On March 29, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the year ended December 31, 2017 (Press release, Altimmune, MAR 29, 2018, View Source [SID1234525052]).

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Corporate Highlights

Enrolled first two cohorts of government funded Phase 1 trial of NasoShield, an intranasal vaccine against anthrax infection

Positive data in two Phase 2 clinical programs:

Announced positive proof-of-concept Phase 2 flu vaccine trial results with our NasoVAX vaccine

Announced positive pre-clinical data from the Company’s SparVax-L trial comparing SparVax-L and BioThrax against anthrax infection

Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office

Elected Mitchel Sayare, Ph.D., as Chairman of its Board of Directors

Raised approximately $30 million in financing, including through a Series B preferred offering, cash acquired in connection with the reverse merger with PharmAthene and a pre-merger private placement with existing investors, providing cash into the first quarter of 2019
"We have had a very data-rich few weeks with results being reported from our NasoVAX, HepTcell, and SparVax-L programs and moving forward on enrollment in our Phase 1 trial of NasoShield," said William J. Enright, Chief Executive Officer of Altimmune. "We are very excited by the positive results from our NasoVAX trial and look forward to continuing to advance that program. NasoVAX is a very different type of flu vaccine that has tremendous potential as an effective, easy-to-use vaccine that potentially provides better protection than current vaccines. We are also excited by the results on our SparVax-L trial and look forward to moving that program forward once we secure additional government funding. We continue to evaluate our HepTcell results will update investors on our next steps as we better understand those results."

Mr. Enright continued, "operationally, we are pleased with our progress. In 2017 we closed the reverse merger with PharmAthene, allowing us to leverage our resources and create a focused immunotherapeutics company. We strengthened our scientific team with the promotion of Dr. Sybil Tasker to Chief Medical Officer in early 2017. Additionally, in January 2018, Mitchel Sayare, Ph.D. was elected as Chairman of our Board of Directors bringing in-depth biotechnology experience as the former CEO of Immunogen. We anticipate continuing to build on our momentum in 2018 as we move forward with our NasoVAX, SparVax-L and NasoShield programs."

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Financial Results for the Year Ended December 31, 2017

Revenue for the year ended December 31, 2017 was $10.7 million compared to $3.2 million for 2016. The increase was due to $5.7 million increase in revenue from our contract with BARDA and $1.8 million revenue from the NIAID contract we assumed from our merger with PharmAthene in May 2017.

Research and development expenses were $18.4 million for the year ended December 31, 2017 compared to $7.2 million for 2016. The increase in research and development expenses was primarily the result of increases relating to NasoShield, NasoVAX, HepTcell, and SparVax-L clinical and preclinical trial costs, partially offset by $0.5 million reduced spending on the Oncosyn program. Research and development expenses for the year ended December 31, 2016 did not include PharmAthene or costs incurred under the NIAID contract.

General and administrative expenses were $8.5 million for the year ended December 31, 2017, compared to $7.1 million for 2016. The increase was the combined result of increased professional fees related to the merger with PharmAthene and costs incurred by us as a public company, including insurance costs and stock compensation expense, offset by $2.4 million of costs related to our initial public offering incurred in 2016 that did not recur in 2017.

We determined that our goodwill was impaired and a non-cash goodwill impairment charge of $35.9 million was recorded during the year ended December 31, 2017 which was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

We recorded an income tax benefit of $5.6 million during the year ended December 31, 2017, which reflected estimated tax refunds we expect to receive from carrying back our 2017 net operating losses to offset the 2016 federal and state income taxes paid by PharmAthene.

Net loss attributable to common stockholders for the year ended December 31, 2017 was $51.4 million compared with $11.5 million for 2016. Excluding the non-cash goodwill impairment charges, net loss attributable to common stockholders for the year ended December 31, 2017 was $15.4 million compared to $11.5 million for 2016.

Net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($4.01) compared with ($1.66) for 2016. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($1.21), compared to ($1.66) for 2016.

At December 31, 2017, the Company had cash, cash equivalents, and restricted cash of approximately $12.3 million, of which $3.5 million was restricted under the terms of the Series B preferred offering.

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Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributable to common stockholders and adjusted net loss per share attributable to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the twelve months ended December 31, 2017 and 2016.

On March 29, OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will release its financial and operating results for the fourth quarter and full year 2017, ended December 31, 2017, on Monday, April 2, 2018, after the close of the U.S. financial markets (Press release, Oncocyte, MAR 29, 2018, View Source;p=RssLanding&cat=news&id=2340277 [SID1234525059]). The Company will host a conference call on Monday, April 2, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 800-281-7973, for international participants the number is 323-794-2093. For all callers, refer to Conference ID 4101947. To access the live webcast, go to the investor relations section on the company’s website, View Source A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 4101947. Additionally, the archived webcast will be available at View Source

On March 29, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CART-cell therapies, reported that the company will present updates on its ongoing Phase I clinical trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14–18, 2018, in Chicago (Press release, Celyad, MAR 29, 2018, View Source [SID1234532518]). Poster presentations will feature updated data from Celyad’s THINK[1] trial, the new SHRINK[2] and LINK[3] trials in metastatic colorectal cancer, as well as data from a preclinical study showing that the addition of either the CD28 or 4-1BB co-stimulatory domains to CYAD-01 construct brings no benefit in terms of in vitro activity of the receptor.

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Poster Presentation Details:

Poster Title: The THINK clinical trial: Preliminary evidence of clinical activity of NKG2D chimeric antigen receptor T cell therapy (CYAD-01) in acute myeloid leukemia.

Poster Number: CT129

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 12

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Poster Title: The SHRINK clinical trial: A phase I study assessing the safety and clinical activity of multiple doses of an NKG2D-based CAR-T therapy, CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer.

Poster Number: CT123

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 6

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Poster Title: The LINK clinical trial: A phase I study assessing the safety and clinical activity of multiple hepatic transarterial administrations of an NKG2D-based CAR-T therapy, CYAD-01, in patients with unresectable liver metastases from colorectal cancer.

Poster Number: CT134

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 17

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Poster Title: NKG2D as a chimeric antigen receptor – DAP 10 provides optimal co-stimulation for NKG2D based CARs.

Session Title: Adoptive Cell Therapy 3

Poster Number: 3583

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 24, Poster Board 21

On March 29, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, reported financial results for the fourth quarter and year ended December 31, 2017 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAR 29, 2018, View Source [SID1234525060]).

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Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, "2017 was an exciting year for CASI and we have entered 2018 with the same strong momentum. We raised $50 million from new and existing investors, which leaves us well-positioned to launch EVOMELA after the CFDA’s priority review is concluded."

Dr. He continued, "We are incredibly excited by our recent acquisition of a portfolio of ANDAs from Sandoz. We saw an opportunity to acquire medicines already approved in the U.S. and delivering them to the large patient population in China seeking high quality medicines from abroad. We think this is an important new direction for the company and allows CASI the opportunity to commercialize a greater number of both high quality and innovative medicines to Chinese patients. We will prioritize the order in which we plan to introduce these medicines based on the commercial opportunity each present and intend to tap into our local networks and potential partners to accelerate commercialization and market penetration. The rapid change and improvement of the regulatory environment in China for drug development coincides with our strategic mission in both the U.S. and China. Going forward, we plan to leverage our development, regulatory, and commercial infrastructure in China by continuing to add safe and effective medicines to our pipeline."

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

Full Year and Recent Business Highlights

·Announced $50 million private placement to new and existing investors – In March 2018, the Company announced a $50 million private placement led by existing shareholders, ETP Global Fund LP and IDG-Accel China. Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc. participated as a new investor in CASI. The Company had previously closed on a $23.8 million registered direct offering in October 2017.

·Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. – In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, and one that the FDA tentatively approved and three that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that it believes have a unique market opportunity and can be manufactured cost-effectively in China and/or in the U.S.

·EVOMELA granted priority review by the CFDA; MARQIBO and ZEVALIN CFDA review in progress – In September 2017, the Company announced that the CFDA granted priority review for CASI’s import drug registration clinical trial application (CTA) for EVOMELA (melphalan) for injection. The CFDA cited the following reasons as grounds for granting priority review (1) multiple myeloma is a rare disease, (2) there is no melphalan in any formulation available in China to address the unmet medical need, and (3) EVOMELA has clear therapeutic advantages to currently available therapeutics. The CFDA review of CTAs for both MARQIBO and ZEVALIN is underway and progressing on schedule.

Financial Results for the Year ended December 31, 2017

Cash Position: As of December 31, 2017, CASI had cash and cash equivalents of approximately $43.5 million.

R&D Expenses: Research and development (R&D) expenses for the year ended December 31, 2017 were $7.6 million compared to $4.6 million in 2016, an increase of $3.0 million. The increase in 2017 R&D spending primarily reflects $2.8 million in higher costs associated with the quality testing phase of the CFDA regulatory review of ZEVALIN and EVOMELA in 2017, as well as $0.2 million in additional personnel costs related to our preclinical activities in China.

G&A Expenses: General and administrative (G&A) expenses for the year ended December 31, 2017 were $3.2 million compared to $4.8 million in 2016. The increase of $1.6 million in G&A over the prior year primarily reflects an increase of $1.8 million in non-cash stock compensation offset by a $0.2 million increase in additional personnel costs related to business development activities.

Net Loss: The net loss for the year ended December 31, 2017 was ($10.8 million), or ($0.18) per share, compared with a net loss of ($9.5 million) or ($0.17) per share in 2016. The larger net loss in 2017 can be attributed to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN and EVOMELA, offset by less non-cash stock compensation expense during 2017.

Financial Results for the Quarter ended December 31, 2017

R&D Expenses: R&D expenses for the quarter ended December 31, 2017 were $3.8 million compared to $1.3 million in 2016, an increase of $2.5 million. The increase in R&D expenses primarily reflects continued investment in CASI’s development of approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. in China.

G&A Expenses: G&A expenses for the quarter ended December 31, 2017 were $1.2 million compared to $1.4 million in 2016. The decrease in G&A over the prior year primarily reflects the decrease in non-cash stock compensation expense offset by increases due to additional personnel within our business development function and higher professional fees. G&A expenses include non-cash share-based compensation of $0.1 million in the fourth quarter 2017 compared to $0.6 million in the fourth quarter 2016.

Net Loss: The Company reported a net loss of ($5.0 million), or ($0.08) per share, for the quarter ended December 31, 2017. This compares with a net loss of ($2.7 million), or ($0.05) per share for the fourth quarter of 2016. The increase in net loss is primarily due to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2017, can be found at www.casipharmaceuticals.com.

On March 29, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2017 (Press release, IntelGenx, MAR 29, 2018, View Source [SID1234525061]). 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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2017 Fourth Quarter Financial Highlights:

Revenue was $1.5 million, compared to $1.9 million in the fourth quarter of 2016
Adjusted EBITDA was ($600,000), compared to $640,000 in Q4-2016
Cash and short-term investments totalled $4.9 million as at December 31, 2017
2017 Full-Year Financial Highlights:

Revenue was $5.2 million, unchanged from $5.2 million in 2016
Net comprehensive loss was $2.7 million, compared to net comprehensive loss of $1.5 million over the same period last year
Adjusted EBITDA was ($1.4 million), compared to ($280,000) in 2016
Recent Operating Highlights:

Regained exclusive worldwide rights to develop and commercialize RIZAPORT
Received a Notice of Allowance from the United States Patent and Trademark Office for a formulation specific orange book eligible patent for Montelukast VersaFilm
Site obtained GMP compliant rating from Health Canada for manufacturing and packaging activities
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients
"2017 was an important year, as we continued down the path to clinical and commercial success," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have taken many important steps to support our efforts in pharmaceutical oral film development, manufacturing and commercialization, and remain on track for bringing our products to market. Moving forward, we believe that 2018 will represent a landmark period for IntelGenx, as we continue to advance our product pipeline, and begin clinical testing of our potentially groundbreaking Montelukast VersaFilm in Alzheimer’s patients."

Financial Results:

Total revenues for the three-month period ended December 31, 2017 amounted to $1.5 million, representing a decrease of $400,000 compared to $1.9 million for the three-month period ended December 31, 2016. The decrease is mainly attributable to upfront payments received in Q4-2016, partially offset by an increase in R&D revenues. Operating costs and expenses were $2.3 million for the fourth quarter of 2017, versus $1.5 million for the corresponding three-month period of 2016. For Q4-2017, the Company had an operating loss of $850,000, compared to operating income of $430,000 for the comparable period of 2016. Net comprehensive loss was $1.1 million, or $0.02 on a basic and diluted per share basis, for the fourth quarter of 2017, compared to net comprehensive loss of $22,000 or $0.00 on a basic and diluted per share basis, for the comparable period of 2016.

Total revenues for the twelve-month period ended December 31, 2017 amounted to $5.2 million, compared to $5.2 million for the twelve-month period ended December 31, 2016. Operating costs and expenses were $7.7 million for the full year 2017, versus $6.2 million for the corresponding 12-month period of 2016. For the twelve-month period of 2017, the Company had an operating loss of $2.5 million, compared to an operating loss of $980,000 for the comparable period of 2016. Net comprehensive loss was $2.7 million, or $0.04 on a basic and diluted per share basis, for the twelve-month period of 2017, compared to net comprehensive loss of $1.5 million, or $0.02 on a basic and diluted per share basis, for the comparable period of 2016.

As at December 31, 2017, the Company’s cash and short-term investments totalled $4.9 million, compared with $4.5 million as at December 31, 2016.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2017 as well as the 2018 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities March 29, 2018 at 4:00 p.m. EDT.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2017 fourth quarter and full year financial results March 29, 2018, at 4:30 p.m. EDT. The dial-in number for the conference call is (833) 211-3233 (Canada and United States) or (647) 689-3955 (International), conference ID 6786519. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.