On May 12, 2020 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended March 31, 2020 (Press release, Adaptive Biotechnologies, MAY 12, 2020, View Source [SID1234557598]).

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"Adaptive’s immune medicine platform was built to decode the specific immune response to any disease, which we are now applying in full force to COVID-19," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Importantly, we are able to do this while maintaining focus on our current products and future pipeline."

Recent Highlights

Revenue of $20.9 million for the first quarter of 2020, representing a 65% increase over the corresponding period in 2019

Clinical tests for clonoSEQ increased 75% to 3,518 clinical tests in the first quarter of 2020, compared to the first quarter 2019

Extended existing partnership with Microsoft to decode the adaptive immune response to COVID-19 and potentially develop an improved diagnostic; data to be made publicly available

Announced strategic partnership with Amgen to leverage Adaptive’s immune medicine platform to discover and develop therapeutic antibodies for COVID-19

Executed South San Francisco lease expansion to construct personalized cell therapy prototyping lab for Genentech collaboration

First Quarter 2020 Financial Results

Revenue was $20.9 million for the quarter ended March 31, 2020, representing a 65% increase from the first quarter in the prior year. Sequencing revenue was $9.5 million for the quarter, representing a 56% increase from the first quarter in the prior year. Development revenue increased to $11.4 million for the quarter, representing a 74% increase from the first quarter in the prior year.

Operating expenses were $55.5 million for the first quarter of 2020, compared to $32.7 million in the first quarter of the prior year, representing an increase of 70%.

Net loss was $31.4 million for the first quarter of 2020, compared to $18.4 million for the same period in 2019.

Adjusted EBITDA (non-GAAP) was a loss of $28.0 million for the first quarter of 2020, compared to a loss of $15.2 million for the first quarter of the prior year.

Cash, cash equivalents and marketable securities was $655.8 million as of March 31, 2020.

2020 Financial Guidance

Given the ongoing uncertainty of the scope, duration and impact of the COVID-19 pandemic, Adaptive Biotechnologies is withdrawing its previously announced annual revenue guidance for 2020, which was issued on February 26, 2020.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter financial results after market close on Tuesday, May 12, 2020 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On May 12, 2020 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the first quarter ended March 31, 2020 (Press release, Novavax, MAY 12, 2020, View Source [SID1234557597]).

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"Our accomplishments to-date in 2020, including significant progress in our influenza and COVID-19 vaccine programs, are the most impressive in the company’s history," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We shared successful pivotal Phase 3 results for NanoFlu that demonstrated both efficacy and safety in a pivotal trial, a significant milestone towards bringing this innovative product to an influenza market in need of new options. We also reacted quickly to the coronavirus pandemic by developing and quickly advancing NVX-CoV2373, our COVID-19 vaccine candidate, which shows strong potential to have a positive impact on this global health crisis. Looking ahead, with a strengthened balance sheet and CEPI’s substantial funding, we will focus on scaling up manufacturing and delivering clinical data for NVX-CoV2373, while simultaneously completing the necessary actions needed to prepare our BLA filing for NanoFlu."

First Quarter 2020 and Subsequent Operational Highlights

NanoFlu Program

·Novavax announced in March that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant, achieved all primary objectives in its pivotal Phase 3 clinical trial in older adults. As required by the FDA’s accelerated approval pathway, the trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to a licensed vaccine (Fluzone Quadrivalent), using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. These endpoints were met for all four strains included in NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu was well-tolerated, with a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).

·NanoFlu also achieved statistical significance for key secondary endpoints. These key endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents. NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine and, importantly, for four tested drifted H3N2 strains not included in the vaccine but circulating this year.

·Results from this Phase 3 clinical trial will support a U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway.

COVID-19 Program

·As announced today, the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to an additional $384 million to advance clinical development of NVX-CoV2373. Novavax will use the CEPI funds to advance NVX-CoV2373 into clinical testing. With its earlier $4 million commitment in March, the extended collaboration brings CEPI’s total investment in NVX-CoV2373 to $388 million.

·In January, Novavax identified its coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Novavax’ proprietary Matrix-M adjuvant is included in NVX-CoV2373, to enhance immune responses and stimulate high levels of neutralizing antibodies.

·NVX-CoV2373 was highly immunogenic in animal models measuring spike protein-specific antibodies, with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies observed. Blocking of the binding of the spike protein to the receptor as well as wild-type virus neutralizing antibodies was also observed, with high levels of spike protein-specific antibodies after a single immunization. The already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.

·The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 portion of this trial will be placebo-controlled and observer blinded in ~130 healthy adults and will include assessment of dosage and vaccination. Recruiting for the trial began this month with preliminary immunogenicity and safety results expected in July.

·Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials. This agreement offers the potential to leverage Emergent’s rapid deployment capabilities and expertise that provide Novavax scalability and capacity to produce vaccine product.

ResVax Program

·Novavax is currently discussing the opportunity to bring ResVax to market globally with multiple potential commercial partners. In addition, Novavax continues to define regulatory licensure requirements and pathways in the U.S., the European Union and other geographies.

Matrix-M Partnership

·In March, Novavax announced a commercial license agreement related to its Matrix-M vaccine adjuvant. Matrix-M is a key component of Serum Institute of India’s malaria vaccine candidate, which it licensed from Jenner Institute at Oxford University. The vaccine candidate is currently in a Phase 2b clinical trial being conducted in Burkina Faso with top-line data expected in the second quarter of 2020.

Corporate

·Through utilization of At-the-market (ATM) offerings during the first quarter of 2020, Novavax raised net proceeds of $186 million. Subsequent to quarter-end, through May 8, 2020, Novavax raised additional net proceeds of $74 million, for a total of $260 million since the beginning of the year.

Financial Results for the Three Months Ended March 31, 2020

Novavax reported a net loss of $25.9 million, or $0.58 per share, for the first quarter of 2020, compared to a net loss of $43.2 million, or $2.11 per share, for the first quarter of 2019.

Novavax revenue in the first quarter of 2020 was $3.4 million, compared to $4.0 million in the same period in 2019. This 15% decrease was primarly due to the conclusion of the Prepare trial in 2019, partially offset by revenue from CEPI’s funding.

Research and development expenses decreased 52% to $16.9 million in the first quarter of 2020, compared to $35.5 million in the same period in 2019. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction in 2019.

General and administrative expenses increased to $9.4 million in the first quarter of 2020, compared to $8.7 million for the same period in 2019.

Interest income (expense), net for the first quarter of 2020 and 2019 was ($3.0) million.

As of March 31, 2020, Novavax had $244.7 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash used in operating activities for the first quarter of 2020 was $23.1 million, compared to $50.6 million for same period in 2019.

Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 1274143. A replay of the conference call will be available starting at 7:30 p.m. ET on May 11, 2020 until 7:30 p.m. ET on May 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 1274143.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until August 11, 2020.

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant. Top-line data from Novavax’ ongoing Phase 3 clinical trial of NanoFlu is expected late in the first quarter of 2020.

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX-CoV2373 will initiate in May 2020 with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX-CoV2373.

About Matrix-M

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

On May 12, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the closing of its previously announced underwritten public offering of 6,388,889 shares of its common stock at a price to the public of $18.00 per share (Press release, Syndax, MAY 12, 2020, View Source [SID1234557596]). This includes the exercise in full by the underwriters of their option to purchase up to 833,333 additional shares of common stock. The aggregate gross proceeds to Syndax from this offering were approximately $115 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Syndax.

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Citigroup and Cowen acted as joint book-running managers for the offering. Barclays acted as joint bookrunning manager. BTIG acted as lead manager, and Baird acted as co-manager.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities 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.

On May 13, 2020 Vaxart, Inc. ("Vaxart" or the "Company"), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Aviragen Therapeutics, MAY 12, 2020, View Source [SID1234557595]).

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"In January we pivoted to COVID-19, and we are now on track to start a first Phase 1 study in the second half of this year with our oral tablet vaccine," said Wouter Latour, MD, chief executive officer of Vaxart, "We are developing a state-of-the-art gene-based vaccine utilizing our proprietary vector platform, and the lead candidate vaccines performed well in preclinical testing, generating very high levels of antibodies."

"For COVID-19, a key challenge will be to manufacture sufficient vaccine and efficiently vaccinate the millions at risk, and ultimately the entire population. Our vaccines are administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectable vaccines in large vaccination campaigns. The bulk vaccine does not require sterile fill and finish, a significant bottleneck for injectable vaccines, but can be tableted very efficiently using high throughput industrial tableting equipment."

Corporate Highlights:

In preclinical testing, the Company’s lead vaccine candidates generated robust anti-SARS CoV-2 antibodies in all tested animals after both the first and second dose, with a clear boosting effect after the second dose. Antibody responses in all vaccinated groups were statistically significant (p<0.002), with median ELISA IgG antibody titers above 10,000 compared to a median titer of 1 in the untreated controls, a larger than 10,000 fold increase.

The manufacturing collaboration with Emergent BioSolutions is progressing well and, provided Vaxart elects to proceed, Emergent is on schedule to produce bulk cGMP vaccine in time for initiation of a Phase 1 clinical study during the second half of 2020.

The Universal Influenza vaccine collaboration with Janssen remains on schedule to provide results by mid-2020.

The Company continues to pursue strategic, financial and public-private partnerships to advance its development candidates, including its coronavirus vaccine candidates, norovirus and seasonal influenza vaccine programs.

Financial Results for the Three Months Ended March 31, 2020

Vaxart reported a net loss of $1.3 million for the first quarter of both 2020 and 2019. Net loss per share was $0.02 in 2020 compared to $0.18 in 2019 due to an increase in the number of shares outstanding.

Vaxart ended the quarter with cash and cash equivalents of $29.9 million compared to $13.5 million at December 31, 2019. The increase was primarily due to $9.2 million of net proceeds raised in a registered direct offering of common stock and warrants and $10.3 million from the exercise of common stock warrants, partially offset by $3.2 million of cash used in operations.

Revenue for the quarter was $2.9 million compared to $5.4 million in the first quarter of 2019. The $2.5 million decrease was principally due to the loss of royalty revenue of $0.7 million for Relenza following the expiration of the patent and a decrease of $1.9 million in royalty revenue for Inavir, partly due to higher sales in the three months ended December 31, 2019.

Research and development expenses were $1.5 million for the quarter compared to $3.8 million for the first quarter of 2019. The decrease was mainly due to a reduction in personnel costs after we ceased internal manufacturing as part of our December 2019 restructuring and a reduction in expenditure on our norovirus vaccine candidate.

General and administrative expenses were $2.0 million for the quarter, substantially unchanged from the first quarter of 2019.

On May 12, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2020 (Press release, Curis, MAY 12, 2020, View Source [SID1234557594]).

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"The first quarter of 2020 was productive for Curis, as we advanced our ongoing study for CA-4948 and accomplished several key licensing and financial objectives to support future progress across our pipeline and business," said James Dentzer, President and Chief Executive Officer of Curis. "In response to the COVID-19 pandemic, we have implemented both clinical and operational measures to help protect patients, staff, study investigators and our community, and I am incredibly proud of the resiliency and dedication our team continues to demonstrate during this difficult period. We look forward to updating efficacy data from our CA-4948 study in patients with non-Hodgkin’s lymphoma (NHL) and remain on track to pursue clinical testing of CA-4948 in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), two areas of critical unmet need."

First Quarter 2020 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating its IRAK4 inhibitor, CA-4948 in an ongoing Phase 1 dose escalation study for the treatment of patients with relapsed or refractory (R/R) NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The Phase 1 study is on track and the Company expects to report updated efficacy data from the study and declare the recommended Phase 2 dose in 2020.
Due to the corona virus, certain sites for the Phase 1 study remain open for enrollment, while other sites have temporarily halted enrollment of new patients. Curis and its study investigators continue to monitor the COVID-19 pandemic and are focused on the safety and treatment of patients currently enrolled in the study.
Curis expects to initiate a separate Phase 1 trial of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, in the second quarter of 2020.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead clinical-stage compound, CI-8993. Ongoing non-clinical studies are underway, and the initial clinical study will begin in the second half of 2020.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Fimepinostat has previously been shown to induce durable single-agent responses in difficult-to-treat lymphomas, including MYC-driven and double-hit disease. Curis is collaborating with DarwinHealth on ongoing analytical research to characterize biomarkers and tumor subtype alignments, which may help guide future clinical development opportunities with fimepinostat.
COVID-19 and Business Operations:

Curis has implemented several clinical and operational measures to support the safety of patients, staff, and study investigators and maintain rigorous clinical trial conduct. Curis currently believes there will be no disruption to the clinical supply of CA-4948 or CI-8993. The Company is in close contact with its partners and manufacturers, and all parties have established procedures to manage drug supply during the COVID-19 pandemic.
Consistent with guidelines from the Centers for Disease Control (CDC) and the Commonwealth of Massachusetts, Curis has implemented certain measures, such as ordering all employees to work remotely and restricting business travel, to help maintain the safety of its employees, families and community.
Upcoming 2020 Planned Milestones

Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study.
Initiate a Phase 1 study of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, in the second quarter of 2020.
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
First Quarter 2020 Financial Results

For the first quarter of 2020, Curis reported a net loss of $9.7 million, or $0.28 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or $0.30 per share on both a basic and diluted basis for the same period in 2019.

Revenues for the first quarter of 2020 were $2.7 million, as compared to $1.8 million for the same period in 2019. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the first quarter of 2020 were $11.2 million, as compared to $7.3 million for the same period in 2019, 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 $0.1 million for both the first quarter of 2020 and 2019.

Research and Development Expenses. Research and development expenses were $7.5 million for the first quarter of 2020, as compared to $4.1 million for the same period in 2019. The increase was primarily due to in-license expenses incurred from Curis’ option and license agreement with ImmuNext, and increased costs related to clinical activities including consulting, outside lab expenses, and Contract Research Organization (CRO) services.

General and Administrative Expenses. General and administrative expenses were $3.6 million for the first quarter of 2020, as compared to $3.1 million for the same period in 2019. The increase was driven primarily by higher legal services during the period.

Other expense, net. Net other expense was $1.2 for the first quarter of 2020, as compared to $4.3 million for the same period in 2019. Net other expense for the first quarter 2020 primarily consisted of imputed interest expense related to future royalty payments, whereas in 2019 the expense related to the extinguishment of debt.

As of March 31, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $12.5 million and there were approximately 36.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, May 12, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.