Black Diamond Therapeutics Inc

Previous wording

We are currently evaluating BDTX-1535 in a Phase 2 clinical trial in patients with EGFRm NSCLC in the second- and third-line settings with non-classical driver mutations and acquired C797S resistance mutation, and in the first-line setting in patients with EGFRm NSCLC harboring non-classical EGFR mutations. We expect to announce results from the second- and third-line cohorts in the third quarter of 2024 and results from the first-line cohort in the first quarter of 2025. We are also assessing the potential development of BDTX-1535 for patients with EGFRm NSCLC following adjuvant treatment with osimertinib, where the broad mutation coverage of BDTX-1535 of C797S and non-classical mutations may be of benefit.

Current wording

We are currently evaluating BDTX-1535 in a Phase 2 clinical trial in patients with EGFRm NSCLC in the second- and third-line settings with non-classical driver mutations and acquired C797S resistance mutation, and in the first-line setting in patients with EGFRm NSCLC harboring non-classical EGFR mutations. We expect to announce results from the second- and third-line cohorts later in the third quarter of 2024 and results from the first-line cohort in the first quarter of 2025. We are also assessing the potential development of BDTX-1535 for patients with EGFRm NSCLC following adjuvant treatment with osimertinib, where the broad mutation coverage of BDTX-1535 of C797S and non-classical mutations may be of benefit.

Previous wording

We released top-line GBM results from the BDTX-1535 Phase 1 dose escalation study in the fourth quarter of 2023, showing clinical activity in heavily pretreated patients with GBM. BDTX-1535 was shown to be generally well tolerated and no new safety signals were observed. In the fourth quarter of 2023, enrollment began in a “window of opportunity” (also known as a Phase 0/1 “Trigger”) trial sponsored by the Ivy Brain Tumor Center, in patients with recurrent high-grade glioma (HGG). We plan to present Phase 1 dose escalation data and “window of opportunity” results at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024, which will inform potential next steps in the development of BDTX-1535 in GBM.

Current wording

In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented additional data from the Phase 1 dose escalation study of BDTX-1535 in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity and a tolerability profile consistent with the clinical data from the dose escalation portion of our Phase 1 clinical trial of BDTX-1535 in patients with NSCLC previously presented in October 2023. In addition, we presented initial intratumoral pharmacokinetic data from a “window of opportunity” (also known as a Phase 0/1 “Trigger”) trial sponsored by Ivy Brain Tumor Center, in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis. Initial results from the investigator-sponsored trial demonstrated that BDTX-1535 exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated with expected EGFR-mediated side effects.

Previous wording

Since our inception in 2014, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, discovering product candidates and securing related intellectual property rights while conducting research and development activities for our programs. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.

Current wording

Since our inception in 2014, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, discovering product candidates and securing related intellectual property rights while conducting research and development activities for our programs. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory marketing approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.

Previous wording

To date, we have funded our operations with proceeds from the sale of common stock and preferred stock. Since inception, we have incurred significant operating losses. Our net losses were $18.2 million and $20.9 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $435.7 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Current wording

To date, we have funded our operations with proceeds from the sale of common stock and preferred stock. Since inception, we have incurred significant operating losses. Our net losses were $38.1 million and $40.0 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $455.6 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Previous wording

As of March 31, 2024, we had cash, cash equivalents and investments of approximately $115.2 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Current wording

As of June 30, 2024, we had cash, cash equivalents and investments of approximately $123.0 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Previous wording

•maintaining a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates.

Current wording

•maintaining a continued acceptable tolerability profile of our product candidates following approval, if any, of our product candidates.

Previous wording

Research and development expenses were $13.5 million for the three months ended March 31, 2024, compared to $14.8 million for the three months ended March 31, 2023. The following table summarizes our research and development expenses for the three months ended March 31, 2024 and 2023:

Current wording

Research and development expenses were $12.6 million for the three months ended June 30, 2024, compared to $13.2 million for the three months ended June 30, 2023. The following table summarizes our research and development expenses for the three months ended June 30, 2024 and 2023:

Previous wording

The decrease of $1.2 million for the three months ended March 31, 2024 was primarily due to an increase of $2.0 million related to the progression of our clinical trial for BDTX-1535, offset by decreased spend relating to other research programs and platform development of $2.2 million due to reduced spending on early discovery projects as we deepen our focus on our clinical-stage assets, compared to the three months ended March 31, 2023. In addition, personnel expenses decreased by $0.6 million as we continue to capitalize on workforce efficiencies and focus on our development programs.

Current wording

The decrease of $0.6 million for the three months ended June 30, 2024 was primarily due to an increase of $1.8 million related to the progression of our clinical trial for BDTX-1535, offset by decreased spend relating to other research programs and platform development of $1.6 million due to reduced spending on early discovery projects as we deepen our focus on our clinical-stage assets, compared to the three months ended June 30, 2023. In addition, personnel expenses decreased by $0.5 million as we continue to capitalize on workforce efficiencies and focus on our development programs.

Previous wording

General and administrative expenses were $6.7 million for the three months ended March 31, 2024 compared to $6.8 million for the three months ended March 31, 2023. This was primarily a result of a decrease in personnel-related costs, legal and other professional fees.

Current wording

General and administrative expenses were $9.6 million for the three months ended June 30, 2024 compared to $6.9 million for the three months ended June 30, 2023. This was primarily a result of an increase in consulting and other professional fees.

Previous wording

Other income was $2.0 million for the three months ended March 31, 2024, compared to $0.7 million for the three months ended March 31, 2023. The increase was primarily attributable to accretion on investments increasing at a higher rate in 2024 compared to 2023.

Current wording

Other income was $2.2 million for the three months ended June 30, 2024, compared to $0.9 million for the three months ended June 30, 2023. The increase was primarily attributable to accretion on investments increasing at a higher rate in 2024 compared to 2023.

Previous wording

Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for several years, if at all. We have funded our operations to date primarily with proceeds from the sale of common and preferred stock.

Current wording

Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for several years, if at all. We have funded our operations to date primarily with proceeds from the sale of our common and preferred stock.

Previous wording

On February 3, 2020, we completed an IPO of 12,174,263 shares of our common stock, including the exercise in full by the underwriters of their option to purchase up to 1,587,947 additional shares of common stock, for aggregate gross proceeds of $231.3 million. We received $212.1 million in net proceeds after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. Through March 31, 2024, we had received net cash proceeds of $200.6 million from previous sales of our preferred stock and as of March 31, 2024, we had cash, cash equivalents and investments of $115.2 million.

Current wording

On February 3, 2020, we completed an IPO of 12,174,263 shares of our common stock, including the exercise in full by the underwriters of their option to purchase up to 1,587,947 additional shares of our common stock, for aggregate gross proceeds of $231.3 million. We received $212.1 million in net proceeds after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. Through June 30, 2024, we had received net cash proceeds of $200.6 million from previous sales of our preferred stock and as of June 30, 2024, we had cash, cash equivalents and investments of $123.0 million.

Previous wording

On November 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500 million. We simultaneously entered into an Open Market Sale Agreement SM(the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150 million of our common stock, or the Shares, from time to time through Jefferies as our sales agent (the ATM Program). The Shelf Registration Statement became effective on November 22, 2022. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of March 31, 2024, we sold 800,000 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $4.0 million ($3.9 million net of offering costs).

Current wording

On November 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500 million. We simultaneously entered into an Open Market Sale Agreement SM(the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150 million of our common stock, or the Shares, from time to time through Jefferies as our sales agent (the ATM Program). The Shelf Registration Statement became effective on November 22, 2022. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of June 30, 2024, we sold 4,490,853 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $25.0 million ($24.5 million net of offering costs).

Previous wording

During the three months ended March 31, 2024, we used cash in operating activities of $21.2 million, primarily resulting from our net loss of $18.2 million, partially offset by the non-cash charge related to stock compensation expense of $1.7 million.

Current wording

During the six months ended June 30, 2024, we used cash in operating activities of $35.9 million, primarily resulting from our net loss of $38.1 million, partially offset by the non-cash charge related to stock compensation expense of $7.0 million.

Previous wording

During the three months ended March 31, 2023, we used cash in operating activities of $20.0 million, primarily resulting from our net loss of $20.9 million, partially offset by the non-cash charge related to stock compensation expense of $2.7 million.

Current wording

During the six months ended June 30, 2023, we used cash in operating activities of $34.4 million, primarily resulting from our net loss of $40.0 million, partially offset by the non-cash charge related to stock compensation expense of $5.3 million.

Previous wording

During the three months ended March 31, 2024, we had cash used in investing activities of $13.7 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Current wording

During the six months ended June 30, 2024, we had cash used in investing activities of $13.0 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Previous wording

During the three months ended March 31, 2023, we had cash provided by investing activities of $24.8 million primarily from the sales and maturities of investments.

Current wording

During the six months ended June 30, 2023, we had cash provided by investing activities of $42.0 million primarily from the sales and maturities of investments.

Previous wording

During the three months ended March 31, 2024, we had cash provided by financing activities of $4.1 million, consisting of proceeds from exercise of stock options and participation in the employee stock purchase plan as well as the sale of shares of our common stock in March 2024 pursuant to the ATM Program.

Current wording

During the six months ended June 30, 2024, we had cash provided by financing activities of $25.5 million, consisting of proceeds from the sale of shares of our common stock pursuant to the ATM Program as well as exercises of stock options and participation in the employee stock purchase plan.

Previous wording

During the three months ended March 31, 2023, we had cash provided by financing activities of $0.1 million consisting of proceeds from the participation in the employee stock purchase plan.

Current wording

During the six months ended June 30, 2023, we had cash provided by financing activities of $0.1 million consisting of proceeds from the participation in the employee stock purchase plan.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and investments of $115.2 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Current wording

As of June 30, 2024, we had cash, cash equivalents and investments of $123.0 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Previous wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 12, 2024. During the three months ended March 31, 2024, there were no material changes to our critical accounting policies from those previously disclosed.

Current wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 12, 2024. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies from those previously disclosed.