ1 FYE2020

6 February 2020

Page 2: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

The statements made by Applied DNA Sciences, Inc. (“the Company”, or “us”) herein regarding the Company and its business may beforward-looking in nature and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of1995. Forward-looking statements describe the Company’s future plans, projections, strategies and expectations, including statementsregarding future results of operations and financial position, business strategy, prospective products, timing and likelihood of success,and objectives of management for future operations, and are based on certain assumptions and involve a number of risks anduncertainties, many of which are beyond the control of the Company, including, but not limited to, the risks detailed in the Company’sAnnual Report on Form 10-K for the fiscal year ended September 30, 2019, and other reports filed by the Company with the Securitiesand Exchange Commission. Forward-looking statements include all statements which are not historical facts, and can generally beidentified by terms such as anticipates, believes, could, estimates, intends, may, plans, projects, should, will, would, or the negative ofthose terms and similar expressions.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantifiedand may be beyond the Company’s control, you should not rely on these statements as predictions of future events. Actual results coulddiffer materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, theuncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s productcandidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food andDrug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receivefinal approval from the U.S. FDA or equivalent foreign regulatory agencies, shifting enforcement priorities of US federal laws relating tocannabis, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings. All forward-looking statementscontained herein speak only as of the date hereof, and the Company undertakes no obligation to update any forward-lookingstatements, whether to reflect new information, events or circumstances after the date hereof or otherwise.

Forward Looking Statement

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Page 3: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Statement of Operations (Unaudited)

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Variance September 30, Variance2019 2018 $ % 2019 $ %

Revenues Product revenues 237,870 321,875 (84,005) -26% 1,250,318 (1,012,448) -81% Service revenues 395,649 562,447 (166,798) -30% 422,522 (26,873) -6%Total revenues 633,519 884,322 (250,803) -28% 1,672,840 (1,039,321) -62%

Cost of revenues 232,031 153,485 78,546 51% 320,105 (88,074) -28%Cost of revenues as a % of product revenues 98% 48% 26%Operating expenses:Selling, general and administrative 2,373,413 3,082,380 (708,967) -23% 2,259,529 113,884 5%Research and development 564,426 709,564 (145,138) -20% 886,668 (322,242) -36%Depreciation and amortization 75,067 135,052 (59,985) -44% 70,385 4,682 7%Total operating expenses 3,012,906 3,926,996 (914,090) -23% 3,216,582 (203,676) -6%

LOSS FROM OPERATIONS (2,611,418) (3,196,159) 584,741 -18% (1,863,847) (747,571) 40%

Interest income (expense) (29,091) (31,611) (55,226) Loss on extinguishment of debt - - (1,260,399) Change in fair value of notes payable - - 1,972,955 Income tax (expense) - - (15,000) Other income (expense) (22,232) (6,550) (15,682) 239% (11,943) (10,289) 86%

NET LOSS (2,662,741)$ (3,234,320)$ 571,579 -18% (1,233,460)$ (1,429,281) 116%Less: Net loss attributable to noncontrolling interest 30$ 9,323 NET LOSS attributable to Applied DNA Sciences, Inc. (2,662,711)$ (3,234,320)$ (1,224,137)$ Deemed dividend related to warrant modification (2,842)$ -$ (309,607)$ Net loss applicable to common stockholders (2,665,553)$ (3,234,320)$ (1,533,744)$

Net loss per share-basic and diluted (1.12)$ (4.25)$ (1.44)$

Weighted average shares outstanding- basic and diluted 2,380,564 761,769 1,062,896

Three Month Period EndedThree Month Period EndedDecember 31,

Page 4: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Calculation & Reconciliation of Consolidated Adjusted EBITDA (Unaudited)

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Calculation and Reconciliation of Consolidated Adjusted EBITDA:

2019 2018 % ∆ 2019 % ∆

Net Loss (2,662,711)$ (3,234,320)$ (1,224,137)$ Interest expense (income), net 29,091 31,611 55,226 Depreciation and amortization 75,067 135,052 70,385 Loss on extinguishment of debt - - 1,260,399 Change in fair value of convertilbe notes payable - - (1,972,955) Stock based compensation expense (income) 205,490 490,244 217,468 Income tax expense - - 15,000 Bad debt expense - (8,633) 16,281 Total non-cash items 309,648 648,274 (338,196) Consolidated Adjusted EBITDA (loss) (2,353,063)$ (2,586,046)$ -9% (1,562,333)$ 51%

Three Month Period EndedDecember 31, September 30,

Three Month Period Ended

Page 5: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Comparative Consolidated Balance Sheets

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December 31, September 30,2019 2019

ASSETS (unaudited) Current assets: Cash and cash equivalents 8,662,853$ 558,988$ Accounts receivable, net 273,969 839,951 Inventories 82,683 142,629 Prepaid expenses and other current assets 618,077 604,740 Total current assets 9,637,582 2,146,308

Property and equipment, net 184,101 226,221

Other assets: Deposits 62,350 62,351 Deferred offering costs - 109,698 Intangible assets:Goodwill 285,386 285,386 Intangible assets, net 702,412 734,771

Total assets 10,871,831$ 3,564,735$

December 31, September 30,2019 2019

LIABILITIES AND STOCKHOLDERS' EQUITY (unaudited) Current liabilites:Accounts payable and accrued liabilities 1,053,554$ 1,616,997$ Deferred revenue 455,051 628,993 Total current liabilities 1,508,605 2,245,990

Long term accrued liabilities 659,692 621,970 Secured convertible notes payable, net 1,479,254 1,545,274

Total liabilities 3,647,551 4,413,234

Commitments and contingencies

Stockholder's Equity

Common stock 3,485 1,200 Additional paid in capital 266,699,007 255,962,930 Accumulated deficit (259,471,142) (256,805,589) Applied DNA Sciences' stockholder's equity 7,231,350 (841,459) Noncontrolling interest (7,070) (7,040) Total stockholders' equity 7,224,280 (848,499)

Total liabilities and stockholder's equity 10,871,831$ 3,564,735$

Page 6: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Revenue Trends by Business

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0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Total Applied DNA Revenue Breakout FY20 Forecast vs. FY19 Actual

2019 Actual 2020 Forecast

Page 7: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Textiles Timeline and Milestones

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Page 8: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Revenue Trends by Business

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0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Total Applied DNA Revenue Breakout FY20 Forecast vs. FY19 Actual

2019 Actual 2020 Forecast

Page 9: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Our Entry to Nutraceuticals

• Company ingredient portfolio is diverse; aimed at sports nutrition, energy, weight management, heart and immune systems

• Over 100 domestic and international issued and pending patents protect IP, brand, quality, market position

• Multi-year agreements signed• First product commercialization complete;

others in the pipeline

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Source: www.nutrition21.com

Page 10: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

LineaRx-Evvivax/Takis JDA Cancer Vaccine

• Directed against human telomerase• Initial linear DNA vaccine trials in

xenographic mice yield strong immune response

• Vaccination clears cancerous tumors efficiently both prophylactically and therapeutically in mice.

• Evvivax planning US clinical trials for companion animals

• If successful, Takis plans to begin clinical trials in humans

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Page 11: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

TEM Credit: China Institute of Veterinary Drug Control

• “Spike” proteins are the site that binds to a specific receptor on human cells

• Spike halo gave rise to the “Corona” name

• Spike gene mutation gave rise to human tropism• Spike protein is the logical target of a linear DNA

vaccine• DNA encoding small antigens of the spike gene is

our strategy

• Briefly expressed before the DNA is eliminated by housekeeping genes in 1-2 weeks

• Brief exposure to Spike Antigens conveys immunity without altering patient genome, with virus, without the use of bacteria, without plasmids

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Linear DNA Vaccine Against 2019-nCoV New Wuhan Coronavirus

European Commission, ec.Europa.eu

Page 12: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

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Liquid Biopsies to Capture INVASIVE Circulating Tumor Cells

Clinicaomics.com

Page 13: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

invasive Circulating Tumor Cell Technology

• Functional metastatic cell isolation kit involving a specialized tube assay to isolate invasive circulating tumor cells (iCTCs) from patient blood samples.

• Cell Adhesion Matrix coated surfaces emulate human tissue to capture tumor cells in blood.

iCTCs are captured based on their preferential

adhesion to CAM

CAM (Cell Adhesion Matrix)

Patient Samples are added to CAM coated

plates or tubes

CAM (Cell Adhesion Matrix) CAM (Cell Adhesion Matrix)

Captured iCTCs are labeled based on their integration of FTTC or

TRITC labeled CAM

Captured iCTCs are suspended for analysis by flow or image cytometry or for gene expression,

gene mutation, or culture in plates for growth

inhibition with drugs or other agents

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Page 14: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

iCTCs Are Metastatic

• iCTCs were characterized using peritoneal and spontaneous metastasis models in vivo to evaluate their metastatic propensity and therapeutic response.

• 1,000-fold more metastatic propensity:Approximately 500 patient-derived iCTCs recapitulated formation of iCTCs in mouse blood and formed micrometastases in the liver and/or lung, a degree of metastatic spread equivalent to the inoculation of 5 × 105 bulk tumor cells isolated from ascites and tumors.

Dong,H., et al 2019 Cancer Medicine

iCTCs in mouse blood

An iCTC in mouse lung metastases

_

GFP+CAM+Bright Field

_

GFP+CAM+Bright Field

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Page 15: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

iCTCs Respond to Therapy and to Patient Status, and Can Be Used as a Prognosticator

• Surveillance screening of recurrence –iCTC™ assay was able to detect recurrences of ovarian cancer up to six months before conventional CT imaging and serum CA125 found evidence of recurrence.

• Monitoring therapy response –Increases in iCTCs (79.5%) were more sensitive than increases in CA125 (67.6%) to predict progressive disease or relapse. Cited from: Pearl, ML 2014; 2015 Gyn. Oncol.

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Page 16: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

iCTCs Are Good for Drug Development:Application in Clinical Trials

• Clinical Trials for Drug Development –Tyme’s SM88 Phase Ib/II; III in plan*.

• Monitoring therapy response – iCTC™ assay was able to detect therapeutic response of prostate cancer three months before conventional CT imaging and serum PSA found evidence of metastatic progression.

* A Phase Ib/II, Open-label, Dose Excalation Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SM88 in Patients with Prostate Cancer

* SM88 in Non-Metastatic Rising PSA-Recurrent Prostate Cancer* https://s22.q4cdn.com/265040820/files/doc_downloads/scientific-

presentations/2019/09/TYME-ESMO_Phase-II-Trial-Prostate_v2jl_2019Sep27.pdf

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Page 17: Q1 FYE2020 6 February 2020 - Applied DNA Sciences...management, heart and immune systems • Over 100 domestic and international issued and pending patents protect IP, brand, quality,

Thank you!