On August 8, 2018 PDL BioPharma, Inc. ("PDL" or the "Company") (NASDAQ: PDLI) reported its financial results for the three and six months ended June 30, 2018 including (Press release, PDL BioPharma, AUG 8, 2018, View Source [SID1234528766]):

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Second Quarter Financial Highlights

Total revenues of $46.6 million.

GAAP net loss attributable to PDL’s shareholders of $112.3 million or $(0.76) per share.

GAAP net loss includes a one-time $133.3 million, net of tax, non-cash accounting charge related to the impairment of an intangible asset from Noden Pharma DAC, due to the increased probability of a generic version of aliskiren being launched in the United States by Anchen, offset by a $19.7 million, net of tax, non-cash decrease in the fair value of the contingent liability related to a reduced estimate of the probability in paying milestones to Novartis for Tekturna.

Non-GAAP net income attributable to PDL’s shareholders of $14.7 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release.

Cash, cash equivalents, short-term investments and other investments of $395.7 million as of June 30, 2018.

Repurchased 6.8 million shares of common stock in the open market during the quarter for $19.4 million.

"Our financial results for the second quarter reflect higher product sales resulting from our change in strategy to equity and product investments, and we continue to have a strong cash balance to pursue acquisitions. While we are disappointed with the write down of the Noden asset, the impairment is not an indication of the performance of the business this quarter, but rather is based upon uncertainty in the future generic aliskiren competition in the United States," said John P. McLaughlin, CEO of PDL.

"Last week we announced an amended agreement with Depomed to purchase Depomed’s remaining interests in future royalties for $20 million in a transaction we view as highly attractive to our shareholders," he added. "While we are shifting our strategy away from royalty agreements, our familiarity with the Depomed assets and our past success with them supported this investment decision. We expect to begin realizing a return on this investment by late 2020 with meaningful cash returns expected through 2026."

Revenue Highlights

Total revenues of $46.6 million for the three months ended June 30, 2018 included:
◦
Product revenues of $31.8 million, which consisted of $25.9 million from sales of Tekturna and Tekturna HCT in the United States and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products), and $5.9 million for product sales of the LENSAR Laser System;
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Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $12.8 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed royalty asset;

Royalties from PDL’s licensees to the Queen et al. patents of $1.2 million, which consisted of royalties earned on sales of Tysabri; and
◦
Interest revenue from note receivable investment to CareView Communications of $0.8 million.

Total revenues for the second quarter of 2018 were $46.6 million, compared with $143.8 million for the second quarter of 2017, reflecting PDL’s strategic shift to a pharmaceutical business model and the decline in royalty income from the expired Queen et al. patents.
◦
Product revenues were $31.8 million, a 69% increase from $18.8 million for the prior year due to sales of the Noden Products and the LENSAR Laser System, the latter of which PDL did not begin to recognize until May 2017. Product revenues accounted for 68% of total revenues compared with 13% in the second quarter of 2017;
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Product revenues from Noden Products were $10.4 million in the U.S. and $15.5 million in the rest of the world.
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PDL recognized $12.8 million in revenue from royalty rights – change in fair value, compared with $83.7 million in the prior-year period. The decrease was primarily due to a higher prior year royalty rights – change in fair value as a result of the increase in fair value of the Depomed, Inc. royalty asset in the second quarter of 2017 based upon revised future cash flows;
◦
PDL received $19.4 million in net cash royalties from its royalty rights for the second quarter of 2018, compared with $34.6 million for the prior-year period. The decrease is mainly due to the launch of the authorized generic for Glumetza in February 2017 sold by a subsidiary of Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.) and included a retroactive payment in the second quarter of 2017;
◦
Royalties from PDL’s licensees to the Queen et al. patents of $1.2 million, compared with $16.3 million for the second quarter of 2017 as product supply of Tysabri manufactured prior to patent expiry in the U.S. have been extinguished and ex-U.S. product supplies are rapidly being depleted; and
◦
Interest revenues decreased primarily due to the sale of the kaléo, Inc. note receivable in September 2017.

Total revenues for the six months ended June 30, 2018, were $85.1 million, compared with $189.3 million for the prior-year period:
◦
Product revenues were $55.1 million, a 75% increase from $31.4 million for the prior-year period. Product revenues for 2018 consisted of $44.2 million from sales of the Noden Products and $10.9 million for product sales of the LENSAR Laser System;
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PDL recognized $23.9 million in net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets, compared with $96.9 million for the prior-year period;
◦
PDL received $38.0 million in net cash royalties from its royalty rights year-to-date 2018, compared with $48.1 million for the prior-year period;
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Royalties from PDL’s licensees to the Queen et al. patents of $4.0 million, compared with $30.4 million for the prior-year period; and
◦
Interest revenue from note receivable investment to CareView Communications of $1.5 million.

Operating Expense Highlights

Operating expenses for the three months ended June 30, 2018 of $171.7 million increased $140.6 million from $31.1 million for the three months ended June 30, 2017. The increase was a result of the impairment of the Noden intangible asset of $152.3 million due to the increased probability of a generic version of aliskiren being launched in the United States, partially offset by the $22.5 million decrease in fair value of the contingent liability related to reduced estimate in the probabilities in paying milestones to Novartis for Tekturna.

Cost of product revenue for the three months ended June 30, 2018 increased as a result of the Noden Products and LENSAR contributing additional cost of product revenue of $8.4 million and $1.6 million, respectively, due to increased revenue from Noden Products and recognition of costs of goods for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017. General and administrative expenses of $14.5 million, increased compared with $11.3 million a year ago, with the increase due to a full quarter of expenses from LENSAR in 2018 versus a partial quarter as a result of its acquisition in May 2017, operation growth for Noden and expenses related to business development activities. Sales and marketing expenses were $5.4 million, compared with $3.6 million in the prior-year period, with the increase due to an increase in marketing efforts for Noden and LENSAR, and research and development costs decreased based upon the completion of a pediatric trial for Tekturna.

Operating expenses for the six months ended June 30, 2018 were $205.9 million, a $147.9 million increase from $58.0 million for the prior-year period, with the increase primarily a result of the impairment of the Noden intangible asset of $152.3 million, as well as a result of Noden and LENSAR contributing additional cost of product revenue of $14.0 million and $4.0 million, respectively, which was due to increased revenue in Noden and recognition of costs of goods for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognized until May 2017, partially offset by the decrease in fair value of the contingent liability.

Stock Repurchase Programs

PDL repurchased 8.2 million shares of its common stock under the $25.0 million share repurchase program during the six months ended June 30, 2018, for an aggregate purchase price of $23.6 million, or an average cost of $2.89 per share, including trading commission. All shares repurchased were retired.

From July 1, 2018 to July 5, 2018, the Company completed this stock repurchase program with the repurchase of 0.6 million shares of its common stock at a weighted average price of $2.44 per share, for a total of $1.4 million.

Since initiating its first stock repurchase program in March 2017, the Company has used $55.0 million to repurchase a total of 22.0 million shares of its common stock.

Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $395.7 million as of June 30, 2018, compared with $532.1 million as of December 31, 2017.

The reduction in cash balance for the six months ended June 30, 2018 was primarily a result of the retiring of the remaining $126.4 million of principal from PDL’s 4.0% Convertible Senior Notes due 2018, plus $2.6 million of accrued interest, and common stock repurchases of $23.6 million.

Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results and provide a business update at 4:30 p.m. Eastern Time today, August 8, 2018. Slides to accompany the conference call are available in the Investor Relations section of www.pdl.com.

To access the live conference call via phone, please dial (844) 535-4071 from the United States and Canada or (706) 679-2458 internationally. The conference ID is 7356309. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 7356309.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to the Investor Relations section and select "Events & Presentations."

On August 8, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported financial results for the fiscal quarter ended June 30, 2018 (Press release, Five Prime Therapeutics, AUG 8, 2018, View Source [SID1234528545]).

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"We are pleased with the progress across our pipeline, including BMS’s ongoing randomized Phase 2 clinical trial to evaluate cabiralizumab and OPDIVO with and without chemotherapy as a second-line treatment in patients with advanced pancreatic cancer," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. "We’ve also advanced bemarituzumab through the Phase 1 safety lead-in portion of the global FIGHT trial in gastric cancer and are on track to begin the Phase 3 portion of the trial before the end of the year. Additionally, we are pleased that the first clinical candidate from our immuno-oncology research collaboration with BMS, the TIM-3 antibody BMS-986258, is now in a Phase 1/2 trial investigating it as a single agent and in combination with OPDIVO. FPA150, our first-in-class B7-H4 antibody, is receiving strong interest from investigators and is progressing well in the Phase 1 trial."

Mr. Knickerbocker continued, "We are committed to making prudent clinical development decisions. Although we continue to observe efficacy in the PVNS Phase 2 trial, we have decided not to advance cabiralizumab into a pivotal trial in PVNS in 2019 because patients with this chronic, non-malignant disease demonstrate a lower tolerance for side effects, such as periorbital edema, relative to patients with cancer."

Second Quarter 2018 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): An antibody that inhibits CSF1R and has been shown to block the activation and survival of macrophages.

Bristol-Myers Squibb Company (BMS) continues to advance a randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.
The Phase 2 clinical trial (NCT03336216) evaluates cabiralizumab and OPDIVO (nivolumab) with and without mFOLFOX6 or gemcitabine/Abraxane chemotherapy compared to chemotherapy alone as a second-line treatment in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients from the United States, Europe, Japan and Taiwan.
Enrollment has closed and treatment continues in Five Prime’s Phase 1a/1b clinical trial of cabiralizumab and OPDIVO (nivolumab).
Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor OPDIVO in advanced solid tumors, including in more than 70 patients with pancreatic cancer.
A poster titled "Pharmacodynamics (PD) and Genomic Profiling of Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide Evidence of On-Target Tumor Immune Modulations and Support Future Clinical Applications" was presented and chosen for oral discussion at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4.
Data suggest cabiralizumab in combination with nivolumab decreases immunosuppressive macrophages and increases CD8+ effector T-cells in the tumor microenvironment.
These data, together with preliminary clinical response data observed in patients with low tumor mutational burden, support further clinical development of cabiralizumab plus nivolumab in multiple indications, including pancreatic cancer.
Five Prime has decided not to advance cabiralizumab in pigmented villonodular synovitis (PVNS), a rare, locally aggressive, non-malignant tumor of the synovium, into a pivotal trial under the current dosing schedule.
Five Prime has been enrolling a second cohort in the Phase 2 portion of a Phase 1/2 clinical trial (NCT02471716) to evaluate dosing every 4-6 weeks instead of every 2 weeks to optimize the therapeutic index of cabiralizumab in PVNS.
Although Five Prime continues to observe efficacy in this second cohort, the frequency of dose interruptions and discontinuations suggests that the current dosing schedule is unlikely to be optimal for a pivotal trial in this chronic, non-fatal disease.
The company is considering alternative dosing schedules as there continues to be a high unmet need for patients with PVNS.
Apexigen, Inc. and Yale Cancer Center announced a clinical trial collaboration to evaluate APX005M (anti-CD40) in combination with cabiralizumab and OPDIVO. The phase 1/1b study (NCT03502330) is designed to identify a safe dose of APX005M to be added to cabiralizumab and OPDIVO. The expansion portion of the trial will study the triple drug combination in patients with melanoma, non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor without intervening therapy.
Bemarituzumab (FPA144): A first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

Five Prime advanced through the Phase 1 safety lead-in portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial.
The company expects to initiate patient dosing in the randomized, controlled Phase 3 portion of the trial before the end of the year in the U.S., Europe and Asia, including China and South Korea, where the incidence of gastric cancer is high.
The trial will evaluate bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b.
Five Prime is using immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with FGFR2b-overexpressing gastric cancer who would be eligible for the trial.
A poster titled "FIGHT: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1 Lead-In" was presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3.
FPA150 (anti-B7-H4): A first-in-class antibody targeting B7-H4 designed to have two mechanisms of action: to block an inhibitory T-cell checkpoint pathway and to enhance killing of B7-H4 overexpressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.

Five Prime continues to dose patients with FPA150 monotherapy in solid tumors in the dose escalation phase of the Phase 1a/1b clinical trial.
Dose escalation will be followed by expansion in pre-specified cohorts of patients whose tumors have high B7-H4 expression levels, as measured by an IHC molecular diagnostic test. The initial targeted tumors for the expansion cohorts are breast, ovarian, endometrial and bladder cancers.
During the dose escalation, Five Prime will also open an exploratory cohort to investigate FPA150 monotherapy in patients with tumors that overexpress B7-H4.
BMS-986258 (anti-TIM-3): A fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.

In January 2018, BMS began a Phase 1/2 trial (NCT03446040), of BMS-986258, which is testing the antibody both as a single-agent and in combination with OPDIVO.
BMS-986258 is the first clinical candidate from BMS’s immuno-oncology research collaboration with Five Prime.
Preclinical Research and Development:

FPT155 (CD80-Fc): A first-in-class CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment.

Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity and may have a synergistic effect when combined with anti-PD1 therapy.
Five Prime anticipates initiating a Phase 1 clinical trial of FPT155 in Australia in the fourth quarter of 2018.
Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $352.8 million as of June 30, 2018, compared to $292.7 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to $107.6 million in net proceeds from the January 2018 public offering of common stock and $34.5 million in milestone and upfront payments Five Prime received from collaboration partners net of cash used by Five Prime in operations to advance its three clinical stage programs as well as preclinical research and development.
Revenue. Collaboration and license revenue for the second quarter of 2018 decreased by $0.2 million, or 3%, to $7.6 million from $7.8 million for the second quarter of 2017. This decrease was primarily due to decreased revenue recognized under the cabiralizumab collaboration agreement with BMS and the Fibrosis and CNS collaboration with UCB, offset by the collaboration and license revenue from our China collaboration with Zai Lab executed in December 2017.
R&D Expenses. Research and development expenses for the second quarter of 2018 decreased by $8.3 million, or 20%, to $33.4 million from $41.7 million in the second quarter of 2017. This decrease was primarily related to decreased spending on preclinical programs offset by an increase in clinical expenses to advance our development programs.
G&A Expenses. General and administrative expenses for the second quarter of 2018 increased by $0.4 million, or 4%, to $9.8 million from $9.4 million in the second quarter of 2017. This is primarily due to increased consulting and facility costs offset by reduced personnel costs, including stock-based compensation.
Net Loss. Net loss for the second quarter of 2018 was $34.1 million, or $0.99 per basic and diluted share, compared to a net loss of $44.3 million, or $1.58 per basic and diluted share, for the second quarter of 2017.
Shares Outstanding. Total shares outstanding were 34.5 million as of June 30, 2018.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. Five Prime estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 4194786. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On August 8, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, reported financial results for the second quarter ended June 30, 2018, and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, AUG 8, 2018, View Source [SID1234528608]). During the second quarter, the Company made continued progress in the development of its two lead clinical programs. BXCL501, a proprietary sublingual thin film formulation of dexmedetomidine (Dex), is being developed for the acute treatment of mild to moderate agitation in neurological and psychiatric disorders such as geriatric dementia and schizophrenia/bipolar disorder. BXCL701, a first-in-class oral small-molecule immunomodulator targeting dipeptyl peptidases 8/9 (DPP 8/9) and fibroblast activation protein (FAP) is being developed for treatment emergent neuroendocrine prostate cancer (tNEPC) and pancreatic cancer.

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Second Quarter 2018 and Recent Highlights

Neuroscience Program (BXCL501)-

· Reported positive results from Phase 1b study of intravenously dosed Dex validating clinical development strategy for BXCL501;

·Data supports potential dosing strengths for sublingual thin film formulation of BXCL501, and initiation of Phase 1b PK/PD safety study using IV Dex in mild probable Alzheimer’s (AD) patients;

Company plans to initiate Phase 1b PK/PD safety study using the IV formulation of Dex in schizophrenia patients in the second half of 2018;

·Data from both AD and schizophrenia studies expected during the second half of 2018.

·Initiation of bioavailability study for the sublingual thin film formulation expected in the second half of 2018 following completion of GMP manufacturing and IND approval;

·Formed world-class neuroscience clinical advisory board to support global development of BXCL501 and other neuroscience programs;

·Maintained active dialog with FDA regarding ongoing clinical development of BXCL501.

Immuno-Oncology Program (BXCL701)-

·Company plans to commence single and combination agent open label clinical trials of BXCL701 in the second half of 2018 following completion of GMP manufacturing and IND approval. Preliminary data from these trials will be available throughout 2019.

· Presented encouraging preclinical data on combination therapy of BXCL701, Nektar Therapeutics’ NKTR-214 and an anti-PD1 agent in pancreatic cancer at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting;

Business & Operations-

· Strengthened management team with C-suite and VP-level appointments;

· Formalized the role of Vincent O’Neill MD, as Senior Vice President and Chief Medical Officer;

· Key hires included Vikas Sharma, Ph.D. as Vice President of Business Development to lead the Company’s strategic partnering initiatives, particularly for BTI’s lead immuno-oncology asset, BXCL701; Cedric Burg, Ph.D. as Vice President and Head of Global Clinical Operations and Project Management to lead the development and execution of BTI’s global clinical operations strategy; and Michael DeVivo Ph.D. as Vice President, Neuroscience, to support the Company’s research and development team in advancing current programs and expanding pipeline candidates using the dual strategy of focusing on symptoms-based treatments, and treatments for rare neurological diseases;

· Continued expanding network of partners to leverage capabilities and augment internal drug development teams;

·Continued to build intellectual property portfolio with multiple global patent submissions to protect lead candidates, BXCL501 and BXCL701.

"During the second quarter, we made tremendous progress advancing our lead neuroscience and immuno-oncology programs with positive results from two important studies, as well as further building out our leadership infrastructure," commented Vimal Mehta, President and Chief Executive Officer of BTI.

"We reported positive data from our first-in-human trial of intravenously (IV)-dosed Dex supporting further development of BXCL501, our sublingual formulation of Dex for the acute treatment of agitation. Data from the trial demonstrated that the doses and exposure levels of IV Dex had calming effects on healthy subjects without producing clinically meaningful changes in blood pressure or heart rate. The results from this trial will be valuable in determining the ideal dosing strategy for BXCL501. Based on our ongoing discussions with the FDA regarding development of BXCL501, we expect that proof-of-concept studies in geriatric dementia and schizophrenia/bipolar disease will be initiated in the second half of 2018. We also expect to initiate a bioavalibility study on our proprietary sublingual thin film formulation this year."

Dr. Mehta added, "At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 annual meeting, we showcased promising preclinical data on a combination of BXCL701, our oral small molecule immunomodulator, Nektar Therapeutics’ NKTR-214 and an anti-PD1 agent in pancreatic cancer models. The study showed durable anti-tumor response with significant improvement in complete tumor regression and development of anti-cancer immunity. Recently, one component of BXCL701’s dual mechanism of action, DPP 8/9 inhibition, was highlighted in peer reviewed journal, Nature Medicine, providing a key validation of our choice of lead immuno-oncology program and clinical strategy. We are now preparing to initiate clinical studies for BXCL701 in tNEPC and pancreatic cancer in the second half of the year."

Dr. Mehta concluded, "We are well positioned as we enter the third quarter of the year, with a strong cash runway of over $50M to develop our two drug candidates. We have established our leadership team with the appointment of renowned executives who bring international pharma expertise to the company, especially in neuroscience and immuno-oncology. We believe we are well-equipped to build upon the progress we have made in the second quarter of 2018 to achieve our operational and clinical development goals. We remain committed to working towards discovery and development of innovative therapeutic options for neuroscience and immuno-oncology indications, while also creating value for our shareholders.

Second Quarter 2018 Financial Results

BTI reported a net loss of $3.0 million for the second quarter of 2018, compared to a net loss of $0.6 million for the same period in 2017.

Research and development expenses were $1.8 million for the second quarter of 2018, as compared to $0.3 million for the same period in 2017. The increase was primarily due to an expansion of research and development activities , including increased personnel costs, professional fees, clinical trial, and manufacturing costs all, associated with BTI’s two main drug candidates.

General and administrative expenses were $1.5 million for the second quarter of 2018, as compared to $0.2 million for the same period in 2017. The increase was primarily due to additional payroll and payroll-related expenses, professional fees and costs associated with operating as a public company.

As of June 30, 2018, cash and cash equivalents totaled $50.3 million.

On August 8, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported its financial results for the second quarter and the first six months 2018 ending June 30 (Press release, Epigenomics, AUG 8, 2018, View Source [SID1234528654]).

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"While we continue to pursue our objective of Medicare coverage for Epi proColon in the U.S., we are moving forward with our innovative liver cancer surveillance test", said Greg Hamilton, CEO of Epigenomics AG. "Based on the recently published excellent clinical data, this new blood-test could provide the next major opportunity for our company. Obtaining CE mark by year-end will be a key milestone for the product."

Q2/6M 2018 Financial Results

-Total Q2 2018 revenue increased to EUR 0.5 million (Q2 2017: EUR 0.2 million) and 6M 2018 revenue grew to EUR 0.8 million (6M 2017: EUR 0.5 million) due to higher revenue in the United States and license payments made by our partner in China.

-Product revenue in Q2 2018 increased by 65% to EUR 0.3 million (Q2 2017: EUR 0.2 million). In the six month period 2018, product revenue increased by 56% to EUR 0.4 million (6M 2017: EUR 0.2 million).

-Adjusted for non-cash expenses related to share-based payment expenses, EBITDA in Q2 2018 was at EUR -2.2 million (Q2 2017: EUR -3.4 million); adjusted EBITDA for 6M 2018 amounted to EUR -5.4 million (6M 2017: EUR -5.8 million). The lower EBITDA loss is mainly due to increased revenue and lower SG&A expenses.

-Net loss amounted to EUR 2.6 million in Q2 2018 compared to EUR 4.1 million in Q2 2017, and EUR 5.8 million for 6M 2018 (6M 2017: EUR 6.5 million). Net loss per share for Q2 2018 decreased to EUR 0.11 (Q2 2017: EUR 0.18) and for 6M 2018 to EUR 0.24 (6M 2017: EUR 0.28).

-Cash consumption (cash outflow from operating and investing activities) was EUR 4.2 million in 6M 2018 compared to EUR 4.7 million in 6M 2017.

-Liquid assets (including marketable securities) amounted to EUR 9.4 million at the reporting date (December 31, 2017: EUR 7million).

Operational highlights

-Centers for Medicare & Medicaid Services published preliminary rate for Epigenomics’ colorectal cancer screening test Epi proColon: The Centers for Medicare & Medicaid Services (CMS) published a preliminary reimbursement rate of $192 per Epi proColon test. Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate is expected in November 2018.

-Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

-Liquid biopsy test for liver cancer detection to obtain CE mark: Epigenomics announced it’s plan to CE mark the mSEPT9 blood test by year-end 2018 as an aid in detecting liver cancer among patients with cirrhosis. In 2019, the Company also plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China. Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in its Annual Report 2017.

-Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

-We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The interim report for the first six months 2018 can be downloaded from Epigenomics’ website at: View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 2.30 pm CET / 8.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598060
USA: +1 516-269-8983

The webcast will be made available on: View Source;lang=en

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On August 8, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the second quarter ended June 30, 2018 (Press release, Tracon Pharmaceuticals, AUG 8, 2018, View Source [SID1234528546]).

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Second Quarter 2018 and Recent Corporate Highlights

In August, we submitted an amendment to the FDA for the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 26 sites in the United States and multiple sites in the United Kingdom and France. The amendment proposes an increase in the trial sample size to account for the fewer than expected number of events that define the endpoint of progression free survival, reflecting a higher than expected rate of withdrawal for progressive disease unconfirmed by central review. The amendment increases the number of patients analyzed at the interim analysis from 70 to 120. Although the trial is enrolling at a higher rate than expected, with more than 80 patients enrolled, the amendment is expected to delay the interim analysis until Q1 2019.

In July, we completed enrollment in the Phase 1 portion of a Phase 1/2 trial of TRC253 and determined the recommended Phase 2 dose for patients with metastatic prostate cancer. Dosing in the Phase 2 portion of the trial commenced in August. The Phase 1/2 trial is designed to assess safety, determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low-single digit royalty.

In June, preclinical data from two murine models assessing the activity of TRC105 in combination with a PD-1 antibody were presented at the 2018 International Cancer Microenvironment Society meeting. The combination of treatment with TRC105 and the PD-1 antibody significantly reduced tumor volume compared to treatment with either individual therapy in both tumor models. Survival was significantly improved with combination treatment versus the individual therapies, with long-term survival demonstrated in 30% to 60% of animals. Combination treatment also increased tumor specific T cells, indicating stimulation of an immune response. TRC105 is being developed with the PD-1 checkpoint inhibitor Opdivo in patients with lung cancer in a Phase 1 trial.

In April, TRACON closed a private placement of its common stock and warrants providing aggregate gross proceeds of approximately $38.7 million. In conjunction with the financing, the Company appointed Ted Wang, Ph.D., Chief Investment Officer of Puissance Capital Management, to its Board of Directors.
"We anticipate significant news flow over the next few quarters with three major data events from TRC105 trials, including two randomized data points: top-line Phase 2 data in renal cell carcinoma and interim Phase 3 results in angiosarcoma" said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We continue to be encouraged by the rapid rate of accrual into the Phase 3 TAPPAS angiosarcoma trial."

Expected Upcoming Milestones

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected prior to the end of 2018.

Announcement of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected prior to the end of 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in Q1 2019.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $53.4 million at June 30, 2018, compared to $34.5 million at December 31, 2017. We expect our current cash, cash equivalents and short-term investments to fund operations into Q4 2019.

Research and development expenses for the second quarter of 2018 were $8.1 million compared to $4.9 million for the second quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the second quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the second quarter of 2018 were $1.6 million compared to $2.1 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was $9.8 million compared to $6.6 million for the second quarter of 2017.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its second quarter of 2018. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR