On February 13, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020 (Press release, Corcept Therapeutics, FEB 13, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-0 [SID1234554286]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.

On February 13, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that presentations from its targeted conditioning portfolio have been accepted for presentation at the 2020 Transplantation & Cellular Therapy (TCT) Meetings, which brings together thousands of transplant professionals from over 500 transplant centers worldwide (Press release, Actinium Pharmaceuticals, FEB 13, 2020, View Source [SID1234554302]). TCT is being held February 19-23, 2020 at the Marriott World Center in Orlando, Florida. Notably, data from the pivotal Phase 3 SIERRA trial of Iomab-B have been selected for an oral presentation.

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"We are excited that Iomab-B and the SIERRA trial have once again been selected as an oral presentation at TCT," said Dr. Mark Berger, Chief Medical Officer of Actinium. "We look forward to highlighting the potential benefit that Iomab-B can provide to a patient population with active disease who are otherwise ineligible for BMT. We are confident these findings will be received with great enthusiasm. TCT, which assembles leading transplant physicians from top centers in the United States and worldwide, is the ideal venue to showcase the extremely encouraging findings from the SIERRA trial thus far. In addition, our other conference activities are expected to provide significant exposure for this important trial and invaluable interactions with BMT thought leaders. Through the SIERRA trial, we aspire to change the treatment paradigm for older patients with relapsed or refractory AML to make potentially curative BMT via Iomab-B the standard of care for this patient population that continues to have poor outcomes."

Actinium’s TCT Presentations:

Late Breaking Oral Presentation:

Title: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial
Presenter: Boglarka Gyurkocza MD, Memorial Sloan Kettering Cancer Center (and SIERRA Investigator)
Time: Thursday, February 20th, 4:45 PM – 5:00 PM ET
Location: Orlando World Center Marriott – Palms: Sabal
Poster Presentation:

Title: Feasibility of Administering Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] for Targeted Conditioning in Older Patients with Active, Relapsed or Refractory AML without Lead-Lined Rooms: Ongoing Phase 3 Sierra Trial Experience at 6 Study Sites
Presenter: Rajneesh Nath, M.D., Banner MD Anderson Cancer Center (and SIERRA Investigator)
Time: Wednesday, February 19th, 6:30 PM – 8:00 PM ET
Location: Orlando World Center Marriott – Palms: Sabal
About the SIERRA Trial
The SIERRA trial (Study of Iomab-B in Elderly Relapse/Refractory Acute Myeloid Leukemia) is the only randomized Phase 3 trial that offers BMT (Bone Marrow Transplant) as an option for older patients with active, relapsed or refractory AML or acute myeloid leukemia. BMT is the only potentially curative treatment option for older patients with active relapsed or refractory AML and there is no standard of care for this indication other than salvage therapies. Iomab-B is an ARC (Antibody Radiation-Conjugate) comprised of the anti-CD45 antibody apamistamab and the radioisotope I-131 (Iodine-131). The 20 active SIERRA trial sites in the U.S. and Canada represent many of the leading bone marrow transplant centers by volume. For more information, visit www.sierratrial.com.

About Transplantation & Cellular Therapy Meetings (TCT)
TCT, formerly known as the BMT Tandem Meetings, are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Each year the conference brings together several thousand investigators, clinicians, researchers, nurses and other allied health professionals from over 500 transplant centers from over 50 countries around a full scientific program focused on bone marrow transplant and cellular therapies.

On February 13, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported operating results on an unaudited basis for its second quarter fiscal year ended December 31, 2019 (Press release, Precision Optics, FEB 13, 2020, View Source [SID1234554318]).

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Second quarter fiscal 2020 highlights:

Revenue for the quarter ended December 31, 2019 was $2.8 million compared to $1.5 million in the same quarter of the previous fiscal year, an increase of 89% driven primarily by Ross Optical operating as a division of Precision Optics. Revenues for both Precision Optics and Ross Optical increased quarter-over-quarter and year-over-year.
Gross margins for the quarter ended December 31, 2019 of 33% compared to 24% in the same quarter of the prior year driven primarily by Ross Optical operating as a division of Precision Optics.
Net loss of $550,825 during the quarter included $274,706 of stock-based compensation.
Precision Optics’ CEO, Joseph Forkey, commented, "I am pleased with the strong top line performance during the second quarter which highlighted the continued traction we are achieving in our Precision Optics operations, as well as our recently acquired Ross Optical division, with both reporting growth in revenues on a quarter-over-quarter, and year-over-year basis. We continued to deliver against our three commercial level production projects and momentum continues to build in our product pipeline with two products anticipated to be launched this year. As previously discussed, the investments we continue to make in certain products advancing through their complex engineering phases negatively impacted our gross margins again this quarter. However, as these new products come to market, we believe they will contribute to a higher level of top line revenue as well as a return to higher blended gross margins."

Dr. Forkey continued, "We also continue to make disciplined investments in the areas of engineering, sales and marketing, and technology advancement. Recently, we announced the appointment of Jon Everett as our new VP of Engineering to increase our product development pipeline and move existing development projects towards commercialization. The joint Precision Optics and Ross Optical sales teams continue to work well together as we take advantage of the anticipated synergies between the operations, including our joint participation at two highly attended west coast industry conferences over the last two weeks. Finally, we are maintaining our leadership position in micro optics and 3D imaging, with a new patent issued recently for single-use devices, and the submission of two additional patent applications last week. I am pleased with the balanced approach we are taking to invest in the future of Precision Optics, while maintaining a focus on achieving consistent positive cash flows."

The following table summarizes the second quarter (unaudited) results for the periods ended December 31, 2019 and 2018:

Conference Call Details
The Company has scheduled a conference call to discuss the second quarter 2020 financial results for Thursday, February 13, 2020 at 5:00 p.m. ET.

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or (412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until February 20, 2020 at (877) 344-7529 or (412) 317-0088 confirmation #10139141. A webcast replay will be available at View Source

About Precision Optics Corporation
Precision Optics Corporation has been a leading developer and manufacturer of advanced

On February 13, 2020 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Acorda Therapeutics, FEB 13, 2020, View Source [SID1234554263]).

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"INBRIJA’s launch was an important milestone for Acorda in 2019. It is the first and only approved inhalation therapy for the treatment of OFF periods in Parkinson’s disease. In 2020, our focus will be on increasing awareness of and driving demand for INBRIJA among people with Parkinson’s," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer.

Dr. Cohen added, "Another top priority for 2020 is continuing to strengthen our capital structure and balance sheet. In December 2019 we successfully restructured the great majority of our convertible debt, and we have also reduced expenses significantly. We are working to identify additional opportunities to manage costs. These actions have helped position Acorda to deliver long-term value for our shareholders."

Fourth Quarter 2019 Financial Results

For the fourth quarter ended December 31, 2019, the Company reported AMPYRA net revenue of $40.8 million compared to $64.2 million for the same quarter in 2018 and INBRIJA net revenue of $6.1 million.

Research and development (R&D) expenses for the quarter ended December 31, 2019 were $9.0 million, including $0.6 million of share-based compensation, compared to $27.1 million, including $1.2 million of share-based compensation, for the same quarter in 2018.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2019 were $41.2 million, including $2.0 million of share-based compensation, compared to $36.8 million, including $3.8 million of share-based compensation, for the same quarter in 2018.

Benefit from income taxes for the quarter ended December 31, 2019 was $0.8 million, compared to a benefit from income taxes of $63.1 million for the same quarter in 2018.

The Company reported GAAP net income of $65.7 million for the quarter ended December 31, 2019, or $1.38 per diluted share. GAAP net income in the same quarter of 2018 was $9.6 million, or $0.20 per diluted share.

Non-GAAP net loss for the quarter ended December 31, 2019 was $7.1 million, or $0.15 per diluted share. Non-GAAP net income in the same quarter of 2018 was $21.5 million, or $0.45 per diluted share. This quarterly non-GAAP net (loss) income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, goodwill impairment charges, gain on extinguishment of debt, and gain on sale of assets. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Full Year Ended December 31, 2019 Financial Results

For the full year ended December 31, 2019, the Company reported AMPYRA net revenue of $163.2 million compared to $455.1 million for the full year 2018 and INBRIJA net revenue of $15.3 million.

Research and development (R&D) expenses for the full year ended December 31, 2019 were $60.1 million, including $2.8 million of share-based compensation, compared to $106.4 million, including $5.6 million of share-based compensation for the full year 2018.

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2019 were $192.8 million, including $10.8 million of share-based compensation, compared to $172.3 million, including $15.7 million of share-based compensation for the full year 2018.

Benefit from income taxes for the full year ended December 31, 2019 was $1.3 million, compared to a benefit from income taxes of $13.3 million for the full year 2018.

For the full year ended December 31, 2019, the Company reported GAAP net loss of $273.0 million, or $5.75 per diluted share. GAAP net income for the full year 2018 was $33.7 million, or $0.71 per diluted share.

Non-GAAP net loss for the full year ended December 31, 2019 was $81.8 million, or $1.72 per diluted share. Non-GAAP net income for the full year ended December 31, 2018 was $103.4 million, or $2.18 per diluted share. This full year non-GAAP net (loss) income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, goodwill impairment charges, gain on extinguishment of debt, and gain on sale of assets. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2019, the Company had cash, cash equivalents, investments and restricted cash of $168.9 million. Restricted cash includes $42.7 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

2020 Financial Guidance

Total product net revenue for the full year 2020 is expected to be $120 – $150 million, with total revenue expected to be $130 – $160 million. Product revenue excludes royalty revenue, primarily Fampyra royalty revenue obligations owed to Healthcare Royalty Partners.
INBRIJA net revenue for the full year 2020 is expected to be $35 – $40 million.
Expected INBRIJA U.S. annual peak sales has been revised to $300 – $500 million
AMPYRA net revenue for the full year 2020 is expected to be $85 – $110 million.
Operating expenses for the full year 2020 are expected to be $170 – $180 million, reduced from previous guidance of $180 – $190 million. This guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Fourth Quarter 2019 Highlights

In December 2019, the Company successfully exchanged $276 million notional value of 2021 convertible notes, at a 5% discount, for $207 million of December 2024 secured convertible notes, convertible at a significant premium, and $55 million of cash.
In October 2019, the Company announced a corporate restructuring and 25% headcount reduction; more than $21 million in expected annualized cost savings expected.
Webcast and Conference Call

The Company will host a conference call and webcast in conjunction with its fourth quarter/year end 2019 update and financial results today at 8:30 a.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4665685. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on February 13, 2020 until 11:59 p.m. ET on March 12, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4665685. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On February 13, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies with biomarker patient enrichment selection, reported updated results from its Phase 1b/2 clinical trial of ciforadenant, an adenosine A2A receptor antagonist, in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Corvus Pharmaceuticals, FEB 13, 2020, View Source [SID1234554287]). The data were presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco by Lawrence Fong, M.D., study investigator and leader of the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

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"We are pleased to see activity in mCRPC both with ciforadenant monotherapy and in combination with atezolizumab," said Richard Miller M.D., chief executive officer of Corvus. "The results from this study and prior results reported with CPI-006, our anti-CD73 antibody, indicate that prostate cancer is another potential disease that is amenable to therapy with adenosine blockade. Many prostate cancers express CD73 and contain adenosine that is produced by multiple biochemical sources. Our recently published adenosine signature allows us to identify tumors where adenosine is playing an immunosuppressive role and where adenosine blockade may be clinically useful. We plan to pursue the mCRPC indication further and we anticipate additional data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting in late May/June. Overall, these results continue to demonstrate our leading position in the development of agents targeting the adenosine pathway."

Ciforadenant, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. The ciforadenant Phase 1b/2 study is currently enrolling patients with renal cell cancer (RCC) and mCRPC. The mCRPC arm of the study, which began enrolling patients in October 2019, is evaluating ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The study is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy and form the basis for future biomarker driven studies.

Ciforadenant Phase 1b/2 Clinical Trial Results at ASCO (Free ASCO Whitepaper) GU
The clinical data from the Phase 1b/2 trial of ciforadenant were presented by Dr. Fong in a poster presentation titled "Adenosine Receptor Blockade with Ciforadenant ± Atezolizumab in Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)" at the ASCO (Free ASCO Whitepaper) GU 2020 conference. The presentation included data from 35 patients with advanced mCRPC, including 11 that received ciforadenant as a monotherapy (100 mg twice daily) and 24 that received ciforadenant (100 mg twice daily) in combination with atezolizumab (840 mg delivered intravenously every two weeks). These patients had failed a median of three prior therapies and 43% had visceral metastases, which is a negative prognostic factor for patients with mCRPC. The key updates from Dr. Fong’s presentation included:

With median follow up of 3.2+ months, there was one partial response (PR, RECIST); this patient had a prostate-specific antigen (PSA) level drop from 98 to less than 1. Ten additional patients had tumor regression not meeting the criteria for PR. Seven patients have confirmed stable disease exceeding 6 months; one of these patients remains on therapy. Five patients have unconfirmed stable disease and continue on therapy. A total of 9 patients continue on therapy.
Gene expression profiling of tumor biopsies demonstrate a significant correlation of tumor CD73 expression with the adenosine signature (p=0.02). This correlation supports the relevance of adenosine in prostate cancer, its production by CD73 and the expression of adenosine induced immunosuppressive genes. Prior work in renal cell cancer, recently published in Cancer Discovery in January 2020, showed that the adenosine signature is associated with resistance to anti-PD(L)1 therapy, and predicted response to ciforadenant.
Treatment was well tolerated with 1 Grade 3 adverse event of fatigue in monotherapy and 1 Grade 3 adverse event of anemia in the combination arm.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These product candidates are being studied in ongoing Phase 1 and 2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant, and in combination with pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

Adenosine Gene Signature
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor. These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated macrophages, which are thought to mediate resistance to anti-PD(L)1 treatment. In renal cell cancer this biomarker is associated with response to ciforadenant.