On February 28, 2020 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported it has entered into securities purchase agreements with institutional investors for the purchase and sale of 4,571,428 shares of the Company’s common stock, par value $0.01 per share, pursuant to a registered direct offering (Press release, Celsion, FEB 28, 2020, View Source [SID1234554991]). The Company has also agreed to issue to such investors, in a concurrent private placement, warrants to purchase 2,971,428 shares of the Company’s common stock. The warrants will be exercisable on the six-month anniversary of the issuance date, will expire on the five-year anniversary of the initial exercise date and have an exercise price of $1.15 per share. The gross proceeds of the offering will be approximately $4.8 million before deducting placement agent fees and other estimated offering expenses.

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The Company intends to use the net proceeds from the offering for working capital and for other general corporate purposes. The closing of the offering is expected to take place on or about March 3, 2020, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as the Company’s financial advisor for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 28, 2020 KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, provided an update on the KP415 NDA and reported its financial results for the fourth quarter and full-year ended December 31, 2019 (Press release, KemPharm, FEB 28, 2020, View Source [SID1234554990]).

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"Our highest priority at KemPharm is filing the New Drug Application (NDA) for KP415, our prodrug product candidate of d-methylphenidate (d-MPH) being developed for the treatment of attention deficit hyperactivity disorder (ADHD)," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "During the last several months, we have been working hand-in-hand with the team of advisors assembled by our partner, Gurnet Point Capital (GPC), with the primary goal of submitting the best NDA for review by the FDA (U.S. Food and Drug Administration). We believe this investment in time and additional review will improve the probability of acceptance and subsequent approval of KP415 with the best possible label. The timing for the filing of the KP415 NDA is subject to the discretion of GPC and we anticipate receiving their approval to proceed shortly. We intend to file as soon as possible and remain on track to submit the NDA this quarter."

Dr. Mickle continued, "Once the KP415 NDA is submitted to the FDA, our full attention will be focused on ensuring a successful completion of the regulatory review process with the goal of achieving approval for KP415 with the broadest label. KP415 has the potential to be the first truly differentiated methylphenidate-based product introduced to the ADHD market in several years. This market accounted for approximately $3.9 billion in sales in 2018, and we believe KP415’s potential attributes, including onset of action at 30 minutes, duration of effect of 13 hours, and substantially lower abuse potential than relevant d-methylphenidate comparators, could provide a solution to these unmet needs that have been repeatedly cited by both patients and prescribers."

Q4 and FY 2019 Financial Results:

For Q4 2019, KemPharm reported revenue of $1.4 million from research and development services, as compared to Q3 2019 revenue of $11.5 million, which was comprised of a one-time upfront payment of $10 million under the KP415 License Agreement (as defined below), and research and development services revenue of $1.5 million. This is KemPharm’s second sequential quarter reporting research and development services revenue, and the Company expects this trend to continue as the Company provides services to GPC and its affiliates under the license agreement by and between KemPharm and Commave Therapeutics, S.A., an affiliate of GPC, dated September 3, 2019 (the KP415 License Agreement).

KemPharm’s net loss for Q4 2019 was $6.0 million, or $0.18 per basic share and diluted share, compared to a net loss of $5.2 million, or $0.20 per basic and diluted share for the same period in 2018. Net loss for Q4 2019 was driven primarily by an operating loss of $4.4 million and net interest expense and other items of $1.8 million. The net operating loss of $4.4 million for Q4 2019 was a decrease of $4.9 million compared to $9.3 million in the same period in 2018, which was primarily due to revenue of $1.4 million, a decrease in research and development expenses of $3.8 million and a decrease in general and administrative expenses of $1.6 million, offset by royalty and direct contract acquisition costs of $1.9 million.

For FY 2019, revenue totaled $12.8 million, which is comprised of the $10.0 million upfront payment under the KP415 License Agreement, and research and development services revenue of $2.8 million. KemPharm’s reported net loss was $24.5 million, or $0.83 per basic and diluted share, compared to a net loss of $56.5 million, or $3.15 per basic and diluted share for the year ended December 31, 2018. FY 2019 net loss was driven primarily by operating loss of $20.3 million and net interest expense and other items of $6.2 million, partially offset by non-cash fair value adjustment income of $2.0 million. Operating loss for FY 2019 of $20.3 million was a decrease of $35.6 million compared to the FY 2018 operating loss of $55.9 million, which was primarily due to FY 2019 revenue of $12.8 million, a decrease in research and development expenses of $22.3 million, a decrease in general and administrative expenses of $1.7 million, and a decrease in severance expense of $1.6 million, offset by royalty and direct contract acquisition costs of $2.9 million.

As of December 31, 2019, total cash and investments, which is comprised of cash, cash equivalents, and restricted cash, was $3.6 million, which was a decrease of $3.4 million compared to September 30, 2019. Based on the Company’s current operating forecast, existing resources are sufficient to continue operations into, but not through Q3 2020. Existing resources combined with the potential milestones and revenue under the KP415 License Agreement have the potential to extend the cash runway into, but not through, Q1 2021.

"The measures we have taken to reduce our operating spend and restructure our debt obligations, as well as the potential milestones and revenue under the KP415 License Agreement, potentially extend our cash runway into, but not through, Q1 2021," stated LaDuane Clifton, KemPharm’s Chief Financial Officer. "We expect research and development services revenue to continue through FY 2020 and beyond as we provide consultation services to support our partner in their commercial preparation activities for KP415 and with the potential initiation of the product development plan for KP484."

On February 28, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, reported a new strategic direction to accelerate the advancement of certain of its clinical development programs (Press release, Verastem, FEB 28, 2020, View Source [SID1234554989]). The Company’s primary focus will be on the development of CH5126766 (VS-6766), its RAF/MEK inhibitor, in combination with defactinib, its focal adhesion kinase (FAK) inhibitor, for the treatment of KRAS mutant solid tumors. Verastem Oncology will also continue to advance the development of duvelisib (COPIKTRA) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

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"With our newly expanded development pipeline and strengthened balance sheet, we believe this new strategic direction will be transformative for Verastem Oncology as we will have the opportunity to rapidly advance the development of the clinical programs that we believe will yield the greatest results for patients, physicians and shareholders," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "We are honored to have leading life science investors participate in our recently announced private placement. Verastem Oncology’s mission is centered on improving the lives of cancer patients and we believe our work in collaboration with the scientific community has presented significant opportunity to make further meaningful strides in areas of critical need."

Accelerating Development of CH5126766 (VS-6766) and Defactinib Combination

In early 2020, Verastem Oncology licensed exclusive global development and commercialization rights to CH5126766 (VS-6766), a unique and promising inhibitor of the RAF/MEK signaling pathway. The combination of CH5126766 (VS-6766) and defactinib is currently being investigated in a Phase 1 clinical study and expansion cohorts in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Data from this Phase 1 study have been submitted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Annual Meeting. Verastem Oncology plans to initiate discussions with regulatory authorities during the first half of 2020, with the goal of commencing a registration-directed trial as soon as possible.

Advancing Duvelisib in Relapsed/Refractory PTCL

At the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, Verastem Oncology presented positive data from the dose optimization portion of the Phase 2 PRIMO study evaluating duvelisib in patients with relapsed or refractory PTCL, an aggressive disease with a lack of effective therapeutic options. This initial phase of the trial demonstrated promising clinical activity including complete and durable responses, as assessed by independent central review, with a manageable safety profile. The expansion phase of this registration-directed study continues to accrue patients and Verastem Oncology expects to complete enrollment in 2020 and report top-line results from the expansion cohorts in early 2021. Verastem Oncology intends to build on the existing Fast Track and Orphan Drug Designations and submit a regulatory package to the U.S. Food and Drug Administration to expand the approved indications for COPIKTRA to include relapsed or refractory PTCL.

Focusing COPIKTRA Commercial Activities

Verastem Oncology generated preliminary unaudited COPIKTRA net product revenue of $3.6 million for the fourth quarter of 2019, compared to $4.0 million for the third quarter of 2019, and $12.3 million for the full year 2019. Net sales were impacted by timing of purchases and gross to net adjustments associated with Medicare Part D ("donut hole"). Demand units increased 20% from third quarter to fourth quarter 2019. Going forward, Verastem Oncology will be reducing the resources directed to the promotion and sale of COPIKTRA in its current indications, including reducing the size of its salesforce and non-core clinical research. Verastem Oncology plans to shift its COPIKTRA promotional resources toward large, community-based practices and academic institutions, which represent the majority of the appropriate third-line patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL).

Financial Benefits of the Strategic Realignment and 2020 Financial Outlook

As a result of this strategic realignment, Verastem Oncology expects to reduce its operating expenses by approximately 40% for 2020 compared to 2019. Based on its current operating plans, Verastem Oncology expects its research and development and selling, general and administrative expenses for the full year 2020 to be in the range of $70 million to $85 million. As of December 31, 2019, Verastem Oncology had preliminary unaudited cash and short-term investments of $111.3 million. As announced today, Verastem Oncology anticipates completing a private placement of approximately 46.5 million shares of its common stock at an offering price of $2.15 per share on March 3, 2020, resulting in gross proceeds of approximately $100 million to Verastem Oncology before deducting expenses to the placement agents and other estimated offering expenses. Verastem Oncology expects that its existing cash and cash equivalents, along with the revenue it expects to generate from COPIKTRA, will be sufficient to fund its planned operations into the fourth quarter of 2021.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Friday, February 28, 2020, at 8:00 AM ET. The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 4164157.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About CH5126766

CH5126766 (VS-6766) (previously referred to as CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, CH5126766 (VS-6766) blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows CH5126766 (VS-6766) to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The combination of CH5126766 (VS-6766) and the focal adhesion kinase (FAK) inhibitor defactinib is currently being investigated in a clinical study (Phase 1 followed by expansion cohorts) with the expansion cohorts now ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The ongoing clinical study of the CH5126766 (VS-6766)/defactinib combination is supported by single-agent Phase 2 studies which investigated defactinib in KRAS mutant NSCLC and CH5126766 (VS-6766) in KRAS mutant NSCLC and LGSOC.

About Defactinib

Defactinib is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2 A Phase 1/2 clinical trial of defactinib in combination with CH5126766 (VS-6766) in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) is underway.3 The CH5126766 (VS-6766)/defactinib combination is supported by single-agent Phase 2 studies which investigated defactinib in KRAS mutant NSCLC4 and CH5126766 (VS-6766) in KRAS mutant NSCLC and LGSOC.5 Defactinib is also in clinical testing in combination with pembrolizumab for treatment of patients with pancreatic cancer, NSCLC and mesothelioma.6

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.7,8,9

COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status and Orphan Drug Designation, and is being investigated in combination with other agents through investigator-sponsored studies.10 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On February 28, 2020 Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, reported fourth quarter and full year 2019 financial results and recent business highlights (Press release, Sangamo Therapeutics, FEB 28, 2020, View Source [SID1234554987]).

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"This quarter marked an important milestone for Sangamo, as we transitioned to a Phase III company following the transfer of the IND for SB-525 hemophilia A gene therapy to our partner Pfizer, who plan to commence the registrational study this year. This is a significant step in our mission to bring our genomic medicines to patients," said Sandy Macrae, CEO of Sangamo. "Additionally this year, we look forward to progressing our wholly owned assets, ST-920 gene therapy for Fabry disease and TX200 CAR-Treg cell therapy, in the clinic, and will work closely with our collaborator, Kite, as they advance KITE-037, an anti-CD19 allogeneic CAR-T therapy into a Phase 1/2 clinical trial. We will also continue to advance new IND targets in highly prevalent diseases, as exemplified by the newly announced Biogen collaboration, and will continue to look for additional synergistic partnership opportunities to advance our mission to bring innovative genomic medicines to patients and to create value for our shareholders."

Recent Highlights

Yesterday, announced global collaboration agreement with Biogen to develop and commercialize gene regulation therapies for Alzheimer’s, Parkinson’s, neuromuscular and other neurodegenerative diseases. Under the terms of the collaboration, Biogen has exclusive global rights to ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, and a third undisclosed neuromuscular disease target. In addition, Biogen has exclusive rights to nominate up to nine additional undisclosed targets over a target selection period of five years. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States (HSR).

Completed the transfer of the investigational new drug application (IND) for SB-525 gene therapy in hemophilia A to development partner Pfizer, triggering a $25 million milestone payment. Pfizer is currently enrolling patients in a 6-month Phase 3 lead-in study, which serves as the foundation of the Phase 3 registrational study.

Presented updated follow-up of the Phase 1/2 Alta Study assessing SB-525 in adult patients with severe hemophilia A in partnership with Pfizer at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019. The data showed that SB-525 was generally well tolerated and demonstrated sustained increased Factor VIII levels following treatment with SB-525 through to 44 weeks, the extent of follow-up for the longest treated patient in the 3e13 vg/kg dose cohort.

Received Orphan Drug Designation from the European Medicines Agency for ST-920, an investigational gene therapy candidate for Fabry disease. Six US sites are currently active and screening subjects for the Phase 1/2 STAAR study evaluating ST-920, which Sangamo is enrolling in 2020.

Presented preliminary data from the Phase 1/2 THALES Study assessing ST-400, investigational ex vivo gene-edited cell therapy in patients with transfusion-dependent beta thalassemia in partnership with Sanofi at ASH (Free ASH Whitepaper).

Achieved $7.5 million milestone from Sanofi for the first patient dosed in their Phase 1/2 PRECIZN-1 trial evaluating BIVV003, investigational ex vivo gene-edited cell therapy for the treatment of sickle cell disease.

Received clinical trial application authorization in the United Kingdom for the Phase 1/2 STEADFAST clinical study evaluating the CAR-Treg cell therapy TX200 for kidney transplantation.

Hosted R&D Day in New York where Sangamo executives and scientists provided updates across the Company’s clinical and preclinical pipeline, as well as an overview of manufacturing capabilities to support clinical and commercial supply.

Established new Scientific Advisory Board comprising industry and academic international thought leaders who will advise Sangamo on its current and future clinical programs and research and development strategy.

Fourth Quarter 2019 Financial Results

For the fourth quarter ended December 31, 2019, Sangamo reported consolidated net income attributable to Sangamo of $4.6 million, or $0.04 per share, compared to a net loss attributable to Sangamo of $18.7 million, or $0.18 per share, for the same period in 2018.

Revenues for the fourth quarter ended December 31, 2019 were $54.9 million, compared to $26.8 million for the same period in 2018. The increase in revenue was primarily attributable to a $25.0 million milestone achieved for the completion of the IND transfer for SB-525 to Pfizer for hemophilia A, and a $7.5 million milestone achieved for dosing the first subject in the BIVV003 sickle cell disease Phase 1/2 clinical trial partnered with Sanofi.

Total operating expenses were $53.4 million for the fourth quarter ended December 31, 2019, compared to $47.6 million for the same period in 2018.

Research and development expenses were $38.3 million for the fourth quarter of 2019, compared to $33.3 million for the same period in 2018. General and administrative expenses were $15.1 million for the fourth quarter of 2019, compared to $14.4 million for the same period in 2018.

Full Year 2019 Results

For the year ended December 31, 2019, the consolidated net loss attributable to Sangamo was $95.2 million, or $0.85 per share, compared to a net loss attributable to Sangamo of $68.3 million, or $0.70 per share, for the year ended December 31, 2018.

Revenues were $102.4 million in 2019, compared to $84.5 million in 2018. The increase in revenues was primarily attributable to milestones achieved with Sanofi and Pfizer as well as higher revenues related to our collaboration agreement with Kite, a Gilead Company.

On a GAAP basis, total operating expenses were $207.6 million in 2019, compared to $161.6 million in 2018. Stock-based compensation expense included in total operating expenses in 2019 was $19.3 million, compared to $14.7 million in 2018.

Non-GAAP total operating expenses excluding the above stock-based compensation expense, were $188.3 million and $146.9 million in 2019 and 2018, respectively.

The increase in total operating expenses was primarily related to the Company’s overall headcount growth and facilities expansion to support the advancement of Sangamo’s therapeutic pipeline.

Research and development expenses were $145.9 million in 2019, compared to $114.9 million in 2018. General and administrative expenses were $61.7 million in 2019, compared to $46.7 million in 2018.

As of December 31, 2019, the Company had cash, cash equivalents, marketable securities and interest receivable of $385.0 million.

Financial Guidance for 2020

On a GAAP basis, Sangamo expects total operating expenses to be in the range of $270 to $285 million in 2020, which includes non-cash stock-based compensation expense of approximately $25 million.

Non-GAAP total operating expenses, excluding expected non-cash stock-based compensation expense of approximately $26 million, are expected to be in the range of $245 to $260 million.

Conference Call

Sangamo will host a conference call today, February 28, 2020, at 8:00 a.m. Eastern Time, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 4609858. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 4609858.

On February 28, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Thursday, March 5, 2020 following release of its fourth quarter and year end 2019 financial results (Press release, Oncolytics Biotech, FEB 28, 2020, https://ir.oncolyticsbiotech.com/news/detail/495/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2019-financial-results-and-operational-highlights [SID1234554986]).

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The live call may be accessed by dialing +1-888-231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at +1-855-859-2056, using the replay code 3119607 and will be available for one week.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.