ACRX AcelRx Pharmaceuticals Inc.

1.14
-0.04  -3%
Previous Close 1.18
Open 1.18
52 Week Low 0.7014
52 Week High 3.02
Market Cap $92,070,676
Shares 80,763,751
Float 79,613,282
Enterprise Value $72,749,226
Volume 874,243
Av. Daily Volume 1,151,359
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Drug Pipeline

Drug Stage Notes
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3
Phase 3
CRL Jul 26 2014. NDA resubmission planned.
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
Approved
Approved
FDA Approval announced November 2, 2018.
ARX-04 (SAP302)
Patients who presented to emergency departments with moderate-to-severe acute pain associated with trauma or injury
Phase 3
Phase 3
Phase 3 data released August 15 2016

Latest News

  1. REDWOOD CITY, Calif., June 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it does not intend to revise further its offer under the terms of its previously announced agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), and it expects the agreement to be terminated by Tetraphase. On June 1, 2020, Tetraphase disclosed that its board of directors had determined that an amended proposal from Melinta Therapeutics, Inc. constituted a "Superior Offer" under the terms of the AcelRx Merger Agreement. Under the terms of the agreement…

    REDWOOD CITY, Calif., June 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it does not intend to revise further its offer under the terms of its previously announced agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), and it expects the agreement to be terminated by Tetraphase. On June 1, 2020, Tetraphase disclosed that its board of directors had determined that an amended proposal from Melinta Therapeutics, Inc. constituted a "Superior Offer" under the terms of the AcelRx Merger Agreement. Under the terms of the agreement, in connection with a termination of the merger agreement, AcelRx will be paid a break-up fee of approximately $1.8 million.

    Vince Angotti, Chief Executive Officer at AcelRx said, "AcelRx is financially disciplined, and while we continue to recognize the merits of an AcelRx and Tetraphase combination, we do not believe that any further increases to our offer would be in the best interests of our stockholders. As a result, we have decided not to further increase our offer and will focus on other exciting opportunities to expand and diversify our product portfolio and create a platform for growth with other potential collaboration partners." 

    The co-promotion agreement between AcelRx and Tetraphase (or any successor to Tetraphase) remains in place – safeguarded by significant financial obligations. The training of both the AcelRx and Tetraphase teams is complete and co-promotion efforts for DSUVIA® and XERAVA™ are currently underway. 

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to the expected termination of the merger agreement with Tetraphase and payment of a break-up fee, anticipated benefits of the co-promotion agreement between AcelRx and Tetraphase, the business strategy to expand and diversify AcelRx's product portfolio, and potential collaborations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including AcelRx's ability to execute on its business strategy. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  2. REDWOOD CITY, Calif., June 1, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the Jeffries Virtual Healthcare Conference to be held June 2 at 1:30 p.m. ET (10:30 a.m. PT). A live webcast link of the event can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.

    For those not available to listen to the live webcast, a replay will be archived for 90 days and available through…

    REDWOOD CITY, Calif., June 1, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the Jeffries Virtual Healthcare Conference to be held June 2 at 1:30 p.m. ET (10:30 a.m. PT). A live webcast link of the event can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.

    For those not available to listen to the live webcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  3. REDWOOD CITY, Calif., May 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the execution of an amendment to its merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), with revised consideration of $37.0 million in stock and cash based on the AcelRx closing share price on May 28, 2020, plus up to $16.0 million in contingent value rights (CVRs) payable in cash.

    The total consideration payable to Tetraphase stockholders and warrant holders includes AcelRx stock valued at $24.2 million, based upon the closing share price…

    REDWOOD CITY, Calif., May 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the execution of an amendment to its merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), with revised consideration of $37.0 million in stock and cash based on the AcelRx closing share price on May 28, 2020, plus up to $16.0 million in contingent value rights (CVRs) payable in cash.

    The total consideration payable to Tetraphase stockholders and warrant holders includes AcelRx stock valued at $24.2 million, based upon the closing share price of AcelRx stock of $1.50 on May 28, 2020, plus $12.8 million in cash.

    Tetraphase stockholders will receive, for each share of Tetraphase common stock, (1) $0.59 in cash and 0.7409 shares of AcelRx common stock, representing approximately $1.70 in upfront per share value, based upon the closing share price of AcelRx stock of $1.50 on May 28, 2020, and (2) one CVR, which would entitle the Tetraphase stockholders to receive potential aggregate payments of up to $16.0 million in cash upon the achievement of certain future XERAVA™ net sales milestones starting in 2021. 

    Tetraphase's board of directors has determined that as a result of the amendment to the merger agreement, competing bidders' proposals were not superior and recommends the merger agreement, as amended, to its stockholders. In addition to delivering overall higher value, the AcelRx agreement delivers a higher per share valuation to Tetraphase warrant holders and stockholders.

    Vince Angotti, Chief Executive Officer at AcelRx said, "We continue to believe there is significant value created for our stockholders in the combination of Tetraphase and AcelRx and stand ready to close this transaction in June."

    Under the terms of the merger agreement, the transaction is expected to close following Tetraphase's stockholder meeting, which is currently set for June 8, 2020.  Closing of the transaction is subject to receipt of approval of its stockholders, as well as satisfaction of other customary closing conditions. The transaction does not require a vote by AcelRx stockholders.

    Cooley LLP is acting as legal counsel to AcelRx.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    About Tetraphase Pharmaceuticals, Inc.
    Tetraphase Pharmaceuticals, Inc. is a biopharmaceutical company using its proprietary chemistry technology to develop and commercialize novel tetracyclines for serious and life-threatening conditions, including bacterial infections caused by many multidrug-resistant, or MDR, bacteria. There is a medical need for new antibiotics as resistance to existing antibiotics increases. The company's commercial product, XERAVA™ (eravacycline), a fully synthetic fluorocycline, is an intravenous, or IV, antibiotic that is approved for use as a first-line empiric monotherapy for the treatment of MDR infections, including those found in complicated intra-abdominal infections, or cIAI.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to future prospects or results, strategy, intentions, plans, hopes, beliefs, anticipations, expectations or predictions of the future, or the expected closing and timing of the Tetraphase acquisition and the potential benefits of the proposed transaction.  These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that we may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the proposed transaction with Tetraphase, that actions taken by competing bidders for Tetraphase or fluctuations in the market price of AcelRx's common stock could delay or prevent the consummation of the proposed transaction, or that the impacts AcelRx experiences from the ongoing COVID-19 pandemic may be prolonged or exacerbated.  In addition, such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx filed with the SEC a registration statement on Form S-4 (No. 333-237584) (the "Registration Statement") containing a document constituting a prospectus of AcelRx and a proxy statement of Tetraphase.  The Registration Statement was declared effective by the SEC on April 24, 2020, and Tetraphase mailed the definitive proxy statement/prospectus to stockholders of Tetraphase on or about April 28, 2020. AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders are able to obtain free copies of the Registration Statement and the definitive proxy statement/prospectus and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx are available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase are available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement/prospectus filed with the SEC on April 24, 2020. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  4. REDWOOD CITY, Calif., May 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its first quarter 2020 financial results.

    "During this unprecedented time, I am proud of the commitment demonstrated by our employees as we continue making progress towards our year-end strategic and operational 2020 goals," said Vince Angotti, Chief Executive Officer of AcelRx. "The Milestone C approval for DSUVIA® in April was a significant catalyst for the Company and validates DSUVIA's key role in modernizing the treatment of acute pain. We expect to see a strong volume of…

    REDWOOD CITY, Calif., May 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its first quarter 2020 financial results.

    "During this unprecedented time, I am proud of the commitment demonstrated by our employees as we continue making progress towards our year-end strategic and operational 2020 goals," said Vince Angotti, Chief Executive Officer of AcelRx. "The Milestone C approval for DSUVIA® in April was a significant catalyst for the Company and validates DSUVIA's key role in modernizing the treatment of acute pain. We expect to see a strong volume of orders from the U.S. Army beginning later this year and into the future. The approval also opens doors to other branches of the military, additional areas of the Federal government, and to state governments and agencies. Specifically, we expect the next step with the Department of Defense will be DSUVIA's inclusion on the Joint Deployment Formulary. We are pleased with the swift integration of our commercial team with Tetraphase under our co-promotion agreement, which we believe will benefit both companies moving forward."  

    First Quarter and Recent Highlights

    • DSUVIA achieved Milestone C approval from the Department of Defense, a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs) with an expectation of expanded use across all branches of the military and the potential for use across additional federal and state agencies. AcelRx expects that initial stocking orders beginning later this year for U.S. Army SKOs alone will approximate $30 million over the next three years based on troop deployment schedules.
    • Prior to the impact from the COVID-19 pandemic, AcelRx was on pace to exceed formulary approvals and REMS-certified facilities goals for 2020. Following the initial impact of COVID, as of April 30, 2020, 221 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 223 formulary approvals have been achieved. As previously communicated, in response to the COVID-19 pandemic, hospitals and ambulatory surgery centers have restricted in-person meetings with pharmaceutical company personnel. Accordingly, year-end 2020 REMS-certified facilities and formulary approvals goals will be re-evaluated once COVID-19 restrictions are lifted and there is greater visibility into healthcare facility access.
    • Expect the publication of two hospital studies of real-world data of DSUVIA in the perioperative setting which analyze DSUVIA's impact on IV opioid requirements in the post-anesthesia care unit (PACU) and discharge time from the PACU in the coming months.
    • Announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.

    Financial Information

    • As previously announced:
      • Cash, cash equivalents and short-term investments balance of $52.7 million as of March 31, 2020;
      • First quarter 2020 net revenues were $0.4 million;
      • Combined R&D and SG&A expenses for the first quarter of 2020 totaled $14.7 million compared to $11.4 million for the first quarter of 2019. Excluding stock-based compensation expense, these amounts were $13.6 million for the first quarter of 2020 compared to $10.3 million for the first quarter of 2019. The increase in combined R&D and SG&A expenses is primarily due to business development costs related to the proposed acquisition of Tetraphase and increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures.
    • For the first quarter of 2020, net loss was $15.9 million, or $0.20 per basic and diluted share, compared to $13.7 million, or $0.17 per basic and diluted share, for the first quarter of 2019.

    Tetraphase Transaction Update

    On March 15, 2020, AcelRx entered into a definitive agreement (the Merger Agreement) to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) and a co-promotion agreement with Tetraphase. Training of both the AcelRx and Tetraphase teams is complete and co-promotion efforts for DSUVIA and XERAVA are underway. 

    AcelRx is aware of the May 8, 2020 disclosure by Tetraphase indicating it received a competing acquisition proposal from La Jolla Pharmaceutical Company (La Jolla) that the Tetraphase board of directors (Tetraphase Board) believes constitutes or could reasonably be expected to lead to a superior offer. The Tetraphase Board also stated that it continued to recommend the AcelRx merger and has not made any recommendations with respect to the other competing acquisition proposal by La Jolla. Our understanding is as follows:

    • The La Jolla proposal is for an upfront value of $22 million, payable in cash, inclusive of an estimate of approximately $11.9 million in Black-Scholes consideration due to select warrant holders and approximately $10.1 million for Tetraphase common equity holders (an implied price per share of $0.93), and contingent value rights of up to $12.5 million.
    • This compares to the AcelRx proposal for an upfront value of approximately $21.7 million payable in stock, based on the closing price of AcelRx stock on May 8th, inclusive of an estimate of approximately $11.8 million in Black-Scholes consideration due to select warrant holders and approximately $9.9 million for Tetraphase common equity holders (an implied price per share of $0.92), and contingent value rights of up to $12.5 million.

    Under the Merger Agreement with Tetraphase, should the Tetraphase Board indicate that it intends to change its recommendation in favor of the Merger Agreement, AcelRx would have the opportunity to respond within a specified time period. 

    Regardless of whether the Tetraphase Board ultimately chooses to accept an offer (including the La Jolla offer) other than the AcelRx transaction under the Merger Agreement, the co-promotion agreement between the two companies would remain in place – safeguarded by significant financial obligations. If a party other than AcelRx ultimately combines with Tetraphase, they will promote DSUVIA and AcelRx will continue to promote XERAVA. AcelRx will provide additional updates to its stockholders regarding Tetraphase at the appropriate time. 

    Webcast and Conference Call Information
    As previously announced, AcelRx will host a live webcast Monday, May 11, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures
    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated procurement by the military, the expected closing and timing and the likelihood of the Tetraphase acquisition, expected benefits from the acquisition of Tetraphase and the co-promotion agreement, and ongoing effects and anticipated impacts to AcelRx's business as a result of the COVID-19 pandemic.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that AcelRx may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the transactions, including through actions taken by competing bidders for Tetraphase, that there may be changes in estimated cash position based on the completion of AcelRx's financial statement closing procedures and the review by AcelRx's independent registered public accounting firm of such financial statements, that potential sales volumes to the Department of Defense may not materialize, or that the impacts AcelRx is experiencing from the ongoing COVID-19 pandemic may be prolonged or exacerbated.  Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx filed with the SEC a registration statement on Form S-4 (No. 333-237584) (the Registration Statement) containing a document constituting a prospectus of AcelRx and a proxy statement of Tetraphase. The Registration Statement was declared effective by the SEC on April 24, 2020, and Tetraphase mailed the definitive proxy statement/prospectus to stockholders of Tetraphase on or about April 28, 2020. AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Registration Statement and the definitive proxy statement/prospectus and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx will be available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase will be available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement/prospectus filed with the SEC on April 24, 2020. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)






     Three Months Ended  


    March 31


    2020


    2019

    Statement of Comprehensive Loss Data








    Revenue:




       Product sales 

    $                 274


    $                       126

       Contract and other collaboration

    112


    139

          Total revenue

    386


    265





    Operating costs and expenses:




    Cost of goods sold (1)

    1,511


    1,230

    Research and development (1)

    1,412


    1,377

    Selling, general and administrative (1)

    13,311


    9,976

    Total operating costs and expenses

    16,234


    12,583

    Loss from operations

    (15,848)


    (12,318)





    Other income (expense):




    Interest expense

    (855)


    (376)

    Interest income and other income (expense), net 

    (65)


    627

    Non-cash interest income (expense) on liability related to sale of future royalties

    843


    (1,607)

    Total other income (expense)

    (77)


    (1,356)

    Net loss

    $          (15,925)


    $                (13,674)





    Basic and diluted net loss per common share

    $              (0.20)


    $                    (0.17)





    Shares used in computing basic and diluted net loss per common share

    80,057


    78,789

















    (1)   Includes the following non-cash, stock-based compensation expense:








                Cost of goods sold

    $                   46


    $                         61

                Research and development

    200


    224

                Selling, general and administrative

    900


    822

                       Total 

    $              1,146


    $                    1,107











    March 31, 2020


    December 31, 2019

    Selected Balance Sheet Data




    Cash, cash equivalents and investments

    $            52,725


    $                  66,137

    Total assets

    77,339


    91,356

    Total liabilities

    132,620


    132,774

    Total stockholders' (deficit) equity 

    (55,281)


    (41,418)

     

    Reconciliation of Non-GAAP Financial Measures

    (Operating Expenses less associated stock-based compensation expense)



     Three Months Ended  


    March 31


    2020


    2019





    Operating expenses (GAAP):




    Research and development 

    $   1,412


    $   1,377

    Selling, general and administrative 

    13,311


    9,976

    Total operating expenses 

    14,723


    11,353

    Less associated stock-based compensation expense 

    1,100


    1,046

    Operating expenses (non-GAAP) 

    $ 13,623


    $ 10,307

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  5. Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals; Acquisition Expected to Close in June 2020

    Continued double digit quarter over quarter growth of XERAVA in U.S. Hospitals and other Institutions with High Antibiotic Usage

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today reported financial results for the first quarter ended March 31, 2020.

    "In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment…

    Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals; Acquisition Expected to Close in June 2020

    Continued double digit quarter over quarter growth of XERAVA in U.S. Hospitals and other Institutions with High Antibiotic Usage

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today reported financial results for the first quarter ended March 31, 2020.

    "In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "In the midst of the ongoing COVID-19 pandemic and the continued rise of antibiotic resistance, our conviction in providing patients with different antibiotic treatment options is stronger than ever, and we believe that together with AcelRx we will be able to more effectively bring XERAVA to patients in healthcare institutions. With an approximate 20% growth in XERAVA net sales in the first quarter compared to the fourth quarter of 2019, we look forward to seeing continued success from the combined Tetraphase and AcelRx teams following the planned close of the acquisition this quarter."

    First Quarter and Recent Highlights

    • Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals, Inc.

    In March 2020, the Company announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA™ net sales milestones starting in 2021. The transaction was unanimously approved by both the AcelRx and Tetraphase boards of directors and is expected to close in the second quarter of 2020. Concurrently with signing the merger agreement, Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA™ for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA® for the treatment of acute pain in medically supervised settings.

    • Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage

    The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date and $1.8 million in XERAVA net sales for the first quarter of 2020, an increase of approximately 20% over the fourth quarter of 2019. Tetraphase's salesforce is focusing on bringing XERAVA to targeted institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be strong, with reorder rates as high as 65% for all accounts and approximately 77% within the Tier 1 account segment. XERAVA is on formulary or available at more than 1,239 accounts. XERAVA continues to outperform all recent IV antibiotic launches anywhere from 3 to 10 fold in patient days of therapy (PDOTs).

    • Completed Equity Financing Totaling Net Proceeds of $15.9 Million

    In January 2020, the Company completed a private placement with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated gross proceeds of approximately $10 million. In addition, the Company concurrently completed a registered direct offering with certain healthcare-focused institutional investors, priced at-the-market, that generated gross proceeds of approximately $7.5 million. The net proceeds from the concurrent January 2020 private placement and registered direct offering were approximately $15.9 million. The Company issued warrants in connection with each financing.

    First Quarter 2020 Financial Results

    As of March 31, 2020, Tetraphase had cash and cash equivalents of $26.1 million and 7.3 million shares outstanding.

    For the first quarter of 2020, Tetraphase reported a net loss of $12.1 million, or $1.31 per share, compared to a net loss of $19.5 million, or $7.25 per share, for the same period in 2019, driven by increased product revenues, lower operating expenses and an increase in the weighted-average number of shares outstanding.

    Total revenues were $1.8 million for the first quarter of 2020, all of which was from sales of XERAVA, compared to $1.3 million for the same period in 2019, of which $0.3 million was from sales of XERAVA and $0.9 million was government contract revenue.

    Research and development (R&D) expenses for the first quarter of 2020 were $1.9 million, compared to $6.7 million for the same period in 2019. The decrease in R&D expenses was driven by the completion of XERAVA development and our corporate reorganization in June 2019, which included the cessation of development of our pipeline candidates.

    Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $10.7 million, compared to $13.3 million for the same period in 2019. The decrease was driven by our 2019 corporate reorganization as well as tight expense control during Q1 2020, offset by increased expenses related to the AcelRX merger transaction announced in March 2020.

    About XERAVATM

    XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

    XERAVATM Important Safety Information

    XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

    XERAVA is not indicated for the treatment of complicated urinary tract infections.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

    The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

    XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

    To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

    Please see full prescribing information for XERAVA.

    About Tetraphase Pharmaceuticals, Inc.

    Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using its proprietary chemistry technology to create novel tetracyclines for serious and life-threatening conditions, including infections caused by many of the multidrug-resistant bacteria highlighted as urgent public health threats by the World Health Organization and the Centers for Disease Control and Prevention. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product XERAVA™ is approved for the treatment of complicated intra-abdominal infections by the U.S. Food and Drug Administration and the European Medicines Agency. The Company's pipeline also includes antibiotics TP-271 and TP-6076, which are Phase 2 ready, and TP-2846, which is in preclinical testing for acute myeloid leukemia. The Company intends to out license its pipeline candidates. Please visit www.tphase.com for more company information.

    Additional Information and Where to Find it

    The Company filed a proxy statement with the Securities and Exchange Commission ("SEC") in connection with the proposed transaction with AcelRx, including a form of proxy card, on April 24, 2020. The proxy statement and form of proxy card have been mailed to the Company's stockholders beginning on April 28, 2020. The proxy statement contains important information about the Company, AcelRx, the merger and related matters. Investors and security holders are urged to read the proxy statement carefully.

    Investors and security holders can obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders can obtain free copies of the proxy statement from the Company by written request to the Company at Tetraphase Pharmaceuticals, Inc., 480 Arsenal Way, Watertown, Massachusetts 02472, Attn: Secretary or by calling (617) 715-3600.

    The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect to the transactions contemplated by the merger agreement. Information regarding the Company's directors and executive officers, including the direct and indirect interests of the Company's directors and executive officers in the merger, is contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 12, 2020 and in the proxy statement dated April 24, 2020, each of which is filed with the SEC. These documents can be obtained free of charge from the sources listed above.

    Forward-Looking Statements

    Statements in this press release regarding the proposed transaction between AcelRx and Tetraphase, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company and any other statements about our future expectations, beliefs, goals, plans or prospects constitute forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing "believes," "anticipates," "plans," "expects," "may," "will," "would," "intends," "estimates" and similar expressions) should also be considered to be forward‑looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether our cash runway and expected revenue will be sufficient to fund our operations in the future; the risk that the proposed merger may not be completed in a timely manner, or at all, which may adversely affect our business and the price of our common stock; the failure to satisfy all of the closing conditions of the proposed merger, including the adoption of the merger agreement by Tetraphase's stockholders; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed merger on Tetraphase's business, operating results and relationships with customers, suppliers, competitors and others; potential difficulties retaining employees as a result of the proposed merger; the outcome of any legal proceedings that may be instituted against us related to the merger agreement or the proposed merger; risks relating to the impact of COVID-19 on our business and operations, including the impact on [demand for our product, our ability to operate remotely given the shut-down of our offices and our ability to access accounts]; risks relating to product development and commercialization; risks associated with competition; and other commercial and other risk factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on [May 7, 2020]. In addition, the forward-looking statements included in this press release represent our views as of [May 7, 2020]. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

     
    Tetraphase Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets (unaudited)
    (In thousands)
     

    March 31,

    December 31,

     

    2020

     

    2019

    Assets
    Cash and cash equivalents

    $

    26,146

    $

    21,239

    Accounts receivable, net

     

    1,706

     

    1,503

    Inventory

     

    788

     

    1,595

    Prepaid expenses and other current assets

     

    1,178

     

    2,156

    Property and equipment, net

     

    78

     

    98

    Intangible assets, net

     

    4,160

     

    4,259

    Operating lease right-of-use assets

     

    2,598

     

    4,836

    Restricted cash

     

    699

     

    699

    Total assets

    $

    37,353

    $

    36,385

     
    Liabilities and Stockholders' equity
    Accounts payable and accrued expenses

    $

    7,212

    $

    8,223

    Operating lease liabilities

     

    2,686

     

    4,995

    Total stockholders' equity

     

    27,455

     

    23,167

    Total liabilities and stockholders' equity

    $

    37,353

    $

    36,385

     
     
    Tetraphase Pharmaceuticals, Inc.
    Condensed Consolidated Statement of Operations (Unaudited)
    (In thousands, except per share data)
     

    Three Months Ended

    March 31,

     

    2020

     

     

    2019

     

     
    Revenues:
    Product revenue, net

    $

    1,755

     

    $

    341

     

    Government revenue

     

    -

     

     

    932

     

    Total revenue

     

    1,755

     

     

    1,273

     

    Expenses:
    Cost of revenue - product sales

     

    1,360

     

     

    164

     

    Cost of revenue - intangible asset amortization

     

    98

     

     

    98

     

    Research and development

     

    1,893

     

     

    6,737

     

    Selling, general and administrative

     

    10,668

     

     

    13,314

     

    Total expenses

     

    14,019

     

     

    20,313

     

    Loss from operations

     

    (12,264

    )

     

    (19,040

    )

    Other income and expenses

     

    140

     

     

    (448

    )

    Net loss

    $

    (12,124

    )

    $

    (19,488

    )

    Net loss per share-basic and diluted

    $

    (1.31

    )

    $

    (7.25

    )

    Weighted-average number of common shares used in net loss per
    share-basic and diluted

     

    9,273

     

     

    2,687

     

     

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