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.

On August 8, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the second quarter ended June 30, 2018 (Press release, Apollo Endosurgery, AUG 8, 2018, View Source [SID1234528549]).

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Second Quarter 2018 Highlights

OverStitch became Apollo’s top selling product in U.S. and OUS direct markets
Completed public offering of common stock generating net proceeds of $21.9 million
Received Special 510(k) clearance from the FDA for OverStitch Sx Endoscopic Suturing System
Todd Newton, CEO of Apollo, commented, "During the second quarter, we made progress on a number of fronts. OverStitch sales were up 37% compared to the second quarter of 2017, becoming our top selling product in direct markets, while we also saw strong growth in sales of Orbera365 in the markets in which it is available. At the beginning of June, we received FDA approval for updated U.S. Orbera labeling to reflect the product’s most current safety information to both physicians and patients. We continued to move closer to the introduction of OverStitch Sx and made progress both on our margin improvement projects and our clinical data initiatives."

Second Quarter 2018 Results

Total revenues in the second quarter of 2018 were $15.8 million, compared to $17.1 million in the second quarter 2017, a decrease of 8%.

Total Endo-bariatric product sales increased 13% to $10.8 million in the second quarter 2018 compared to $9.5 million in the second quarter 2017 and comprised 68% and 56% of total revenues, respectively.

Total Endoscopic Suturing System ("ESS") product sales increased 37% to $5.5 million in the second quarter 2018 compared to $4.0 million in the second quarter 2017. Outside the U.S. ("OUS") ESS product sales increased 44%, to $2.8 million and U.S. ESS product sales increased 31% to $2.7 million due to new user adoption and greater product utilization in existing accounts.

Total Intragastric balloon product ("IGB") sales decreased 4% to $5.3 million in the second quarter 2018 compared to $5.5 million in the second quarter 2017. OUS IGB product sales increased 4%, to $3.6 million as higher unit sales and average selling prices of Orbera365 in Europe was partially offset by weaker six-month balloon sales in Brazil. In the U.S., IGB product sales decreased 18% to $1.7 million due to decreased consumer demand in reaction to the June 4, 2018 FDA letter to Health Care Professionals issued to highlight the new U.S. Orbera labeling.

Total Surgical product sales decreased $2.7 million, or 36% in the second quarter 2018 compared to the second quarter 2017 due to reductions in gastric banding procedures being performed worldwide.

Gross margin for the second quarter 2018 was 58%, compared to 61% for the second quarter 2017 as the result of a greater proportion of our overall product sales coming from our ESS products which realize a lower gross margin than our other products. While gross margin was down due to our changing sales mix, ESS product gross margin improved compared to the same period in 2017 due to completed gross margin improvement projects and higher selling prices. We expect additional ongoing and planned gross margin improvement projects to further improve Endo-bariatric product gross margin in 2019.

Total operating expenses increased $0.8 million to $16.7 million in the second quarter 2018, compared to the second quarter 2017. The increase was due to higher research and development expenses in the second quarter attributable to clinical study activities associated with our ESS and IGB products.

Net loss for the second quarter 2018 was $9.5 million compared to $6.9 million for the second quarter 2017. The increased net loss was primarily due to lower gross margin and higher research and development expenses.

Cash, cash equivalents and restricted cash were $35.4 million as of June 30, 2018, which includes total net proceeds of approximately $21.9 million from the Company’s follow-on common stock offering that closed on June 22, 2018.

Conference Call

Apollo will host a conference call on August 8, 2018 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the second quarter ended June 30, 2018.

To participate in the conference call dial (800) 263-0877 for domestic callers and (646) 828-8143 for international callers. The conference ID number is 7723529. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, until Apollo releases its third quarter 2018 financial results. In addition, a telephonic replay of the call will be available until August 14, 2018. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. The replay conference ID number is 7723529.

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 Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer’s, lupus and cancer, among other diseases, reported financial results for the three and nine months ended June 30, 2018 and provided an update on its business (Press release, Stellar Biotechnologies, AUG 8, 2018, View Source [SID1234528534]).

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During the third fiscal quarter, Stellar reported positive research results from viral clearance and glycosylation studies associated with its manufacturing scale-up initiatives. The company also completed equity financings and warrant exercises resulting in net cash proceeds of approximately $8.8 million.

Stellar’s President and Chief Executive Officer Frank R. Oakes said, "We are delivering on a number of initiatives. We achieved positive research results and a quality assurance milestone, advanced key operational programs designed to support our customers, and significantly strengthened our financial position. Additionally, with third-party clinical results now available, Stellar has the opportunity to support an anticipated pivotal Phase 3 clinical study of a KLH-conjugated vaccine candidate."

Stellar Chief Financial Officer Kathi Niffenegger said, "With a stronger balance sheet, which includes $11.2 million in working capital and no debt, we are well positioned to complete planned upgrades to our core aquaculture infrastructure, continue our optimization work, and advance our initiatives to develop additional market opportunities for our technology and products."

Financial Results

Three months ended June 30, 2018

Total revenues increased by $0.05 million to $0.07 million for the three months ended June 30, 2018 compared to $0.02 million for the same period last year due to an increase in product sales.

Total expenses decreased by $0.08 million to $1.23 million for the three months ended June 30, 2018 compared to $1.31 million for the same period last year:

Cost of sales and contract services decreased by $0.03 million to $0.05 million for the three months ended June 30, 2018 compared to $0.08 million for the same period last year. The decrease was primarily due to reduced expenses related to sales of KLH that was produced as a byproduct of the company’s research and development activities.
Research and development expenses decreased by $0.07 million to $0.47 million for the three months ended June 30, 2018 compared to $0.54 million for the same period last year. The decrease was primarily due to a reduction in KLH product inventory utilized for internal research and development activities.
General and administrative expenses increased by $0.02 million to $0.65 million for the three months ended June 30, 2018 compared to $0.64 million for the same period last year primarily due an increased noncash share-based compensation expenses, which were partially offset by reduced professional fees and travel expenses.
For the third quarter of fiscal year 2018, Stellar reported a net loss of $1.16 million, or $0.38 per basic share, compared to a net loss of $ 1.22 million, or $ 0.84 per basic share, for the third quarter of the prior year.

Nine months ended June 30, 2018

Total revenues decreased by $0.07 million to $0.16 million for the nine months ended June 30, 2018 compared to $0.23 million for the same period last year due to a decrease in product sales.

Total expenses decreased by $0.03 million to $4.05 million for the nine months ended June 30, 2018 compared to $4.08 million for the same period last year:

Cost of sales and contract services decreased by $0.12 million to $0.11 million for the nine months ended June 30, 2018 compared to $0.23 million for the same period last year primarily due to decreased product sales volume as well as reduced expenses related to sales of KLH that was produced as a byproduct of the company’s research and development activities.
Research and development expenses increased by $0.26 million to $1.59 million for the nine months ended June 30, 2018 compared to $1.33 million for the same period last year. The increase was primarily due to an increase in research and development activities intended to increase the scalability and throughput capacity of existing manufacturing systems, including engineering lots of KLH produced under the company’s optimization initiative.
General and administrative expenses decreased by $0.21 million to $2.10 million for the nine months ended June 30, 2018 compared to $2.31 million for the same period last year primarily due to reduced professional fees and travel expenses.
For the nine months ended June 30, 2018, Stellar reported a net loss of $3.91 million, or $1.93 per basic share, compared to a net loss of $3.81 million, or $2.63 per basic share, for the nine months ended June 30, 2017.

Working Capital

At June 30, 2018, the company had working capital of $11.2 million. Cash, cash equivalents and short-term investments totaled $11.3 million.

Stellar will file its Form 10-Q for the quarter ended June 30, 2018 with the Securities and Exchange Commission on or about August 8, 2018. To view the company’s filings with the Canadian Securities Administrators (CSA), visit the CSA’s SEDAR website.

On August 8, 2018 Agilent Technologies Inc. (NYSE: A) reported that its PD-L1 IHC 22C3 pharmDx assay is now labeled for an updated use in urothelial carcinoma in Europe (Press release, Agilent, AUG 8, 2018, View Source [SID1234528550]).

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"We are pleased that PD-L1 IHC 22C3 pharmDx will help physicians identify urothelial carcinoma patients for whom KEYTRUDA may be an appropriate first-line treatment option. Being able to support the use of immuno-oncology therapeutics by bringing their associated diagnostics to market is truly encouraging"

Physicians in Europe can now use the assay as an aid to identify urothelial carcinoma patients who are ineligible for cisplatin and may respond to KEYTRUDA (pembrolizumab) as a first-line treatment option. KEYTRUDA is a targeted anti-PD-1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada). It is a humanized monoclonal antibody that may increase the ability of the body’s immune system to help detect and fight tumor cells.

"We are pleased that PD-L1 IHC 22C3 pharmDx will help physicians identify urothelial carcinoma patients for whom KEYTRUDA may be an appropriate first-line treatment option. Being able to support the use of immuno-oncology therapeutics by bringing their associated diagnostics to market is truly encouraging," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 expression in urothelial carcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC) patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS).