On May 11, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2022 (Press release, Tracon Pharmaceuticals, MAY 11, 2022, View Source [SID1234614259]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We are pleased with the pace of enrollment under the amended ENVASARC protocol and remain on track to deliver interim efficacy data in the second half of this year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, with the arbitration hearing now completed we look forward to the outcome of the binding arbitration for the TJ4309 and Bispecific Antibody agreements during the second half of this year. We also continue preparations to initiate dosing of the Phase 1/2 clinical trial of envafolimab with our potential best-in-class CTLA-4 antibody, YH001, as well as doxorubicin chemotherapy in the second half of 2022."

Recent Corporate Highlights

In March, we announced the amended ENVASARC protocol using a higher dose of envafolimab was approved by the FDA.

In April, we announced the amended ENVASARC protocol was approved by internal review boards or ethic committees at each of the 30 clinical sites in the U.S. and U.K. and that all sites were open for enrolment, with more than 10 patients enrolled.
Expected Key Upcoming Milestones

Two interim safety reviews and the interim efficacy data review by the ENVASARC Independent Data Monitoring Committee (IDMC) in the second half of 2022.

Initiate dosing of a Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy in the second half of 2022.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s binding decisions on the legal disputes involving the TJ4309 and bispecific antibody agreements with I-Mab this year.

Complete the TJ4309 Phase 1 trial permitting I-Mab the opportunity to terminate the license for $9M this year.

Initiate dosing of a randomized Phase 2 trial of TRC102 in locally advanced non-small cell lung cancer sponsored and funded by the National Cancer Institute this year.
First Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments were $16.6 million at March 31, 2022, compared to $24.1 million at December 31, 2021. The Company expects that its current cash and cash equivalents will fund operations into 2023.

Research and development expenses for the first quarter of 2022 were $3.0 million, compared to $2.3 million for the first quarter of 2021.

General and administrative expenses for the first quarter of 2022 were $6.5 million, compared to $2.7 million for the first quarter of 2021. The increase was primarily attributable to legal expenses incurred due to the arbitration hearing held in February 2022 with I-Mab related to the TJ4309 and bispecific antibody agreements, and the Company expects general and administrative expenses to decrease significantly for the remainder of the year.

Net loss for the first quarter of 2022 was $9.5 million, compared to $5.1 million for the first quarter of 2021.
Conference Call Details

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 11, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first quarter 2022 (Press release, Evotec, MAY 11, 2022, View Source [SID1234614176]).

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HIGHLIGHTS
STRONG REVENUE GROWTH IN ALL BUSINESS AREAS FUELLED BY ONGOING EXPANSION AND STRENGTHENS POSITIVE DEVELOPMENT
Group revenues increased by 24% to € 164.7 m (Q1 2021: € 133.1 m); like-for-like base revenue growth (excluding fx effects) up 19%
Revenues from milestones, upfronts and licenses of € 4.5 m above last year (Q1 2021: € 4.4 m)
Strong progress in both segments: Total EVT Execute revenues up 27% to € 174.5 m (Q1 2021: € 136.9 m); EVT Innovate revenues also up 27% to € 35.9 m (Q1 2021: € 28.2 m)
Adjusted Group EBITDA of € 18.9 m (Q1 2021: € 21.1 m) primarily driven by capacity expansions at all sites, in particular the continued ramp-up of our J.POD Redmond (US) facility, an increase in unpartnered R&D (up 12%), partially offset by positive currency effects
Other non-operating result of € (69.2) m (Q1 2021: € 47.7 m) affected from a non-cash fair value adjustments of the equity participation in public listed Exscientia plc.

SETTING THE PACE WITH PRECISION MEDICINE PLATFORMS
New data-driven drug discovery collaboration with Eli Lilly and Company ("Lilly") in metabolic diseases
Drug discovery partnership with Boehringer Ingelheim in ophthalmology based on induced pluripotent stem cells ("iPSCs")
Launch of Evotec’s translational molecular patient database E.MPD, one of the largest and highest quality molecular databases globally
Further strong progress in neuroscience and oncology collaboration with Bristol Myers Squibb ("BMS")
Strong growth momentum in all areas e.g., new INDiGO agreements, CMC, screening and sample management alliances as well as several new integrated drug discovery & development alliances
Grant from BMBF to support clinical development of EVT075 in viral indications
Bayer initiated Phase II of bradykinin receptor B1 BAY 2395840 in diabetic neuropathic pain but also terminated further development of P2X3 antagonist eliapixant
Expansion of licensing agreement with JingXin for EVT201, submission of regulatory approval in China through JingXin (after period-end)
Successful expansion of the EVOequity portfolio with new equity stakes in several highly promising companies (e.g., Tubulis; after period-end)

CORPORATE
Dr Matthias Evers joins Evotec as Chief Business Officer (after period-end)

BUSINESS OUTLOOK FOR FULL-YEAR 2022 AND MID-TERM TARGETS 2025 CONFIRMED
Group revenues expected to be in a range of € 700 – 720 m (€ 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m by 2025
The forecast takes in account – as far as possible – the current global uncertainties related to the COVID-19 pandemic and the Russian invasion of Ukraine.

Webcast/Conference Call

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.
The on-demand version of the webcast will be available on our website: View Source

On May 11, 2022 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its third quarter, fiscal year 2022 operating results on Tuesday, May 17, 2022, before the open of the U.S. financial markets (Press release, Palatin Technologies, MAY 11, 2022, View Source [SID1234614220]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on May 17, 2022, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source

On May 11, 2022 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported results from its Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Genentech, MAY 11, 2022, View Source [SID1234614238]). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

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"While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab program as they emerge."

The tiragolumab program continues to explore advances in multiple clinical trials, building on Tecentriq, with the goal of providing new treatment options in advanced and difficult-to-treat cancers as well as expanding into earlier stages of disease.

About the SKYSCRAPER-01 study

SKYSCRAPER-01 is a global Phase III, randomized double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab

Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint, which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab). The TIGIT pathway is distinct, but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as a treatment for their lung cancer:
to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
their cancer tests positive for "PD-L1".
Tecentriq may be used alone as their first treatment when their lung cancer:
has spread or grown, and
their cancer tests positive for "high PD-L1", and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may also be used when their lung cancer:
has spread or grown, and
they have tried chemotherapy that contains platinum, and it did not work or is no longer working
if their tumor has an abnormal "EGFR" or "ALK" gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of the skin or the whites of the eyes
severe nausea or vomiting
pain on the right side of their stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
their voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in their amount of urine
blood in their urine
swelling of their ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to their chest area
have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
decreased appetite
nausea
cough
shortness of breath
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or View Source

Report side effects to Genentech at 1-888-835-2555.

Please see View Source for full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On May 11, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 11, 2022, View Source [SID1234614260]).

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"We continue to build a pipeline of novel MasterKey therapies with our product candidates, including BDTX-1535 and BDTX-4933, and we are focused on delivering development candidates generated from our MAP drug discovery engine as we work to address major unmet needs of oncology patients. With our recently announced pipeline prioritization and realignment of resources to strengthen our financial position, we believe Black Diamond is well-positioned for strong execution across our upcoming clinical and preclinical milestones into the third quarter of 2024," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are incredibly pleased with the pace at which our BDTX-1535 Phase 1 study has been advancing with the recently announced first patient dosed. This next generation brain-penetrant inhibitor of oncogenic EGFR represents a unique opportunity to potentially address existing gaps in the treatment landscape for patients with EGFR mutant NSCLC and GBM and we look forward to providing a clinical update for the program in 2023."

Recent Developments

BDTX-1535:

BDTX-1535 is designed as a potent, selective, irreversible and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in GBM and of intrinsic and acquired resistance EGFR mutations to third generation EGFR inhibitors in NSCLC.
In April 2022, the first patient was dosed in the Phase 1, global study of BDTX-1535.
The Company expects to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is a brain-penetrant BRAF inhibitor against families of Class I, II, III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors. BDTX-4933 is designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond initiated investigational new drug (IND)-enabling studies in the first quarter of 2022 and expects to submit an IND application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline:

Black Diamond continues to leverage its Mutation-Allostery-Pharmacology, or MAP, drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards a development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In April 2022, Black Diamond announced plans to realign its resources to prioritize research and development programs for BDTX-1535, BDTX-4933 and discovery efforts, and decided to discontinue the development of BDTX-189 and reduce its workforce by approximately 30% to extend its cash runway into the third quarter of 2024.
In March 2022, Black Diamond appointed Wendy L. Dixon, Ph.D. to its Board of Directors, who joined the Board with over 40 years of biopharmaceutical industry experience, including service as a member of the board of several publicly traded biopharmaceutical companies.
In February 2022, Black Diamond appointed Elizabeth Montgomery as its Chief People Officer, who joined the Company with nearly 20 years of expertise and experience in developing strong corporate culture at a number of life sciences organizations.
Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2022 with approximately $179.7 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $28.6 million for the first quarter of 2022 compared to $100.1 million for the year ended December 31, 2021.
Research and Development Expenses: Research and development (R&D) expenses were $17.8 million for the first quarter of 2022 compared to $22.8 million for the first quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.9 million for the first quarter of both 2022 and 2021.
Net Loss: Net loss for the first quarter of 2022 was $25.5 million, as compared to $30.3 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.