DiaMedica Therapeutics to Report Second Quarter 2020 Financials and Provide a Business Update August 12, 2020

On August 6, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its second quarter 2020 financial results will be released after the markets close on Tuesday, August 11th (Press release, DiaMedica, AUG 6, 2020, View Source [SID1234563044]). DiaMedica will host a live conference call on Wednesday, August 12th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Date:

Wednesday, August 12, 2020

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Conference ID:

7689626

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. All participants on the conference call will be provided with the dial in instructions and a unique passcode once they register. This information will also be sent in an email confirmation. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 13, 2020, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 7689626.

Kura Oncology Reports Second Quarter 2020 Financial Results

On August 6, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2020 financial results and provided a corporate update (Press release, Kura Oncology, AUG 6, 2020, View Source [SID1234563043]).

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"Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe tipifarnib and KO-539 provide opportunities to address large proportions of head and neck cancers and acute leukemias, respectively. Now, following a successful public offering this past quarter, we are well-positioned to advance each of these programs toward important upcoming catalysts."

Corporate Update

Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.

Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program in May 2020. The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company’s efforts in HRAS mutant HNSCC, a disease of high unmet need.

Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.

Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.
Financial Results

Research and development expenses for the second quarter of 2020 were $13.7 million, compared to $11.4 million for the second quarter of 2019.

General and administrative expenses for the second quarter of 2020 were $7.5 million, compared to $4.5 million for the second quarter of 2019.

Net loss for the second quarter of 2020 was $20.5 million, compared to a net loss of $14.9 million for the second quarter of 2019.

Cash, cash equivalents and short-term investments totaled $338.9 million as of June 30, 2020, including net proceeds of approximately $134.9 million from a public offering completed in May 2020, compared with $236.9 million as of December 31, 2019.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (866) 278-7953 for domestic callers and +1 (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

Monopar Therapeutics Reports Second Quarter 2020 Financial Results and Business Updates

On August 6, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2020 financial results and business updates (Press release, Monopar Therapeutics, AUG 6, 2020, View Source [SID1234563042]).

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Second Quarter and Recent Highlights

Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

Monopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.

Monopar will provide its pre-IND stage humanized uPAR targeted monoclonal antibody, known as MNPR-101, and NorthStar will supply a cytotoxic radioisotope. The aim is to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells thought to be largely responsible for the severe lung injury that contributes to poor outcomes and death in patients with severe COVID-19.

Provisional patent has been filed that covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radio-immuno-therapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases.
Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2 Clinical Trial Continue on Schedule

Monopar’s two clinical-stage programs both continue to be on schedule for first patient dosing in the second half of 2020.
Second Quarter Summary Financial Results

Results for the Quarter Ended June 30, 2020 Compared to the Quarter Ended June 30, 2019

Cash and cash equivalents as of June 30, 2020 were $12.5 million. Net loss for the three months ended June 30, 2020 was $1.4 million or $0.14 per share compared to net loss of $0.9 million or $0.10 per share for the three months ended June 30, 2019.

Research and Development (R&D) Expenses

R&D expenses for the three months ended June 30, 2020 were $0.8 million, compared to $0.3 million, for the three months ended June 30, 2019. This represents an increase of $0.5 million primarily attributed to increases in camsirubicin and Validive clinical trial planning and materials manufacturing costs and increases in personnel expenses for three new R&D employees and higher salary and stock-based (non-cash) compensation for 2020.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2020 were $0.6 million, compared to $0.6 million, for the three months ended June 30, 2019.

PRA Health Sciences, Inc. Reports Second Quarter 2020 Results and Provides Third Quarter and Full Year 2020 Guidance

On August 6, 2020 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2020 (Press release, PRA Health Sciences, AUG 6, 2020, View Source [SID1234563041]).

"Considering the very difficult circumstances, I was delighted with our second quarter financial results. We reported revenue and earnings that were better than the revised guidance we provided in May and had record levels of gross and net new business awards. Our second quarter results were obviously impacted by the pandemic, but our team did an excellent job delivering to our revised forecast," said Colin Shannon, PRA’s President and Chief Executive Officer. "For the remainder of 2020, we will continue to manage our business in a fiscally responsible manner and continue to look for ways to provide innovative solutions to our customers. I would like to thank all of our employees for their hard work during this challenging period."

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Net new business for our Clinical Research segment for the three months ended June 30, 2020 excluding reimbursement revenue was $701.6 million, representing a net book-to-bill ratio of 1.35 for the period. Net new business for our Clinical Research segment for the three months ended June 30, 2020 including reimbursement revenue was $1,083.3 million, representing a net book-to-bill of 1.62 for the period. Consistent with the first quarter, we did not experience any material COVID-19 related cancellations during the second quarter. Net new business, excluding reimbursement revenue, contributed to an ending backlog at June 30, 2020 of $4.9 billion.

For the three months ended June 30, 2020, revenue was $729.9 million, which represents a decrease of 4.4%, or $33.4 million, compared to the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue decreased $28.8 million, a decrease of 3.8% compared to the second quarter of 2019. By segment, the Clinical Research segment generated revenues of $667.3 million, while the Data Solutions segment generated revenues of $62.6 million. The decrease in revenue for the quarter was attributable to the impact the COVID-19 pandemic had on our business and the global economy. We saw a decrease in billable hours and volume-related clinical activities, primarily driven by a lack of access to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.
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Direct costs, exclusive of depreciation and amortization, were $395.3 million during the three months ended June 30, 2020 compared to $386.2 million for the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, direct costs increased $16.8 million compared to the second quarter of 2019. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 54.2% of revenue during the second quarter of 2020 compared to 50.6% of revenue during the second quarter of 2019.

Selling, general and administrative expenses were $110.0 million during the three months ended June 30, 2020 compared to $98.8 million for the three months ended June 30, 2019. Selling, general and administrative costs were 15.1% of revenue during the second quarter of 2020 compared to 12.9% of revenue during the second quarter of 2019.

GAAP net income was $13.9 million for the three months ended June 30, 2020, or $0.22 per share on a diluted basis, compared to GAAP net income of $41.1 million for the three months ended June 30, 2019, or $0.62 per share on a diluted basis.

EBITDA was $65.4 million for the three months ended June 30, 2020, representing a decrease of 38.9% compared to the three months ended June 30, 2019. Adjusted EBITDA was $95.1 million for the three months ended June 30, 2020, representing a decrease of 26.5% compared to the three months ended June 30, 2019.

Adjusted net income was $55.2 million for the three months ended June 30, 2020, representing a decrease of 32.4% compared to the three months ended June 30, 2019. Adjusted net income per diluted share was $0.86 for the three months ended June 30, 2020, representing a decrease of 29.5% compared to the three months ended June 30, 2019.
First Half 2020 Financial Highlights

For the six months ended June 30, 2020, revenue was $1,513.6 million, which represents an increase of 1.9%, or $28.3 million, compared to the six months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue increased $38.2 million, representing an increase of 2.6% compared to the six months ended June 30, 2019. For the six months ended June 30, 2020, our revenue growth was impacted by the COVID-19 pandemic. We saw an increase in billable hours during January and February, however, from mid-March through the end of June billable hours were impacted by limited accessibility to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.

Reported GAAP income from operations was $106.8 million, reported GAAP net income was $54.5 million and reported GAAP net income per diluted share was $0.85 for the six months ended June 30, 2020.

Adjusted Net Income was $122.6 million for the six months ended June 30, 2020, a decrease of 21.0% compared to the same period in 2019. Adjusted Net Income per diluted share was $1.90 for the six months ended June 30, 2020, down 18.1% compared to the same period in 2019.
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Full Year 2020 and Q3 2020 Guidance

The full extent of the COVID-19 pandemic and its impact on the Company’s 2020 operations remains uncertain. Specifically, the duration of the pandemic, the geographic location of specific outbreaks, and the length and scope of travel restrictions and business closures imposed by the governments of impacted countries could impact our financial results in the second half of 2020. These uncertainties could impact the assumptions used in the Company’s 2020 guidance if they result in business interruptions, such as the closure of our Phase I clinics, a slowdown in recruitment activities, or limited access to sites worldwide. However, the Company has used its best efforts to estimate the impact of COVID-19 on its business and the resulting impact on financial performance for the remainder of the year.

For full year 2020, the Company expects to achieve total revenues between $3.07 billion and $3.13 billion, GAAP net income per diluted share between $2.40 and $2.60 and adjusted net income per diluted share between $4.35 and $4.55, with an expected effective income tax rate of 23%.

For Q3 2020, the Company expects to achieve total revenues between $754 million and $784 million, GAAP net income per diluted share between $0.58 and $0.68 and adjusted net income per diluted share between $1.09 and $1.19, with an expected effective income tax rate of 23%.

Our actual effective tax rate may differ from our estimate due to, among other things, changes in the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

Our Full Year and Q3 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of June 30, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our full year and Q3 2020 guidance to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 7, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 7368954. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 7368954.

Additional Information

A financial supplement with second quarter 2020 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q2 2020 Earnings Presentation."

Coherus BioSciences Reports Second Quarter 2020 Financial Results

On August 6, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2020 (Press release, Coherus Biosciences, AUG 6, 2020, View Source [SID1234563040]).

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Second Quarter 2020 and Recent Corporate Highlights

Net product revenue for the second quarter of 2020 was $135.7 million, and net income was $59.0 million, or $0.70 per share on a diluted basis.

Non-GAAP income during the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis.

Cash flow from operating activities was $60.2 million for the second quarter of 2020.

The Healthcare Distribution Alliance recognized Coherus’ successful launch of UDENYCA (pegfilgrastim-cbqv) by awarding the 2019 Diana Award in the category for Best New Product Introductions in the Biotechnology Pharmaceutical Product sector.

The Company appointed veteran healthcare leader, Kimberly Tzoumakas, J.D. to its Board of Directors.
Second Quarter 2020 Financial Results

Net product revenue for the second quarter of 2020 was $135.7 million. Net product revenue included a favorable revision of the Company’s prior period payer rebate estimate of $13.3 million recorded in the second quarter of 2020. Cost of goods sold for the second quarter of 2020 was $10.1 million, resulting in a gross profit margin of 93%.

Research and development (R&D) expense for the second quarter of 2020 was $26.2 million, as compared to $18.9 million for the same period in 2019. R&D expense for the six months ended June 30, 2020 was $59.3 million, as compared to $37.7 million for the same period in 2019. The increase in R&D expense in both periods was primarily due to preparations for the biologics license application (BLA) filing of CHS-1420, Coherus’ biosimilar to Humira (adalimumab), and to the manufacturing scale-up to initiate planned clinical trials in 2021 for CHS-2020, Coherus’ biosimilar to Eylea (aflibercept).

Selling, general and administrative (SG&A) expense for the second quarter of 2020 was $34.1 million, as compared to $36.5 million for the same period in 2019. SG&A expense for the six months ended June 30, 2020 was $69.4 million, as compared to $69.1 million for the same period in 2019.

Cash, cash equivalents and investments in marketable securities for the second quarter increased to $456.5 million as of June 30, 2020, as compared to $193.3 million as of March 31, 2020 and $177.7 million as of December 31, 2019. The increase in the second quarter of 2020 is primarily due to generating $60.2 million in net cash from operating activities and receiving $222.8 million in net proceeds from issuing convertible debt notes due 2026 in April 2020, which was offset by purchasing $18.2 million in capped call options related to the convertible notes.

Net income for the second quarter of 2020 was a $59.0 million, or $0.70 per share on a diluted basis, compared to $23.6 million, or $0.32 per share on a diluted basis for the same period in 2019.

Non-GAAP net income for the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis, compared to non-GAAP income of $31.5 million, or $0.43 per share on a diluted basis for the same period in 2019. See "Non-GAAP Financial Measures" below for a discussion on how the Company calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measure.

Guidance for the Remainder of 2020

Coherus will continue to lay the foundation for long-term growth across its three therapeutic areas:

Oncology

Deliver continued market success with UDENYCA (pegfilgrastim-cbqv) against all Neulasta dosage forms, while maintaining average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.

Advance the Company’s biosimilar candidate to Avastin (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome and the timing of required interactions with the FDA in completing a three-way pharmacokinetic ("PK") study, as well as completing additional analytical similarity exercises.
Ophthalmology

Facilitate Bioeq’s resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the second half of 2020.

Advance the Company’s internally developed CHS-2020 biosimilar candidate to Eylea (aflibercept) to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
Immunology

Complete certain manufacturing, regulatory and development activities for the Company’s internally developed Humira (adalimumab) biosimilar, CHS-1420, and file the 351(k) BLA in the fourth quarter of 2020. The Company expects this timing will enable a projected market entry in the United States on or after July 1, 2023, if approved.
Financial Guidance

R&D and SG&A expenses combined together are expected to range between $285 million and $310 million for the full fiscal year 2020, excluding upfront or milestone payments from any potential new collaborations, consistent with prior quarter guidance.
Conference Call Information

When: Thursday, August 6, 2020 starting at 4:30 p.m. ET

Webcast: at View Source

The conference call will be broadcast live in listen-only mode on the Company’s investor relations website at View Source If you would like to ask a question, the dial in number for the conference call is 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International).

Conference ID: 4956327

Please dial-in 15 minutes early to ensure a timely connection to the call.

Second quarter 2020 financial results are posted on the Coherus website at View Source The webcast will be archived on the Coherus website.