On November 10, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with cancer, reported its financial and operational results for the third quarter of 2016 (Press release, ProNAi Therapeutics, NOV 10, 2016, View Source [SID1234516692]).

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"Over the past few months we’ve successfully re-established ProNAi as a clinical stage oncology company advancing promising drug candidates that target the DNA Damage Response (DDR) network. This is a particularly compelling target space in oncology, highlighted by growing enthusiasm for the PARP inhibitors, which also inhibit a component of the DDR network," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "Our candidates seek to leverage the DDR network beyond PARP with ‘next generation’ DDR therapeutics targeting Chk1 and Cdc7, and we plan to conduct broad clinical development programs for these assets supported by robust research with the goal of efficiently determining their potential utility for the treatment of a variety of oncology indications."

During the quarter, ProNAi reported it had licensed the exclusive worldwide rights to PNT737, a highly selective, orally available, small molecule inhibitor of Checkpoint kinase 1 (Chk1). PNT737 is being investigated in two Phase 1 clinical trials being conducted at the Royal Marsden NHS Foundation Trust and other centers in the United Kingdom. ProNAi anticipates expanding on the current clinical program underway for PNT737, including into the United States, with the expectation of filing an Investigational New Drug application in the second half of 2017.

To support broader studies in well-defined patient populations, ProNAi plans to conduct research designed to explore markers of sensitivity to PNT737 that may facilitate patient selection and to identify additional therapeutic combination opportunities. A possible development path for PNT737 is the treatment of tumors carrying mutations in genes known to contribute to DNA damage and genomic instability – a key hallmark of cancer. The significant and persistent DNA damage caused by these mutations, coupled with Chk1 inhibition, may result in death of the cancer cells, a synergistic effect referred to as ‘synthetic lethality’. Similarly, excessive DNA damage can be induced with other DDR targeting agents such as PARP inhibitors, as well as certain chemotherapies or radiation, highlighting the potential for synergies between these modalities and Chk1 inhibition.

ProNAi is also advancing PNT141, a Cdc7 inhibitor that regulates DNA replication and the DDR network in a different, potentially complementary way to PNT737. Inhibiting both Chk1 and Cdc7 simultaneously may be advantageous and presents the potential for novel combination strategies for PNT737 and PNT141.

Third Quarter 2016 Financial Results (all amounts reported in U.S. currency)
Research and development expenses increased to $12.3 million for the three months ended September 30, 2016 from $8.3 million for the three months ended September 30, 2015. Research and development expenses increased to $28.1 million for the nine months ended September 30, 2016 from $18.3 million for the nine months ended September 30, 2015. These increases in 2016 were primarily due to a $7.0 million upfront fee due to CRT Pioneer Fund LP (CPF) for the exclusive license of PNT737, the recognition of a $2.0 million fee that will be due upon the successful transfer of two ongoing clinical trials in accordance with the license agreement and a $0.9 million upfront fee paid to Carna Biosciences, Inc. for the exclusive license of PNT141. The remaining increase was attributable to increased personnel-related costs and a non-recurring $2.4 million restructuring charge related to estimated close-out expenses for PNT2258. These were partially offset by a decrease in third-party manufacturing and clinical trial costs.

General and administrative expenses increased to $3.0 million for the three months ended September 30, 2016 from $2.7 million for the three months ended September 30, 2015. General and administrative expenses increased to $10.8 million for the nine months ended September 30, 2016 from $6.1 million for the nine months ended September 30, 2015. These increases in 2016 were primarily due to increased personnel-related costs and fees incurred in support of activities as a public company and corporate growth, costs pertaining to business development activities and a $0.4 million non-recurring restructuring charge.

Total operating expenses for the three months ended September 30, 2016 were $15.3 million compared to $11.0 million for the three months ended September 30, 2015. Total operating expenses for the nine months ended September 30, 2016 were $38.8 million compared to $24.4 million for the nine months ended September 30, 2015. Total operating expenses included non-cash stock based compensation of $1.3 million and $4.0 million for the three and nine months ended September 30, 2016 and of $1.3 and $1.9 for the three and nine months ended September 30, 2015, respectively.

For the three months ended September 30, 2016, ProNAi incurred a net loss of $15.2 million compared to a net loss of $18.5 million for the three months ended September 30, 2015. For the nine months ended September 30, 2016, ProNAi incurred a net loss of $38.6 million compared to a net loss of $41.8 million for the nine months ended September 30, 2015. During the three and nine months ended September 30, 2015, net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $7.5 million and $17.4 million.

At September 30, 2016, ProNAi had $122.7 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015. Subsequent to the end of the quarter, ProNAi paid the $7.0 million upfront fee due to CPF for the exclusive license of PNT737.

At September 30, 2016, there were 30,350,560 shares of common stock issued and outstanding and stock options to purchase 6,629,163 shares of common stock issued and outstanding.

On November 10, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported its third quarter 2016 financial results (Press release, OncoGenex Pharmaceuticals, NOV 10, 2016, View Source [SID1234516669]).

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Recent Events

In November 2016, the company announced positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The company does not currently intend to fund further development of apatorsen in bladder cancer without a collaboration partner.
Also in November 2016, OncoGenex discontinued the development of its custirsen program after the AFFINITY and ENSPIRIT Phase 3 clinical trials failed to meet their primary endpoints.
Financial Results
As of September 30, 2016, the company’s cash, cash equivalents, and short-term investments were $32.5 million compared with $55.2 million as of December 31, 2015. Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations for at least the next 12 months.

Revenue for the three and nine months ended September 30, 2016 decreased to zero and $5.1 million, respectively, from $6.7 million and $12.1 million for the three and nine months ended September 30, 2015, respectively. The advanced reimbursement payment made by Teva, as part of the Termination Agreement, was deferred and recognized as collaboration revenue on a dollar for dollar basis as costs were incurred as part of the continuing research and development activities related to custirsen. The decrease in collaboration revenue in 2016 as compared to 2015 was due to the full recognition of the remaining amounts of deferred revenue in 2016.

Total operating expenses for the three and nine months ended September 30, 2016 were $4.4 million and $20.2 million, respectively, compared to $11.4 million and $27.4 million for the three and nine months ended September 30, 2015, respectively.

Net loss for the three and nine months ended September 30, 2016 was $3.7 million and $14.3 million, respectively, compared to $4.6 million and $15.1 million for the three and nine months ended September 30, 2015, respectively.

As of November 10, 2016 OncoGenex had 30,020,294 shares outstanding.

OncoGenex is continuing work with MTS Health Partners in the exploration of strategic alternatives as announced in mid-August.

On November 10, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months of 2016 (Press release, Evotec, NOV 10, 2016, View Source [SID1234516586]).

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FINANCIAL PERFORMANCE – PROFITABLE AND STRONG GROWTH

– Strong revenue growth in both operating segments:

EVT Execute revenues up 36% to EUR 126.6 m;
EVT Innovate revenues up 26% to EUR 17.9 m
– Consolidated Group revenues up 37% to EUR 120.6 m (9M 2015: EUR 88.2 m); base revenues up 30% to EUR 105.0 m

– Adjusted Group EBITDA increased to EUR 30.6 m (9M 2015: EUR 3.4 m)

– R&D expenses of EUR 12.8 m

– Strong liquidity position of EUR 120.0 m despite loan repayments

EVT EXECUTE – STRONG OPERATIONAL PERFORMANCE

– Significant milestone achievements in Bayer, Boehringer Ingelheim and Padlock collaborations

– Phase I clinical start for the treatment of endometriosis with Bayer

– Extensions of ongoing collaboration, e.g. with Genentech and Janssen Pharmaceutica NV

– New long-term strategic drug discovery alliances, e.g. with C4X Discovery, Antibiotic Research UK, UCB

– New compound management partnerships, e.g. with Pierre Fabre and UCB

– New licences enhancing existing drug discovery platform, e.g. with CRISPR/Cas9 and Trianni

– Proposed acquisition of ADME-Tox and DMPK specialist company Cyprotex PLC (after period-end)

EVT INNOVATE – NEW PATHS OF ACCELERATING FIRST-IN-CLASS DRUG DISCOVERY

– New multi-target alliance with Bayer in kidney diseases

– First research collaboration under French Academic Bridge with Inserm in oncology

– Acceleration of TargetNASH programme with Ellersbrook GmbH & Co. KG

– Innovation partnership with ex scientia to develop bispecific small molecule immuno-oncology therapeutics

– Formation of spin-off company Topas Therapeutics GmbH in the field of nanoparticle-based therapeutics to treat immunological disorders

– Participation in Series A funding of Carrick Therapeutics

– Establishing of EVT BRIDGE LAB282 partnership with Oxford University, OSI and OUI (after period-end)

ALL ELEMENTS OF GUIDANCE CONFIRMED – PROFITABILITY GUIDANCE RAISED IN JULY 2016

– Adjusted Group EBITDA (before changes in contingent consideration) expected to more than double compared to 2015

– All other elements of financial guidance as of 22 March 2016 and positive outlook confirmed

– Strong initial outlook for 2017

1. FINANCIAL PERFORMANCE

PROFITABLE AND STRONG GROWTH

Evotec’s Group revenues for the first nine months of 2016 grew to EUR 120.6 m, an increase of 37% compared to the same period of the previous year (9M 2015: EUR 88.2 m). This increase is due to growth in the core EVT Execute business, a full nine month contribution of the Sanofi collaboration as well as significant milestone payments. Excluding milestones, upfronts and licences, Evotec’s base revenues for the first nine months of 2016 were EUR 105.0 m and increased by 30% over the same period of the previous year (9M 2015: EUR 80.7 m). The gross margin in the first nine months of 2016 was strong at 38.5% and improved over the first nine months of 2015 (9M 2015: 27.2%). The margin increase over 2015 is attributable to the same drivers as the trend in revenue growth as well as capacity utilisation and favourable foreign exchange rate effects.

R&D expenses for the first nine months of 2016 decreased by 5% to EUR 12.8 m (9M 2015: EUR 13.5 m) due to successful partnering of EVT Innovate projects in 2015. Total SG&A expenses for the first nine months of 2016 decreased by 7% to EUR 17.8 m (9M 2015: EUR 19.0 m). SG&A expenses in 2015 included one-time M&A and related costs. Adjusted Group EBITDA in the first nine months of 2016 increased significantly to EUR 30.6 m (9M 2015: EUR 3.4 m). Evotec’s operating result for the first nine months of 2016 amounted to EUR 20.4 m (9M 2015: EUR 12.3 m).

Liquidity, which includes cash and cash equivalents (EUR 62.4 m) and investments (EUR 57.6 m) amounted to EUR 120.0 m at the end of September 2016 (31 December 2015: EUR 133.9 m). In Q2 2016, Evotec initiated the repayment of loans, which was continued in Q3 2016.

Revenues from the EVT Execute segment amounted to EUR 126.6 m in the first nine months of 2016, an increase of 36% compared to the prior-year period (9M 2015: EUR 93.4 m). Included in this amount are EUR 23.9 m of intersegment revenues (9M 2015: EUR 19.5 m). The EVT Innovate segment generated revenues in the amount of EUR 17.9 m consisting entirely of third-party revenues (9M 2015: EUR 14.3 m). The increase in revenues resulted from EVT Innovate projects which were partnered in 2015. Gross margin for EVT Execute amounted to 32.9% while EVT Innovate generated a gross margin of 45.6%. R&D expenses for the EVT Innovate segment at EUR 16.3 m in the first nine months of 2016 remained largely unchanged (9M 2015: EUR 16.6 m). Due to growth in the base business, milestone achievements and three full quarters of the Sanofi contribution, the adjusted EBITDA of the EVT Execute segment amounted to EUR 41.3 m in the first nine months of 2016 and increased significantly compared to EUR 16.1 m in the prior-year period. The EVT Innovate segment reported an improved adjusted EBITDA of EUR (10.7) m (9M 2015: EUR (12.7) m).

2. EVT EXECUTE & EVT INNOVATE

EVT EXECUTE – STRONG OPERATIONAL PERFORMANCE

During the first nine months of 2016, EVT Execute demonstrated a strong operational performance, shown also by important milestones achievements in its collaborations with Bayer, Boehringer Ingelheim and Padlock. Furthermore, Evotec was able to announce the progression of a first programme from its strategic alliance with Bayer in the field of endometriosis into Phase I clinical development. In addition, the compound management business is gaining momentum, underlined by new alliances with UCB and Pierre Fabre. Various collaborations were extended in the first nine months of 2016, such as the drug discovery alliances with Genentech and Janssen Pharmaceutica NV. Additionally, Evotec was able to enter new drug discovery alliances with C4X Discovery, UCB and Antibiotic Research UK, the latter underlining the recent trend of an increasing number of non-governmental organisations and foundations accessing Evotec’s drug discovery platforms.

Consistent with the Company’s strategy to offer its clients the most advanced technological platforms, Evotec continued to expand its drug discovery platforms, e.g. with a non-exclusive licence to the leading technology on the market for gene editing (CRISPR-Cas9 licence) and Trianni’s next-generation transgenic technology. Along these lines, Evotec announced the proposed acquisition of Cyprotex PLC after period-end, which would add world-leading high-quality ADME-Tox services and strengthen Evotec’s leadership in drug discovery. This proposed acquisition, which has been unanimously recommended by the board of Cyprotex, is expected to close before year-end 2016.

EVT INNOVATE – NEW PATHS OF ACCELERATING FIRST-IN-CLASS DRUG DISCOVERY

The EVT Innovate portfolio continued to make very good scientific and commercial progress in the third quarter of 2016, resulting in a very strong performance of the segment. EVT Innovate again demonstrated its ability to partner promising early-stage scientific approaches with Pharma companies with the start of a five-year, multi-target alliance with Bayer in the field of kidney diseases based on assets from its CureNephron portfolio. Furthermore, the Company entered into its first research collaboration under its French Academic Bridge with Inserm in the field of oncology. In addition, EVT Innovate is accelerating its TargetNASH programme together with Ellersbrook GmbH & Co. KG, with both partners committed to investing up to EUR 5 m over an initial three-year period. An innovation partnership with ex scientia (UK) to develop bispecific small molecule immuno-oncology therapeutics was formed.

In March 2016, Evotec announced the formation of a spin-off company called Topas Therapeutics GmbH, focused in the field of nanoparticle-based therapeutics to treat autoimmune diseases. The establishment of Topas is the first example of the acceleration of Evotec’s business model to take advantage of carving out or investing in promising programmes with additional upside potential. In addition, Evotec announced an investment of up to $ 6 m towards Carrick Therapeutics’ latest $ 95 m funding round, thereby deepening its already existing relationship with Carrick.

EVT Innovate is also pursuing new approaches in scouting new innovations and accelerating them along the drug discovery value chain. After period-end, Evotec announced a highly innovative strategic partnership called "LAB282" with the University of Oxford, Oxford University Innovation Ltd and Oxford Sciences Innovation aimed at accelerating the translation of basic biomedical research from Oxford into new clinical therapeutics. These efforts, referred to as "EVT BRIDGE", are focused on highly capital efficient translation of academic science into potentially transformative pharmaceutical projects.

3. ALL ELEMENTS OF GUIDANCE CONFIRMED

PROFITABILITY GUIDANCE RAISED IN JULY 2016

Evotec’s financial guidance was last updated in July 2016 due to an increased margin contribution and a positive outlook for the remainder of the year.

Guidance July 2016 Original Guidance 2016 Actual 2015

Group revenues1)

More than 15% growth

More than 15% growth
EUR 115.4 m
Adjusted Group EBITDA2)
More than double Positive and significantly improved compared to prior year EUR 8.7 m
R&D expenses Approx. EUR 20 m Approx. EUR 20 m EUR 18.3 m

Liquidity3)
Similar level compared
to 2015

Similar level compared to 2015 EUR 134.5 m
Capex investments Up to EUR 10 m Up to EUR 10 m EUR 11.2 m
1) Excluding milestones, upfronts and licences
2) Before contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result
3) Excluding any potential cash outflow for M&A or similar transactions

On November 10, 2016 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical company focused on microRNA-based oncology therapeutics, reported financial results for the third quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, NOV 10, 2016, View Source [SID1234516571]).

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MRX34 CLINICAL PROGRAM

In September 2016, the Company voluntarily halted the ongoing Phase 1 trial of its first product candidate, MRX34, following multiple immune-related serious adverse events (SAEs) observed in patients dosed with MRX34 over the course of the trial. Three of these immune-related events resulted in the patient’s death. Subsequently, the U.S. Food and Drug Administration (FDA) notified the Company that the Investigational New Drug (IND) Application for MRX34 has been placed on full clinical hold. Among other comments, the FDA requested a final clinical study report be submitted and noted that a risk-benefit summary with sufficient justification for the continued development of MRX34 would be necessary if the Company requested removal of the clinical hold.

"We were disappointed with the outcome of our Phase 1 study, however, our first priority in developing innovative therapeutics is the safety of patients," said President and CEO Paul Lammers, M.D., M.Sc. "Based on our assessment of both potential therapeutic benefit and risk, we have decided to discontinue development of MRX34 and suspend our pipeline R&D programs."

The Company has initiated a plan to reduce personnel and expenses in order to preserve capital and streamline operations, and it plans to focus on meeting regulatory requirements related to closure of the Phase 1 trial as well as other operating activities consistent with the decision to discontinue development of MRX34. The Company also expects to explore and evaluate strategic alternatives with the goal of enhancing stockholder value.

THIRD QUARTER 2016 FINANCIAL RESULTS

• Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $66.7 million as of September 30, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt.

Beginning in the first quarter of 2017, after giving effect to the personnel and expense reductions, the Company expects its quarterly cash burn rate will range from $2.1 million to $2.3 million. This 2017 quarterly guidance includes contractual commitments and obligations, but excludes any one-time charges related to a strategic transaction should one be concluded.

• Research and development expenses: Research and development expenses were $3.4 million and $11.6 million for the three and nine months ended September 30, 2016, respectively, compared to $4.7 million and $12.6 million during the comparable periods in 2015. The decrease for the three and nine months ended September 30, 2016 compared to the same period in 2015 was primarily attributable to higher costs incurred in 2015 associated with our Phase 1 clinical trial for MRX34, specifically adding additional sites and upfront drug manufacturing costs. The decrease in 2016 was partially offset by an increase in employee compensation, benefits and stock compensation.

• General and Administrative Expenses: General and administrative expenses were $2.0 million and $6.1 million for the three and nine months ended September 30, 2016, respectively, compared to $1.6 million and $3.6 million during the comparable periods in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.

• Net Loss: Net loss was approximately $5.4 million and $17.6 million for the three and nine months ended September 30, 2016, compared to a net loss of $6.2 million and $16.2 million for the comparable periods in 2015. The results included non-cash, stock-based related compensation charges of $513,000 and $1,202,000 for the three and nine months ended September 30, 2016, respectively, and $210,000 and $561,000 for the comparable periods in 2015.

On November 10, 2016 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported its third quarter 2016 financial results for the three-month and nine-month periods ended September 30, 2016 (Filing, Q3, IntelGenx, 2016, NOV 10, 2016, View Source [SID1234516563]). All amounts are in U.S. Dollars unless otherwise stated. The Company will host a conference call today at 4:30 p.m. EST to provide a corporate update.

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2016 Third Quarter Financial Highlights:

• Revenue was $1.8 million, compared to $2.4 million over the same period last year
•
Net comprehensive income was $62 thousand, compared to net comprehensive income of $1.2 million over the same period last year

•
Adjusted EBITDA was $311 thousand, compared to adjusted EBITDA of $1.4 million over the same period last year

•
Cash and short-term investments totaled $5.7 million as at September 30, 2016 compared to the balance of $2.9 million as at December 31, 2015

Recent Highlights:

• Signed commercialization term sheet for RizaportTM with Pharmatronic for Korea
•
Announced the successful completion of a phase 1 clinical study of Montelukast that demonstrated a significantly improved pharmacokinetic profile – bioavailability increased by 52% against the reference product. Montelukast is approved for the treatment of asthma and has shown promising results in the treatment of degenerative diseases of the brain, such as mild cognitive impairment and Alzheimer’s disease, the most prominent form of dementia

•
Signed a development and commercialization agreement with Chemo Group for three generic products

•
Monetized its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million) – the largest influx of capital in the history of the company

"We are most pleased by our progress in executing our business plan and transforming IntelGenx into a global leader in pharmaceutical oral films," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "The completion of the definitive agreement with Chemo Group is a significant achievement for the Company. This important strategic partnership offers IntelGenx an opportunity to expand its global reach with its innovative product pipeline. The excellent results from our recently completed phase 1 study with Montelukast demonstrating a significantly increased bioavailability of the drug further confirms that this important drug repurposing opportunity has the potential to significantly accelerate IntelGenx’ long-term growth."

Financial Results:
Total revenues for the three-month period ended September 30, 2016 amounted to $1.8 million, representing a decrease of $564 thousand or 24% compared to $2.4 million for the three-month period ended September 30, 2015. The decrease for the three-month period ended September 30, 2016 compared to the last year’s corresponding period is mainly attributable to a decrease in royalties of $248 thousand as well as a decrease in milestone revenues of $1.7 million and a decrease in deferred license revenues of $409 thousand, offset by an increase in upfront and deferred revenue on monetization of $1.8 million. Going forward, the royalty revenue should diminish due to the Company’s strategic decision to monetize the royalty on future sales of Forfivo XL.

Operating costs and expenses were $1.7 million for the three-month period ended September 30, 2016 compared to $1 million for the corresponding period of 2015. The increase for the three-month period ended September 30, 2016 is mainly attributable to an increase in Research and Development expenses of $114 thousand and Selling, General and Administrative of $519 thousand. The increase in expenses relates to the investment into additional hiring’s to strengthen IntelGenx’s team as it executes its strategic plan to establish its state-of-the-art manufacturing facility.

For the third quarter of 2016, the Company generated operating income of $88 thousand compared to operating income of $1.4 million for the comparable period of 2015.

Net comprehensive income was $62 thousand or $0.00 on a basic and diluted per share basis for the third quarter of 2016 compared to net comprehensive income of $1.2 million or $0.02 on a basic and diluted per share basis for the comparable period of 2015.

"We are pleased that the company is well funded to advance our current innovative pipeline forward," said Andre Godin, Executive Vice-President and CFO of IntelGenx. "The Company is working hard to bring further visibility to the marketplace in building a stronger presence in the capital markets."

Cash and short-term investments as at September 30, 2016 was $5.7 million, representing an increase of $2.8 million compared with the balance of $2.9 million as at December 31, 2015. The increase in cash relates to the monetization of its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million).