On August 8 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the second quarter ended June 30, 2018 (Press release, Akebia, AUG 8, 2018, View Source [SID1234528547]).

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"In the second quarter, we continued to drive our Phase 3 vadadustat program while executing on our long-term growth strategy with the announcement of the pending merger with Keryx Biopharmaceuticals," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The combination is expected to create a fully-integrated company focused on the development and commercialization of therapeutics for patients with kidney disease. We are actively engaged in integration planning and continue to target the closing of the transaction by the end of 2018."

Second Quarter 2018 and Recent Corporate Highlights

Merger Announcement:

The definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) was announced, offering potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Completed U.S. enrollment of the Phase 3 INNO2VATE Conversion study, targeting full enrollment of the INNO2VATE program globally by the end of 2018. The company expects top-line results for the program in the fourth quarter of 2019 or the first quarter of 2020, subject to the accrual of major adverse cardiac events (MACE);
Continued to enroll subjects in the Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE;
Initiated the Phase 2 FO2RWARD-2 study in dialysis dependent patients with anemia due to CKD, with top-line results expected in the first half of 2019. Results from this study are expected to provide additional characterization and differentiation of vadadustat and may further strengthen the company’s commercial position, subject to vadadustat’s regulatory approval; and
Completed a type-C meeting with the FDA, in which Akebia and the agency aligned on the statistical analysis plan in advance of a planned NDA filing for vadadustat.
Financial Results

Akebia reported a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018 as compared to a net loss for the second quarter of 2017 of $21.5 million or ($0.53) per share.

Collaboration revenue was $48.8 million for the second quarter of 2018 compared to $28.5 million for the second quarter of 2017. Collaboration revenue recognized in the second quarter of 2018 related to revenue recognized under both the collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, related to the United States, or the Otsuka U.S. Agreement, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement, as well as revenue recognized in connection with the collaboration agreement with Mitsubishi Tanabe Pharma Corporation. Collaboration revenue recognized in the second quarter of 2017 only related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $71.9 million for the second quarter of 2018 compared to $43.8 million for the second quarter of 2017. The increase was primarily attributable to external costs related to the continued advancement of the global PRO2TECT and INNO2VATE Phase 3 programs, including enrollment; and the manufacture of drug substance and drug product in support of the global Phase 3 program. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $12.5 million for the second quarter of 2018 compared to $6.9 million for the second quarter of 2017. The increase was primarily attributable to an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs, and costs incurred related to the proposed merger with Keryx Biopharmaceuticals.

Akebia ended the second quarter of 2018 with cash, cash equivalents and available for sale securities of $402.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan into the first quarter of 2020.

Conference Call and Webcast

Akebia management will host its second quarter 2018 investor update conference call and webcast beginning at 4:30 p.m. Eastern Time today, Wednesday, August 8, 2018.

Individuals interested in participating in the call should dial (877) 458-0977 (U.S. and Canada) or (484) 653-6724 (international) using conference ID number 1398303. To access the webcast, visit the Investors section of Akebia’s website at www.akebia.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

Beginning the morning of August 9, 2018, the call will be available for replay via telephone and the archived webcast will be available on Akebia’s website. To listen to the telephone replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 1398303. The telephone replay will be available for six days following the call.

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

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 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported second quarter 2018 financial results (Press release, CytomX Therapeutics, AUG 8, 2018, View Source [SID1234528544]).

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As of June 30, 2018, CytomX had cash, cash equivalents and short-term investments of $335.1 million.

"The highlight of our second quarter was the presentation of encouraging data from our first clinical trial of CX-072, a PD-L1-targeting Probody therapeutic, comprising a critical milestone for the Company," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "Based on these promising initial clinical findings, we have broadened the CX-072 development program to encompass eight distinct tumor types as we explore the full potential of this molecule, while continuing to advance combination arms with Yervoy and Zelboraf. We also continued to make progress across our entire therapeutic pipeline including the entry of our fourth program into the clinic, CX-2029, a CD71 Probody drug conjugate, in collaboration with AbbVie. The CytomX team continues to execute at a high level as we drive towards realizing our company vision of transforming patients’ lives."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
CytomX presented preliminary clinical data with an April 20, 2018 data cutoff from two arms of the Phase 1/2 PROCLAIM-CX-072 program at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.
CX-072 monotherapy dose escalation arm evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas (Part A)
CX-072 was generally well tolerated in the 22 patients treated, Grade 3/4 TRAEs were reported in two patients with both events successfully managed with therapeutic intervention including steroids and discontinuation of CX-072 with the maximum tolerated dose (MTD) not reached.
CX-072 demonstrated encouraging efficacy in the 20 evaluable patients with objective responses in 3 (15%) patients, all occurring at doses of 3mg/kg or above. Stable disease was observed in 8 (40%) patients.
CX-072 in combination with Yervoy (ipilimumab) in patients with advanced unresectable solid tumors or lymphomas (Part B)
CX-072 in combination with ipilimumab was generally well tolerated in the 16 patients treated with five (31%) reporting a Grade 3/4 TRAE with the MTD not reached at the time of data cutoff.
CX-072 in combination with ipilimumab demonstrated encouraging efficacy in the 12 evaluable patients with objective responses in 3 (25%) patients and stable disease observed in 8% of the patients, for an overall Disease Control Rate of 33%.
CytomX also presented a preliminary single-dose pharmacokinetic analysis showing that CX-072 as a single-agent, as designed, circulates predominantly as the intact masked prodrug across all dose levels.
Based on encouraging data from the PROCLAIM-CX-072 monotherapy arm, CytomX announced the opening of expansion cohorts in 8 undisclosed tumor types at the dose of 10mg/kg (Part D).
Follow-up data from Part A and Part B of the PROCLAIM-072 trial is expected to be presented in October at the Annual Meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) in Munich, Germany.
CytomX expects to present initial data from the accompanying CX-072 translational science program in the second half of 2018.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer.
Dose escalation continues in Part A of the PROCLAIM-CX-2009 Phase 1/2 clinical program and preliminary data is expected to be presented in the second half of 2018.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC.
Clearance of the Investigational New Drug (IND) application for CX-2029 was received from the U.S. Food and Drug Administration in May 2018.
The first subject enrolled in the PROCLAIM-CX-2029 Phase 1/2 dose escalation trial has been treated.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND-enabling studies.
CytomX expects to file an IND application for CX-188 in the second half of 2018.
Corporate Highlights

In July, CytomX completed an underwritten public offering of 5,867,347 shares of its common stock at a price of $24.50 per share, which includes the exercise in full by the underwriters of their option to purchase up to 765,306 additional shares of common stock. The public offering resulted in net proceeds of $134.5 million to CytomX. Proceeds from the offering are not reflected in the Company’s June 30, 2018 balance sheet.
CytomX announced the appointment of Lloyd A. Rowland, Jr. as Senior Vice President, General Counsel.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $335.1 million as of June 30, 2018, compared to $374.1 million as of December 31, 2017.

Revenue was $21.3 million for the three months ended June 30, 2018, compared to $8.8 million for the three months ended June 30, 2017. The increase was primarily attributable to the recognition of $9.9 million in revenue of the $21 million (net of the associated sublicense fee of $4 million) milestone payment from AbbVie related to the clearance of the CX-2029 IND, an increase of $1.6 million in revenue related to the Amgen collaboration, an increase of $1.4 million in revenue related to the BMS collaboration, and an increase of $0.7 million in revenue from the collaboration extension agreement with ImmunoGen, partially offset by a decrease in revenue of $0.5 million from the termination of the Pfizer collaboration in March 2018.

Research and development expenses decreased by $2.5 million during the three months ended June 30, 2018 compared to the corresponding period in 2017. The net decrease was primarily attributed to a $10.0 million sublicense payment to UCSB in Q2 2017, which was triggered by the $200 million upfront payment from BMS, offset by a $4.6 million increase in lab contracts and services and clinical trial expenses related to CX-072 and CX-2009 into phase 1 / 2 clinical development, an increase of $2.5 million in personnel related expenses due to an increase in headcount and a $0.4 million sublicense fee payable to UCSB for the IND success criteria achieved on the AbbVie CD71 Agreement in Q2 2018.

General and administrative expenses increased by $3.0 million during the three months ended June 30, 2018 compared to the corresponding period in 2017. This increase was largely attributed to an increase of $1.4 million in personnel related expenses due to increases in headcount, an increase of $1.0 million in consulting expenses and an increase of $0.5 million in legal fees.

On August 8, 2018 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the second quarter and six months ended June 30, 2018 (Press release, Novavax, AUG 8, 2018, View Source [SID1234528543]).

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"In keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVax and NanoFlu programs," said Stanley C. Erck, Novavax President and CEO. "With ResVax, we achieved a critical enrollment goal in the Prepare trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively."

"On the NanoFlu front," Mr. Erck continued, "the data published in The New England Journal of Medicine demonstrated that NanoFlu induced significantly improved immune response compared to the current leading high-dose influenza vaccine. We are on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending successful Phase 2 data, based on discussions with the FDA, we anticipate initiating a Phase 3 immunogenicity clinical trial that may provide the basis of licensure via the FDA’s accelerated approval pathway."

Operational Highlights:

ResVax Program

In May 2018, Novavax’ Prepare trial reached enrollment of 4,636 pregnant women, at least 3,000 of whom received ResVax.

Novavax recently reached agreement with the FDA that the efficacy analysis to be conducted in the first quarter of 2019 will be the final analysis used to support the future biologics license application (BLA). This agreement was based on meeting the FDA’s minimum standards for evaluation of both the safety and efficacy of ResVax. We anticipate using the same data for filing a marketing authorization application (MAA) submission in Europe. The current and projected numbers of blinded primary endpoint cases provide Novavax with confidence that the trial is powered to make a statistically sound efficacy conclusion. Novavax expects to report on these data in the first quarter of 2019 and, assuming successful results, expects to submit the BLA and the MAA by the first quarter of 2020.
NanoFlu Program

In June 2018, The New England Journal of Medicine published a peer-reviewed letter to the editor detailing the positive results from Novavax’ Phase 1/2 clinical trial in older adults of NanoFlu compared to the leading licensed egg-based, high-dose influenza vaccine. Novavax had previously presented top-line results from this clinical trial at the World Vaccine Congress in April 2018.

In June 2018, the FDA acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.
Corporate

In April 2018, Novavax conducted a public offering of approximately 34.8 million shares of its common stock, resulting in net proceeds of $54 million.
Anticipated Events:

Final efficacy results of the Prepare trial are expected in the first quarter of 2019.

The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.

Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.
Financial Results for the Three and Six Months Ended June 30, 2018

Novavax reported a net loss of $44.5 million, or $0.12 per share, for the second quarter of 2018, compared to a net loss of $44.5 million, or $0.16 per share, for the second quarter of 2017. For the six months ended June 30, 2018, the net loss was $90.8 million, or $0.25 per share, compared to a net loss of $88.3 million, or $0.32 per share, for the same period in 2017.

Novavax revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017. This 60% increase was driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million as a result of increased enrollment in the Prepare trial and increased activities of Novavax AB, a wholly owned subsidiary of Novavax.

Research and development expenses increased 13% to $44.5 million in the second quarter of 2018, compared to $39.3 million for the same period in 2017. The increase was primarily due to increased development activities of ResVax.

General and administrative expenses decreased 8% to $8.2 million in the second quarter of 2018, compared to $8.9 million for the same period in 2017. The decrease was primarily due to lower employee-related costs.

Interest income (expense), net for the second quarter of 2018 was ($2.6) million, compared to ($3.0) million for the same period of 2017.

As of June 30, 2018, Novavax had $178.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the second quarter of 2018 was $40.0 million, compared to $12.4 million for same period in 2017. The increase in cash usage was primarily due to the receipt of a $25 million payment under the BMGF grant in the six months ended June 30, 2017, whereas no payment was received in the same period of 2018 (however, we expect to receive a $15 million payment in the third quarter of 2018).

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 5886748. A replay of the conference call will be available starting at 7:30 p.m. ET on August 8, 2018 until 7:30 pm ET on August 15, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5886748.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 8, 2018.

About RSV in infants

RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Estimated annual infections of 64 million and an estimated 160,000 deaths make it the second leading cause of death in children under one year of age. RSV results in a total global economic burden of $6.2 billion annually. In the U.S., RSV is the leading cause of hospitalization of infants. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate. It is being developed to protect infants from RSV disease via maternal immunization and is the only RSV vaccine in a Phase 3 clinical trial for this indication. Protecting infants via maternal immunization has been shown to be effective against influenza, another respiratory virus, in prospective clinical studies. In addition, maternal immunization with tetanus and pertussis vaccines has been shown to be effective in preventing these diseases in infants. Maternal immunization may offer the best method of protection from RSV disease in infants through the first months of life.

Currently, ResVax is being evaluated in Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.2

About NanoFlu and Matrix-M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes. Novavax expects to begin a Phase 2 for its quadrivalent NanoFlu clinical trial in the third quarter of 2018.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a BLA for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.