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.

On May 12, 2020, Genocea Biosciences Presented the Corporate Presentation (Presentation, Genocea Biosciences, MAY 12, 2020, View Source [SID1234557593]).

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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.