On March 10, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the year and three months ended December 31, 2019 and reported on corporate developments (Press release, Aptose Biosciences, MAR 10, 2020, View Source [SID1234555356]).

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The net loss for the quarter ended December 31, 2019 was $7.7 million ($0.13 per share) compared with $6.3 million ($0.17 per share) for the quarter ended December 31, 2018. The net loss for the year ended December 31, 2019 was $26.3 million ($0.52 per share) compared with $28.9 million ($0.86 per share) for the year ended December 31, 2018. Total cash and cash equivalents and investments as of December 31, 2019 were $97.6 million. Based on current operations, we expect that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into early 2022.

"2019 was a transformative year for Aptose as we became a true clinical-stage company, treating patients in two distinct clinical programs – with our first in class FLT3 / BTK inhibitor CG-806 and our MYC inhibitor APTO-253," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We have been treating patients with ascending doses in each trial and have reported early clinical data that illustrate initial pharmacologic activity for both compounds, in addition to clean safety profiles to date.

"We expect 2020 to be a year of continued execution. We believe we are approaching a therapeutic dose with CG-806 in our current trial in B-cell cancers and plan to initiate a clinical trial for patients with AML who are resistant or refractory to current standard-of-care therapies. Indeed, we look forward to bringing a new treatment option to these patients, while bringing a long-term value proposition to Aptose shareholders."

Key Corporate Highlights

CG-806 Phase 1 a/b B-cell Malignancy Clinical Trial –- During the year, Aptose initiated dosing of CG-806 in the Phase 1 a/b clinical trial: a multicenter, open-label, dose-escalation study in patients with relapsed or refractory B-cell malignancies (BCM), including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or non-Hodgkin lymphomas (NHL). After dosing one patient each at the 150 mg BID and 300 mg BID dose levels, and after review from the Cohort Safety Review Committee (CSRC), the Company proceeded to the 3rd dose cohort of 450 mg BID which requires a minimum of three patients. The 450 mg BID dosing cohort is expected to be completed imminently, and the resulting data will be reviewed by the CSRC. Upon satisfactory review of the data, we plan screening and dosing patients for the 4th dose cohort of 600 mg BID followed by planned ascending dose cohorts with three patients each at 750 and 900 mg BID, with the intent to select the recommended phase 2 dose for patients with B-cell cancers, including relapsed or refractory CLL/SLL or NHL. Upon selection of a phase 2 dose, we plan to enroll up to 100 patients in an expansion phase of the trial. Currently, 18 U.S. sites are open for screening and enrolling patients for the study, with additional sites scheduled to come on board. More information is available at www.clinicaltrials.gov (here).

CG-806 Proposed AML Study –- In 2019, preclinical data presented at a number of respected medical conferences supported Aptose’s plans to develop CG-806 for patients with acute myeloid leukemia (AML). Tested against AML primary patient samples and cell lines, CG-806 was more potent than other FLT3 inhibitors including midostaurin, sorafenib, sunitinib, dovitinib, quizartinib, crenolanib and gilteritinib. Now in 2020, Aptose is well under way with the clinical protocol for an AML trial and, upon identification of a potential therapeutic dose for AML patients in the ongoing Phase 1 a/b trial in patients with CLL and NHL, we plan to seek allowance from the FDA to initiate clinical testing in patients with AML.

APTO-253 Phase 1b Clinical Study –- Throughout the year, Aptose successfully completed three dose cohorts in the Phase 1b trial of MYC inhibitor APTO-253 in patients with AML and myelodysplastic syndromes (MDS). We have completed dosing of one patient at the fourth dose cohort of 100 mg/m2 and now are screening for the second and third patients for the 100 mg/kg dose cohort and expect to complete this dose cohort in Q2. No drug-related toxicities have been observed, including no myelosuppression, and dosing will continue to ascend until a maximum tolerated dose is reached. MYC biomarker data from patients at all dose levels thus far continue to demonstrate reductions of MYC gene expression in their peripheral blood cells. The dose escalation portion of the study is designed to transition, as appropriate, to single-agent expansion cohorts in AML and MDS, followed by combination studies. More information can be found at www.clinicaltrials.gov (here).

2019 Financial Equity Offerings –- During 2019, Aptose closed two public offerings of common shares, raising gross proceeds of $74.2 million in December and $21.3 million in June. Aptose is using the net proceeds of the offerings to accelerate and expand its clinical trial programs, and for working capital and general corporate purposes.
RESULTS OF OPERATIONS

Net loss of $26.3 million for the year ended December 31, 2019 decreased by approximately $2.6 million as compared with $28.9 million for the year ended December 31, 2018, primarily as a result of a decline in research and development expenses of $5.0 million in license fees paid to CG for development and commercial rights of CG-806 in fiscal 2018 and a decrease in stock option compensation expense of approximately $2.0 million, offset by increased expenditures of approximately $3.7 million on our CG-806 and 253 development programs, reflecting program costs and related labor and higher cash-based general and administrative expenses of $1 million in the year ended December 31, 2019. The net loss was also lower in 2019 due to higher net finance income, which increased by $341 thousand compared to 2018, mostly as a result of higher interest earned on larger balances of cash equivalents and investments held during the year ended December 31, 2019.

Research and Development Expenses

Research and development expenses of $16.8 million for the year ended December 31, 2019, decreased by approximately $1.9 million compared with $18.7 million for the prior year, primarily as a result of the following events:

License fees paid in the year ended December 31, 2018 to CG of $2.0 million for development and commercial rights of CG-806 in all territories outside of Korea and China, and a further $3.0 million paid for development and commercial rights of CG-806 in China. CG is eligible for development, regulatory and commercial-based milestones, as well as royalties on future product sales. There were no license fees paid to CG or other collaborators in the year ended December 31, 2019.

An increase in research and development activities related to our CG-806 development program of approximately $2.4 million, mostly as a result of increases to our clinical trial operating costs for our CG-806 BCM phase 1a/b clinical trial and planned CG-806 AML phase 1 clinical trial. For the year ended December 31, 2019, program costs consisted mostly of manufacturing costs to supply our clinical trials, operating costs to conduct our CG-806 BCM phase 1a/b clinical trial, which was approved by the FDA in March 2019, as well as preparation costs for our planned CG-806 AML clinical trial. For the year ended December 31, 2018, program costs consisted mostly of manufacturing costs to supply our clinical trials, for preclinical studies to support the IND application we filed in February of 2019 to test CG-806 in patients with BCM, and for consultant and CRO costs to prepare for the CG-806 BCM trial.

A decrease in research and development activities related to our APTO-253 development program of approximately $313 thousand related to lower manufacturing costs to supply the trial, and offset by an increase in costs associated with conducting the phase 1b clinical trial for APTO-253. For both the fiscal years ended December 31, 2018 and 2019, program costs consisted of costs for manufacturing APTO-253 to supply the trial, and for operating costs to conduct the ongoing phase 1b clinical trial. The APTO-253 clinical trial, which had been on a clinical hold since November 2015 was taken off clinical hold in June 2018.

An increase in personnel expenses of $1.6 million in the year ended December 31, 2019, as compared with prior year mostly related to additional clinical research staff to support two Phase 1 clinical trials. At December 31, 2019, we had 23 employees in research and development, including clinical operations as compared to 16 employees as at December 31, 2018.

A decrease in stock option compensation of approximately $552 in the year ended December 31, 2019, related mostly to higher forfeitures in the year ended December 31, 2019, as well as faster vesting of certain stock options granted in the period ended December 31, 2018. In the three-month period ended March 31, 2018, 100,000 stock options with a grant date fair value of $2.03 vested immediately, contributing to higher expenses in that period.
General and Administrative Expenses

General and administrative expenses of $10.0 million for the year ended December 31, 2019, decreased by approximately $352 thousand as compared with $10.4 million for the prior year. Changes to the components of our general and administrative expenses presented in the table above are primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment increased by approximately $1.0 million to $8.1 million for the year ended December 31, 2019, primarily as a result of higher compensation costs, increased travel, rent, consulting and office administrative costs associated with additional employees to support increased operations of the Company, and offset by lower professional and regulatory costs.
Stock-based compensation decreased for the year ended December 31, 2019, by approximately $1.4 million compared with the year ended December 31, 2018, mostly related to faster vesting of certain stock options granted in 2018 when 850,000 of the approximately 1.7 million stock options granted had immediate vesting.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the year and quarter ended December 31, 2019 today, Tuesday, March 10, 2020 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll free number) and 1-574-990-9707 (international/toll number) and using conference ID # 1097606. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 1097606.

The press release, the financial statements and the management’s discussion and analysis for the year and quarter ended December 31, 2019 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On March 10, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2019 (Press release, Akebia, MAR 10, 2020, View Source [SID1234555355]). The Company will host a conference call today, Tuesday, March 10, 2020, at 9:00 a.m. Eastern Time to discuss its fourth quarter and full-year 2019 financial results and recent business highlights.

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"2019 was a year of considerable progress for Akebia and with many milestones on the horizon, 2020 is shaping up to be equally, if not more, exciting," stated John P. Butler, Chief Executive Officer of Akebia. "Our highest priority remains the successful execution of our global Phase 3 program for vadadustat, our investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). We have a tremendous amount of confidence in our vadadustat clinical program and believe we’ve developed an exciting path forward to drive significant value for all our stakeholders. We believe our ability to potentially access a Priority Review Voucher (PRV) for the vadadustat New Drug Application (NDA) to expedite FDA review would meaningfully enhance the potential of bringing vadadustat to patients as quickly as possible, subject to regulatory approval."

Butler continued, "We look forward to sharing data from our global Phase 3 studies of vadadustat, starting with top-line data from INNO2VATE on track for the second quarter of 2020 followed by PRO2TECT in mid-2020. We expect vadadustat to be the first drug of the HIF-PHI class to deliver clear data that directly compare its outcomes to the current standard of care in dialysis-dependent and non-dialysis dependent patients for the treatment of anemia due to chronic kidney disease (CKD)."

Agreement with Vifor Pharma regarding a Priority Review Voucher

In February 2020, Akebia entered into a letter agreement with Vifor (International) Ltd. (Vifor Pharma) relating to Vifor Pharma’s agreement with a third party to purchase a PRV issued by the U.S. Food and Drug Administration (FDA), subject to satisfaction of customary closing conditions. Akebia will pay Vifor Pharma $10.0 million following the closing of the PRV purchase. In exchange, Vifor Pharma is obligated to reserve the PRV for the vadadustat NDA for the treatment of anemia due to CKD in dialysis-dependent and non-dialysis dependent patients until Akebia and Vifor Pharma agree on the financial and other terms under which it will assign the PRV to Akebia or make a mutual decision to sell the PRV. A PRV entitles the holder to priority review of an NDA or a Biologics License Application for a new drug, which reduces the target FDA review time to six months after official acceptance of the submission and could lead to expedited approval.

Jason A. Amello, Chief Financial Officer of Akebia stated, "We are pleased to have extended our cash runway well into 2021 through planned, disciplined spending and the identification of operating efficiencies, coupled with the sales of common stock via our At-the-Market facility over the last few months." The Company’s cash runway, consistent with previous commentary, includes the receipt of a $15.0 million regulatory milestone from Mitsubishi Tanabe Pharma Corporation, Akebia’s development and commercialization collaboration partner in Japan for vadadustat, assuming approval of vadadustat in Japan.

Fourth Quarter and Full-Year 2019 Financial Results

Cash Position: Cash, cash equivalents and available-for-sale securities as of December 31, 2019 were $147.7 million.

Revenues: Total revenue was $69.6 million for the fourth quarter of 2019 compared to $59.9 million for the fourth quarter of 2018(1), and $335.0 million for the full-year 2019 compared to $207.7 million for the full-year 2018(1).

Collaboration revenue was $40.6 million for the fourth quarter of 2019 compared to $53.0 million in the fourth quarter of 2018, and $223.9 million for the full-year 2019 compared with $200.9 million for the full-year 2018. The change in both periods is due to the timing in which vadadustat development expenses are incurred and the associated revenue is recognized on a percentage-of-completion basis.

Net product revenue was $28.9 million for the fourth quarter of 2019 compared with $6.8 million in the fourth quarter of 2018(1), and $111.1 million for the full-year 2019 compared to $6.8 million for the full-year 2018(1). Pro forma net product revenue for the full-year 2018, inclusive of pre-merger net product revenue recorded by Keryx Biopharmaceuticals, Inc. (Keryx), was approximately $96 million.

COGS: Cost of goods sold was $38.1 million for the fourth quarter of 2019, which includes non-cash charges, related to the application of purchase accounting as a result of the merger with Keryx, of $18.8 million for inventory step-up and $9.1 million for amortization of intangibles. Cost of goods sold was $145.3 million for the full-year 2019, which includes non-cash charges of $70.4 million for inventory step-up and $36.4 million for amortization of intangibles.

R&D Expenses: Research and development expenses were $80.4 million for the fourth quarter of 2019 compared to $87.1 million for the fourth quarter of 2018(1), and $323.0 million for the full-year 2019 compared to $291.0 million for the full-year 2018(1). The change in both periods was largely attributable to a change in costs associated with our research and development programs, including vadadustat.

SG&A Expenses: Selling, general and administrative expenses were $44.9 million for the fourth quarter of 2019 compared to $55.1 million for the fourth quarter of 2018(1) (which included $41.7 million of merger-related expenses), and $149.5 million for the full-year 2019 compared to $87.1 million for the full-year 2018(1) (which included $49.5 million of merger-related expenses).

Net Loss: Net loss was $94.5 million for the fourth quarter of 2019 compared to $60.1 million for the fourth quarter of 2018(1), and $279.7 million for the full-year 2019 compared to $143.6 million for the full-year 2018(1).

Includes only 18 days of operating results of Keryx following completion of Akebia’s merger with Keryx on December 12, 2018, whereby Keryx became Akebia’s wholly owned subsidiary.

Conference Call

Akebia will host a conference call at 9:00 a.m. Eastern Time today, Tuesday, March 10th, to discuss its fourth quarter and full-year 2019 financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 6572299. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through March 16, 2020. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 6572299. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On March 10, 2020 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results, including an update on its transformation program, for the year ended December 31, 2019 (Press release, Trillium Therapeutics, MAR 10, 2020, View Source [SID1234555348]).

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2019 Transformation Program

2019 was a critical year in Trillium’s evolution toward a more clinical development-focused CD47 immuno-oncology company. Key developments, as part of a wide-ranging transformation program, were:

Transitioned leadership to a new CEO, Jan Skvarka, who joined in September. Mr. Skvarka is an experienced healthcare executive, who was previously CEO of a PureTech Health portfolio company (Tal Medical), and leading Partner in the Healthcare practice at Bain & Company. He holds an MBA from Harvard Business School.
Established office in Cambridge, MA, which will allow the company to tap the local talent pool. The CEO office and clinical development are now based in Cambridge.
Restructured the company’s footprint by reducing staff by 40% to create a more efficient organization with stronger clinical development focus, as well as extend the cash runway.
Substantially revised the company strategy, namely:
Refocused on intravenous TTI-621 & TTI-622 programs and large hematologic malignancy indications, specifically acute myeloid lymphoma & myelodysplastic syndromes (AML/MDS), peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL) and multiple myeloma;
Deprioritized a lead intratumoral TTI-621 program with intended focus on early-stage cutaneous T-cell lymphoma (CTCL).
Zeroed in on execution of TTI-621 & TTI-622 dose escalation studies, which were declared mission critical path in the near term.
Subsequently, on January 7, 2020, the company announced a data update that confirmed TTI-621 monotherapy activity at initial low dose escalation levels (up to 0.5 mg/kg) across several hematologic malignancies. As such, TTI-621 is the only CD47 blocker that has shown meaningful single agent activity. Further dose optimization is in progress, and TTI-621 is now enrolling patients at a 1.4 mg/kg dose level, or 7 times the initially selected dose at which monotherapy activity was observed.

Following the (i) transformation program, (ii) changes in strategic direction, and (iii) encouraging data update, the company raised $117 million in January 2020, in a substantially oversubscribed public offering. Among key investors were experienced healthcare funds, such as Boxer Capital, Logos Capital, New Enterprise Associates, Venrock Healthcare Capital Partners and Vivo Capital. Paul Walker joined the Board of Directors, and Ali Behbahani became Board Observer; both are General Partners at NEA.

Cash Position and Guidance

As of February 28, the company had approximately $130 million in cash and cash equivalents.

Over the next three years (2020-22), the company plans to accomplish the following goals:

Complete TTI-621 and TTI-622 dose escalation studies, expected in 2020 (potentially in 2021, depending on the dose selected);
Conduct 3-4 new hematologic malignancy studies in AML/MDS, PTCL, DLBCL and/or multiple myeloma; and
Initiate and complete a solid tumor exploratory effort with TTI-621 in several key indications.
In 2020, the company will provide the following updates:

TTI-622 study update at the 2020 ASCO (Free ASCO Whitepaper) annual meeting;
TTI-621 study update mid-year and at the 2020 ASH (Free ASH Whitepaper) annual meeting;
TTI-621 and TTI-622 study updates once maximum tolerated doses or recommended phase 2 doses are identified.
Annual 2019 Financial Results:

As of December 31, 2019, Trillium had cash and cash equivalents and marketable securities, and working capital of $22.7 million and $9.8 million, respectively, compared to $33.4 million and $25.1 million, respectively at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital were due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering. The decrease in working capital was due mainly to cash used in operations and an increase to accounts payable and accrued liabilities due to timing of clinical trial related payments.

-2-

Net loss for the year ended December 31, 2019 of $41.6 million was higher than the loss of $32.9 million for the year ended December 31, 2018. The net loss was higher due mainly to a warrant liability revaluation loss of $5.7 million, the write down of Fluorinov intangible assets of $3.0 million, higher manufacturing costs, and a net foreign currency loss of $0.8 million in the current year compared to a net foreign currency gain of $2.7 million in the prior year. The higher loss was partially offset by lower clinical trial expenses.

In January 2020, the Company completed an underwritten public offering for gross proceeds of $117 million comprising 41,279,090 common shares and 1,250,000 Series II Non-Voting Convertible First Preferred Shares, each issued at $2.75 per share.

On March 10, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2019, as well as anticipated corporate milestones for 2020 (Press release, Surface Oncology, MAR 10, 2020, View Source [SID1234555347]).

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"We have made tremendous progress readying our lead programs, SRF617 and SRF388, for clinical trials. With opened INDs for both of these highly differentiated investigational immunotherapies, we are looking forward to initiating a new phase in our mission to deliver breakthrough treatments to help those affected by cancer," said Jeff Goater, chief executive officer. "Furthermore, with strengthened preclinical data packages across our portfolio, we continue to explore collaborations to enhance our clinical development strategy for each of our lead product programs, an example of which is the clinical collaboration we recently signed with Arcus Biosciences. We look forward to providing initial clinical updates for both SRF617 and SRF388 by the end of 2020."

Recent Corporate Highlights:

Entered into a clinical collaboration with Arcus Biosciences (NYSE: RCUS) in January 2020, to evaluate SRF617 (targeting CD39) in combination with AB928 (a dual A2a/A2b adenosine receptor antagonist) in clinical trials
FDA clearance of the Investigational New Drug applications (INDs) for both SRF617 and SRF388 (targeting IL-27) in January 2020
Continued progression of the ongoing phase 1/1b trial of NZV930 (targeting CD73) by Surface Oncology’s partner Novartis
Promotion of Liisa Nogelo to chief legal officer and Alison O’Neill to senior vice president, clinical development
Selected 2019 Corporate Highlights:

Filed INDs for both SRF617 and SRF388
Strengthened its team and Board of Directors with key additions, including the board appointment of Ramy Ibrahim, M.D., the chief medical officer of the Parker Institute for Cancer Immunotherapy
Announced a development candidate, SRF813 (CD112R), targeting the activation of natural killer and T cells
Published a peer-reviewed manuscript in the scientific journal ImmunoHorizons1 describing the biological activity of IL-27, an immunosuppressive cytokine and the target of SRF388
Gave multiple preclinical data presentations related to Surface Oncology’s pipeline programs at key scientific conferences, including the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting and the Brisbane Immunotherapy 2019 Conference
Secured a debt financing facility for up to $25 million from K2 HealthVentures
Held Surface Oncology’s inaugural Investor and Analyst Day
Selected Anticipated 2020 Corporate Milestones:

Initiation of phase 1 trial for SRF617 in the first half of 2020
Initiation of phase 1 trial for SRF388 in the first half of 2020
Multiple preclinical data presentations anticipated at key medical and scientific conferences throughout 2020, including at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April
Initial clinical updates for both SRF617 and SRF388 anticipated by the end of 2020
Financial Results:

As of December 31, 2019, cash, cash equivalents and marketable securities were $105.2 million, compared to $158.8 million on December 31, 2018.

Research and development (R&D) expenses were $11.7 million for the fourth quarter ended December 31, 2019, compared to $10.5 million for the same period in 2018. This increase was primarily driven by additional spend incurred for SRF617 and SRF388 associated with the IND filings in the fourth quarter of 2019. R&D expenses were $52.1 million for the full year 2019, compared to $52.5 million for the same period in 2018. This decrease was primarily driven by a reduction of manufacturing spend on the SRF231 (CD47) program, which was partially offset by increased spend on SRF617 and SRF388 associated with the IND filings in the fourth quarter of 2019. R&D expenses included $2.4 million in stock-based compensation expense for the full year 2019.

General and administrative (G&A) expenses were $5.1 million for the fourth quarter ended December 31, 2019, compared to $4.8 million for the same period in 2018. G&A expenses were $20.6 million for the full year 2019, compared to $16.1 million for the same period in 2018. The increase in G&A expenses for both the fourth quarter of 2019 and the full year 2019 was primarily due to increased personnel costs and professional fees. G&A expenses included $3.6 million in stock-based compensation expense for the full year 2019.

For the fourth quarter ended December 31, 2019, net loss was $16.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.57. Net loss was $4.7 million for the same period in 2018, or basic and diluted net loss per share attributable to common stockholders of $0.17. For the full year ended December 31, 2019, net loss was $54.8 million, or basic and diluted net loss per share attributable to common stockholders of $1.97. Net loss was $6.6 million for the same period in 2018, or basic and diluted net loss per share attributable to common stockholders of $0.33.

Financial Outlook:

Following the strategic restructuring implemented in January, Surface Oncology’s current cash and cash equivalents are projected to fund the Company into 2022. Anticipated milestones under the NZV930 collaboration with Novartis and additional capital potentially available under the K2 HealthVentures debt financing, in aggregate, would extend Surface Oncology’s cash runway into the second half of 2022.

On March 10, 2020 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the fourth quarter and full year ended December 31, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, MAR 10, 2020, View Source [SID1234555346]).

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"Last year was transformational for Bicycle as the completion of our initial public offering and the strengthening of corporate leadership enabled successful execution against our pipeline development strategy," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This year is already off to a strong start, with two new immuno-oncology collaborations designed to expand upon our wholly owned portfolio of systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs). We look forward to the momentum continuing as we progress multiple Bicycle Toxin Conjugates through the clinic this year and prepare to begin clinical development of our first TICA. We believe our anticipated near-term milestones will further demonstrate the role Bicycles could play in creating a much-needed new treatment paradigm for people living with cancer and other serious diseases."

Fourth Quarter 2019 and Recent Highlights

Entered into Strategic Collaboration with Genentech to Discover, Develop and Commercialize Novel Bicycle-based Immuno-oncology Therapies. In February 2020, Bicycle entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Bicycle will be responsible for discovery research and early preclinical development up to candidate selection. Bicycle will receive a $30 million upfront payment. The upfront payment and potential milestone payments could total up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties. None of Bicycle’s wholly owned oncology assets, including its immuno-oncology candidates, are included in the collaboration.
Announced Collaboration with Cancer Research UK to Develop New Bicycle Immuno-oncology Candidate, BT7401. In January 2020, Bicycle announced a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research. Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase I/IIa clinical study.
Dosed First Patient in Phase I/II Trial of BT5528, a Second-generation Bicycle Toxin Conjugate (BTC) Targeting EphA2, in Patients with Advanced Solid Tumors. In November 2019, Bicycle announced that the first patient had been dosed in the Phase I dose escalation portion of its Phase I/II trial of BT5528 in patients with advanced solid tumors associated with EphA2 expression. BT5528 is the first second-generation BTC to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies.
Presented New Preclinical Data for Novel, Fully Synthetic TICAs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. In an oral presentation at SITC (Free SITC Whitepaper), Bicycle presented new data showing that its lead immuno-oncology candidate, BT7480, a TICA targeting Nectin-4 and agonizing CD137, rapidly penetrates tumors and effects powerful anti-tumor activity in preclinical models.
Anticipated Key Events in 2020

Initiation of Phase IIa trial of BT1718, a BTC targeting MT1-MMP, in patients with solid tumors expressing MT1 (trial sponsored by Cancer Research UK)
Interim BT5528 Phase I data readout from the ongoing Phase I/II trial
Initiation of nivolumab arm in BT5528 Phase I portion of the ongoing Phase I/II trial
Initiation of a Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, a tumor antigen shown to be overexpressed in tumor cells, in patients with solid tumors
Financial Results

Cash was $92.1 million as of December 31, 2019, compared with $63.4 million as of December 31, 2018. Cash at December 31, 2019 does not include the $30 million upfront payment from Genentech.
Research and development expenses were $6.6 million for the three months ended December 31, 2019 and $25.5 million for the year ended December 31, 2019, compared to $6.5 million for the three months ended December 31, 2018 and $20.8 million for the year ended December 31, 2018. The increase of $0.1 million for the three months ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $0.4 million of incremental non-cash share-based compensation expense, offset by a decrease of $0.9 million in direct program spending. The increase of $4.8 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase of $2.1 million in direct program spending as well as an increase in personnel-related expenses, including $0.8 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $3.4 million for of the three months ended December 31, 2019 and $14.6 million for the year ended December 31, 2019, compared to $2.1 million for of the three months ended December 31, 2018 and $8.1 million for the year ended December 31, 2018. The increase of $1.3 million for the three months ended December 31, 2019 as compared to the same period in the prior year is primarily due $0.9 million in personnel-related costs, including $0.4 million of incremental non-cash share-based compensation expense, as well as $1.6 million in professional fees and costs related to operations as a public company, offset by a $1.2 million favorable effect of foreign exchange rates. The increase of $6.4 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $1.2 million of incremental non-cash share-based compensation expense, as well as an increase in professional fees and costs related to operations as a public company, offset by a $0.6 million favorable effect of foreign exchange rates.
Net loss was $4.4 million, or $(0.25) basic and diluted net loss per share, for the three months ended December 31, 2019 and net loss was $30.6 million, or $(2.77) basic and diluted net loss per share for the year ended December 31, 2019, compared to net loss of $6.6 million, or $(13.19) basic and diluted net loss per share for the three months ended December 31, 2018, and net loss of $21.8 million, or $(49.78) basic and diluted net loss per share for the year ended December 31, 2018.