Aerovate Therapeutics : December 2023 Corporate Presentation

Meaningfully Improving the Lives of

Patients with Rare

Cardiopulmonary Disease

Targeting the Hyperproliferative Cause

of Pulmonary Arterial Hypertension

December 2023

Nasdaq: AVTE

Disclaimer; Forward-Looking Statements

This presentation has been prepared by Aerovate Therapeutics, Inc. ("we," "us," "our," "Aerovate" or the "Company") and is made for informational purposes only. The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this presentation unless stated otherwise, and this presentation shall not under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof.

The following presentation contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "believe," "could," "estimate," "expect," "future," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "seek," "strategy," "should," "will," "would" and similar expressions regarding future periods. These forward-looking statements include, but are not limited to, statements regarding Aerovate's business plans and objectives; future plans for AV-101, including expectations regarding timing and success of the planned clinical trial, therapeutic potential, clinical benefits and safety thereof; growth as a company; the potential value and market for AV-101; and uses and need of capital, expenses and other financial results currently or in the future. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties and are based on our current beliefs, expectations and assumptions regarding future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Among the factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation are those risks and uncertainties, without limitation, associated with the following: the impact of the COVID-19 pandemic on the company's business, operations, patient enrollment and retention, strategy, goals and anticipated milestones; the therapeutic potential of AV-101, and the timing associated with the initiation, continuation or success of Aerovate's ongoing or planned clinical trials of AV-101; Aerovate's ability to execute on its strategy; positive results from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; AV-101 may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; Aerovate's ability to protect and maintain its intellectual property position; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our Quarterly Report on Form 10-Q, as well as other risks detailed in our subsequent filings with the United States Securities and Exchange Commission (SEC). Any forward-looking statement made by us is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.

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Experienced Management Team

Timothy Noyes

Chief Executive Officer

• 30 years' commercial experience in pharma and biotech, including Merck, Genzyme, Proteon
• Extensive launch planning and commercial launch experience

Ben Dake, PhD

President & Founder

• Entrepreneur, Cancer Biologist and Investor
• Conceptualized AV-101 and secured up to $79M in financing for Aerovate

Hunter Gillies, MB ChB

Chief Medical Officer

• Led AMBITION trial for Gilead that established current first-line PAH combination therapy
• Led successful Phase 2 and 3 trials for PAH product candidates at Pfizer and Gilead

Donna Dea

Head of Regulatory

• 35 years of pharmaceutical experience at AstraZeneca
• 20 years of global regulatory experience designing/ implementing strategies resulting in approval of treatments for asthma, COPD, rhinitis and others

Susan Fischer

SVP, Clinical Ops.

• 20 years' experience in clinical operations in both academic and the pharmaceutical industry.
• Previously built/led clinical ops teams at Syndax, EMD Serono, Acetylon

George Eldridge

Chief Financial Officer

• 25 years' experience in biotech, with both public and private companies, including Curis, Targanta, Proteon
• Extensive background raising capital in private, IPO and follow-on settings, investment banking and M&A

Ralph Niven, PhD

Chief Development Officer

• 25 years' broad expertise in translational medicine and inhalation dosage forms
• Managed experimental and clinical development at public and private companies, including Amgen, AIR and Novartis

Timothy Pigot

Chief Commercial Officer

• 25 years' experience in biotech and pharma working to launch and commercialize a range of products
• 10 years' experience in PAH overseeing the US launches of Revatio and Leairis while at Pfizer and Gilead Sciences, respectively

Marco Verwijs

Chief Technical Officer

• 15 years' experience developing drugs from clinical product development thru commercial launch
• Proven leader in drug product scale-up and validation.

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Aerovate: An Inventive Way Forward in PAH

Demonstrated Clinical Benefit

The molecule in AV- 101, imatinib, already has shown clinical benefit in a Phase 3 clinical trial conducted by Novartis of oral imatinib mesylate in PAH patients on top of two or more standard of care therapies.

Unfortunately, AEs with oral imatinib were common and development was discontinued

Inventive

Solution

Anti-proliferative targeted inhaled dry powder PAH product candidate AV-101 designed to provide robust clinical benefit of imatinib without systemic AEs observed with oral imatinib

Significant Unmet Need

Despite three drug classes approved,

5-year survival for newly diagnosed PAH patients is 61%

Efficient Execution

FDA and EMA orphan designation for AV- 101 for the treatment of PAH

Phase 1 SAD/MAD in healthy volunteers complete

Phase 2b dose- ranging portion of a Phase 2b/3 trial in PAH patients initiated in Q4 2021

Established Market

$6B+ market, yet outcomes are poor

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Relentless Disease Progression Impairs Daily Life

No		Activity		Marked		Severe
limitation		limited		limitation		limitation

Comfortable at rest, but ordinary physical activity causes shortness of breath, fatigue, chest pain, fainting

Comfortable at rest, but less than ordinary physical activity causes shortness of breath, fatigue, chest pain, fainting

Symptoms at rest. Overt heart failure

Despite standard of care (SOC) most patients progress to overt heart failure

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Pulmonary Arterial Hypertension

~ 70,000		~ 35,000		$6B+
People with PAH		People with PAH		Global	annual	drug
	spending
in the US/EU		in the US
65-80%		53 years	61-65%
Female		Average age at	5-year survival
		diagnosis		Newly diagnosed and
				prevalent patients

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Patient Outcomes Are Poor Despite $6B+

PAH Vasodilator Market

NO pathway

$0.7B

~65% patients take

2-3 drugs

5-year survival

61-65%

for newly diagnosed and prevalent patients

Prostanoids

$3.0B

SOC

Vasodilators

ERAs

$2.3B

No approved PAH therapy primarily addresses

abnormal cellular proliferation

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Reinventing Imatinib From a Cancer Drug to a Potential PAH Therapy

88

Phase 3 IMPRES Trial: Oral Imatinib Demonstrated Improvement on Top of Maximal Background

Novartis global Phase 3 trial (n=202) of oral imatinib

Required to be on at least 2 SOC PAH drugs

WHO functional class II- IV

Statistically significant and clinically meaningful benefit on primary endpoint 6MWD after 24 weeks

6MWD is an accepted endpoint for approval in PAH

Change in 6MWD from baseline (m)

70

60

50

40

30

20

10

0

0

Imatinib

Placebo

*

*P<0.05

*

*

*

4	8	12	16	20	24
		Time (weeks)

32m

(Adapted from Circulation. 2013;127:1128-1138.)

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Phase 3 IMPRES Trial: Benefit Consistent Across Secondary Endpoints

Secondary Endpoints (24wk)

Demonstrated robust hemodynamic effect

1. Decreased mean pulmonary artery pressure
2. Increased cardiac output
3. Pulmonary vascular resistance (PVR) dropped 32% (P < 0.001), a validated efficacy endpoint typically used for dose-finding
4. Right atrial pressure lowered

Aerovate's Phase 2b trial will use PVR

as the primary endpoint

(Circulation. 2013;127:1128-1138.)

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