On November 8, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the third quarter ended September 30, 2018 (Press release, AmpliPhi Biosciences, NOV 8, 2018, View Source [SID1234531191]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

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"We made significant progress in the third quarter of 2018. We announced an updated set of positive outcomes from our ongoing expanded access program for seriously ill patients, who suffer from resistant bacterial infections. Additionally, we received agreement from the FDA to proceed to randomized clinical trials for our lead product candidates, AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "AmpliPhi now intends to initiate one of the FDA agreed clinical trials for AB-SA01 in 2019, the bacteremia trial, and also to seek non-dilutive financing for our AB-PA01 program."

Recent Business Highlights

Announced in September 2018 that 84% of patients achieved treatment success at the end of therapy for the company’s expanded access program. Twenty-one patients at 7 hospitals, with serious or life-threatening infections not responding to antibiotics, were treated with AB-SA01 or AB-PA01. Over 1,000 doses of AmpliPhi’s bacteriophage product candidates have now been administered as part of the program since mid-2017. Treatment was generally well tolerated, with no treatment-related serious adverse events.
Received positive U.S. Food and Drug Administration (FDA) feedback for AB-SA01 in September 2018, following a Type B pre-IND meeting. AmpliPhi announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-SA01, for S. aureus bacteremia and prosthetic joint infections, and that no additional preclinical or clinical data are required to proceed with both trials. In addition, AmpliPhi continues to investigate if AB-SA01 may be eligible for approval under the limited population pathway for antibacterial and antifungal drugs (LPAD) which is intended to facilitate development of therapeutics to treat serious or life-threatening infections in a limited population of patients with unmet need.
Received positive feedback from the FDA for AB-PA01 in September 2018. The company announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-PA01, hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due to P. aeruginosa and for P. aeruginosa bacteremia, and no additional preclinical or clinical data are required to proceed. AmpliPhi intends to seek non-dilutive financing and explore other opportunities to conduct these clinical trials.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. 83% (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed an underwritten public offering in October 2018 that raised gross proceeds of $6.8 million, before deducting underwriting discounts and commissions and other offering expenses. AmpliPhi anticipates using the net proceeds from the offering for general corporate purposes, including manufacturing, research and development and general and administrative expenses.
Third Quarter and Nine Months Ended September 30, 2018 Financial Results

Research and development (R&D) expenses for the third quarter of 2018 were $0.4 million compared to an $0.8 million benefit for the third quarter of 2017. The change was primarily attributable to a $1.2 million tax incentive payment received in July 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in the same quarter of 2017. Excluding any benefit from tax incentive payments, R&D expense was $1.6 million in the third quarter versus $1.2 million in the prior year period. The increase of $0.4 million was primarily attributable to a $0.3 million increase in clinical costs and a $0.1 million increase in payroll-related costs.
R&D expenses for the nine months ended September 30, 2018, net of incentive tax payments, were $3.5 million, up from $1.8 million for the nine months ended September 30, 2017. Excluding any benefit from tax incentive payments, R&D expense for the nine months ended September 30, 2018 and 2017 were $4.7 million and $3.8 million, respectively. The increase of $0.9 million was primarily related to a $0.7 million increase in clinical costs, a $0.1 million increase in professional and consulting fees, and a $0.1 million increase in payroll-related costs.
General and administrative (G&A) expenses were $1.3 million for the third quarter of 2018 compared to $1.6 million for the third quarter of 2017. The decrease was primarily due to lower legal and professional fees, as well as a $0.1 million decrease in certain non-cash charges.
G&A expenses for the nine months ended September 30, 2018 decreased by $2.1 million to $4.2 million from $6.3 million for the nine months ended September 30, 2017. The decrease was primarily attributable to a decrease in payroll-related costs and professional fees and the non-recurrence of a non-cash fair value adjustment charge of $0.5 million.
Net cash used in operating activities for the nine months ended September 30, 2018 was $7.0 million compared to $6.8 million for the nine months ended September 30, 2017.
Cash and cash equivalents as of September 30, 2018 totaled $4.5 million, which excludes the proceeds from the company’s October 2018 public offering.
As of November 5, 2018, there were approximately 32.3 million shares of common stock outstanding.

On November 8, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it will be presenting clinical and preclinical data on the company’s next generation AKT inhibitor, ARQ 751, in three poster presentations at the 30th EORTC/AACR/NCI Symposium to be held from November 13 to 16, 2018 in Dublin, Ireland (Press release, ArQule, NOV 8, 2018, View Source [SID1234530928]).

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Presentation Details

Title: A Phase 1 Dose Escalation Study of ARQ 751 in Adult Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic Alterations, Activating PI3K Mutations, PTEN-null, or Other Known Actionable PTEN Mutations
Abstract #:

395
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Combination of the AKT inhibitor ARQ 751 with Immune Checkpoint Inhibitor and Other Therapeutic Agents
Abstract #:

371
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Miransertib and ARQ 751 exhibit superior cell-death-inducing properties compared to other AKT inhibitors and can overcome resistance to other allosteric AKT inhibitors
Abstract #:

442
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

About ARQ 751
ARQ 751 is an orally bioavailable, selective small molecule inhibitor of the AKT serine/threonine kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications. ARQ 751 is currently in a Phase 1 study in adult patients with refractory and/or metastatic tumors that harbor genetic alterations along the AKT pathway.

About Miransertib
Miransertib (ARQ 092) is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has been implicated in a variety of rare overgrowth diseases and cancers; however, there are currently no approved inhibitors of AKT. AKT inhibitors, either as single agent or combination therapy, show significant promise in molecularly defined patient populations. Miransertib is currently in a Phase 1/2 company-sponsored study for PIK3CA-Related Overgrowth Spectrum (PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH/NHGRI), and a Phase 1b study in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer with AKT and PI3K mutations. Miransertib has been granted Rare Pediatric Disease Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), as well as Orphan Designation by the FDA and European Medicines Agency in the rare overgrowth disease, Proteus syndrome.

On November 8, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that it will present at the 2018 Canaccord Genuity Medical Technologies and Diagnostics Forum in New York City on Thursday, November 15, 2018 at 9:30 a.m. Eastern Time (Press release, Genomic Health, NOV 8, 2018, View Source;diagnostics-forum-300746203.html [SID1234531043]).

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To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary. An archived replay will be available for three months beginning 24 hours after the live presentation.

On November 8, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium for patients with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, NOV 8, 2018, View Source [SID1234531409]).

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"2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer."

Recent Highlights

In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
In October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bio to Fujifilm.
Upcoming Events

Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2018, compared to $1.6 million for the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
Net Loss: Net loss was $14.0 million, or $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
Financial Guidance: Based on current operating plans, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.

On November 8, 2018 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2018 (Press release, IntelGenx, NOV 8, 2018, View Source [SID1234531028]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 Third Quarter Financial Highlights:

Total revenue was $700,000, which reflected decreases in deferred revenues on monetization of $972,000, offset by an increase in R&D revenues of $418,000 vs same period last year.
Negative adjusted EBITDA was ($2.3 million), compared to negative adjusted EBITDA of ($340,000) in the same period last year.
Cash and short-term investments totalled $2.2 million as at September 30, 2018, which did not include $499,000 in proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.
Recent Developments:

Announced that an Abbreviated New Drug Application ("ANDA") for a generic buccal film product was submitted to the US Food and Drug Administration ("FDA") by its partner, Insud Pharma (formerly Chemo Group).
Commenced patient recruitment in Phase 2a study with Montelukast VersaFilm in patients with mild to moderate Alzheimer’s Disease ("AD").
Announced successful results from a bioequivalence study for RIZAPORT, its proprietary anti-migraine VersaFilm product, demonstrating that RIZAPORT is bioequivalent to the U.S. reference, Maxalt-MTL, as well as the European reference, Maxalt-Lingua.
Executed a definitive world-wide agreement with Tilray, a global leader in cannabis research, cultivation, production and distribution, to co-develop and commercialize oral film products infused with recreational and medical cannabis ("cannabis-infused VersaFilm").
"This was a landmark quarter, where the Company continued to push the frontiers of oral film drug development," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "From the initiation of AD patient recruitment for the Phase 2a Montelukast VersaFilm study, to the generic buccal film product ANDA submission, to executing our definitive agreement with Tilray, many important milestones were achieved as we continue to advance toward bringing multiple exciting VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2018 amounted to $700,000, compared to $1.3 million for the three-month period ended September 30, 2017. The decrease for the three-month period ended September 30, 2018 compared to last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $972,000 offset by an increase in R&D revenues of $418,000.

Operating costs and expenses were $3.3 million for the third quarter ended September 30, 2018, versus $1.8 million for the corresponding quarter in 2017. The increase for the three-month period ended September 30, 2018 is mainly attributable to a $874,000 increase in Research and Development expenses mainly attributable to an increase in clinical study costs and a $750,000 increase in Selling, General and Administrative expenses mainly attributable to an increase in manufacturing costs.

For the third quarter ended September 30, 2018, the Company had an operating loss of $2.6 million, compared to an operating loss of $569,000 for the comparable period of 2017.

Net comprehensive loss was $2.9 million, or $0.04 on a basic and diluted per share basis, for the three-month period ended September 30, 2018, compared to a net comprehensive loss of $586,000, or $0.01 on a basic and diluted per share basis, for the comparable period of 2017.

As at September 30, 2018, the Company’s cash and short-term investments totalled $2.2 million, which did not include $499,000 in recently reported proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.

Conference Call Details:

IntelGenx will host a conference call to discuss its third quarter 2018 financial results today, November 8, 2018, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 8659745. The call will also be webcast live and archived for twelve months at www.intelgenx.com.