On May 09, 2016 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the first quarter ended March 31, 2016 (Press release, Curis, MAY 9, 2016, View Source [SID:1234512108]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the initiation of the Phase 2 study with CUDC-907 earlier this year in patients with relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL) that harbor MYC alterations," said Ali Fattaey, Ph.D., Curis’s President and CEO. "At the recent AACR (Free AACR Whitepaper) annual conference, we presented preclinical data, which provide further evidence for CUDC-907’s effect on downregulating MYC and its anti-tumor activity in multiple lymphoma and solid tumor models with alterations in MYC oncogene."

Dr. Fattaey continued, "All IND enabling studies with CA-170 have been completed, and we remain on track to initiate a Phase 1 study in cancer patients in the first half of 2016 with CA-170 as our first oral immuno-oncology drug candidate. Additionally, preclinical development of small molecule leads that target PD-L1 and TIM3 in our second immuno-oncology program is progressing well and these candidates further underscore the potential of this discovery platform to generate multiple oral small molecule drug candidates that can modulate independent immune checkpoint targets."

First Quarter 2016 Financial Results

Curis reported a net loss of $9.4 million, or ($0.07) per share, on both a basic and diluted basis for the first quarter of 2016, as compared to a net loss of $31.8 million, or ($0.30) per share, on both a basic and diluted basis for the same period in 2015. The net loss for the prior year period includes a non-cash in-process research and development charge of $24.3 million related to Curis’s license agreement with Aurigene.

Revenues were $1.7 million for each of the first quarters of 2016 and 2015. Revenues for both periods are comprised primarily of royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $10.5 million for the first quarter of 2016, as compared to $32.7 million for the same period in 2015, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $89,000 for the first quarter of 2016, up from $84,000 during the first quarter of 2015.

In-Process Research and Development Expense. No in-process research and development expenses were recorded for the three months ended March 31, 2016 as compared to $24.3 million recorded during the first quarter of 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of our January 2015 collaboration agreement.

Research and Development Expenses. Research and development expenses were $6.8 million for the first quarter of 2016, as compared to $4.7 million for the same period in 2015. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and programs under the Aurigene collaboration over the prior year period. Employee-related expenses increased over the prior year period primarily due to additional headcount to support the multiple programs.

General and Administrative Expenses. General and administrative expenses remained unchanged at $3.5 million for first quarter of 2016 and $3.5 million for the same period in 2015.

Other expense was $635,000 for the first quarter of 2016, as compared to $827,000 for the same period in 2015. Other expense primarily consisted of $740,000 and $867,000 in interest expense for the quarters ended March 31, 2016 and 2015, respectively, related to the loan made by BioPharma-II (an investment fund managed by Pharmakon Advisors) to Curis Royalty (a wholly-owned subsidiary of Curis).

As of March 31, 2016, Curis’s cash, cash equivalents, marketable securities and investments totaled $73.1 million and there were approximately 129.0 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology (HDAC / PI3K inhibitor program):

In April 2016, preclinical data were presented for CUDC-907 at the Annual Meeting of American Association of Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans. The presentation included data for CUDC-907’s anti-tumor activity in multiple in vitro and in vivo MYC-altered disease models, including lymphomas and solid tumors, and the molecule’s effect on downregulating MYC levels.

In January 2016, Curis initiated an open label Phase 2 study to evaluate the efficacy and safety of CUDC-907 with and without rituximab in patients with relapsed/refractory MYC-altered DLBCL.
Immuno-oncology (PD-L1 / VISTA antagonist program):

In April 2016, preclinical data were presented for CA-170, a small molecule, orally available antagonist of PD-L1 and VISTA at the Annual AACR (Free AACR Whitepaper) meeting in New Orleans. The data presented included the pharmacologic and safety profile of CA-170 to support its progression into human clinical trials.
Immuno-oncology (PD-L1 / TIM-3 antagonist program):

In April 2016, preclinical data were presented from the orally available, small molecule PD-L1/TIM-3 immune checkpoint antagonist program. Results from in vitro studies with AUPM-327, a representative molecule from the PD-L1/TIM-3 program showed that AUPM-327 can selectively rescue T cell functions that are inhibited by PD-L1 or TIM-3 checkpoint proteins, but does not modulate the effects of other regulators such as VISTA, CTLA4, LAG-3, or CD-28, demonstrating its selectivity. Additionally, daily oral administration of the PD-L1/TIM-3 antagonist resulted in anti-tumor activity in multiple syngeneic tumor models including melanoma and colon cancer.
Precision oncology (IRAK4 inhibitor program):

In April 2016, preclinical data were presented for CA-4948, the oral IRAK4 inhibitor at the Annual AACR (Free AACR Whitepaper) meeting in New Orleans. The presentations outlined CA-4948’s detailed pharmacologic and biologic profile as well as data on its metabolism, pharmacokinetics properties and in vitro toxicity profile. CA-4948 demonstrated potent anti-tumor activity in two in vivo models of MYD88 mutant- DLBCL disease and anti-inflammatory effects in a rodent model of inflammation suggesting the potential use of an IRAK4 inhibitor in both cancer and inflammatory diseases.
Erivedge:

Roche initiated patient enrollment in a Phase 1 clinical study to evaluate the safety and efficacy of Erivedge in combination with ruxolitinib for the treatment of patients with intermediate- or high-risk myelofibrosis.
Roche initiated patient enrollment in a study of Erivedge in combination with pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The study is designed as a single arm, multicenter Phase 1b study to evaluate the safety and tolerability of Erivedge in combination with pirfenidone in participants with IPF currently being treated with pirfenidone.
Upcoming Activities

Curis expects that it will make presentations at the following scientific and investor conferences through June 2016:

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting on June 3-7 in Chicago
Jefferies Healthcare Conference on June 7-10 in New York City
21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) on June 9-12 in Copenhagen, Denmark
Our partner, Roche/Genentech expect to present data on Erivedge at ASCO (Free ASCO Whitepaper) 2016 Annual Meeting in Chicago from June 3-7.

On May 9, 2016 The Medicines Company (NASDAQ:MDCO) reported its business and financial results for the first quarter ended March 31, 2016 (Press release, Medicines Company, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166297 [SID:1234512129]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the first quarter of 2016, the Company has:

PCSK9si (PCSK9 synthesis inhibitor): Continued on pace to recruit up to 480 patients in the ORION-1 clinical program, a Phase 2, placebo-controlled, double-blind, randomized trial to test the efficacy, safety and durability of a range of doses in patients with atherosclerotic cardiovascular disease; we anticipate completion of the trial by the end of 2016.
MDCO-216: Advanced enrollment of patients in the MILANO-PILOT study evaluating the drug’s effects on atherosclerotic plaque burden; trial is set to enroll 120 evaluable patients, with the first 40 patients expected to be analyzed around mid-year 2016;
ABP-700: Transitioned to Phase 2 clinical development with the expectation of enrolling patients for the first study of a global procedural sedation colonoscopy program by end of second quarter; with continued success, we expect to launch Phase 3 clinical testing in 2017;
CARBAVANCE: Announced the granting of fast track status and the anticipated completion of Phase 3 clinical trials during second half 2016; anticipate filing NDA and MAA by end of year;
Revenues for newly- launched products (Kengreal, Cleviprex, Orbactiv, Minocin IV and Ionsys) increased 161% to $10.9 million in the first quarter of 2016 over the same period in 2015.
The Company announced earlier today that it has entered into a definitive agreement to sell its non-core cardiovascular products—Cleviprex (clevidipine), Kengreal (cangrelor) and its rights to Argatroban for Injection—to Chiesi USA, Inc. and its parent company, Chiesi Farmaceutici S.p.A., for up to $792 million, consisting of $260 million in cash payable at closing, up to $480 million in sales-based milestone payments, the assumption by Chiesi of up to $50 million in milestone payment obligations and approximately $2 million for product inventory. The transaction, which is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, is expected to close early in the third quarter of 2016.

Clive Meanwell, MD, PhD, Chief Executive Officer of The Medicines Company, stated: "The divestiture of our non-core cardiovascular products will enable us to drive the continued development of our potential blockbuster R&D products without diluting our shareholders. Each of our four products in development have critical data milestones which we expect will be unveiled over the course of the year. In addition to completing and reporting data for the ORION-1 Phase 2 clinical trial of PCSK9si, we plan to initiate ORION-2, a Phase 2 study in familial homozygous hypercholesterolemia patients during 2016. For MDCO-216, we expect to secure clinical re-proof of concept from the MILANO-PILOT study. Finally, we expect to complete and report data for the Phase 3 registrational trial of Carbavance, as well as the Phase 2 trial of ABP-700. We look forward to sharing these critical updates throughout the year."

First-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $50.3 million for the first quarter of 2016 compared to $110.1 million in the first quarter of 2015. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $16.9 million in the first quarter of 2016 compared to $100.7 million in the first quarter of 2015, with net product sales in the United States decreasing to $13.2 million in the first quarter of 2016 from $95.1 million in the first quarter of 2015 driven by the loss of Angiomax exclusivity in July 2015. Included in total net revenue for the first quarter of 2016 is $18.9 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Other products including Cleviprex, Argatroban for Injection, Minocin for Injection, Orbactiv, Ionsys and Kengreal recorded sales of $14.5 million during the first quarter of 2016 compared to $9.4 million in the first quarter of 2015.

The net loss from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $90.3 million, or $1.31 per share, compared to net income from continuing operations attributable to The Medicines Company of $4.4 million, or $0.07 per share, for the first quarter of 2015. Adjusted net loss(1) from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $71.2 million, or $1.03(1) per share, compared to adjusted net loss(1) from continuing operations attributable to The Medicines Company of $0.1 million for the first quarter of 2015.

First-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. The net loss for the first quarter of 2016 from discontinued operations attributable to The Medicines Company was $2.1 million, or $0.03 per share, compared to net income from discontinued operations attributable to The Medicines Company for the first quarter of 2015 of $0.7 million, or $0.01 per share.

(1) Adjusted net loss and adjusted loss per share from continuing operations attributable to The Medicines Company are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss Per Share sections of this release for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts.

As of March 31, 2016, the Company had $430 million in cash and investments compared to $373 million at the end of 2015.

On May 9, 2016 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the first quarter of 2016 and provided a corporate update on its priorities for 2016 (Filing, 8-K, Apricus Biosciences, MAY 9, 2016, View Source [SID:1234512412]). Apricus will hold a previously announced webcast this morning at 8:00 am PDT with Edward D. Kim, M.D., a member of the Company’s Scientific Advisory Board and a Vitaros clinical investigator, to discuss the Vitaros opportunity as part of the Company’s corporate activities concurrent with the American Urological Association’s 2016 Annual Meeting, May 6 – 10 in San Diego. Please join the webcast at www.apricusbio.com to view the presentation slides or, to participate by telephone, dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In March, we sharpened our focus on growth of the Vitaros brand, as we streamlined our organization in an effort to align our corporate strategy and our financial resources with the goal of achieving profitability in 2017," stated Richard W. Pascoe, Chief Executive Officer. "Importantly, we experienced record Vitaros royalties in Europe in the first quarter of 2016 and we continue to have a productive dialogue with the Food and Drug Administration ("FDA") regarding the Vitaros New Drug Application ("NDA") resubmission content and format. As such, we remain on track to resubmit the NDA for Vitaros U.S. in the third quarter of 2016 with an approval decision expected after a six month review period. Finally, we will continue to work closely with our partners to grow Vitaros revenue by supporting additional regulatory approvals and launches, licensing additional territories, and leveraging our existing partnerships to help ensure Vitaros is actively commercialized in all approved territories."

First Quarter Highlights and Recent Developments

Apricus recently updated its corporate goals to focus on increasing Vitaros’ value through the fostering and expansion of its commercial partnerships, in the U.S. and globally, and strengthening the Company’s financial position. First quarter and recent highlights include:

• Closed on a $10 million registered direct offering with certain institutional investors, including existing investors Sarissa Capital and Aspire Capital;

• Reported top-line Phase 2b data for fispemifene in symptomatic secondary hypogonadism that failed to achieve statistical significance in key clinical benefit endpoints and abandoned further clinical activities surrounding fispemifene; and

• Expanded the Company’s exclusive distribution agreement with Ferring Pharmaceuticals to market Vitaros in the United Kingdom as part of the Company’s ongoing initiative to consolidate Vitaros territories with existing partners in an effort to maximize efficiencies and revenue.

2016 Priorities

Apricus is focused on achieving the following key strategic objectives:

Vitaros* (alprostadil)

• Continue implementation of the U.S. regulatory approval strategy to address the safety and manufacturing issues raised by the FDA in the original Vitaros NDA submission, with an NDA resubmission on target for the third quarter of 2016;

• Continue to support the Company’s ex-U.S. partners’ efforts to increase revenue in countries where partners have launched Vitaros, seek solutions to ensure that Vitaros is available to patients in every country where it is approved but not currently marketed, support new commercial launches by the Company’s partners and assist the Company’s partners in obtaining additional regulatory approvals in their respective territories; and

• Continue to generate the required data in 2016 to support delivery device improvements and related regulatory submission(s) with a priority to support the U.S. NDA resubmission of the refrigerated version of Vitaros.

RayVa (alprostadil)

• Complete the formulation development for at-home dosing;

• Finalize the Phase 2b study protocol;

• Explore Orphan Drug Designation in the U.S. and EU; and

• Explore global or regional partnerships prior to initiating the Phase 2b study.

First Quarter Financial Results

Revenue during the quarter ended March 31, 2016 was $0.6 million, compared to revenue of $0.5 million during the first quarter of 2015. Revenue during the quarter ended March 31, 2016 was comprised of $0.4 million in royalty revenues, an increase of $0.3 million or 317% over the quarter ended March 31, 2015. Revenue during the quarter ended March 31, 2015 included $0.4 million in license fee revenue related to the expansion of the Company’s license agreement with Sandoz to commercialize Vitaros in certain Asian and Pacific countries. Basic net loss for the quarter ended March 31, 2016 was $2.5 million, or basic loss per share of $0.05, compared to a net loss of $6.4 million, or $0.13 per share for the first quarter of 2015. Reducing the net loss for the quarter ended March 31, 2016 was a non-cash change in the fair value of the Company’s warrant liability in the amount of $2.6 million.

As of March 31, 2016, cash and cash equivalents totaled $6.9 million, compared to $3.9 million as of December 31, 2015.

2016 Financial Outlook

Early in the second quarter of 2016, Apricus reduced its staff, including the executive team, by approximately 30%, decreased the size of the Board by one member and reduced the Board’s cash compensation. Apricus plans to continue to reduce operating expenses (excluding non-cash stock-based compensation expense and depreciation expense), with a goal of achieving reductions of approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding non-cash stock-based compensation expense and depreciation expense).

In 2016, Apricus expects to continue to generate cash from milestone or licensing payments and royalty revenues from its partners’ sales of Vitaros. Apricus will also continue to pursue out-licensing opportunities for Vitaros in Asia-Pacific. Apricus’ expenditures will include minimal costs for the preparatory Phase 2b clinical development of RayVa, as well as costs for activities associated with supporting the regulatory approval of Vitaros in the U.S. and the commercialization of Vitaros in Europe.

On May 9, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the first quarter ended March 31, 2016 (Press release, Dynavax Technologies, MAY 9, 2016, View Source [SID:1234512109]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company had $166.8 million in cash, cash equivalents and marketable securities as of March 31, 2016, compared to $196.1 million at December 31, 2015. The net loss for the first quarter of 2016 was $27.0 million, compared to $26.2 million for the first quarter of 2015.

First Quarter Financials

Total revenues for the three months ended March 31, 2016 increased by $0.3 million, or 50%, compared to the same period in 2015.

Research and development expenses for the first quarter decreased by $2.2 million, or 10%, compared to the same period in 2015, reflecting an increase in employee headcount and activities in preparation for the anticipated commercial launch of HEPLISAV-B and a reduction in outside services expense due to lower activity related to HBV-23 following its completion in the fourth quarter of 2015.

General and administrative expenses for the three months ended March 31, 2016, increased by $3.3 million, or 68%, compared to the same period in 2015, as we added headcount and addressed information technology systems and other infrastructure needs in preparation for the anticipated commercial launch of HEPLISAV-B.

The net loss for the quarter ended March 31, 2016 was $27.0 million, or $0.70 per basic and diluted share compared to $26.2 million, or $0.97 per basic and diluted share for the quarter ended March 31, 2015.

Recent Progress

At the end of the quarter, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for HEPLISAV-B, the company’s vaccine for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established December 15th as the Prescription Drug User Fee Act (PDUFA) action date for the BLA.

"We are focused on working with the FDA to obtain approval of HEPLISAV-B before year end and on preparing for launch, including preparation for an advisory panel in case one is called, hiring of key commercial personnel, market and pricing research and manufacturing of launch inventory," said Dynavax Chief Executive Officer, Eddie Gray.

In April, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the National Foundation for Infectious Diseases’ (NFID) 19th Annual Conference on Vaccine Research (ACVR).

Also in April, we presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients. The clinical data, along with preclinical SD-101 data, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

On May 09, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2016 (Press release, Vical, MAY 9, 2016, View Source [SID:1234512130]). Net loss for the first quarter of 2016 was $2.4 million, or $0.03 per share, compared with a net loss of $3.8 million, or $0.04 per share, for the first quarter of 2015. Revenues for the first quarter of 2016 were $4.6 million, compared with revenues of $4.9 million for the first quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under our ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vical had cash and investments of $40.3 million at March 31, 2016. The Company’s net cash use for the first quarter of 2016 was $1.7 million, which was consistent with the Company’s guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million.

Program updates include:

ASP0113 CMV Vaccine

The multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is ongoing and over 80% of the subjects have now been enrolled. Astellas expects enrollment to be completed by the third quarter of 2016, with the top-line data available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have initiated process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

Enrollment in the multinational Phase 2 trial in kidney transplant recipients was completed in May 2015 and the last subject is expected to complete 1 year of follow up later this month. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at 1 year after transplantation. Astellas expects the top-line trial data to be available in the third quarter of 2016.

HSV-2 Therapeutic Vaccine

Trial results, including data on multiple endpoints evaluating safety and efficacy, from our recently completed HSV-2 Phase 1/2 trial will be presented in an oral late-breaker presentation at the American Society of Microbiology (ASM) Microbe/ICAAC 2016 conference on June 20, 2016 in Boston, Massachusetts.

VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be complete by the end of 2016. The U.S. Food and Drug Administration has granted Vical Fast Track, qualified infectious disease product (QIDP) and orphan drug designations for VL-2397 for the treatment of invasive aspergillosis. This invasive fungal infection is associated with a high rate of mortality in immunocompromised patients, underscoring the need for new antifungal therapies. Vical is working closely with a core team of expert advisors to design a proof of concept efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis.

Vical will conduct a conference call and webcast today, May 9, at noon Eastern Time, to discuss the Company’s financial results and program updates with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2484 (preferred), or (888) 523-1228 (toll-free), and reference confirmation code 9062407. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 9062407. The call will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by e-mail at [email protected].