Part 1: Performance Analysis

The financial statements of Acelrx Pharmaceuticals Inc. indicate that the company has been performing relatively well in the current period despite the impact of COVID-19. During this period, the company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Acelrx's portfolio includes nafamostat product candidates and pre-filled syringe product candidates. On April 3, 2023, the company closed the transactions contemplated by the DSUVIA Agreement with Alora pursuant to which Alora acquired certain assets and assume certain liabilities relating to the Product.

The company has also submitted an investigational device exemption, or IDE, and received Breakthrough Device Designation from the United States Food and Drug Administration, or FDA. Additionally, it submitted a request for Emergency Use Authorization to the FDA. Its portfolio consists of nafamostat product candidates and pre-filled syringe product candidates. The company has promising product categories such as Niyad, LTX-608, Fedsyra, and Phenylephrine to offer improved solutions to medical treatment.

Part 2: Forward-Looking Analysis

Acelrx Pharmaceuticals Inc. has already received Breakthrough Device Designation from the FDA and submitted a request for Emergency Use Authorization to the FDA for its products. Furthermore, the company is preparing to submit New Drug Applications (NDAs) for its product candidates. It is also worth noting that the company's product candidates have been developed in a ready-to-use strength and pre-filled into syringes that can be immediately administered to patients, potentially eliminating the need for calculations and additional dilution and filling steps.

With the global healthcare industry shifting toward patient-centric innovations and the growing need to improve healthcare facilities, Acelrx Pharmaceuticals Inc.'s innovative medical solutions and promising product categories are well-positioned to benefit from these trends. The company's management is confident that their innovative therapies will demonstrate strength and giving a broader range of treatment solutions to medical practitioners, all while reducing the risks of complications and ensuring the highest of standards. Based on these and other factors, Acelrx Pharmaceuticals Inc. is well-positioned for sustainable growth in the period ahead.

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Acelrx Pharmaceuticals Inc

Acelrx Pharmaceuticals: Strong Performance & Promising Portfolio for Medical Treatment Solutions.

AcelRx Pharmaceuticals, a specialty pharmaceutical company, has released its Q1 2023 financial results, reporting a cash balance of $13.4 million as of March 31, 2023. The company divested its DSUVIA® to Alora Pharmaceuticals and submitted a request for Emergency Use Authorization of Niyad to the FDA in April. Niyad, a lyophilized formulation of Nafamostat, is under investigation as an anti-coagulant for the extracorporeal circuit. AcelRx also plans to initiate an FDA-informed single registrational study for Niyad in the second half of this year. CEO Vince Angotti stated that the company has embarked on a new chapter by closing the DSUVIA transaction and submitting the request for an EUA for Niyad. Investors can participate in the company's conference call on May 10, 2023. The company's financial statements should be considered in the context of the details provided in AcelRx's most recent annual, quarterly, or current report to the SEC.

Form 8-K - Current report - Item 2.02 Item 9.01

$ACRX Reports Q1 2023 Financial Results, Divests DSUVIA®, Submits Request for Emergency Use Authorization for Niyad to FDA.

Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend]

Announcement: ACRX 10-K/A Special Filing Amendment

Announcement: ACRX 8-K Special Filing

Form 8-K - Current report - Item 1.02 Item 2.01 Item 7.01 Item 9.01

Part 1: Analysis of Performance 

ACELRX PHARMACEUTICALS INC is a specialty pharmaceutical company focusing on the development and commercialization of innovative therapies for medically supervised settings. The company has signed an agreement to divest its sufentanil sublingual products (DSUVIA and DZUVEO) and has acquired Lowell Therapeutics, Inc., a privately held company, for the consideration of approximately $32.5 million plus net cash acquired and certain other adjustments, including up to approximately $26.0 million of contingent consideration. In addition, the company has entered into a License and Commercialization Agreement with Laboratoire Aguettant to commercialize ephedrine and phenylephrine pre-filled syringe products.

In 2021, the company entered into a DZUVEO Agreement with Aguettant, pursuant to which Aguettant obtained the exclusive right to commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland, and the United Kingdom, for the management of acute moderate to severe pain in adults in medically monitored settings. Furthermore, the company received approximately $2.9 million under the DZUVEO Agreement.

In March 2023, the company entered into an asset purchase agreement with Alora to acquire certain assets and assume certain liabilities relating to DSUVIA or DZUVEO or any other single-dose pharmaceutical product containing a sublingual tablet that includes sufentanil as the sole active ingredient. The company expects to close the transaction in April 2023 and support the transition to Alora under a Transition Services Agreement signed at or prior to the closing of the transaction.

Part 2: Forward Looking Analysis 

ACELRX PHARMACEUTICALS INC is continuing its focus on the development and commercialization of innovative therapies for medically supervised settings. With the divestment of sufentanil sublingual products and acquisition of Lowell Therapeutics, Inc., the company is reinforcing its portfolio and focusing on the commercialization of nafamostat product candidates and pre-filled syringe product candidates. The company has also entered into a License and Commercialization Agreement with Laboratoire Aguettant to develop and commercialize ephedrine and phenylephrine pre-filled syringe products.

Furthermore, the company's agreement with Alora to acquire certain assets and assume certain liabilities relating to DSUVIA or DZUVEO or any other single-dose pharmaceutical product containing a sublingual tablet that includes sufentanil as the sole active ingredient is expected to close in April 2023. With this agreement, the company expects to focus on its core strategies and allocate resources to drive innovation as the pharmaceutical industry continues to evolve.

According to the CEO Vince Angotti, “We are very excited to complete the decision to sell our commercial business and position AcelRx for its future dedicated solely to the expansion of its nafamostat program. With these initiatives, we believe we are well-positioned to enhance stockholder value, address the needs of patients and healthcare providers, and advance new treatment options for patients in medically supervised settings.” Management believes that the company's portfolio of innovative therapies and its strategic focus will position it for long-term growth and success.

In conclusion, ACELRX PHARMACEUTICALS INC has made strategic decisions to divest itself of certain products and focus on its core strategies of developing and commercializing innovative therapies for medically supervised settings. With its current portfolio of nafamostat product candidates and pre-filled syringe product candidates, the company is well-positioned to drive innovation and increase stockholder value. The agreement with Alora is expected to be a significant opportunity for the company to focus on its core business and strategic initiatives.

Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

Acelrx Pharmaceuticals: Strong Performance & Promising Portfolio for Medical Treatment Solutions.

Acelrx Pharmaceuticals: Strong Performance & Promising Portfolio for Medical Treatment Solutions.

$ACRX Reports Q1 2023 Financial Results, Divests DSUVIA®, Submits Request for Emergency Use Authorization for Niyad to FDA.

$ACRX Reports Q1 2023 Financial Results, Divests DSUVIA®, Submits Request for Emergency Use Authorization for Niyad to FDA.

Announcement: ACRX 10-K/A Special Filing Amendment

Announcement: ACRX 10-K/A Special Filing Amendment

Announcement: ACRX 8-K Special Filing

Announcement: ACRX 8-K Special Filing

Announcement: ACRX 8-K Special Filing

Announcement: ACRX 8-K Special Filing

ACELRX Pharmaceuticals: Reinforcing Portfolio & Focusing on Innovation

ACELRX Pharmaceuticals: Reinforcing Portfolio & Focusing on Innovation