On August 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a price of $15.25 per share, with expected gross proceeds to Stemline of $76,250,000 (Press release, Stemline Therapeutics, AUG 8, 2019, View Source [SID1234538521]). Stemline has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about August 13, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering and ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, and Aegis Capital Corp. are acting as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL-401), (ii) clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and potentially other diseases such as certain lymphomas; (iii) clinical development of additional pipeline candidates (felezonexor (SL-801), SL-1001, SL-901 and SL-701); (iv) research and development and regulatory activities; (v) potential acquisitions and in-licensing; and (vi) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-230341) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The preliminary prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. 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.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including CMML, MF, and AML.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including BPDCN, certain myeloproliferative neoplasms (MPNs) including CMML and MF, AML (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On August 8, 2019 Varian (NYSE: VAR) reported that its executive staff will be meeting with analysts and investors at the American Society for Radiation Oncology (ASTRO) Annual Meeting in Chicago on Monday, September 16, 2019 at 2:00 p.m. Central Time (Press release, Varian Medical Systems, AUG 8, 2019, View Source [SID1234538502]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/investors.

To attend Varian’s ASTRO investor meeting, please RSVP to Katie Glenn at [email protected] by August 23, 2019.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On August 8, 2019 Oncternal Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical needs, reported financial results for the second quarter, which ended June 30, 2019, and provided a business update (Press release, Oncternal Therapeutics, AUG 8, 2019, View Source [SID1234538501]).

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"Oncternal is thrilled to provide its first quarterly results as a Nasdaq-listed Company. We are making great progress developing our clinical and preclinical programs as we head into the second half of 2019," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are very encouraged by initial results from our lead clinical program’s Phase 1/2 study of cirmtuzumab in combination with ibrutinib in patients with chronic lymphocytic leukemia, and excited to be opening the randomized Phase 2 portion of the study. The early results for cirmtuzumab in combination with ibrutinib in patients with mantle cell lymphoma are also encouraging, and we expect to report data in this patient population before the end of the year. With respect to our other pipeline programs, our clinical study of TK216 in combination with vincristine in patients with Ewing sarcoma is advancing as planned, and we expect to begin enrolling patients in an expansion cohort of this study soon. Finally, we anticipate selecting a construct for IND-enabling studies of our ROR1 CAR-T program before the end of this year."

Recent Corporate Highlights

In August 2019, Oncternal announced it has opened for enrollment its randomized Phase 2 study of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib in patients with chronic lymphocytic leukemia (CLL). The decision to open the Phase 2 portion of the Company’s ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was triggered by favorable outcomes from the Part 1 dose-finding and Part 2 dose-confirming cohorts of the clinical trial, including the recently announced interim objective response rate (ORR) of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part 2. The Company continues to see a well-tolerated safety profile consistent with that seen with ibrutinib treatment alone.

In June 2019, Oncternal announced that the reverse merger between GTx, Inc., GTx’s merger subsidiary and privately-held Oncternal Therapeutics, Inc., had closed and the combined company was renamed Oncternal Therapeutics, Inc. Trading on the Nasdaq stock exchange under the ticker symbol "ONCT" began on June 10, 2019. The closing of the merger was a transformative event that the Company believes will allow it to pursue its next level of corporate growth and continue to advance its oncology drug candidates in multiple cancer indications.

In June 2019, Oncternal presented interim data from its ongoing Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – the largest oncology conference of the year. Results from the first 12 patients with CLL treated in the Part 1 dose-finding portion of the Phase 1 study showed an interim ORR of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone.

Oncternal also disclosed at the ASCO (Free ASCO Whitepaper) meeting that six patients with mantle cell lymphoma (MCL), had been treated in a separate cohort of the CIRLL study. One patient with MCL who had relapsed following an allogeneic stem cell transplant experienced a confirmed complete response (CR) after 3 months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This CR appears to be durable, and has been confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib treatment.

Expected Upcoming Milestones

Cirmtuzumab Program

Oncternal anticipates reporting additional data from its Phase 1/2 study of cirmtuzumab in combination with ibrutinib from patients with CLL at a scientific conference in the fourth quarter of 2019

Oncternal anticipates reporting additional data from its Phase 1/2 study of cirmtuzumab in combination with ibrutinib from patients with MCL at a scientific conference in the fourth quarter of 2019

Oncternal anticipates reporting data from its Phase 1 study of cirmtuzumab in combination with paclitaxel from patients with breast cancer at a scientific conference in the fourth quarter of 2019

TK216 Program

Oncternal anticipates completing the dose finding portion of its Phase 1 study of TK216 for patients with Ewing sarcoma and opening the expansion cohort in the third quarter of 2019

Oncternal anticipates reporting data from its Phase 1 study of TK216 from patients with Ewing sarcoma at a scientific conference in the fourth quarter of 2019

ROR1 CAR-T Program

Oncternal anticipates selecting a candidate CAR-T construct for IND-enabling studies in hematologic cancers in the second half of 2019, and opening clinical trials for hematological cancers in 2020

Oncternal anticipates selecting a candidate CAR-T construct for IND-enabling studies in solid tumors in 2020

Financial Results

On June 7, 2019, the former privately-held Oncternal Therapeutics, Inc. ("Private Oncternal"), completed a reverse merger transaction with GTx, Inc. and its merger subsidiary. Under the merger agreement, a wholly-owned subsidiary of GTx, Inc. merged with and into Private Oncternal, with Private Oncternal surviving as a wholly-owned subsidiary of the merged parent company. The surviving parent entity changed its corporate name from GTx, Inc. to Oncternal Therapeutics, Inc., and commenced trading on the Nasdaq stock exchange under the ticker symbol "ONCT."

The transaction was accounted for as a reverse asset acquisition in accordance with generally accepted accounting principles. Under this method of accounting, Private Oncternal was deemed to be the accounting acquirer for financial reporting purposes. As a result, effective as of the closing date of the merger, the reported historical operating results prior to the merger closing date will be those of Private Oncternal. Information regarding the reverse merger transaction and our financial results is also included on form 10-Q to be filed with the SEC.

Grant revenue was $0.7 million for the quarter ended June 30, 2019. Our grant revenue is derived from a California Institute for Regenerative Medicine (CIRM) grant subaward with the University of California, San Diego. The grant was awarded to advance our lead program in a Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with B-cell lymphoid malignancies CLL and MCL.

Total operating expenses for the second quarter ended June 30, 2019 were $22.3 million, which included in-process research and development expenses of $18.1 million that was recorded in connection with the closing of our merger transaction in June 2019.

Research and development expenses for the quarter totaled $2.6 million.

General and administrative expenses for the quarter totaled $1.6 million.

Including the one-time merger charge, net loss for the second quarter was $22.8 million, or a loss of $3.38 per share, basic and diluted.

As of June 30, 2019, Oncternal has $28.5 million in cash and cash equivalents. The Company believes these funds will be sufficient to fund its operations into the second quarter of 2020. As of June 30, 2019, we had 15.4 million shares of common stock outstanding.

Oncternal Management Hosting Conference Call and Live Webcast

Oncternal will host a conference call today, August 8, 2019, at 2:00 p.m. PDT (5:00 p.m. EDT) to review quarterly results and provide an update on clinical and preclinical development programs. A live webcast of the call will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On August 8, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the second quarter ended June 30, 2019 (Press release, IntelGenx, AUG 8, 2019, View Source [SID1234538500]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2019 Second Quarter Financial Summary:

Revenue was $197,000, compared to $234,000 in the second quarter of 2018
Adjusted EBITDA was ($2.1 million), compared to ($1.9 million) in Q2-2018
Cash and short-term investments totaled $6.1 million as at June 30, 2019 compared to $3.7 million in Q2-2018
Recent Developments:

Received its first shipment of cannabis extract from Tilray, Inc. (NASDAQ:TLRY) ("Tilray"), providing sufficient quantities for ongoing R&D batch production of cannabis-infused VersaFilm.
In connection with its ongoing Montelukast clinical program, announced that a poster, entitled "The BUENA Study: A Phase 2a Clinical Trial to Test Safety and Efficacy of Montelukast VersaFilm in Alzheimer’s Patients," will be presented in collaboration with Prof. Dr. Ludwig Aigner’s group from the Paracelsus Medical University in Salzburg at the 12th edition of Clinical Trials on Alzheimer’s Disease (CTAD2019), to be held in San Diego, California, from December 4-7, 2019.
Entered into a definitive worldwide agreement with Aquestive Therapeutics, Inc. (NASDAQ:AQST) for the co-development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction.
Filed a non-provisional U.S. patent application for newly-developed platform that enables the incorporation of oil-based (lipophilic) active ingredients into oral film formulations.
Received a second U.S. Patent for its topical oral film technology platform.
Company remains on track to resubmit the RIZAPORT new drug application in Q3, which will address the questions contained in the U.S. Food and Drug Administration’s Complete Response letter IntelGenx received in Q2.
Promoted its oral films CDMO services at CPhI North America and received significant interest from potential partners for the development and manufacture of novel oral film products based on its proprietary VersaFilm technology platform.
"We made progress on two key VersaFilm programs recently, with the addition of BUENA clinical trial sites in Ottawa and Peterborough, and the commencement of cannabis-infused VersaFilm R&D production as part of our worldwide partnership with Tilray," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We believe our oral cannabis-infused films offer a discrete, precise and convenient option for adult-use and medical cannabis consumers, putting IntelGenx in a strong position among the many other companies preparing to launch edible cannabis products soon after their legalization in Canada later this year. Now approaching a period of anticipated growth, we look forward to updating our stakeholders as we continue to make progress towards bringing these and other VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended June 30, 2019 amounted to $197,000, a decrease of $37,000 compared to $234,000 for the three-month period ended June 30, 2018. The decrease is mainly attributable to the $37,000 decrease in R&D revenues.

Operating costs and expenses were $2.5 million for the second quarter of 2019, versus $2.4 million for the corresponding three-month period of 2018. The increase for the three-month period ended June 30, 2019 is mainly attributable to a $325,000 increase in R&D expenses primarily related to the Montelukast clinical program.

For the second quarter of 2019, the Company had an operating loss of $2.3 million, compared to an operating loss of $2.1 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended June 30, 2019 was $2.5 million, or $0.03 on a basic and diluted per share basis, compared to $2.4 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of June 30, 2019, the Company’s cash and short-term investments totalled $6.1 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 second quarter financial results today on August 8, 2019, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5684153. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

On August 8, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 8, 2019, View Source [SID1234538498]).

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"This has been a very productive quarter with the achievement of multiple regulatory and clinical milestones. We had a positive pre-NDA meeting with the FDA on roxadustat. Supported by positive efficacy and safety data, including compelling MACE and MACE+ results, we look forward to submitting our U.S. NDA in October. In IPF, the first patient was dosed in our Phase 3 pamrevlumab program," said Thomas B. Neff, Chief Executive Officer. "We are pleased to see the publication of two articles in the New England Journal of Medicine on our pivotal roxadustat Phase 3 studies in China."

Recent Developments and Upcoming Milestones

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and Europe

Positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA)

Reached agreement on the content of the NDA, including cardiovascular safety analyse

On-track to submit U.S. NDA in October 2019

Astellas anticipates the submission of Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) within the second half of their 2019 fiscal year, ending March 2020

Roxadustat for Anemia in CKD in China

Two articles on the China Phase 3 studies were published in the New England Journal of Medicine (NEJM)

Commercial manufacturing plant certified; commercial product manufactured and shipped

Regulatory decision for treatment of anemia in non-dialysis-dependent CKD anticipated in the third quarter of 2019

Roxadustat for Anemia in CKD in Japan

Regulatory decision for treatment of anemia in dialysis-dependent CKD anticipated in the second half of 2019

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Initiated dosing in the ZEPHYRUS Phase 3 randomized, double-blind, placebo-controlled study

Pamrevlumab for Locally Advanced Pancreatic Cancer (LAPC)

Screening patients in the LAPIS Phase 3 randomized, double-blind, placebo-controlled study of pamrevlumab as a neoadjuvant therapy in combination with gemcitabine and nab-paclitaxel

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Reported positive one-year Phase 2 preliminary clinical findings at the Parent Project Muscular Dystrophy (PPMD) 2019 Annual Conference in June

Relative to previously published data of DMD patients, our single-arm study of pamrevlumab showed:

Less than expected decline in pulmonary function tests

Increase in cardiac function measured by mean change of left ventricular ejection fraction from baseline

Increase in grip-strength score in both dominant and non-dominant hands

Less than expected decline in the performance of the upper limb test

Corporate and Financial

Net income for the second quarter of 2019 was $116.0 million, or $1.34 net income per basic share and $1.26 net income per diluted share, compared to a net loss of $23.4 million, or $0.28 net loss per basic and diluted share one year ago

In accordance with U.S. GAAP, in the second quarter, we are including in our revenue recognition methodology a total of $180 million, in anticipated milestone payments related to the filing of the U.S. NDA and EU MAA, of which $171.1 million was recognized in the current quarter and the remaining balance will be recognized in future periods 1

At June 30, 2019, FibroGen had $686.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Thursday, August 8, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (800) 708-4540 (U.S. and Canada) or 1 (847) 619-6397 (international), reference the FibroGen second quarter 2019 financial results conference call, and use confirmation number 48879852. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 4887 9852.

About Roxadustat

Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and has been granted Orphan Drug Designation (ODD) in these indications as well as in Duchenne muscular dystrophy (DMD). Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer. Pamrevlumab is currently in a Phase 2 trial for DMD. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Under U.S. GAAP revenue recognition guidelines, we are required to include estimated consideration from milestones in the determination of revenue recognition in the period that milestone achievement becomes probable. Receipt of milestone payments is dependent on the occurrence of the triggering event.