On May 6, 2020 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported its financial results for the first quarter of 2020 and recent business highlights (Press release, Ionis Pharmaceuticals, MAY 6, 2020, View Source [SID1234557120]).

"We achieved numerous value-driving catalysts in the first quarter, setting us up to achieve our strategic objectives for the year. Our commercial medicines continued to perform well, led by SPINRAZA. Our late-stage pipeline continues to advance, and we are particularly pleased that the tominersen Phase 3 study is fully enrolled, bringing us closer to potentially delivering this medicine to patients with Huntington’s disease. Additionally, AKCEA-APO(a)-LRx was granted fast track designation in the U.S., underscoring the significant value this medicine could deliver to the millions of patients with Lp(a)-driven cardiovascular disease," said Brett P. Monia, chief executive officer at Ionis. "Thanks to the commitment and resilience of our employees, we delivered strong first quarter results while effectively managing the challenges inherent with the global COVID-19 pandemic, keeping us on track to achieve our 2020 goals. We plan to initiate the pivotal study for AKCEA-APOCIII-LRx in patients with FCS, bringing us to six pivotal studies underway this year. We also plan to refile the WAYLIVRA U.S. NDA and report additional proof-of-concept data from several of our programs this year. Our significant financial strength enables us to invest in our highest priorities, including advancing our Ionis-owned pipeline and our technology, and strengthening our commercial capabilities. Together, these achievements keep us positioned to deliver NDAs for ten or more of our medicines through 2025."

Financial Results and Highlights

"We are reaffirming our 2020 financial guidance, including ending 2020 meaningfully profitable. We expect our results to be driven by continued significant commercial revenue and R&D revenue from numerous programs," said Elizabeth L. Hougen, chief financial officer of Ionis. "We remain well-capitalized, with a strong balance sheet and $2.4 billion in cash and investments. Enabled by our financial strength, we have the resources to execute on our near- and longer-term strategic priorities, even in the challenging COVID-19 pandemic environment."

Growing commercial revenues combined with a substantial base of R&D revenues

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Commercial revenue from SPINRAZA (nusinersen) royalties increased by more than 10 percent to $66 million compared to Q1 2019

Product sales from TEGSEDI (inotersen) and WAYLIVRA (volanesorsen) more than doubled to $15 million compared to Q1 2019

R&D revenue of $49 million included over $25 million from Ionis’ neurology disease franchise and $15 million from its cardiometabolic franchise

First quarter results in line with projections to be meaningfully profitable this year

Operating loss and net loss of $61 million and $48 million, respectively, on a GAAP basis

Non-GAAP operating loss and net loss of $20 million and $15 million, respectively

Cash position of $2.4 billion provides substantial financial strength to continue executing on strategic goals

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of non-GAAP and GAAP measures, which is provided later in this release.

Commercial Medicine Highlights

SPINRAZA: a global foundation-of-care for the treatment of spinal muscular atrophy (SMA) patients of all ages

Worldwide sales increased to $565 million in the first quarter, a 9 percent increase compared to the first quarter of 2019

Worldwide patients on treatment increased to approximately 10,800 at the end of the first quarter, including patients across commercial, expanded access and clinical trial settings

Patient treatment is underway in the Phase 2/3 DEVOTE study evaluating the safety, tolerability and potential to achieve even greater efficacy with a higher dose of SPINRAZA

Data from an independent study published in Lancet Neurology demonstrated statistically significant improvement in motor function with SPINRAZA treatment in teens and adults

TEGSEDI: launched in multiple markets for the treatment of hereditary transthyretin amyloidosis (hATTR) with polyneuropathy in adult patients

Commercially available in 12 countries

Launching in additional EU countries this year and expanding in Latin America through PTC Therapeutics

Results from the NEURO-TTR Phase 3 open-label extension study were published in the European Journal of Neurology

WAYLIVRA: launched in the EU as the only approved treatment for adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis

Launch progressing in Germany, Austria and through the ATU in France

Launching in additional EU countries this year

Pipeline Highlights

Roche completed enrollment in the global, GENERATION HD1 Phase 3 study in patients with Huntington’s disease

Initiated the CARDIO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with TTR-mediated amyloid cardiomyopathy

Two medicines granted Fast Track Designation by the U.S. FDA

AKCEA-APO(a)-LRx for the treatment of cardiovascular disease due to elevated Lp(a) levels

IONIS-C9Rx for the treatment of C9orf72-ALS

Ionis generated more than $20 million as numerous partnered medicines advanced

$10 million from AstraZeneca for ION532, targeting APOL1 for the treatment of kidney disease

$7.5 million from Biogen for IONIS-MAPTRx for the treatment of Alzheimer’s disease

$5 million from Dynacure for IONIS-DNM2-2.5Rx for the treatment of centronuclear myopathies

Ionis and Akcea reported positive topline results for AKCEA-APOCIII-LRx and vupanorsen (AKCEA-ANGPTL3-LRx)

Results from the Phase 2 study of AKCEA-APO(a)-LRx in patients with Lp(a)-driven cardiovascular disease, highlighting the favorable safety and tolerability profile and the potential to address a major area of unmet need, were published in the New England Journal of Medicine

Initiated a Phase 1 study of ION224, an Ionis-owned medicine in development for the treatment of NASH

Upcoming Catalysts

Initiate the Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS

Refile WAYLIVRA new drug application for U.S. marketing authorization

File for WAYLIVRA marketing approval in Brazil with PTC Therapeutics

Report clinical proof-of-concept results for four or more programs

Initiate a first-in-human study of ION541 in patients with sporadic ALS, conducted by Biogen

Advance five or more new medicines into development, including several Ionis-owned medicines

Revenue

R&D revenue in the first quarter of 2019 included $185 million from two large items, including $150 million for the license of AKCEA-APO(a)-LRx.

Operating Expenses

Operating expenses increased for the first quarter of 2020, compared to the same period in 2019, principally due to Ionis’ investments in the global launches of TEGSEDI and WAYLIVRA, the Phase 3 program for AKCEA-TTR-LRx and the Company’s Ionis-owned pipeline.

Income Tax Expense (Benefit)

Ionis recorded an income tax benefit in the first quarter of 2020, compared to income tax expense in the same period in 2019. Ionis recorded an income tax benefit in the first quarter of 2020 because it generated a pre-tax loss.

Net (Income) Loss Attributable to Noncontrolling Interest in Akcea

At March 31, 2020, Ionis owned approximately 76 percent of Akcea. The shares of Akcea third parties own represent an interest in Akcea’s equity that Ionis does not control. However, because Ionis continues to maintain overall control of Akcea through its voting interest, Ionis reflects the assets, liabilities and results of operations of Akcea in Ionis’ consolidated financial statements. Ionis reflects the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line called "Net (income) loss attributable to noncontrolling interest in Akcea" on Ionis’ statement of operations. Ionis recognized a net loss attributable to noncontrolling interest in Akcea in the first quarter of 2020 compared to net income in the first quarter of 2019. Net income attributable to noncontrolling interest in Akcea in the first quarter of 2019 was due to the significant license fee revenue Akcea earned when Novartis licensed AKCEA-APO(a)-LRx.

3
Net Income (Loss) Attributable to Ionis Common Stockholders

Ionis’ net loss attributable to Ionis’ common stockholders for the first quarter of 2020 was primarily due to Ionis’ investments in advancing its strategic priorities. Ionis’ net income attributable to Ionis’ common stockholders for the first quarter of 2019 was primarily due to the $150 million in revenue the Company earned when Novartis licensed AKCEA-APO(a)-LRx combined with lower operating expenses compared to the first quarter of 2020.

Balance Sheet

Ionis ended the first quarter of 2020 with cash, cash equivalents and short-term investments of $2.4 billion, nearly flat compared to $2.5 billion at December 31, 2019. During the first quarter of 2020, Ionis repurchased 1.5 million shares of its common stock under its share repurchase program for a total purchase price of $91 million.

Webcast

Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast to discuss this earnings release and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

On May 6, 2020 Genmab reported that Financial Results for the First Quarter of 2020 (Press release, Genmab, MAY 6, 2020, View Source [SID1234557119])

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Interim Report for the First Quarter Ended March 31, 2020

Highlights

DARZALEX (daratumumab) net sales increased approximately 49% compared to the first quarter of 2019 to USD 937 million, resulting in royalty income of DKK 775 million
DARZALEX approved in Europe in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
U.S. FDA approved TEPEZZA (teprotumumab-trbw), developed and commercialized by Horizon Therapeutics, for thyroid eye disease
U.S. FDA accepted, with priority review, Novartis’ supplemental Biologics License Application for subcutaneous ofatumumab in relapsing multiple sclerosis
Anthony Pagano appointed Chief Financial Officer
Anthony Mancini appointed Chief Operating Officer
"Despite the unprecedented challenges posed by the coronavirus (COVID-19) pandemic, we will continue to invest in our innovative proprietary products, technologies and capabilities and use our world-class expertise in antibody drug development to create truly differentiated products with the potential to help cancer patients. While Genmab is closely monitoring the developments in the rapidly evolving landscape, we are extremely fortunate to have a solid financial foundation and a fabulous and committed team to carry us through these uncertain times," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2020

Revenue was DKK 892 million in the first quarter of 2020 compared to DKK 591 million in the first quarter of 2019. The increase of DKK 301 million, or 51%, was mainly driven by higher DARZALEX royalties.
Operating expenses were DKK 821 million in the first quarter of 2020 compared to DKK 617 million in the first quarter of 2019. The increase of DKK 204 million, or 33%, was driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 71 million in the first quarter of 2020 compared to an operating loss of DKK 26 million in the first quarter of 2019. The increase of DKK 97 million was driven by higher revenue, which was partly offset by increased operating expenses.
Subsequent Event

May: The U.S. Food and Drug Administration (U.S. FDA) approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Outlook
Genmab is maintaining its 2020 financial guidance published on February 19, 2020.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2020 today, Wednesday, May 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 6486367.

On May 6, 2020 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company developing its drug, onvansertib, to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and relapsed/refractory leukemias, reported it is changing its company name to Cardiff Oncology, Inc. and Mark Erlander, PhD, will assume the role of Chief Executive Officer (CEO) (Press release, Trovagene, MAY 6, 2020, View Source [SID1234557118]). In connection with the new corporate name, the Company’s Nasdaq ticker symbol will change to ‘CRDF’ and will be effective at the open of the market on Friday, May 8, 2020. The new website will be View Source
The new name, Cardiff Oncology, reflects the Company’s mission and commitment to turning the tide on cancer with its development of onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the treatment of cancers representing the greatest need for new effective treatment options.
Dr. Erlander has served as Chief Scientific Officer since joining the Company in 2013 and has been an integral part in its evolution in drug development and biomarker technology. Dr. Thomas Adams, Chairman of the Board since 2009, and CEO since June of 2018, will transition his role to Executive Chairman, and continue to provide his strategic guidance and drug development expertise to the Company.
"We are very pleased to announce the change in leadership and company name," said Dr. Thomas Adams, Executive Chairman. "Mark has a proven track record in drug research and development and one of the deepest oncology skills sets in our industry. We believe we are establishing a strong corporate identity with our name change to Cardiff Oncology and demonstrating our expertise and accomplishments as an oncology drug development company."
"We already have a significant foundation in place with an experienced and talented team of people, deep science and an advancing clinical development program," said Dr. Mark Erlander, Chief Executive Officer. "I’m excited to lead our company into the next stage of development that includes continuing to rapidly advance development of our investigational drug, onvansertib, in cancers with the greatest medical need for new effective treatments."

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On May 6, 2020 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported its financial and operating results for the three months ended March 31, 2020 (Press release, AEterna Zentaris, MAY 6, 2020, View Source [SID1234557117]).

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The Company also provided an update on its clinical program to develop macimorelin for the diagnosis of child-onset growth hormone deficiency ("CGHD"), an area of significant unmet need, and its plans to expand macimorelin for the diagnosis of adult growth hormone deficiency ("AGHD") in Europe.

Dr. Klaus Paulini, Chief Executive Officer of Aeterna commented, "Over the course of the first quarter, we made significant progress on clinical and corporate fronts. We successfully executed Study P01 in our clinical program to develop macimorelin for the diagnosis of CGHD, an area of significant unmet need. We are encouraged by the final results from the study, which demonstrated positive safety and tolerability data for use of macimorelin in CGHD. With these positive Study P01 results, we have the necessary data to lay the foundation for our test validation, Study P02, which we expect to commence later this year. Additionally, we were pleased to have received the decision from the EMA to accept a modification to our agreed pediatric investigation plan for macimorelin, ultimately supporting the development of one globally harmonized study protocol for Study P02, which will be accepted both in Europe and the United States of America."

Dr Paulini concluded, "In tandem, we have continued to work alongside our U.S. and Canadian commercialization partner, Novo Nordisk, to raise awareness and position Macrilen (macimorelin) for the diagnosis of AGHD. We remain focused on advancing our business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets. We are pleased with the progress we have made over the first quarter and believe that 2020 holds significant potential for the advancement of macimorelin."

Recent Highlights

Announced the decision of the European Medicines Agency ("EMA") to accept a modification request by Aeterna of the Company’s PIP for macimorelin as originally approved in March 2017 which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies
Announced the positive results for the dose-finding pediatric study, Study P01, of macimorelin as a growth hormone stimulation test for the evaluation of CGHD; and
Closed a $4.5 million registered direct offering priced at-the-market (the "February 2020 Financing").

Macimorelin Clinical Program Update

The Company’s lead product, macimorelin, is the only United States Food and Drug Administration ("FDA") approved oral drug indicated for the diagnosis of AGHD and is currently marketed in the United States ("U.S.") under the tradename Macrilen, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.

The Company recently announced positive results for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of CGHD. The dose-finding results from Study P01 provides the clinical framework to advance the Company’s pediatric investigation plan for macimorelin as a growth hormone deficiency diagnostic. The completed study included 24 subjects aged 4 to 15 years. In the subjects who completed the study in accordance with the protocol, macimorelin demonstrated an excellent safety and tolerability profile. There were 88 adverse events ("AE") reported in 23 subjects, none of which were assessed by the investigator as related to macimorelin. The majority of AEs (approximately 70%) were expected side effects related to the hypoglycemia introduced by the Insulin Tolerance Test. No significant changes in electrocardiogram parameters and safety laboratory values were noted in any of the three dosing cohorts.

The pharmacokinetic and pharmacodynamic profile of macimorelin proved to be in the expected range and in general comparable to data in adults.

For more information about Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

Upcoming Anticipated Program Milestones

Commence CGHD safety and efficacy study, Study P02 (multi-national, including U.S.); and
Advance business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets.

The Company is closely monitoring the evolving situation with coronavirus, or COVID-19, and is following guidance from health authorities. COVID-19 is affecting the global community and is adversely affecting our business operations, in a manner which at this time cannot be fully determined or quantified. The situation with COVID-19 is rapidly evolving and the impact of COVID-19, including travel and business restrictions, and other impediments to undertaking clinical studies, may significantly affect the Company’s business, operations, results, projected timelines and market price for Aeterna’s common shares. Aeterna has developed protocols and procedures should they be required to deal with any potential epidemics and pandemics and has implemented these protocols and procedures to address the current COVID-19 pandemic. Despite appropriate steps being taken to mitigate such risks, there can be no assurance that existing policies and procedures will ensure that the Company’s operations will not be further adversely affected. For more information, please see the Risk Factor entitled, "The economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price of our Common Shares," in the Company’s Annual Report on Form 20-F for the year ended December 31, 2019.

Summary of First Quarter 2020 Financial Results

All amounts are in U.S. dollars

For the three-month period ended March 31, 2020, the Company reported a consolidated net income of $0.8 million, or $0.04 income per common share (basic), as compared with a consolidated net loss of $4.9 million, or $0.30 loss per common share (basic) for the three-month period ended March 31, 2019. The $5.7 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.5 million and increase in revenues of $1.1 million.

Revenues

The Company reported total revenue for the three-month period ended March 31, 2020 of $1.1 million as compared with $0.04 million for the same period in 2019, representing an increase of $1.06 million. The 2020 revenue was comprised of $0.01 million in royalty revenue (2019 – $0.01 million), $1.0 million in product sales of Macrilen (macimorelin) to Novo Nordisk (2019 – $nil), $0.04 million in supply chain revenue (2019 – $0.01 million) and $0.02 million in licensing revenue (2019 – $0.02 million). The product sales in 2020 represented sales of Macrilen (macimorelin) to Novo Nordisk.

Operating Expenses

The Company reported total operating expenses for the three-month period ended March 31, 2020 of $2.4 million as compared with $3.0 million for the same period in 2019, representing a decrease of $0.6 million. This decrease arises primarily from a $0.5 million decline in general and administrative, a $0.2 million decline in research and development costs, a $0.2 million gain on modification of building lease, $0.3 million impact from impairment in right of use assets, $0.2 million impact in impairment of prepaid asset, and a $0.1 million decline in selling expenses, offset by a $0.9 million increase in cost of sales. The impact of the Company’s June 2019 restructuring in its German subsidiary, namely for payroll and share-based compensation costs, is a key influence in the declines in general and administrative expenses, selling and research and development expenses.

The further impact on the decline in research and development costs is attributed to the different phases of activity of Study P01. In the first quarter of 2019, study activities included study start with document development, medication manufacturing, study feasibility testing at different sites and clinical trial applications in Hungary, Poland, Belarus, Russia, Ukraine and Serbia, while in 2020, all sites had completed their enrollment and clinical activities.

Net Finance Income

The Company reported net finance income for the three-month period ended March 31, 2020 of $2.1 million as compared with net finance costs of $2.0 million for the same period in 2019, representing an increase of $4.1 million. This is primarily due to a $4.5 million change in fair value of warrant liability offset by increased finance costs of $0.3 million from the February 2020 Financing and $0.1 million from changes in currency exchange rates. Such a non-cash change in fair value of warrant liability results from the periodic "mark-to-market" revaluation, which occurs through the application of the Company’s pricing model, of Aeterna’s outstanding share purchase warrants.

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the first quarter of 2020, as well as the Company’s audited consolidated financial statements as of March 31, 2020, will be available at www.zentaris.com in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

On May 6, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the pricing of an underwritten public offering of 9,100,000 shares of its common stock at a price to the public of $13.75 per share (Press release, Kura Oncology, MAY 6, 2020, View Source [SID1234557116]). The gross proceeds to Kura from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Kura, are expected to be approximately $125.1 million. In addition, Kura has granted the underwriters a 30-day option to purchase up to an additional 1,365,000 shares of common stock. The offering is expected to close on or about May 8, 2020, subject to customary closing conditions.

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SVB Leerink, Cowen and Credit Suisse are acting as joint bookrunning managers in the offering. JMP Securities and H.C. Wainwright & Co. are acting as co-managers for the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 28, 2019. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected], or by phone at (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.