On May 8, 2018 AVEO Oncology (NASDAQ:AVEO) reported financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, AVEO, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347579 [SID1234526198]).

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"We continue to work toward reporting topline results from our Phase 3 TIVO-3 Study, which we now anticipate will occur in the third quarter of 2018. We are working closely with our contract research organization (CRO) to shorten the time required to do the data cleaning and analysis upon reaching the requisite number of events. Together with the TIVO-1 study, the TIVO-3 study has been designed to serve as the basis for a potential U.S. approval of tivozanib as a first- and third-line treatment for advanced renal cell carcinoma (aRCC)," said Michael Bailey, president and chief executive officer of AVEO. "This important milestone, if achieved, would add to the continued commercial progress of FOTIVDA which is approved in Europe, with launches currently underway in Germany, the U.K. and Austria. We finished the quarter with $27 million in cash, cash equivalents and investments as of March 31, 2018. Under our agreement with our partner EUSA, we have double-digit royalty payments due to us on net sales of FOTIVDA in Europe, potential milestone payments including $8 million related to reimbursement approvals for France, Germany, Italy, and Spain, and $20M in potential R&D reimbursement for access to TIVO-3 data in the event of a positive study."

Mr. Bailey added, "As we work toward our goal of commercialization in the U.S., we also continue to aggressively pursue the third pillar of our tivozanib strategy, combinations with immunotherapy. We were pleased to present results from the ongoing Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO) in aRCC at ASCO (Free ASCO Whitepaper) GU. These early results demonstrated a combination of a favorable safety profile and activity that we believe hold significant promise for patients with aRCC and potentially other tumor types such as hepatocellular carcinoma (HCC)."

Tivozanib TIVO-3 Study North America Update

Update on Anticipated Timeline to Topline Data from Phase 3 TIVO-3 Study. AVEO reported that the pre-specified number of progression free survival (PFS) events required to trigger data analysis of the Phase 3 TIVO-3 trial have not been reached at this time and, as such, the Company is amending its guidance for the anticipated topline data readout from the second to the third quarter of 2018. In collaboration with the CRO conducting the TIVO-3 study, AVEO has taken measures to shorten the data cleaning and analysis period following the pre-specified events trigger from 8-10 weeks down to 6-8 weeks. Together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of aRCC, TIVO-3 is designed to support regulatory approval of tivozanib in the U.S. as a first- and third-line treatment for aRCC.

Tivozanib (FOTIVDA) European Union Updates

Tivozanib (FOTIVDA) Launched in Austria for the Treatment of aRCC. In April 2018, FOTIVDA was launched in Austria for the treatment of adult patients with aRCC. This follows the February 2018 publication by the United Kingdom’s National Institute for Health and Care Excellence (NICE) of a Final Appraisal Determination recommending FOTIVDA for the first line treatment of adult patients with aRCC, which triggered the commercial launch in the UK as well as a $2M milestone payment to AVEO from EUSA Pharma, the licensee for tivozanib in Europe. FOTIVDA is now available in the Germany, the U.K., and Austria.

FOTIVDA was granted European Commission (EC) approval in August 2017 for the treatment of adult patients with aRCC in the European Union plus Norway and Iceland.
Additional Tivozanib Updates

Long-term Follow-up Results from TIVO-1 Extension Study (Study 902), Published in the European Journal of Cancer. In March 2018, AVEO announced the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA) as second-line treatment for aRCC, in the European Journal of Cancer. Findings from the study underscore the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI and support the rationale for the ongoing Phase 3 TIVO-3 study. The publication, titled "Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study," is available on our website at www.aveooncology.com.
Results from Phase 2 Portion of the TiNivo Study of Tivozanib and Nivolumab (OPDIVO) in mRCC Presented at ASCO (Free ASCO Whitepaper) GU. In February 2018, Bernard Escudier, M.D., from the Institute Gustav Roussy in Paris, France presented results from the ongoing Phase 2 portion of the TiNivo study at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium (ASCO GU). TiNivo is a Phase 1b/2 multi-center trial of oral tivozanib in combination with intravenous nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of metastatic renal cell carcinoma (mRCC). The presentation noted the favorable safety profile and promising preliminary anti-tumor activity observed to date. These results continue to support the potential advantages of using a high-specificity VEGF inhibitor TKI in building upon the benefit of immune checkpoint therapy in renal cancer. AVEO and EUSA Pharma expect to present further updates to the TiNivo study at upcoming medical meetings in the second half of 2018.
Phase 1b/2 Study Results of Tivozanib in Patients with Advanced Hepatocellular Carcinoma Presented at ASCO (Free ASCO Whitepaper) GI. In January 2018, AVEO announced the presentation of data from a multi-center, Phase 1b/2 study of tivozanib in previously untreated patients with advanced, unresectable HCC at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI). Findings from the study suggest that tivozanib has the potential to yield comparable PFS and a favorable response rate when compared to current first-line standards of care for HCC patients, and demonstrated a favorable safety profile which may enable therapeutic combinations with immunotherapy. The Phase 1b/2 study was led by Renuka Iyar, M.D., from the Roswell Park Cancer Center and was one of several studies funded by a grant provided to the National Comprehensive Cancer Network by AVEO.
Ficlatuzumab Update

Trials in Progress Poster for Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer to be Presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. An ongoing, investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC) will be presented as a trials in progress poster (Poster Board: #330b, Abstract TPS4152) at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is currently enrolling, with an expected total enrollment of approximately 30 patients.
Corporate Updates

Refinanced Debt Facility, Extending Cash Runway into 2019. In January 2018, AVEO announced that it completed the refinancing of its existing $20.0 million debt facility with Hercules Capital, Inc. and its affiliates, the terms of which enable approximately an additional $12.1 million in cash flow over 2018 and 2019, when compared to the prior loan. The new $20.0 million facility has a 42-month maturity from closing, no financial covenants, a lower interest rate and an interest-only period of no less than 12 months, which could be extended up to a maximum of 24 months, assuming the achievement of specified milestones relating to the development of tivozanib. Extension of the interest-only period is expected to enable the Company to extend its cash runway into the first quarter of 2019. Proceeds of the new facility were used to retire the Company’s previous $20.0 million of secured debt with Hercules.
Strengthened Board of Directors. In February 2018, AVEO announced the appointment of John H. Johnson to the Company’s Board of Directors. Mr. Johnson brings to AVEO over three decades of experience in the biotechnology and pharmaceuticals industries, having held commercial and executive management roles at leading global corporations that have a focus on oncology.
First Quarter 2018 Financial Highlights

AVEO ended Q1 2018 with $27.0 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.
Total revenue for Q1 2018 was approximately $1.0 million compared with $2.5 million for Q1 2017.
Research and development expense for Q1 2018 was $5.4 million compared with $8.0 million for Q1 2017.
General and administrative expense for Q1 2018 was $2.6 million compared with $2.3 million for Q1 2017.
Net loss for Q1 2018 was $9.0 million, or a loss of $0.08 per basic and diluted share, compared with net loss of $8.8 million for Q1 2017, or a loss of $0.12 per basic and diluted share. Approximately $1.5 million of the Q1 2018 net loss was a non-cash loss attributable to the increase in the fair value of the warrant liability that principally resulted from the increase in the stock price that occurred within the quarter. In Q1 2017, the non-cash loss attributable to the increase in the fair value of the warrant liability was $0.5 million.
Financial Guidance

We believe that our $27.0 million in cash resources would allow us to fund our planned operations into the first quarter of 2019. This estimate assumes no receipt of additional milestones from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of our outstanding warrants issued in connection with our 2016 private placement.

On May 8, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the first quarter ended March 31, 2018, and provided an update on recent clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 8, 2018, View Source [SID1234526229]).

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"Deciphera is off to a strong start in 2018, with data presented at last month’s AACR (Free AACR Whitepaper) Annual Meeting adding to the growing body of research supporting the favorable safety and tolerability profile of DCC-2618, our lead product candidate, and its ability to inhibit a broad range of primary and secondary KIT mutations and primary PDGFRα mutations that arise in drug resistant gastrointestinal stromal tumor patients," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We look forward to presenting additional data from the Phase 1 DCC-2618 expansion study throughout the year, including at the upcoming ASCO (Free ASCO Whitepaper) meeting in June. Enrollment in our ongoing Phase 3 INVICTUS study in fourth-line and fourth-line plus GIST is proceeding on track, and we continue to expect the initiation of a second pivotal study in second-line GIST later this year."

Clinical Programs

DCC-2618
Reported preclinical data at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2018 demonstrating that compared to the in vitro profiles of the FDA-approved kinase inhibitors imatinib, sunitinib, regorafenib, and midostaurin, and the investigational agent avapritinib (BLU-285), DCC-2618 demonstrated the broadest profile of inhibition of primary and secondary KIT mutations and primary PDGFRα mutations.
The Company also reported updated clinical data at the 2018 AACR (Free AACR Whitepaper) Annual Meeting demonstrating the safety and tolerability profile of DCC-2618 in 100 GIST patients treated at the recommended Phase 2 dose of 150 mg QD, which supports the selection of this dose for the ongoing pivotal, randomized Phase 3 INVICTUS study. As of March 19, 2018, 81 of 137 GIST patients treated at 100 mg or more per day and enrolled as of the cut-off date of January 18, 2018, remained on study. Of these, 46 patients were treated for more than six months, including 10 patients who were treated for more than 12 months.
Enrollment continues in the dose expansion stage of the ongoing Phase 1 clinical trial for DCC-2618 in patients with solid tumors, including GIST and systemic mastocytosis. The Company will present updated data from this clinical trial in a poster presentation and discussion titled "Mutation profile of drug resistant gastrointestinal stromal tumor (GIST) patients (pts) enrolled in the phase 1 study of DCC-2618," at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 2, 2018 in Chicago, Illinois.
Rebastinib
Investigators at Albert Einstein College of Medicine presented preliminary clinical data at the 2018 AACR (Free AACR Whitepaper) Annual Meeting from their ongoing Phase 1b study with rebastinib, the Company’s selective TIE2 immunokinase inhibitor, in combination with anti-tubulin therapy in patients with metastatic breast cancer. Deciphera is encouraged by the preliminary findings from the investigator-sponsored study and expects to initiate a company-sponsored Phase 1b study with rebastinib later in 2018.
First Quarter 2018 Financial Results

Cash Position: As of March 31, 2018, Deciphera Pharmaceuticals reported cash and cash equivalents of $179.9 million compared to cash and cash equivalents of $196.8 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities.
R&D Expenses: Research and development expenses for the first quarter of 2018 were $16.9 million compared to $5.7 million for the same period in 2017. The increase was primarily due to an increase in spending on the DCC-2618 program of $7.3 million as a result of clinical trial costs related to the ongoing Phase 1 trial and the pivotal Phase 3 INVICTUS study in fourth-line GIST that began enrollment in January 2018. Clinical costs also increased as a result of start-up activities related to the pivotal Phase 3 study in second-line GIST, which is expected to be initiated in the second half of 2018. Manufacturing costs increased for DCC-2618 as a result of new process development to support anticipated greater drug requirements for commercialization as well as the manufacture of registration lots required to support a new drug application. Manufacturing costs for DCC-3014 increased $0.4 million in preparation for our current and planned clinical trials. In addition, personnel related and other costs increased an aggregate of $3.5 million as the result of an increase in costs associated with headcount, early-stage drug discovery programs and consulting fees. Personnel costs for each of the first quarters of 2018 and 2017 included non-cash share-based compensation expense of $1.0 million and $0.1 million, respectively.
G&A Expenses: General and administrative expenses for the first quarter of 2018 were $5.0 million, compared to $2.1 million for the same period in 2017. The increase was primarily due to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company as well as costs incurred for pre-commercialization activities. In addition, non-cash share-based compensation was $1.1 million and $0.3 million for each of the first quarters of 2018 and 2017, respectively.
Net Loss: For the first quarter of 2018, Deciphera reported a net loss of $21.4 million, or $0.66 per share, compared with a net loss of $7.7 million, or $0.66 per share for the same period in 2017.

On May 8, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported that management will hold a business update conference call on Tuesday, May 15, 2018 beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) (Press release, AmpliPhi Biosciences, MAY 8, 2018, View Source [SID1234526263]).

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Live Call: U.S. 866-652-5200
International 412-317-6060
Passcode 10120002

Live Webcast: AmpliPhi IR Website

The webcast replay will be available approximately 2 hours after completion of the call and will be archived for 30 days.

Replay: U.S. 877-344-7529
International 412-317-0088
Passcode 10120002
The replay will be available for 48 hours starting approximately 2 hours after completion of the call.

On May 8, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that on May 15, 2018, the Company will release its financial results for the quarter ended March 31, 2018 (Press release, Affimed,MAY 8, 2018, View Source [SID1234526279]). The Company’s management team will host a conference call to discuss the Company’s financial results and recent corporate developments on Tuesday, May 15, 2018 at 8:30 a.m. ET. The call can be accessed by dialing one of the numbers listed below five minutes prior to the start of the call and providing the confirmation code 3326332.

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United States: +1 720-543-0214
Germany: +49 (0)89 20303 5709
Netherlands: +31 (0) 20 721 9251
Denmark: +45 35 15 80 49
France: +33 (0)1 76 77 22 74
Switzerland: +41 (0)22 567 5729
United Kingdom: +44 (0)330 336 9105
An audio webcast of the conference call can be accessed in the "Events" section on the "Investors & Media"
page of the Affimed website at View Source A replay of the webcast will be
available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed
website for 30 days following the call.

On May 8, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the first quarter ended March 31, 2018 (Press release, BioCryst Pharmaceuticalsa, MAY 8, 2018, View Source [SID1234526199]).

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"We are off to a strong start in 2018 as we continue to make progress advancing all our HAE development programs and remain on track to read out top line data from APeX-2 in the first half of next year," said Jon P. Stonehouse, BioCryst’s President and Chief Executive Officer. "We remain excited about our proposed merger with Idera Pharmaceuticals, Inc., which we believe will create greater and more sustainable value for the benefit of our stockholders and our patients. We look forward to positive data readouts from Idera in early June, which would reinforce the value creation potential in combining our synergistic discovery engines and creating a more robust and diversified late-stage pipeline."

First Quarter 2018 Financial Results

For the three months ended March 31, 2018, total revenues were $4.0 million, compared to $9.4 million in the first quarter of 2017. The decrease in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018. Those 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA and a $2.0 million payment for the Canadian regulatory approval of RAPIVAB.

Research and Development ("R&D") expenses for the first quarter of 2018 increased to $18.4 million from $16.8 million in the first quarter of 2017, primarily due to additions in R&D personnel and increased spending on our hereditary angioedema ("HAE") and preclinical programs. These increases were partially offset by a decrease in the Company’s peramivir and galidesivir development spending in 2018.

General and administrative ("G&A") expenses for the first quarter of 2018 increased to $7.6 million, compared to $3.1 million in the first quarter of 2017. The increase was primarily due to approximately $4.7 million of merger-related costs associated with the Company’s pending merger with Idera Pharmaceuticals, Inc. ("Idera").

Interest expense was $2.2 million in the first quarter of 2018, compared to $2.1 million in the first quarter of 2017. Also, a $1.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first quarter of 2018, as compared to a $1.5 million mark-to-market loss in the first quarter of 2017. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate.

Net loss for the first quarter of 2018 was $25.8 million, or $0.26 per share, compared to a net loss of $14.2 million, or $0.19 per share, for the first quarter 2017.

Cash, cash equivalents and investments totaled $137.5 million at March 31, 2018, and reflect a decrease from $159.0 million at December 31, 2017. Net operating cash use for the first quarter 2018 was $22.9 million.

Clinical Development Update & Outlook

On February 28, 2018, BioCryst announced the dosing of the first patient in APeX-S, a long-term safety trial evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment in patients with HAE. APeX-S is an open label two-arm trial to evaluate the safety of two dose levels of BCX7353 (110 mg once daily and 150 mg once daily) over 48 weeks in patients with Type I and II HAE. The trial will enroll approximately 160 patients.

On March 15, 2018, BioCryst announced the dosing of the first patient into APeX-2, a Phase 3 clinical trial evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. APeX-2 is a randomized, double-blind, placebo-controlled, three-arm trial testing two doses of BCX7353 (110 mg and 150 mg) for prevention of angioedema attacks. The trial is expected to enroll approximately 100 patients with Type I and II HAE in the United States, Canada and Europe. The primary efficacy endpoint of APeX-2 is the rate of angioedema attacks over 24 weeks of study drug administration.

Enrollment in both the 750 mg and 500 mg cohorts of the ZENITH-1 proof-of-concept Phase 2 clinical trial liquid formulation of BCX7353 for treatment of acute angioedema attacks in HAE have been completed, and the 250 mg cohort is enrolling. We expect to report top-line results from the first cohort in the second half of 2018.

On May 1, 2018, BioCryst announced that the European Medicines Agency ("EMA") has approved peramivir with the brand name of ALPIVABTM, a single intravenous infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years. The EMA approval of ALPIVAB under the centralized licensing procedure provides marketing authorization for all 28-member states of the European Union, Norway and Iceland.

BioCryst has a license agreement with Seqirus regarding peramivir. As previously disclosed, BioCryst and Seqirus are engaged in a formal dispute resolution process involving many items under the contract including, but not limited to, the EMA approval milestone of $5 million, which BioCryst maintains is due.

In April 2018, the Therapeutic Goods Administration approved RAPIVAB (peramivir injection), an intravenous treatment for acute influenza, for commercial sale in Australia.
Financial Outlook for 2018

Based upon development plans and awarded government contracts, on a stand-alone basis, BioCryst continues to expect its 2018 net operating cash use to be in the range of $67 to $90 million, and its 2018 operating expenses to be in the range of $85 to $110 million. With merger-related costs and the aggressive advancement of programs thus far, it is expected the Company will trend to the upper-end of both ranges. The Company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, May 8, 2018 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed live or in archived form in the "Investors" section of the Company’s website at www.BioCryst.com. An accompanying slide presentation may also be accessed via the BioCryst website. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

Special Meetings of Stockholders

On April 10, 2018, BioCryst and Idera jointly announced that they have each rescheduled their respective Special Meetings of Stockholders to vote on the proposed merger of BioCryst and Idera to July 10, 2018 at 10:00 a.m. Eastern Time.

The BioCryst Board of Directors unanimously recommends that BioCryst stockholders vote "FOR" the proposed merger at the BioCryst Special Meeting.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.