FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction ...

AcelRx Pharmaceuticals, Inc. (ACRX) Q1 2021 Earnings Conference Call May 17, 2021 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vince Angotti - Chief Executive Officer Pam Palmer - Chief Medical Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Michael Higgins - Ladenburg Thalmann Ed Arce - H.C. Wainwright Operator Welcome to the AcelRx First Quarter 2021 Earnings Call. This call is being webcast live on the events page of the Investors section of AcelRx's w ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdictio ...

Financial Data and Key Metrics Changes - Q4 2020 revenues were $0.7 million, a 55% increase from $0.5 million in Q4 2019 [65] - Total 2020 product sales reached $2.5 million, a 38% increase from $1.8 million in 2019 [65] - Gross profit was negative for the quarter and year, but losses narrowed compared to 2019, with expectations for continued improvement as sales grow [67] Business Line Data and Key Metrics Changes - The company achieved significant progress in its four pillars, including a $3.6 million contract from the U.S. Army and a partnership with Zimmer Biomet for oral and dental surgery [14][18] - The orthopedic surgery market is identified as a key specialty for DSUVIA in 2021, with ongoing studies showing benefits such as faster discharge times and reduced opioid use [28][99] Market Data and Key Metrics Changes - The backlog of elective surgeries has grown significantly, with expectations for a ramp-up in surgeries in the second half of 2021 as COVID-19 restrictions ease [12][66] - The company anticipates having 615 hospitals and surgery centers approved for DSUVIA by the end of 2021 [70] Company Strategy and Development Direction - The company is focused on expanding its market presence through partnerships and addressing the backlog of elective surgeries [7][60] - Plans include exploring additional product licensing or acquisition opportunities to complement DSUVIA [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the return of elective surgeries and the potential for increased formulary approvals as restrictions are lifted [66][73] - The company is committed to improving access to healthcare institutions and expects stronger revenue growth in the second half of 2021 [66][73] Other Important Information - The automated packaging line is expected to significantly reduce production costs and increase capacity starting in Q3 2022 [58][68] - The company is addressing a recent FDA warning letter and is committed to proper promotion and education regarding DSUVIA [62][63] Q&A Session Summary Question: What are the current hospital protocols affecting DSUVIA? - Management noted that about one-fourth of formulary approvals have been for hospitals, with delays primarily due to COVID-19 [77][78] Question: What is the current status of formulary approvals? - As of the end of February, the company had 387 approvals and expects to reach 615 by year-end, with the second half of the year being crucial for this growth [85][86] Question: Are there any additional marketing efforts planned? - Management indicated that ongoing real-world data from investigator-initiated studies has been the strongest marketing tool, with no new promotional efforts planned [93] Question: What trends are being observed in outpatient versus inpatient procedures? - Management noted that while restrictions are still in place, there is a strong demand for outpatient procedures, particularly in orthopedics and plastics [99][100] Question: What is the expectation for the Milestone C approval from the DoD? - The company expects some procurement under the Milestone C this year, but logistics and administrative issues are still being worked through [112] Question: What proportion of formulary approvals are expected from targeted facilities? - The target includes 300 hospitals and 600 ambulatory surgery centers, with a focus on high-performing centers [115][116]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of inc ...

AcelRx Pharmaceuticals, Inc. (ACRX) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vincent Angotti - Chief Executive Officer & Director Pamela Palmer - Co-Founder, Chief Medical Officer & Director Conference Call Participants Michael Higgins - Ladenburg Evan Seigerman - Credit Suisse Operator Welcome to the AcelRx Third Quarter 2020 Conference Call. This call is being webcast live on the Events page of the Investors section of Acel ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdi ...

Financial Data and Key Metrics Changes - The company ended Q2 2020 with $43.7 million in cash and short-term investments, a decrease of $9 million from Q1 2020 [21] - Revenues for Q2 2020 were $2.9 million, compared to $0.9 million in Q2 2019, with approximately $2.6 million attributed to previously deferred revenues [23] - Cash operating expenses for the quarter were $7.3 million, down from $11.2 million in Q2 2019, primarily due to a reduction in DSUVIA-related commercialization expenses and personnel costs [22] Business Line Data and Key Metrics Changes - The company received Milestone C approval for DSUVIA placement in U.S. Army sets, kits, and outfits, with initial stocking orders expected to approximate $30 million over the next three years [8][9] - An exclusive promotion and distribution partnership with Zimmer Biomet for DSUVIA in dental and oral surgery markets is anticipated to accelerate sales, with initial benefits expected in Q4 2020 [11][13] Market Data and Key Metrics Changes - The Department of Defense represents a significant market opportunity, with expectations for initial orders to be placed in Q3 2020 [9][25] - The dental and oral surgery market is estimated to involve 7.5 million annual procedures suitable for DSUVIA, with various procedures identified as potential applications [32][33] Company Strategy and Development Direction - The company aims to advance the use of DSUVIA through partnerships and internal sales teams focused on hospitals and ambulatory surgery centers [6] - Future growth is expected to be supported by successful partnerships in specialty markets, such as plastic surgery and fertility services, with minimal investment required from the company [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of DSUVIA, particularly in light of recent approvals and partnerships, despite challenges posed by the COVID-19 pandemic [7][19] - The company is optimistic about the upcoming publications that will provide real-world data supporting the benefits of DSUVIA, which is expected to enhance its market position [18] Other Important Information - The company is in discussions for potential out-licensing of DSUVIA in Europe and exploring additional partnerships for marketing and distribution in specialty markets [26] - The timeline for the resubmission of the Zalviso NDA is still under evaluation, pending further guidance from the FDA [26] Q&A Session Summary Question: Can you elaborate on the market opportunity for the Zimmer deal? - The company estimates that all 7.5 million procedures are addressable for DSUVIA, including third molar extractions and dental implants [32][33] Question: Where is DSUVIA currently being used? - DSUVIA is being utilized in ambulatory surgery settings, emergency rooms, and fertility clinics, among others [35] Question: How is the onset of action and duration of effect being reported in practice? - The onset of action is consistent with clinical trials, and the duration of analgesia is reported to be longer in real-world settings [42][45] Question: What feedback have you received from dentists regarding using the product in-office? - Dentists are comfortable with the product as they already have the necessary infrastructure for opioid storage and administration [52]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2020 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction ...

Financial Data and Key Metrics Changes - The company ended Q1 2020 with $52.7 million in cash and short-term investments, a decrease of $13.4 million from year-end 2019 [57] - Revenues for Q1 2020 were $0.4 million, compared to $0.3 million in Q1 2019, indicating a slight increase [59] - Cash operating expenses for the quarter were $13.6 million, with a significant portion attributed to commercial costs related to the launch of DSUVIA [58] Business Line Data and Key Metrics Changes - DSUVIA achieved Milestone C approval, allowing its use in all US Army sets kits and outfits, with initial stocking orders expected to approximate $30 million over the next three years [14][15] - The company noted that DSUVIA sales were impacted by the postponement of elective surgeries due to COVID-19, but anticipates capturing increased volumes once surgeries resume [60] Market Data and Key Metrics Changes - The company reported 223 formulary approvals and 221 REMS-certified facilities as of April 30, 2020, prior to the impact of COVID-19 [19] - The company expects delays in achieving original year-end 2020 goals for access metrics by approximately one quarter due to COVID-19 restrictions [20] Company Strategy and Development Direction - The company is focused on expanding DSUVIA's market presence, particularly within military and civilian healthcare settings, and is actively pursuing partnerships for marketing and distribution [66] - The company is evaluating alternatives to accelerate final acceptance tests for its high-volume packaging line, which is expected to reduce production costs [63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DSUVIA's long-term success and its potential to change the standard of care for acute pain management [69] - The company anticipates that the approval from the Department of Defense will serve as a catalyst for further adoption in both military and civilian markets [70] Other Important Information - The company is in discussions with potential out-licensing partners for DZUVEO in Europe and is exploring additional business development opportunities [66][67] - The company has shifted to virtual meetings for sales and promotional efforts due to COVID-19, reporting strong engagement from healthcare practitioners [100][102] Q&A Session Summary Question: Where in the hospital is DSUVIA being used effectively? - DSUVIA is being utilized across various types of surgeries, including orthopedic and soft tissue procedures, with a focus on same-day operations [74][75] Question: What are the military advancements regarding DSUVIA? - The company expects DSUVIA to be added to the Joint Deployment Formulary within the next few months, which will facilitate its use across other military branches [84][85] Question: Will there be a formal contract for military stocking orders? - Initial stocking orders will depend on deployment schedules, and the Joint Deployment Formulary will facilitate orders from other military branches [95][97] Question: How is the company adapting to COVID-19 restrictions? - The company has successfully transitioned to virtual meetings and has seen strong engagement from healthcare practitioners during this shift [100][102] Question: What are the early efforts in the co-promotion of DSUVIA and DZUVEO? - The co-promotion efforts have just begun, with training completed and initial customer engagement showing excitement for both products [104]