On May 10, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported financial results for the quarter ended March 31, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 10, 2018, View Source [SID1234526496]).

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"Our priorities for 2018 are advancing our first-in-class drug candidates SY-1425 and SY-1365, leveraging our leading gene control platform to continue fueling our pipeline, and building on our strong financial position and company fundamentals," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We have made terrific progress on all three fronts this year, presenting preclinical data that support the planned expansion of our Phase 1 trial of SY-1365 into ovarian cancer, entering into a collaboration with Incyte that applies our platform to diseases beyond our current areas of focus, and fortifying our financial position with a successful public offering. We continue to build momentum as we prepare for our planned data readouts in the fourth quarter of this year for both SY-1425 and SY-1365, and we remain focused on executing with excellence as we strive to build a great and enduring company with medicines that make a profound difference for currently underserved patients."

Upcoming Milestones

Syros plans to report initial clinical data in the fourth quarter of 2018 from cohorts in its Phase 2 trial evaluating SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS) patients. The primary objective of the trial is to evaluate the safety and efficacy of these combinations in biomarker-positive AML and higher-risk MDS patients. The Company announced today that it plans to add approximately 25 biomarker-negative newly diagnosed AML patients who are not suitable candidates for standard chemotherapy to its ongoing Phase 2 trial in order to support the development of a commercial companion diagnostic test for SY-1425. These patients will be treated with SY-1425 in combination with azacitidine.
Syros plans to open expansion cohorts in mid-2018 in its ongoing Phase 1 trial of SY-1365 in multiple patient populations with ovarian and breast cancer to evaluate SY-1365 as a single agent and in combination with standard-of-care therapies.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its ongoing Phase 1 trial of SY-1365 in advanced solid tumor patients.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Platform and Pipeline Highlights

In April 2018, Syros and its collaborators at the Dana-Farber Cancer Institute presented new preclinical data on SY-1365 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago. SY-1365 demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer, inhibiting tumor growth in 10 of the 17 patient-derived xenograft models studied, including inducing complete regressions. These responses were observed irrespective of BRCA status or sensitivity to a PARP inhibitor. Preclinical studies also pointed to potential biomarkers of response to SY-1365.
First Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2018 were $121.7 million, compared with $72.0 million on December 31, 2017. This increase in cash reflects aggregate gross proceeds of approximately $46.0 million from Syros’ underwritten public offering of common stock that closed in February 2018, $1.4 million in proceeds from a private placement of stock to Incyte Corporation concurrent with this public offering, and a $10.0 million upfront payment and $10.0 million in proceeds from the sale of Syros common stock received in January 2018 in connection with Syros’ entry into its collaboration with Incyte.

For the first quarter 2018, Syros reported a net loss of $14.5 million, or $0.48 per share, compared to a net loss of $11.5 million, or $0.49 per share, for the same period in 2017. Stock-based compensation included in the net loss was $1.7 million for the first quarter 2018, compared to $0.9 million for the same period in 2017.

Revenues were $0.4 million for the first quarter of 2018, as compared to $1.1 million for the same period in 2017. Revenues in the first quarter of 2018 were earned under Syros’ collaboration with Incyte, compared to revenues in the first quarter of 2017, which were earned from a research agreement with a multinational pharmaceutical company.
Research and development (R&D) expenses were $11.1 million for the first quarter of 2018, as compared to $9.6 million for the same period in 2017. This increase was primarily attributable to increased external research and development costs associated with Syros’ ongoing clinical trials. Stock-based compensation included in R&D expenses was $0.6 million for the first quarter 2018, compared to $0.3 million for the same period in 2017.
General and administrative (G&A) expenses were $4.1 million for the first quarter of 2018, as compared to $3.1 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related costs, including salary, benefits and stock-based compensation, as well as legal and professional fees associated with entry into Syros’ collaboration with Incyte. Stock-based compensation included in G&A expenses was $1.1 million for the first quarter 2018, compared to $0.6 million for the same period in 2017.
Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to enable it to fund its planned operating expenses and capital expenditure requirements into 2020.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 2967666. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days

On May 10, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it will be giving a company presentation at Bio€quity Europe 2018, Ghent, Belgium, 14 – 16 May 2018 (Press release, STORM Therapeutics, MAY 10, 2018, View Source [SID1234561044]).

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Keith Blundy, CEO of STORM Therapeutics will be presenting on Wednesday, 16 May 2016 at 9:10am CEST in Rector Gillis Suit, Level 1, Het Pand, Onderbergen 1, Ghent, Belgium.

Now celebrating its 19th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals.

On May 10, 2018 Alkermes plc (NASDAQ: ALKS) reported that its corporate presentation will be webcast live at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 at 11:20 a.m. PT (2:20 p.m. ET/7:20 p.m. BST) from Las Vegas (Press release, Alkermes, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348542 [SID1234526463]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Jennifer Zibuda
Corporate Communications
+1 781 609 6129

On May 10, 2018 Geron Corporation (Nasdaq: GERN) reported financial results for the first quarter ended March 31, 2018 (Press release, Geron, MAY 10, 2018, View Source [SID1234526481]).

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First Quarter 2018 Results

For the first quarter of 2018, the company reported operating revenues of $318,000 and operating expenses of $7.8 million compared to $537,000 and $8.0 million, respectively, for the comparable 2017 period. Net loss for the first quarter of 2018 was $7.2 million, or $0.04 per share, compared to $7.2 million, or $0.05 per share, for the comparable 2017 period.

Revenues for the first quarter of 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the first quarter of 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior period presented. As a result, the decrease in revenues for the first quarter of 2018 compared to the same period in 2017 reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Research and development expenses for the three months ended March 31, 2018 and 2017 were $2.4 million and $3.4 million, respectively. The decrease in research and development expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects reduced personnel related expenses due to lower stock-based compensation expense and lower clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen).

General and administrative expenses for the three months ended March 31, 2018 and 2017 were $5.3 million and $4.7 million, respectively. The increase in general and administrative expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher consulting and legal costs associated with business development activities.

Interest and other income for the three months ended March 31, 2018 and 2017 was $394,000 and $332,000, respectively. The increase in interest and other income for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher yields on the company’s marketable securities portfolio. For the three months ended March 31, 2018, the company also recognized a loss of $125,000 for the change in the fair value of an equity investment as required under a new accounting standard adopted by the company as of January 1, 2018.

The company ended the first quarter of 2018 with $103.2 million in cash and marketable securities. Subsequently, in April 2018, the company completed the sale of the remaining common stock subject to its At Market Issuance Sales Agreement (Sales Agreement). Under the Sales Agreement, the company sold a cumulative total of approximately 13.8 million shares of common stock and raised net cash proceeds of approximately $48.7 million after deducting sales commissions and offering expenses payable by Geron. No further shares of common stock can be issued under the Sales Agreement. The company expects the net cash proceeds to provide additional capital structure flexibility to potentially support (i) the future development of imetelstat in collaboration with Janssen, if Janssen elects to continue the collaboration, including potentially conducting one or more imetelstat independent development plans (IDPs) under the Collaboration Agreement; (ii) the further development of imetelstat by Geron in the event the collaboration with Janssen does not continue and Geron elects to continue development of imetelstat; or (iii) prospective in-licenses or acquisitions of other oncology products, programs or companies.

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"As we have previously announced, we expect Janssen to make its decision about whether to continue their development of imetelstat by the end of third quarter of 2018," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "Regardless of Janssen’s future decision, we believe imetelstat warrants further development because of the activity observed in lower risk MDS patients from Part 1 of IMerge as presented at ASH (Free ASH Whitepaper) last December, and the evolving overall survival in relapsed or refractory MF patients observed in IMbark."

Annual Meeting of Stockholders

Geron’s Annual Meeting of Stockholders will be held at 4:00 p.m. PDT / 7:00 p.m. EDT on May 15, 2018. Further information about the Annual Meeting is available on Geron’s website at www.geron.com on the homepage and in the Investors section under Events.

Due to the proximity of the Annual Meeting, Geron management will not be hosting a separate first quarter conference call.

On May 10, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the first quarter ended March 31, 2018 (Press release, Tocagen, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348569 [SID1234526497]).

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"We are off to a strong start this year and are well positioned to execute on our key priorities, including completing enrollment in our Phase 3 trial in recurrent brain cancer by year end," said Marty Duvall, chief executive officer of Tocagen. "In parallel, we are working to expand Toca 511 & Toca FC into newly diagnosed brain cancer while exploring its potential in other tumor types."

First Quarter 2018 and Recent Highlights

Entered into a license agreement with ApolloBio: In April 2018, Tocagen and ApolloBio entered a license agreement to develop and commercialize Toca 511 & Toca FC within the greater China region. Tocagen is eligible to receive up to $127 million in upfront payment, development and commercial milestones, plus additional double-digit tiered sales royalties. Upfront and near-term development milestone payments total up to $20 million. More details are available in the corresponding Form 8-K filed with the U.S. Securities and Exchange Commission (SEC).
Updated durable response data from Phase 1 recurrent high grade glioma (rHGG) resection study: Updated durable response data from the Phase 1 study involving patients with rHGG who received Toca 511 & Toca FC at the time of surgical resection were presented by trial investigators at the 2018 American Academy of Neurology (AAN) Annual Meeting and 2018 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting. Tocagen previously presented data from this study as of August 15, 2017. In the presentations at AAN and AANS, updated data showed Toca 511 & Toca FC continue to demonstrate a favorable safety profile and all study responders remained alive and in complete response as of December 20, 2017. As of this cutoff date, the median duration of durable response had not yet been reached, with a median follow-up period of 37.4 months.
Presented preliminary Toca 6 Phase 1 data: At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, research collaborators presented preliminary clinical data that suggest the potential feasibility of intravenous (IV) administration of Toca 511 from the ongoing Toca 6 Phase 1 trial of Toca 511 & Toca FC in patients with advanced solid tumors. Safety, tolerability and confirmation of vector deposition in metastatic tumors was demonstrated in five patients with advanced solid tumors who received Toca 511 intravenously. These data inform Tocagen’s plans to initiate additional studies evaluating the efficacy of Toca 511 & Toca FC in patients with advanced cancers.
First Quarter 2018 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $10.4 million for the quarter ended March 31, 2018, compared to $6.6 million for the quarter ended March 31, 2017. The increase in R&D expenses in 2018 was primarily driven by higher costs to support the expanded Toca 5 trial and increased activities in manufacturing of Toca 511 & Toca FC.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million for the quarter ended March 31, 2018, compared to $1.9 million for the quarter ended March 31, 2017. The increase in G&A expenses was primarily due to increased stock-based compensation expense and costs associated with being a public company during the first quarter of 2018.

Net Loss: Net loss was $12.9 million, or $0.65 per common share (basic and diluted), for the quarter ended March 31, 2018, compared to a net loss of $9.1 million, or $4.11 per common share (basic and diluted), for the quarter ended March 31, 2017. The 2018 calculation is based on 19.9 million average common shares outstanding for the first quarter of 2018, compared to 2.2 million average common shares outstanding for the first quarter of 2017.

Cash Position and Guidance

Cash, cash equivalents and marketable securities were $74.0 million at March 31, 2018 compared to $88.7 million at December 31, 2017. Subsequent to the close of the first quarter 2018, Tocagen signed a license agreement with ApolloBio and expects to receive $16 million by early in the third quarter of 2018, according to the terms of the licensing agreement. Tocagen reiterates its annual guidance and continues to estimate the total cash used in 2018 to fund operations, capital expenditures and debt amortization will not exceed $50 million.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.