On August 9, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the second quarter ended June 30, 2018 (Press release, Jounce Therapeutics, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363021 [SID1234528610]).

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"We recently reported safety and preliminary efficacy data from our lead program, JTX-2011, at ASCO (Free ASCO Whitepaper) in June and are pleased to announce that enrollment is now underway in the dose escalation cohorts of the Phase 1/2 ICONIC trial evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab. For the broader pipeline derived from our Translational Science Platform, we remain on track to file an IND for JTX-4014 this year and are conducting IND-enabling studies for our first tumor-associated macrophage candidate," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our experienced and talented team remains focused on our key value drivers as we work to discover and develop first-in-class immunotherapies. We remain committed to interrogating the tumor microenvironment to inform and refine our clinical trials and, ultimately, impact the lives of cancer patients."

Ongoing Phase 1/2 ICONIC Trial of JTX-2011:

In June 2018, Jounce began enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab.

In June 2018, Jounce presented safety and preliminary efficacy data from its ongoing Phase 1/2 ICONIC (ICOS AgONist Antibody for Immunotherapy in Cancer Patients) trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. The Phase 1 portion of ICONIC was a dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The patients in Phase 2 received JTX-2011 0.3 mg/kg every 3 weeks alone or in combination with nivolumab 240 mg every 3 weeks. Preliminary efficacy evaluation included tumor reductions and response evaluation criteria in solid tumors (RECIST) responses. Key data included:

Safety: JTX-2011 was well tolerated alone and in combination with nivolumab 240 mg every 3 weeks. The overall safety profile observed was consistent with previously reported data from the Phase 1 portion of the ICONIC trial.

Biological and Clinical Activity: The patients with RECIST partial responses (PRs), alone and in combination with nivolumab, reported at ASCO (Free ASCO Whitepaper), remained on study with ongoing response. The RECIST PRs were seen in PD-1 inhibitor naïve patients with Gastric and Triple Negative Breast cancers. In addition, tumor reductions and stable disease have occurred including in patients with Non-Small Cell Lung cancers who are PD-1 inhibitor failures.

Biomarkers: In a preliminary analysis of evaluable fresh pre-treatment biopsies, rates of disease control and tumor reduction appear higher in subjects with high ICOS scores. A potential ICOS pharmacodynamic biomarker (emergence of a peripheral blood ICOS high CD4 T cell population) that appears to associate with anti-tumor activity has been identified.
Additional Pipeline Highlights:

Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in the second half of 2018.

In March 2018, Jounce advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $232.7 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter, offset by the receipt of state and federal income tax refunds.

Collaboration Revenue: Collaboration revenue was $19.4 million for the second quarter of 2018, compared to $20.3 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene. Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, which was adopted in the first quarter of 2018, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene. Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Research and Development (R&D) Expenses: R&D expenses were $18.5 million for the second quarter of 2018, compared to $17.2 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.0 million in increased employee compensation costs related to increased headcount and $0.2 million in increased external research and development costs primarily attributable to IND-enabling activities related to JTX-4014.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the second quarter of 2018, compared to $6.1 million for the same period in 2017. The increase in G&A expenses was primarily due to increased stock-based compensation expense.

Net Loss: Net loss was $4.7 million for the second quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.14. Net loss was $3.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.11. The increase in net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the second quarter of 2017 to the second quarter of 2018.
Financial Guidance:

In March 2018, Jounce provided gross cash burn guidance for 2018 of $80.0 to $100.0 million. This cash burn projection excluded any tax refund impact. During the second quarter of 2018, Jounce received tax refunds of $16.8 million relating to taxes previously paid on the Celgene upfront payment. These refunds resulted from a change in tax accounting method elected as a result of the Tax Cuts and Jobs Act of 2017.

Jounce expects to now be at the lower end of the gross cash burn guidance previously provided and expects to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8881737. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue, cash burn and other financial results, the timing and progress of the Phase 1/2 ICONIC trial, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On August 8, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the three months ended June 30, 2018 (Press release, Synthetic Biologics, AUG 8, 2018, View Source [SID1234528532]).

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"Following several productive meetings earlier this year, we are pleased to have reached preliminary agreement on key elements of our planned Phase 3 clinical trial for ribaxamase, our first-in-class therapeutic intervention designed to prevent the onset of primary C. difficile infection (CDI) by protecting the gut microbiome from antibiotic-mediated dysbiosis. We are in the process of optimizing a protocol synopsis for the Phase 3 clinical trial which we will discuss with the FDA at our end of Phase 2 meeting which is currently planned to take place towards the end of the third quarter," stated Steven A. Shallcross, Interim Chief Executive Officer and Chief Financial Officer.

"We will continue to work closely and collaboratively with the FDA to define a clear and achievable pathway toward gaining marketing approvals. In our ongoing interactions with FDA, what has become clear is their recognition of the unmet need for novel interventions to combat and prevent the proliferation of CDI. With more than 450,000 cases of CDI each year in the U.S., if approved, ribaxamase will be the first intervention specifically designed to prevent CDI associated with the most commonly used IV antibiotics," concluded Shallcross.

Clinical Development and Operational Update

Announced the Company reached preliminary agreement with the FDA on key elements of a proposed Phase 3 clinical program for SYN-004 (ribaxamase), which is expected to:
Comprise a global, event driven clinical trial with a fixed maximum number of patients for total enrollment,
Evaluate the potential efficacy and safety of ribaxamase in a broader patient population by the inclusion of additional IV β-lactam antibiotics in addition to ceftriaxone and by enrolling patients with a variety of underlying infections,
Evaluate the ability of ribaxamase to reduce the incidence of Clostridium difficile infection (CDI) in the ribaxamase treatment group compared to placebo as the primary efficacy endpoint,
Evaluate mortality risk as the co-primary safety endpoint which will be separate from the primary efficacy endpoint of reduction in the incidence of CDI,
Anticipate End-of-Phase 2 meeting with the FDA in 3Q 2018 to solidify the remaining elements of the planned SYN-004 (ribaxamase) Phase 3 clinical trial;
Plan to initiate SYN-004 (ribaxamase) Phase 3 clinical trial in 2H 2019;
Continue efforts to solidify clinical infrastructure, including exploring international regulatory and market access structures to support advancement of SYN-010, designed to treat an underlying cause of the symptoms associated with irritable bowel syndrome with constipation (IBS-C);
Reported supportive data from a second canine animal model demonstrating that when co-administered with oral amoxicillin and oral Augmentin, oral SYN-007 did not interfere with systemic absorption of the antibiotics but did diminish microbiome damage associated with these antibiotics in 2Q 2018.
Quarter Ended June 30, 2018 Financial Results

General and administrative expenses decreased by 13% to $1.4 million for the three months ended June 30, 2018, compared to $1.6 million for the same period in 2017. This decrease is primarily the result of lower salary expense, stock compensation, and related benefits costs incurred during the three months ended June 30, 2018 as compared to the three months ended June 30, 2017 due to the resignation of the Chief Executive Officer, along with the reduction of travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge related to stock-based compensation expense was $264,000 for the three months ended June 30, 2018, compared to $539,000 for three months ended June 30, 2017.

Research and development expenses decreased by 25% to $3.6 million for the three months ended June 30, 2018, from $4.8 million for the three months ended June 30, 2017. This decrease is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2018 since no clinical trials were ongoing during the quarter. The research and development costs incurred during the quarter were primarily related to planning for future Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs as we seek to secure the financial resources necessary for the completion of these clinical trials. The charge related to stock-based compensation expense was $293,000 for the three months ended June 30, 2018, compared to $331,000 for the same period in 2017.

Other income was $789,000 million for the three months ended June 30, 2018, compared to other income of $2.2 million for the same period in 2017. Other income for the three months ended June 30, 2018 is primarily comprised of non-cash income of $783,000 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter.

Cash and cash equivalents as of June 30, 2018 was $7.1 million, a decrease of $10.0 million from December 31, 2017.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, August 8, 2018, at 4:30 p.m. (EDT). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On August 8, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2018 (Press release, Celldex Therapeutics, AUG 8, 2018, View Source [SID1234528548]). The Company will host a conference call at 4:30 p.m. ET today to provide an in-depth update on its pipeline and upcoming milestones for 2018.

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"During the second quarter, we continued to focus on advancing CDX-1140, our promising antibody targeted to CD40, a key activator of immune response, and CDX-3379, which blocks the ErbB3 receptor, an important regulator of cancer cell growth and survival," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We have completed the third monotherapy dose level in the ongoing Phase 1 study of CDX-1140 and are encouraged with the tolerability, immune system activation and early signs of biological activity we have seen to date. We will also be exploring the potential of combining CDX-1140 with our dendritic cell mobilizer, CDX-301, and plan to begin enrolling those cohorts in September. In the next few months, we expect to complete enrollment in the first stage of our Phase 2 combination study of CDX-3379 and Erbitux in advanced head and neck squamous cell carcinoma. Additionally, we have IND enabling studies underway with CDX-0159, our anti-KIT antibody, with the aim of adding it as a new clinical program in 2019."

Recent Highlights:

Enrollment continues in the Phase 1 dose-escalation study of CDX-1140 in multiple types of solid tumors. CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses; however, balancing systemic dosing and safety has proven elusive to date for CD40 targeted activating therapeutics. CDX-1140 is a unique, potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile. Three dosing cohorts have been completed, 0.01, 0.03 and 0.09 mg/kg, and data to date from these cohorts suggest that CDX-1140 has a desirable safety profile and, based on biomarker data, is demonstrating early signs of biological activity. The fourth cohort at 0.18 mg/kg is currently being enrolled. As planned, the study protocol was recently amended to explore CDX-1140 in combination with CDX-301, and enrollment to this cohort is expected to begin in September. CDX-301 is a dendritic cell growth factor that will be used as a priming agent to potentially increase the number of cells available to respond to CDX-1140. In addition, combination with varlilumab could have significant potential, especially in lymphomas which co-express CD40 and CD27 receptors.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced head and neck squamous cell carcinoma (HNSCC) in combination with Erbitux in Erbitux-resistant patients who have been previously treated with checkpoint therapy or are not candidates for checkpoint therapy. Celldex intends to complete enrollment to the first stage of the Phase 2 study and will use these data to inform next decisions. In line with this, the Company continues to explore potential other opportunities in additional indications where ErbB3 is believed to play a role.

Data from the Phase 1/2 study of varlilumab in combination with Opdivo across multiple solid tumors were presented in an oral presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting in June. In the ovarian cancer cohort, for patients with paired tumor samples from before and during treatment, increases in tumor expression of PD-L1 and CD8+ tumor infiltrating lymphocyte (TIL) levels were observed. These increases were associated with improved clinical outcomes, including improved progression-free survival (PFS) and response rate. Celldex recently reviewed preliminary data from the HNSCC and renal cell carcinoma (RCC) cohorts. Twenty-seven patients with HNSCC were treated in the study (3 in Phase 1; 24 in Phase 2). Patients had a median of two prior lines of therapy. 96% had Stage IV disease. 63% had PD-L1 negative tumors. 52% had HPV positive tumors. The overall response rate was 15% (n=4 confirmed) across 27 response-evaluable patients. In this small sample size, no correlation between PD-L1 status and clinical outcome was observed. Given the changing treatment paradigm in renal cell carcinoma, only 14 patients with RCC were treated in the study, all in Phase 2. All patients had prior anti-angiogenic therapy, with a range of 1 to 4 prior treatments. 100% had Stage IV disease, and 50% had PD-L1 negative tumors. 39% of patients experienced stable disease. Celldex plans to present data from the glioblastoma cohort at a medical meeting later this year.
Second Quarter and First Six Months 2018 Financial Highlights and 2018 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2018 were $114.0 million compared to $123.2 million as of March 31, 2018. The decrease was primarily driven by second quarter cash used in operating activities of approximately $17.4 million, of which $5.5 million were glembatumumab vedotin-related payments, partially offset by the receipt of $8.3 million from sales of common stock under the Cantor agreement. Celldex expects that it will make an additional $5.0 to $6.0 million in glembatumumab vedotin-related payments related to the discontinuation of that program. At June 30, 2018, Celldex had 156.6 million shares outstanding.

Revenues: Total revenue was $2.8 million in the second quarter of 2018 and $6.8 million for the six months ended June 30, 2018, compared to $3.8 million and $5.4 million for the comparable periods in 2017. The decrease in revenue for the second quarter of 2018 compared to the second quarter of 2017 was primarily due to lower contract revenue from the International AIDS Vaccine Initiative. The increase in revenue for the six months ended June 30, 2018 compared to the six months ended June 30, 2017 was primarily due to an increase in revenue related to the collaboration agreement with Bristol-Myers Squibb Company.

R&D Expenses: Research and development (R&D) expenses were $21.4 million in the second quarter of 2018 and $43.3 million for the six months ended June 30, 2018, compared to $25.0 million and $50.8 million for the comparable periods in 2017. The decrease in R&D expenses was primarily due to lower personnel, clinical trial, contract manufacturing and contract research expense, partially offset by severance expense of $1.0 million.

G&A Expenses: General and administrative (G&A) expenses were $5.6 million in the second quarter of 2018 and $11.2 million for the six months ended June 30, 2018, compared to $6.5 million and $13.8 million for the comparable periods in 2017. The decrease in G&A expenses was primarily due to lower personnel and marketing expense.

Changes in Fair Value Remeasurement of Contingent Consideration: Gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition was $7.4 million in the second quarter of 2018 and $21.0 million for the six months ended June 30, 2018, primarily due to discontinuation of the glembatumumab vedotin and CDX-014 programs and updated assumptions for the varlilumab program.

Net Loss: Net loss was $16.4 million, or ($0.11) per share, for the second quarter of 2018, and $134.5 million, or ($0.93) per share, for the six months ended June 30, 2018, compared to a net loss of $28.6 million, or ($0.23) per share, for the second quarter of 2017 and $62.8 million, or ($0.51) per share, for the six months ended June 30, 2017.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2018, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call

Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2018 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4768019.

A replay of the call will be available approximately two hours after the live call concludes through August 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4768019. The webcast will also be archived on the Company’s website.

On August 8, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported on its corporate activities, product pipeline and financials for the second quarter ended June 30, 2018 (Press release, G1 Therapeutics, AUG 8, 2018, View Source [SID1234528755]).

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"We have made impressive clinical progress on trilaciclib in the first half of 2018 and are approaching several important clinical milestones later this year. Additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer have been accepted for presentation at the European Society for Medical Oncology Congress in October. We will also be reporting preliminary data from our randomized Phase 2 trials of trilaciclib in second-/third-line SCLC and triple-negative breast cancer in the fourth quarter," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We have been engaged in productive discussions with U.S. and European regulatory authorities regarding the trilaciclib development program and expect that dialogue to continue."

Dr. Velleca added: "We presented the first clinical data on lerociclib in patients with ER+, HER2- breast cancer in June at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which showed promising safety, tolerability and anti-tumor activity. We are currently enrolling the Phase 2a dose-expansion portion of that trial, with patients receiving 500 mg once daily without a dosing holiday. In addition, we have initiated the first clinical trial for G1T48, our oral SERD, in ER+, HER2- breast cancer and expect preliminary data next year."

Corporate Highlights

Completed enrollment of Phase 2 trials of trilaciclib in second-/third-line small cell lung cancer (SCLC) and triple negative breast cancer (TNBC): G1 expects to report preliminary data from both randomized trials in the fourth quarter of 2018.

USAN name lerociclib adopted for G1T38: G1 has received approval from the United States Adopted Names Council that lerociclib has been adopted to refer to G1T38. All future communications from G1 will refer to G1T38 as lerociclib.

Reported positive lerociclib data in breast cancer patients at ASCO (Free ASCO Whitepaper) 2018: in June, G1 announced preliminary Phase 1b data on lerociclib in combination with Faslodex (fulvestrant) that showed promising safety, tolerability and anti-tumor activity when lerociclib was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer.

Initiated enrollment of Phase 2a expansion of lerociclib in combination with Faslodex in ER+, HER2- breast cancer: based on Phase 1b data, the Phase 2a dose expansion portion of the trial is enrolling. Approximately 30 patients will receive lerociclib 500 mg once daily without a dosing holiday.

Initiated Phase 1/2a clinical trial of G1T48, an oral SERD, as monotherapy for treatment of ER+, HER2- breast cancer: in June, G1 initiated the first clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD). This open-label study is expected to enroll up to 96 patients in two parts: a safety, pharmacokinetic and dose escalation portion (Phase 1); and an expansion portion at the recommended Phase 2 dose (Phase 2a). G1 plans to study a G1T48/lerociclib combination regimen for breast cancer in 2019, contingent on the Phase 1 findings.

Expanded leadership team, appointing Chief Commercial Officer and General Counsel: in July, the company named John Demaree as Chief Commercial Officer and Stillman Hanson as General Counsel. Mr. Demaree has more than 20 years of oncology experience, building commercial capabilities and leading multiple successful product launches. Mr. Hanson most recently served as Associate General Counsel and Vice President at IQVIA, and has extensive life sciences corporate legal experience.

Appointed Cynthia Schwalm and Willie Deese to G1 Board of Directors: in June, the company announced the election of two new Board members. Ms. Schwalm most recently served as President and Chief Executive Officer of Ipsen North America. Mr. Deese previously served as President of the Merck Manufacturing Division and as a member of the Merck Executive Committee before retiring in 2016.

Anticipated Upcoming Milestones

Present additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line SCLC at ESMO (Free ESMO Whitepaper) 2018, being held October 19-23 in Munich, Germany.

Report preliminary data from the randomized Phase 2 trilaciclib/chemotherapy trials in second-/third-line SCLC and first-/second-/third-line TNBC in the fourth quarter of 2018.

Complete enrollment of the Phase 2a trial of lerociclib/Faslodex in ER+, HER2- breast cancer by the end of 2018.

Second Quarter 2018 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $188.2 million as of June 30, 2018, compared to $103.8 million as of December 31, 2017. This increase results from the receipt of $107.9 million in net proceeds from the secondary offering in March of this year and $12.1 million in net-proceeds from "at the market offerings" in June, partially offset by cash used in operating activities.

Operating Expenses: Operating expenses were $21.7 million for the second quarter of 2018, compared to $15.4 million for the second quarter of 2017. GAAP operating expenses include stock-based compensation expense of $2.1 million for the second quarter of 2018, compared to $0.8 million for the second quarter of 2017.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2018 were $18.4 million, compared to $13.7 million for the second quarter of 2017. The increase in expense was due to an increase in clinical program costs, drug

manufacturing costs to support clinical programs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2018 were $3.3 million, compared to $1.7 million for the second quarter of 2017. The increase in expense was largely due to an increase in personnel-related costs.

Net Loss: G1 reported a net loss of $20.9 million for the second quarter of 2018, compared to $15.2 million for the second quarter of 2017.

Webcast and Conference Call

The G1 management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3088562. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.

On August 8, 2018 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported the successful completion of its Series B and Series C financings in which it raised a total of $73 million (Press release, Apexigen, AUG 8, 2018, View Source [SID1234528533]).

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The $15 million Series B financing was led by Decheng Capital and the recent $58 million Series C financing was led by 3E Bioventures Capital, Virtus Inspire Ventures, and SV Tech Ventures. As a result of these financings, Apexigen’s Board of Directors was expanded to include Dan Zabrowski, Ph.D. of Decheng Capital, and Karen Liu, Ph.D. of 3E Bioventures Capital.

Apexigen intends to use these proceeds to advance the clinical development of its lead immuno-oncology (I-O) therapeutic APX005M, a monoclonal antibody targeting CD40. Currently, APX005M is in multiple Phase 2 clinical trials to treat different types of cancers. The proceeds will also be used to discover and develop Apexigen’s broader pipeline of therapies.

"Completing these financings puts Apexigen on a new trajectory for growth. We now have the resources to both execute our clinical development strategy for APX005M and accelerate building our pipeline of novel therapeutics based on our proprietary product discovery platform APXiMAB", said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "For APX005M, we are conducting a robust clinical program with 8 ongoing clinical trials, as we believe CD40 activation by APX005M will become a key component in several new I-O therapeutic regimens for treating cancer patients. Looking ahead, we will use our powerful discovery research engine to accelerate generation of new I-O therapeutics."

About APX005M
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as melanoma, non-small cell lung cancer, pancreatic cancer and renal cell carcinoma in various combinations with immunotherapy, chemotherapy or radiation therapy.