On March 25, 2021 SignalChem Lifesciences, a clinical-stage company developing novel targeted therapies for oncology, reported a collaboration with Merck, known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of SLC-391, a selective AXL inhibitor developed by SignalChem, with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Lifescience Newswire, MAR 25, 2021, View Source [SID1234577132]).

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AXL, a member of the TAM family protein tyrosine kinases (Tyro3, AXL and Mer), plays a key role in cell survival, angiogenesis, metastasis and therapeutic resistance. SLC-391 is a clinical stage small molecule AXL inhibitor with high potency, selectivity and desirable pharmaceutical properties. SLC-391 disrupts cell division, inhibiting tumor growth and causing cancer cells to die.

Based on emerging evidence, a clinical investigation has been initiated to evaluate SLC-391 in combination with KEYTRUDA in the treatment of patients with advanced NSCLC.

SignalChem will conduct the study in multiple cancer centers in the US and Canada to evaluate the clinical outcome of combining SLC-391 and KEYTRUDA. The two companies plan to conduct the SKYLITE trial, a phase 2 study for patients with NSCLC.

The SKYLITE trial is a multi-centre, single arm, open-label, Phase 2 Study of SLC-391 in combination with KEYTRUDA in subjects with NSCLC. Subjects will receive daily doses of SLC-391 orally for 21-day cycles in combination with the commercially approved dose and schedule of KEYTRUDA. The SKYLITE trial will evaluate the safety and efficacy of the combination therapy, and includes the exploration of biomarkers relating to AXL signaling that may correlate with anti-tumor activity.

"We welcome the collaboration with Merck. We consider Merck’s clinical development expertise to be valuable and believe this relationship may contribute to the development of SLC-391 for the treatment of patients with advanced stage lung cancer. These patients experience aggressive tumors that are often difficult to treat. We hope this collaboration with Merck will lead to a new approach that addresses this important unmet need," says Mr. Jun Yan, President, SignalChem Lifesciences. "We look forward to partnering with Merck as we aim to deliver new cancer treatments and advance SLC’s drug discovery platform. We at SLC are working hard to identify new anti-tumor, anti-metastatic, and anti-chemo-resistance therapies that provide meaningful alternatives to existing treatments."

About Lung Cancer
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses. The overall 5-year survival rate for NSCLC is 24%, ranging from 61% for localized NSCLC to 6% for metastatic disease.

About SLC-391
SLC-391 is a potent, selective and orally bioavailable small molecule AXL inhibitor. Currently, phase I clinical trial is ongoing in Canada to evaluate the safety and tolerability of SLC-391 in cancer patients with solid tumor.

On March 25, 2021 Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported financial, clinical and operational updates for the year ended December 31, 2020 (Press release, Heat Biologics, MAR 25, 2021, View Source [SID1234577131]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "We made tremendous progress on our clinical programs in 2020. Earlier this year, we reported positive interim data from our Phase 2 trial of HS-110, which demonstrated evidence of substantial survival benefit. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the FDA as well as potential partners. In 2020, we initiated a Phase 1 clinical trial of our first-in-class antibody therapeutic PTX-35 in patients with solid tumors. Leveraging our proprietary gp96 platform and in response to the COVID-19 pandemic, we initiated a COVID-19 vaccine program in collaboration with the University of Miami and have advanced this program forward into scale-up manufacturing. We have a strong balance sheet with approximately $132 million of cash, which should allow us to accelerate our current clinical programs and enhance our development and manufacturing capability to expand our therapeutic portfolio. We look forward executing key milestones in our growing pipeline in 2021."

Pipeline Highlights and Updates

HS-110

In previously treated, checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC) (Cohort A, N = 47), the median overall survival (OS) observed was 24.6 months was with a median follow-up time of 19.4 months and the one-year survival rate was 61.7%.
The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study1.
The addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.
For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median OS of 11.9 months was observed.
Published data from other studies reported median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after PD-(L)1 progression2,3.
NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options4.
The addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.
As of this data cut, there were no treatment-emergent serious adverse reactions related to HS-110.
PTX-35

In June 2020, the Company initiated a first-in-human Phase 1 clinical trial evaluating PTX-35.
PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction.
COVID-19

In March 2020, the Company initiated a COVID-19 vaccine program leveraging its proprietary gp96 technology platform in collaboration with University of Miami.
Positive preclinical data demonstrated a robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2, including induction of systemic and tissue-specific memory CD8+ T-cells and tissue-resident memory CD8+ T-cells in the lung.
The Company has initiated manufacturing of ZVX-60 and is conducting IND-enabling activities.
2020 Financial Results

As of December 31, 2020, the Company had approximately $111.8 million in cash and cash equivalents and short-term investments.
Research and development expenses stayed consistent at $12.9 million and $13.0 million for the years ended December 31, 2020 and December 31, 2019.
General and administrative expense increased approximately 59% to $14.9 million for the year ended December 31, 2020 compared to $9.4 million for the year ended December 31, 2019. The increase of $5.5 million is primarily due to the increase in personnel and stock compensation expense.
Net loss attributable to Heat Biologics, Inc. was $26.0 million, or ($1.63) per basic and diluted share for the year ended December 31, 2020 compared to a net loss attributable to Heat Biologics, Inc. of $20.0 million, or ($4.21) per basic and diluted share for the year ended December 31, 2019.

On March 25, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the fourth quarter ended December 31, 2020 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 25, 2021, View Source [SID1234577130]).

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"Advancing the Phase 1 clinical study of our lead program, FPI-1434, continues to be our primary focus," said Chief Executive Officer John Valliant, Ph.D. "We are working towards determining the recommended Phase 2 dose, and defining tumor-specific cohorts, which we expect to occur in the first half of 2022."

Dr. Valliant continued, "Employing Fusion’s adaptable platform, we are expanding our pipeline of targeted alpha therapies using different targeting moieties to treat an array of cancers with high unmet medical need. The recent transactions with Ipsen and AstraZeneca expand and diversify our pipeline and underscore the growing interest in harnessing the power of alpha-emitting radiopharmaceuticals to create innovative precision cancer treatments for patients."

Recent Highlights and Future Milestones

Corporate Updates

On March 2, Fusion announced it has entered into an asset purchase agreement (APA) to acquire Ipsen’s intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to utilize its expertise and IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an investigational new drug application in the first half of 2022.
FPI-1434 Monotherapy

In December 2020, Fusion announced that the first patient had been dosed in the multi-dose portion of the Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The multi-dose portion follows completion of the single-ascending dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is enrolling patients at sites in Canada, the United States and Australia. The current patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose/schedule, in the first half of 2022.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-1966

FPI-1966 is designed to target and deliver actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021.
Fourth Quarter 2020 Financial Results

Cash and Investments: As of December 31, 2020, Fusion held cash, cash equivalents and investments of $299.5 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash, cash equivalents and investments as of December 31, 2020 will enable the Company to fund its operations through the end of 2023.
R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $5.0 million, compared to $3.4 million for the same period in 2019. The increase was primarily related to increased employee-related costs associated with hiring and increases in clinical, preclinical and discovery activities, partially offset by lower manufacturing expenses.
G&A Expenses: General and administrative expenses for the fourth quarter of 2020 were $6.6 million, compared to $2.7 million for the same period in 2019. The increase was primarily related to increased salaries, benefits and stock compensation costs due to increased hiring, and increased professional and consulting fees as a result of public company activities.
Net Loss: For the fourth quarter of 2020, Fusion reported a net loss of $13.4 million, or $0.32 per share, compared with a net loss of $8.2 million, or $4.25 per share, for the same period in 2019. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability, net loss was $5.9 million for the fourth quarter of 2019.
Impact of COVID-19

While Fusion has commenced dosing in the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced moderate delays in patient recruitment and enrollment as a result of COVID-19.

Fusion is closely monitoring how the spread of COVID-19 is affecting the Company’s employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion’s research labs are operating but with reduced capacity.

At this time, there is significant uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On March 25, 2021 InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported financial results for the year ended December 31, 2020 (Press release, InflaRx, MAR 25, 2021, View Source [SID1234577129]).

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Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: "The year 2020 was a challenging one for all of us dealing with a pandemic. As a physician and scientist, it has been extremely rewarding to see how quickly effective vaccines have been developed and are already in the arms of thousands of people. However, we continue to see a need for novel treatments for COVID-19 and similar future viral diseases. We are happy to be evaluating vilobelimab as a potential treatment to help severe COVID-19 patients and look forward to seeing those results, as well as results from ongoing trials in other disease areas, later this year."

Prof. Riedemann continued: "We have submitted as planned a Special Protocol Assessment to the FDA to reach agreement on the path forward for our phase III plans with vilobelimab in hidradenitis suppurativa. We were excited to announce a new area of clinical development – oncology – and are on track to start our first cancer trial with vilobelimab in cutaneous squamous cell carcinoma in the second quarter of this year. I am also pleased that our team recently completed a $75 million public offering, further strengthening our cash position and putting us on a firm financial footing to advance vilobelimab in a number of indications. We look forward to reporting our progress in the months ahead."

Recent Highlights and R&D Update

Issue of Share Capital
On March 1, 2021, InflaRx announced the closing of a public offering of common shares pursuant to which the Company sold 15,000,000 common shares and warrants to purchase up to 15,000,000 common shares. The common shares were sold at a price to the public of $5.00 per share. For each common share purchased, an investor also received a warrant to purchase a common share at an exercise price of $5.80. The warrants are exercisable immediately and have a term of up to one year. The gross proceeds from this offering were $75.0 million (€61.6 million), before deducting the $4.5 million (€3.7 million) underwriting discount and other estimated offering expenses of approximately $0.5 million (€0.5 million) and excluding the exercise of any warrants.

Vilobelimab for Hidradenitis Suppurativa (HS)
InflaRx has submitted a Special Protocol Assessment (SPA) to the Food & Drug Administration (FDA) for the planned Phase III program in HS in the first quarter of 2021. Details on the Phase III design will be provided once agreement has been reached with the FDA.

In Europe, as previously reported in 2020, InflaRx received scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval, including supporting the use of a new primary endpoint, the International Hidradenitis Suppurativa Severity Score ("IHS4"). The Company is working diligently to address the additional feedback received to achieve alignment with the US strategy for a global Phase III development program in HS.

New data supporting the continued development of vilobelimab in the treatment of HS were presented in February 2021 at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V. (EHSF). The data from the SHINE Phase II trial showed that significantly elevated baseline C5a levels occurred in HS patients versus healthy volunteers. Data also showed that vilobelimab dose-dependently suppressed C5a levels over time accompanied by the previously reported reduction in inflammatory lesion counts and scores.

Vilobelimab for Severe COVID-19
The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September 2020, and recruitment is currently ongoing with sites open in several countries in Europe and Latin America. Additional countries are in the process of being added. The study is enrolling as planned with a total goal of 360 patients. A blinded interim analysis is planned after 180 patients, with a potential early stop of the trial for efficacy or futility. Topline data from the trial are expected to be available by the end 2021.

Vilobelimab for ANCA-associated Vasculitis (AAV)
InflaRx reported the completion of enrollment in the European Phase II IXCHANGE study of vilobelimab in AAV in Q1 2021. Topline data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021.

Vilobelimab is also being studied in the US phase II IXPLORE study in patients with AAV. The main objective of this randomized, double-blind, placebo-controlled study is to evaluate the safety of vilobelimab, as this is the first time the drug is being administered to patients with AAV in the US. Topline results are expected by mid-2021.

Vilobelimab in cutaneous squamous cell carcinoma (cSCC)
The Company has recently announced plans to initiate an open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC.

The non-comparative two-stage multi-national Phase II trial is expected to start enrolling patients in Q2 2021 with sites in Europe, the US and other countries. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.

Vilobelimab in Pyoderma Gangraenosum
The Phase IIa open label trial continues to enroll patients in the higher dose groups. Promising initial data from the first five patients in the study were announced in 2020. Results from the higher dose groups are expected by the end of 2021.

Financial highlights 2020

Research and development expenses decreased by €18.9 million to €25.7 million in the year ended December 31, 2020 compared to the year ended December 31, 2019.

This decrease is attributable to lower CRO and CMO costs from clinical trials in the amount of €16.9 million due to the conclusion of the Phase IIb for HS in 2019, the expense of which was higher than 2020 costs associated with the new Phase II/III clinical trial in patients with COVID (2020: €4.9 million, 2019: nil) or other running trials like Phase II clinical program in patients with AAV, the Phase II clinical program in patients with PG, the preparation of a Phase II clinical program in patients cSCC or ongoing manufacturing activities for clinical trial related materials.

In addition there was a €1.8 million decrease in employee-related costs mainly caused by a €2.0 million decrease in expenses from non-cash share-based compensation.

General and administrative expenses decreased by €4.0 million to €8.5 million for the year ended December 31, 2020, from €12.5 million for the year ended December 31, 2019. This decrease is primarily attributable to a €3.8 million decrease in expenses from non-cash share-based compensation. Legal, consulting and audit fees and other expenses decreased by €0.6 million to €1.6 million for the year ended December 31, 2020, from €2.2 million for the year ended December 31, 2019, which decrease is mainly attributable to lower consulting and travel costs. The increase of other expenses by €0.2 million is primarily related to higher D&O insurance cost.

Net financial result decreased by €3.6 million in the year ended December 31, 2020 compared to the year ended December 31, 2019. This decrease is mainly attributable to (a) higher foreign exchange losses, which increased by €1.7 million and (b) lower interest on marketable securities, which decreased by €2.0 million.

Net loss for the year 2020 was €34.0 million or €1.3 per common share, compared to €53.3 million or €2.1 per common share for the year 2019. On December 31, 2020, the Company’s total funds available were approximately €81.4 million, composed of cash and cash equivalents (€26.0 million) and financial assets (€55.4 million).

Net cash used in operating activities decreased to €36.5 million in the year ended December 31, 2020, from €43.2 million in the year ended December 31, 2019, mainly due to the decrease of research and development expenditures and lower personnel costs, excluding stock-based compensation.

Additional information regarding these results and other relevant information is included in the notes to the financial statements as of December 31, 2020 in "ITEM 18. Financial statements," which is included in InflaRx’s Annual Report on Form 20-F as filed with the US Securities and Exchange Commission.

InflaRx N.V. and subsidiaries
About vilobelimab:

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum, Cutaneous Squamous Cell Carcinoma and severe COVID‑19.

On March 25, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the fourth quarter and full year ended December 31, 2019, while providing a corporate update (Press release, Black Diamond Therapeutics, MAR 25, 2021, View Source [SID1234577128]).

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"Black Diamond has achieved important scientific, clinical, and operational milestones over the past year," said David M. Epstein, Ph.D., President and CEO. "Our IND for our lead product candidate, BDTX-189, was allowed in December and we have initiated our Phase 1/2 clinical trial. We believe the $316 million raised since November, including via our initial public offering, will enable us not only to execute on the clinical development of BDTX-189, but also to continue to invest in our proprietary MAP platform, and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs."

2019 Corporate Highlights

Advanced BDTX-189, Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged, to investigational new drug (IND) application submission in November 2019 and IND allowance by the U.S. Food and Drug Administration in December 2019.
Initiated a Phase 1/2 clinical trial of BDTX-189, which is actively enrolling and dosing patients in the Phase 1 portion.
— The Phase 1 portion of the trial will evaluate escalating doses of BDTX-189 and is designed to determine the recommended Phase 2 dose and to assess preliminary indications of anti-tumor activity. The Phase 2 portion will determine the objective response rate and duration of response in patients with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutation determined using next-generation sequencing.
Continued to advance its program in glioblastoma (GBM) toward nominating a development candidate that targets a range of driver mutations in GBM and progress the Company’s other earlier stage programs derived from Black Diamond’s Mutation-Allostery-Pharmacology (MAP) platform.
— Black Diamond’s MAP platform is built on three central pillars – discover, reveal, and target. The Company uses population-level cancer genetic data obtained from all tumor types to identify potential families of mutations that occur within individual oncogenes and rank the mutations for potential oncogenicity. Black Diamond then uses its MAP platform to understand the mechanism for oncogenic activation and the Company’s team of experienced medicinal chemists then develops mutation spectrum-selective drugs for the identified targets.
Raised $85.0 million in an oversubscribed Series C financing round in November 2019 led by Boxer Capital of the Tavistock Group. Additional new investors Wellington Management Company, BVF Partners L.P., Deerfield Management, funds managed by Janus Henderson Investors, Casdin Capital, and Logos Capital joined existing investors Versant Ventures, New Enterprise Associates, RA Capital Management, Nextech Invest, Invus, Perceptive Advisors, City Hill Ventures, and Roche Venture Fund in the round.
Strengthened Black Diamond’s management team and Board of Directors in 2019 by adding Brent Hatzis-Schoch as Chief Operating Officer and General Counsel, Thomas (Tommy) Leggett as Chief Financial Officer, and Christopher D. Roberts, Ph.D., as Chief Scientific Officer, along with Samarth (Sam) Kulkarni, Ph.D., CEO of CRISPR Therapeutics AG, to its Board of Directors.
Recent Developments

In February 2020, Black Diamond completed an initial public offering pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.
Financial Highlights

Black Diamond ended 2019 with $154.7 million in cash and cash equivalents compared to $51.7 million as of December 31, 2018. Net cash from financing activities for the year ended December 31, 2019 was $127.8 million compared to $52.3 million for the year ended December 31, 2018. Net cash used in operations was $24.7 million for the year ended December 31, 2019 compared to $8.5 million for the year ended December 31, 2018.
Net loss for the year ended December 31, 2019 was $35.3 million compared to $8.9 million for the year ended December 31, 2018.
Research and development (R&D) expenses were $21.8 million for the year ended December 31, 2019 compared to $7.0 million for the year ended December 31, 2018. The increase in R&D expenses was primarily related to increase in headcount, preclinical development, and IND filing of BDTX-189.
General and administrative (G&A) expenses were $7.6 million for the year ended December 31, 2019, compared to $2.0 million for the year ended December 31, 2018. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.