Danaher Announces Closing Of Common Stock Offering And Mandatory Convertible Preferred Stock Offering

On May 12, 2020 Danaher Corporation (NYSE: DHR) ("Danaher") reported that it has closed concurrent offerings of 9,509,203 shares of common stock at a price to the public of $163.00 per share and 1,717,500 shares of 5.00% Series B Mandatory Convertible Preferred Stock at a price to the public of $1,000 per share (the "offerings") (Press release, Danaher, MAY 12, 2020, View Source [SID1234557623]). These offerings were made by means of separate prospectus supplements and were not contingent on each other. The shares of Series B Mandatory Convertible Preferred Stock sold include 167,500 shares issued pursuant to the exercise in full of the separate option granted to the underwriters in the Series B Mandatory Convertible Preferred Stock offering to purchase additional shares. The option granted to the underwriters to purchase an additional 1,426,379 shares of common stock in the common stock offering was exercised in full on May 12, 2020 and is anticipated to close on or about May 14, 2020.

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The net proceeds from the common stock offering and the Series B Mandatory Convertible Preferred Stock offering were approximately $1.50 billion and $1.67 billion, respectively, which includes the proceeds of the exercise in full of the underwriters’ option to purchase additional Series B Mandatory Convertible Preferred Stock, in each case after deducting issuance costs and discounts. The net proceeds from the closing of the option to purchase the additional 1,426,379 shares is anticipated to be approximately $225.5 million.

Danaher anticipates using the net proceeds for general corporate purposes, which may include, without limitation and in our sole discretion, funding potential future acquisitions and investments, working capital, capital expenditures, investments in or loans to our subsidiaries, refinancing of outstanding indebtedness, refinancing of outstanding capital securities, share repurchases (including, but not limited to, repurchases of our common stock), dividends and satisfaction of other obligations.

Goldman Sachs & Co. LLC, J.P. Morgan, Citigroup and Evercore acted as representatives of the underwriters and joint book-running managers for the offerings. Credit Suisse also served as a joint book-running manager for the offerings and BTIG, COMMERZBANK, Mizuho Securities, MUFG, Raymond James, RBC Capital Markets, Scotiabank, SMBC, TD Securities, US Bancorp and Wells Fargo Securities served as co-managers for the offerings.

The offerings were made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission. Each offering was made only by means of a prospectus supplement relating to such offering and the accompanying base prospectus. An electronic copy of each prospectus supplement, together with the accompanying prospectus, is available on the SEC’s website at www.sec.gov. Alternatively, copies of each prospectus supplement and accompanying prospectus relating to either offering can be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, Telephone: 1-866-471-2526, Email: [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, Email: [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: 1-800-831-9146; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, Telephone: 888-474-0200, Email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the common stock, the Series B Mandatory Convertible Preferred Stock or any other securities, nor shall there be any offer, solicitation or sale of any security mentioned in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

VBL Therapeutics Closes $10.0 Million Registered Direct Offering and Announces $8.1 Million Registered Direct Offering to Key Current Shareholders, Each Priced At-the-Market under Nasdaq Rules

On May 12, 2020 VBL Therapeutics (Nasdaq: VBLT), reported that it has closed the previously announced registered direct offering of 6,349,208 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, VBL Therapeutics, MAY 12, 2020, View Source [SID1234557562]). VBL has also issued to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 6,349,208 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, are immediately exercisable and will expire on November 11, 2020. The registered direct offering closed on May 11, 2020.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from this offering were approximately $10.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) were offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The offering of the ordinary shares was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares offered have been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

$8.1 Million Registered Direct Offering to Key Current Shareholders

VBL also announced today that it has entered into definitive agreements with two of the Company’s largest current shareholders (the "Second Offering") for the purchase and sale of 5,142,857 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules. VBL has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 5,142,857 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, will be immediately exercisable and will expire on November 11, 2021.

This Second Offering enables the participating shareholders to maintain, or increase, their relative holdings at the Company, under the same terms of the offering that was concluded on May 11, 2020.

The Second Offering is expected to close on or about May 12, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the Second Offering.

The gross proceeds from the Second Offering are expected to be approximately $8.1 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) to be issued in the Second Offering are being offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The Second Offering of the ordinary shares will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares being offered in the Second Offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above are being offered in the Second Offering in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Capital Increase in Genmab as a Result of Employee Warrant Exercise

On May 12, 2020 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 69,090 shares as a consequence of the exercise of employee warrants (Press release, Genmab, MAY 12, 2020, View Source [SID1234557592]).

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The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

815 shares at DKK 31.75,
3,200 shares at DKK 40.41,
38,750 shares at DKK 46.74,
250 shares at DKK 66.60,
250 shares at DKK 67.50,
1,000 shares at DKK 199.00,
1,000 shares at DKK 210.00,
600 shares at DKK 220.40,
750 shares at DKK 225.30,
14,162 shares at DKK 225.90,
275 shares at DKK 231.50,
1,000 shares at DKK 337.40,
175 shares at DKK 466.20,
275 shares at DKK 623.50,
1,550 shares at DKK 636.50,
2,000 shares at DKK 815.50,
1,280 shares at DKK 939.50,
675 shares at DKK 1,136.00,
815 shares at DKK 1,145.00,
150 shares at DKK 1,233.00, and
118 shares at DKK 1,402.00

Proceeds to the company are approximately DKK 12 million. The increase corresponds to approximately 0.11% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription, i.e. inter alia full rights to dividends for the financial year 2020. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No 377 of April 2, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,280,093 which is made up of 65,280,093 shares of a nominal value of DKK 1 each, corresponding to 65,280,093 votes.

Seattle Genetics Announces the Approval of TUKYSA™ (tucatinib) in Switzerland for the Treatment of Patients with Metastatic HER2-Positive Breast Cancer

On May 12, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (T–DM1) (Press release, Seattle Genetics, MAY 12, 2020, View Source [SID1234557608]).

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The application for TUKYSA approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies in Canada, Australia and Singapore. On April 17, the FDA approved TUKYSA in the U.S. under the FDA’s Real-Time Oncology Review (RTOR) pilot program, four months prior to its action date, and represented the first new drug approved under Project Orbis.

"We’re grateful to Swissmedic for their collaboration through FDA’s Project Orbis in approving this important new medicine in Switzerland," said Jennifer Stephens, Vice President of Regulatory Affairs at Seattle Genetics. "We’re committed to bringing new targeted therapies to patients, and we are excited about this important first step toward making TUKYSA available to patients in Switzerland."

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.i,ii

The approval is based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published inThe New England Journal of Medicinein December 2019.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe. iii Between 15 and 20 percent of breast cancer cases are HER2-positive.iv Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.v,vi,vii Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.viii,ix,x

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.xi In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Important U.S. Safety Information

Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 5% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.
For more information, please see the full Prescribing Information for TUKYSA here.

Aridis Pharmaceuticals Announces First Quarter 2020 Results

On May 12, 2020 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, reported financial and corporate results for the first quarter ended March 31, 2020 (Press release, Aridis Pharmaceuticals, MAY 12, 2020, View Source [SID1234557624]).

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First Quarter Highlights and Recent Developments

Enrolled the first patient with COVID-19 in AR-301 Phase 3 trial for patients with ventilator associated pneumonia (VAP)
Initiated dosing of the last dose cohort in the healthy volunteer portion of the AR-501 Phase 1/2a clinical trial with top-line data provisionally expected in 1H 2020 (healthy subjects), and in 2H 2021 (cystic fibrosis subjects)
Commenced COVID-19 monoclonal antibody and vaccine discovery activities utilizing the APEX platform technology
"While the COVID-19 pandemic has provided significant headwinds to patient trial enrollment across therapeutic indications including our own ongoing studies, we were still able to advance our lead programs and in fact, enrolled our first patient diagnosed with COVID-19 and on a ventilator into the AR-301 Phase 3 VAP study," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Furthermore, the pandemic provided a unique opportunity to leverage our APEX platform technology for the rapid discovery and development of highly potent monoclonal antibodies from convalescent COVID-19 patients."

During the quarter, Aridis initiated COVID-19 monoclonal antibody and vaccine discovery activities utilizing its APEX technology platform for the unbiased discovery of new and highly potent antibodies against pathogens. The APEX platform is comprised of a silicon wafer-based array of nanoliter sized tissue micro-culture wells that enable rapid screening of antibody secreting cells, enabling discovery of potent antibodies against targets such as the virus that causes COVID-19 disease (called ‘SARS-CoV-2’) within a few days of patient sample availability. It also features CRISPR enabled activation of endogenous genetic control elements that dramatically increase the yield of bio-therapeutic drugs from manufacturing production cell lines. The technology also features a proprietary production cell line that is designed to rapidly manufacture multiple monoclonal antibody therapeutics at approximately half the manufacturing cycle time than currently available manufacturing technologies.

Clinical Program Update

AR-301: In April, Aridis enrolled its first COVID-19 patient in the Company’s ongoing Phase 3 clinical trial of AR-301. COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called ‘superinfections’) by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and rate of mortality. The Company’s ongoing AR-301 Phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. While AR-301 is not an agent to treat SARS-CoV-2 virus itself, it can potentially reduce the morbidity associated with secondary S. aureus pneumonia, which is a coronavirus complication and a contributing cause of death in such patients.

The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. However, the advent of coronavirus infections which became apparent during the fourth quarter of 2019, impacted the global patient enrollment rate, and delayed further clinical site activations in regions with large number of clinical sites, such as in China and India. Contingent upon the evolution of the coronavirus pandemic, Aridis is provisionally expecting interim data to be reported in 2H 2020, and top line data in 2H 2021. Participating clinical centers that are activated continue to follow the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-301 is a fully human monoclonal IgG1 antibody specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

AR-501: During the first quarter, Aridis initiated dosing of the last dose cohort in healthy volunteer portion of the AR-501 Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated for the treatment of chronic lung infections associated with cystic fibrosis. The single ascending dose cohorts of healthy subjects have completed dosing and the safety monitoring committee has recommended proceeding into the multiple ascending dose cohorts. The Company expects to report data from the Phase 1 portion of the trial which consists of healthy subjects provisionally in 1H 2020 and the Phase 2a segment with cystic fibrosis subjects in 2H 2021.

AR-501, which is being developed in collaboration with the Cystic Fibrosis Foundation (CFF), has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the U.S. Food and Drug Administration (FDA). In addition, the European Medicines Agency (EMA) granted ODD to AR-501. Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study is expected to accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S.

Corporate Update

During the first quarter, Aridis continued to present at leading investor and medical conferences, which due to the COVID-19 pandemic have been transitioned to virtual forums. The Company participated in Maxim Group’s Infectious Disease Virtual Conference held on May 5, 2020. The event consisted of four panels of companies in various stages of development, from early stage to near commercialization, that represent the next wave of innovation in the infectious disease sector. Vu Truong, Ph.D., Aridis’ Chief Executive Officer, was a speaker on two panels entitled "Non-antibiotic Anti-infectives" and "COVID-19 (Therapeutics)." The presentation slides can be found at View Source

Fiscal 2020 First Quarter Results:

Cash: Total cash and cash equivalents as of March 31, 2020 was $16.3 million.
Revenues: Grant revenue decreased from approximately $1.0 million for the quarter ended March 31, 2019 to zero for the quarter ended March 31, 2020 primarily due to the recognition of revenue related to a milestone under the grant award from the CFF during the first quarter of 2019 and none during the first quarter of 2020.
Research and Development Expenses: Research and development expenses incurred in the quarter ended March 31, 2020 were $4.9 million, a decrease of approximately $2.2 million over the same period in 2019 due primarily to a decrease in spending on clinical trial activities for the AR-105 Phase 2 program, which was completed in 2019, and a decrease in drug manufacturing expenses related to the AR-301 Phase 3 program. These decreases were partially offset by an increase in spending on clinical trial activities for both the AR-301 Phase 3 and the AR-501 Phase 1/2a programs.
General and Administrative Expenses: There was no material difference in general and administrative expenses for the quarter ended March 31, 2020 when compared to the same period in 2019.
Interest and Other Income, net: Interest and other income, net was $61,000 for the quarter ended March 31, 2020, a decrease of approximately $55,000 over the same period in 2019. These decreases were due primarily to a lower average cash balance and lower interest rates.
Share of Loss from Equity Method Investment: Loss from equity method investment decreased by $433,000 to $9,000 for the quarter ended March 31, 2020 over the same period in 2019 due to our share of loss from our minority interest under the equity method was limited to the book value of the investment.
Net Loss: The net loss for the quarter ended March 31, 2020 was $6.5 million, or ($0.73) per share, compared to a net loss of approximately $8.1 million, or ($0.99) per share, for the quarter ended March 31, 2019. The weighted average common shares outstanding was approximately 8.9 million and approximately 8.1 million for the first quarter of 2020 and 2019, respectively.