Pulse Biosciences Reports Second Quarter 2022 Financial Results

On August 10, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the second quarter ended June 30, 2022 (Press release, Pulse Biosciences, AUG 10, 2022, View Source [SID1234618047]).

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Company Updates

Continued active engagement and collaboration with the nine commercial clinics participating in the CellFX System utilization program.
Received FDA 510(k) clearance of expanded energy settings for use with the family of CellFX System treatment tips in dermatology.
Generated second quarter 2022 revenue of $265 thousand.
Completed two commercial sales of CellFX Systems in the second quarter of 2022.
Transitioned four Controlled Launch Program participants to commercial use, totaling 43 commercial conversions with 12 clinics remaining in the Controlled Launch program, after a total of 15 clinics opted out, as of the end of Q2.
Reduced Q2 GAAP operating expenses by $3.9 million, or 23%, and Non-GAAP operating expenses by $2.9 million, or 21%, compared to the prior quarter.
Completed a rights offering in June, raising $15.0 million in gross proceeds with the potential to raise additional gross proceeds of up to $15.0 million through the exercise of accompanying warrants.
"In the second quarter, we transitioned our commercial focus toward driving utilization of CellFX Systems in a select group of our dermatology clinics. The development and implementation of best practices for clinic integration is demonstrating more clearly the novel value proposition of our NPS technology for patients and clinicians. Looking forward, we will continue to work closely with this subset of clinics to develop a deep understanding of the factors that drive consistent utilization and adoption of the CellFX System," commented Darrin Uecker, President and CEO of Pulse Biosciences. "At the same time, we continue to work towards expanding indications for the CellFX System to support treatments across specific patient populations and in other medical specialties."

Second Quarter 2022 Results

Revenue for the three months ended June 30, 2022 was $265 thousand, including System revenue of $209 thousand and Cycle Units revenue of $56 thousand. Total revenues of $118 thousand were recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems during the quarter.

Total GAAP cost and expenses representing cost of revenues, research and development, sales and marketing, and general and administrative expenses for the three months ended June 30, 2022 were $14.3 million, compared to $14.8 million for the prior year period. Non-GAAP cost and expenses for the three months ended June 30, 2022 were $12.2 million, compared to $12.1 million for the prior year period. While there were no direct restructuring charges incurred during the quarter, $195 thousand remains in accrued expenses as of June 30, 2022 that will be paid over the remainder of the year.

GAAP net loss for the three months ended June 30, 2022 was ($14.0) million compared to ($15.3) million for the three months ended June 30, 2021. Non-GAAP net loss for the three months ended June 30, 2022 was ($11.9) million compared to ($12.6) million for the three months ended June 30, 2021.

Cash and cash equivalents totaled $14.8 million as of June 30, 2022 compared to $47.4 million as of June 30, 2021 and $12.7 million as of March 31, 2022. Cash used in the second quarter of 2022 totaled $12.8 million excluding net proceeds received in the Company’s June 2022 rights offering. This compares to $15.0 million used in the same period in the prior year and $15.9 million used in the first quarter of 2022.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, August 10, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

Harpoon Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update

On August 10, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 10, 2022, View Source [SID1234618046]).

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"We continue to focus our resources and efforts on lead programs HPN328 and HPN217 from the TriTAC platform and next generation ProTriTAC T cell engager HPN601 to address unmet needs in both solid and liquid tumors," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "We are making changes in resource allocation to ensure Harpoon is well positioned for future success in the current challenging biotech climate. The HPN536 program shows promise however, requires continued dose optimization. Based on our decision to prioritize other assets in our portfolio, we will seek a partnership for further development of this program in monotherapy and combination settings. As a result of our focus and cost saving initiatives, we expect our current cash balance to extend into the second half of 2023."

Ms. Eastland continued, "Georgia Erbez, CFO, has decided to pursue a COO opportunity. We would like to thank Georgia for her leadership and financial stewardship since joining the company in 2018. Georgia built an organization that can provide the necessary support until we fill this role. We wish her continued success in her future endeavors."

Recent Highlights and Upcoming Milestones

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

In June 2022 Harpoon presented encouraging interim clinical results in a peer reviewed setting from the ongoing Phase 1 portion of the trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022. HPN328 demonstrated clinical activity and a favorable safety profile in patients with small cell lung cancer (SCLC), neuroendocrine prostate cancer and other neuroendocrine cancers. To date, study investigators have observed HPN328 is well tolerated, with 27% of SCLC patients having demonstrated target lesion reductions of 30% or more, including one confirmed partial response.
In April 2022, Harpoon entered into a Master Clinical Supply Agreement with F. Hoffmann-La Roche Ltd for the supply of atezolizumab (Tecentriq). Harpoon is planning to conduct clinical trials to evaluate HPN328 in combination with atezolizumab for the treatment of patients with SCLC.
Dose exploration is continuing with the goal to identify an initial expansion dose in the Phase 1 safety study by year-end 2022. Additional clinical supply of HPN328 is on track for delivery early in the fourth quarter of2022, which is expected to allow further exploration of select doses. Data is anticipated in the first half of 2023.
HPN217 (BCMA) Phase 1/2 trial for relapsed, refractory multiple myeloma

Granted Fast Track designation for the treatment of patients with relapsed and refractory multiple myeloma.
Compelling initial clinical activity observed in dose escalation phase of the ongoing trial. Maximum tolerated dose (MTD) has not been reached.
Dose exploration is continuing with ongoing enrollment into initial expansion cohorts in the Phase 1 safety study.
Interim data expected by year end 2022.
HPN536 (MSLN) Phase 1/2a trial in ovarian cancer and other solid tumors

HPN536 has successfully dose escalated in both fixed and step-dosing regimens and has been well tolerated at doses up to 7200ng/kg once weekly. Promising pharmacodynamic signals of T cell engagement have been observed even at sub-therapeutic doses in patients enrolled in our Phase 1 clinical study, consistent with published preclinical data.
Advancement of the program requires further optimization of the dose and schedule. Based on corporate priorities, Harpoon intends to seek a partner to further develop HPN536 in monotherapy or combination studies.
Patients enrolled in the trial who are benefiting from HPN536 will continue to receive doses and be followed per study protocol.
ProTriTAC

ProTriTAC is a conditionally active T cell engager platform designed to be preferentially active in the tumor. This enables Harpoon’s T cell engagers to address more broadly expressed solid tumor targets across multiple tumor types.

HPN601 (EpCAM)

HPN601 is the first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.
IND preparation is advancing, however, due to a contract manufacturer-driven delay, Harpoon expects to submit the IND in the first half of 2023.
TriTAC-XR

The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target cytokine release syndrome (CRS), a characteristic of many T cell engagers that can lead to dose limiting toxicities and reduce the efficacy of these potent anti-tumor drugs.

In April 2022, preclinical data supporting Harpoon’s TriTAC-XR platform were highlighted in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating improved safety by minimizing CRS.
Nomination of a second clinical candidate from one of our new platforms is expected by the end of 2022.

Corporate Update

Georgia Erbez is leaving her current role as Chief Financial Officer, effective August 31, 2022. Ms. Erbez will serve as a consultant to the company through the end of the year. A search is underway for a replacement.

In July 2022, Harpoon announced the appointments of Wendy Chang to Senior Vice President, Human Resources and Banmeet Anand, Ph.D., to Senior Vice President, Translational Medicine. Both bring deep experience to their respective roles.
Second Quarter 2022 Financial Results

Harpoon ended the second quarter of 2022 with $90.2 million in cash, cash equivalents and marketable securities compared to $136.6 million as of December 31, 2021. Current cash is expected to fund operations into the second half of 2023.

Revenue for the quarter ended June 30, 2022 was $8.3 million, compared to $5.8 million for the quarter ended June 30, 2021. For the six months ended June 30, 2022, revenue was $14.2 million compared to $14.8 million for the six months ended June 30, 2021. For the second quarter ended June 30, 2022, the increase in revenue was primarily due to an increase in revenue recognized related to Harpoon’s Development Option Agreement with AbbVie. For the six months ended June 30, 2022, the decrease in revenue was primarily due to a $5.2 million decrease in revenue recognized related to the Restated Collaboration Agreement due to the delivery of the second target in first quarter of 2021, under the Restated Collaboration Agreement, where all remaining deferred revenue associated with that target was recognized since Harpoon had no further continuing performance obligations, offset by $4.6 million increase in revenue recognized related to the Development and Option Agreement, for research and development services performed.

Research and development (R&D) expense for the quarter ended June 30, 2022 was $20.7 million, compared to $18.3 million for the quarter ended June 30, 2021. For the six months ended June 30, 2022, R&D expense was $41.5 million compared to $34.5 million for the six months ended June 30, 2021. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN536, HPN217 and HPN328.

General and administrative (G&A) expense for the quarter ended June 30, 2022 was $5.1 million, compared to $4.3 million for the quarter ended June 30, 2021. For the six months ended June 30, 2022, G&A expense was $10.5 million compared to $8.9 million for the six months ended June 30, 2020. The increase for both periods was primarily attributable to an increase in personnel-related expenses due to an increase in headcount and other professional services to support Harpoon’s operations as a public company.

Net loss for the quarter ended June 30, 2022 was $17.4 million, compared to $16.8 million for the quarter ended June 30, 2021. The net loss for the six months ended June 30, 2022 was $37.7 million compared to $78.5 million in the first six months of the prior year

Oncocyte Reports Second Quarter 2022 Financial Results

On August 10, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, reported that financial results for the second quarter 2022, ended June 30, 2022 (Press release, Oncocyte, AUG 10, 2022, View Source [SID1234618045]).

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Second Quarter and Recent Highlights:

Recent rightsizing of organization to match new program priorities is expected to reduce headcount carrying costs by over $4.5 million annually and, in combination with reprioritization cost reduction and anticipated strategic activities, annualized operating costs are expected to be reduced by approximately $12 million in 2023 as compared to 2022.
Reported total revenue of $2.1 million in the second quarter of 2022, compared with $2.0 million in the second quarter of 2021.
Received $1.0 million milestone payment from the final delivery of DetermaRx to Burning Rock, our Chinese partner.
Grew DetermaRx sample volume by 66% compared to second quarter of 2021 and increased onboarded physician base by 82% as compared to the same period in 2021.
Launched our CLIA validated laboratory test for our newly branded VitaGraft Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test.
Submitted VitaGraft Liver and VitaGraft Kidney for CMS reimbursement.
Clinical Partners presented five abstracts at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) expanding the evidence supporting DetermaIO as clinically relevant to decision making in six different cancer types including:
Independent, prospective randomized clinical trial (RCT) evidence that DetermaIO can identify responders and expand the market for immune checkpoint inhibitor (ICI) therapy in colorectal cancer.
Phase II independent blinded clinical trial evidence that DetermaIO can inform the use of pembrolizumab therapy (Keytruda) in the neoadjuvant treatment of triple negative breast cancer, expanding upon prior reported RCT data with atezolizumab.
Closed an underwritten offering of $32.8 million in net proceeds of common stock and warrants, and a preferred stock offering of $4.9 million in net proceeds, to strengthen the balance sheet and further support our product portfolio.
"Our recent reprioritization efforts have led to a rightsizing of our employee base to better match the resourcing required to deliver DetermaIO, DetermaCNI and VitaGraft to the market. The expected program cost reductions combined with the reduction in headcount and planned monetization of assets through strategic activities are anticipated to result in a decrease of approximately $12 million in annualized operating expenses year over year, extending our cash runway into 2024," said Ron Andrews, Chief Executive Officer of Oncocyte. "We continued to make solid progress in the second quarter, delivering 66% year over year growth in DetermaRx sample volumes and successfully onboarding new physicians and accounts. We also successfully completed our CLIA lab test validation of our VitaGraft product line and submitted both Liver and Kidney for CMS reimbursement."

Continuing, Mr Andrews commented, "Looking ahead, we are excited by the response to the anticipated launch of our VitaGraft Liver test and expect our first samples from a high-profile liver transplant center by the end of August. We also remain on track to submit our dossier for DetermaIO reimbursement this fall. Despite the continued market headwinds, we believe that Oncocyte has an incredibly bright future in front of us as the product development efforts from the past few years are expected to result in new product launches of high value, reimbursed products over the next four to six quarters. I would also like to recognize the promotion of Anish John to CFO and Gisela Paulsen to President and COO. These are well-deserved promotions for two executives that have been instrumental in reshaping our priorities and helping find ways to reduce our burn while still accomplishing our mission. We are now aligned around key areas where our skill sets can best serve Oncocyte’s future. I appreciate the continued support of our shareholders and look forward to updating you as we work to deliver on the key product milestones throughout the second half of 2022."

Second Quarter 2022 Financial Results

Total revenue was $2.1 million for the second quarter of 2022, compared to $1.4 million for the prior quarter. Second quarter revenues associated with DetermaRx were $0.8 million, down $0.2 million sequentially, and up $0.2 million year over year. Operating expenses for the second quarter 2022 were $8.2 million, compared to $13.2 million, a decrease of $5.0 million from the same period in the prior year. Research and Development expense for the second quarter 2022 was $5.6 million, an increase of $3.0 million from the same period a year ago. The increase in R&D expense was due to full integration of the Chronix R&D team, the growth and enrolment of our clinical trials, and added headcount related to the buildout of our IVD product development capabilities. General and Administrative expense for the second quarter of 2022 was $5.5 million, a decrease of $2.4 million for the same period in 2021, primarily due to one-time acquisition related costs related Chronix Biomedical acquisition in the same period in the prior year. Sales and Marketing expense in the quarter was $3.5 million, an increase of $0.8 million year over year, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities related to the transplant business, as well as support the commercialization efforts within oncology.

Net loss was $8.3 million for the second quarter of 2022 and net loss per share was $0.07 on a weighted-average basic and diluted share count of 113.0 million, compared to a net loss of $10.5 million and a net loss per share of $0.12 on a weighted-average basic and diluted share count of 89.8 million in the same period of the prior year.

Cash, cash equivalents, restricted cash and marketable securities were $47.1 million as of June 30, 2022.

Webcast and Conference Call Information
Oncocyte will host a conference call to discuss the second quarter 2022 financial results after market close on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or (201) 493-6779 for international callers, using conference ID: 13731553. The live webinar can be accessed at View Source

Adamis Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

On August 10, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the second quarter of 2022 and provided an update on recent corporate developments (Press release, Adamis Pharmaceuticals, AUG 10, 2022, View Source [SID1234618044]).

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"I committed to the CEO role in May because I could see beyond Adamis’ current position to where it could go. I knew the Company had strong assets which we could leverage to unlock shareholder value," said David J. Marguglio, CEO of Adamis. "We have two FDA-approved products competing in large markets. We have an ongoing Phase 2/3 trial for Tempol that, if it shows significant efficacy, could not only potentially become a blockbuster treatment for COVID-19, but could be potentially expanded to treat other respiratory diseases. Most importantly, we have a small, yet devoted team of highly qualified and experienced individuals committed to both saving patient lives and growing Adamis."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI (naloxone) Injection

US WorldMeds (USWM) began shipping ZIMHI to wholesalers at the end of March. The commercial launch is proceeding as planned.
USWM-relayed feedback from the field has been decidedly positive. Many customers feel ZIMHI’s combination of a higher dose with intramuscular delivery provides an advantage and significantly differentiates it from the leading competitors.
A recently launched website enables institutional customers to order and receive product directly through ZimhiDirect.com.
Progress continues in adding ZIMHI to formularies for payors and PBMs. It has been added to the standing orders in 25 states – which permits pharmacies to dispense ZIMHI without a prescription.
While market access is increasing, USWM has fielded a team of sales reps detailing doctors and clinics to increase awareness and ultimately drive scripts.
SYMJEPI (epinephrine) Injection

In March, the Company announced that manufacturing issues had led to a voluntary recall of four lots of SYMJEPI due to the potential for clogged needles.
An investigation lasting several months determined a single batch of stainless-steel needles was the root cause of the failures. Adamis and the manufacturer have developed corrective and preventive actions, and new syringes have been sourced.
Adamis is committed to returning SYMJEPI to the market as soon as all stakeholders are satisfied that these corrective actions should prevent a similar failure in future batches.
TEMPOL

Adamis believes that patient enrollment in the Phase 2/3 clinical trial is nearly completed.
The Data Safety Monitoring Board is scheduled to meet near the end of September to review unblinded interim data including safety and efficacy. Adamis will remain blinded to the data until the final study data is compiled and reviewed.
If interim trial data shows significant efficacy, the DSMB may recommend stopping the trial in light of the significant efficacy, and Adamis would likely seek to meet with FDA to discuss next steps and requirements for applying for Emergency Use Authorization, which could be a significant positive development for the Company, patients and healthcare providers.
The Company is exploring other potential indications for Tempol and seeking both government and non-government funding to further development.
Financial Results

Revenues for the six months ending June 30, 2022 and 2021 were approximately $1.2 million and $2.6 million, respectively. The decrease in revenues was primarily due the manufacturing hold and recall of SYMJEPI in 2022, offset by the product launch of ZIMHI.
Selling, general and administrative expenses for the first six months ending June 30, 2022 and 2021 were approximately $7.6 million and $8.5 million, respectively. The decrease was primarily due to the decreases in compensation and legal expenses.
Research and development expenses were higher for the first six months of 2022, at approximately $7.5 million, compared to $4.4 million in the same period in 2021. The increase was primarily related to the ongoing clinical trial for Tempol.
Net loss from discontinued operations for the six months ended June 30, 2022 and 2021 was approximately $0.2 million and $3.1 million, respectively. This decreased loss was primarily attributable to the cessation of US Compounding’s operations.
Cash and cash equivalents at the end of the second quarter totaled $8.9 million. Cash expenses were higher than expected due to approximately $5.2 million in disbursements relating to the repayment of the Second Draw Paycheck Protection Program loan, expenses related to the SYMJEPI recall and employment separation expenses. Although there are no assurances, the Company expects to receive additional proceeds during the second half of 2022, which could range from collections of approximately $2.0 to 3.5 million pursuant to the sale of certain USC assets to Fagron in 2021, and from the disposition of the remaining USC assets.
Conference Call Information

Management will host a live webcast/conference call today, August 10, 2022 at 4:30 p.m. ET / 1:30 p.m. PT, during which Company executives will review financial information for the second quarter of 2022 and provide a corporate update.

A live audio webcast of the conference call will also be available via this link. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source

Bolt Biotherapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 10, 2022 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immuno-oncology therapeutics for the treatment of cancer, reported financial results for the second quarter ended June 30, 2022 and provided a business update (Press release, Bolt Biotherapeutics, AUG 10, 2022, View Source [SID1234618043]).

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"The second quarter was one of continued progress, highlighted by steady clinical enrollment in our BDC-1001 monotherapy and combination dose-escalation studies. While we are fortunate to be operating from a position of financial strength, we have implemented a pipeline prioritization and new capital allocation initiative focused on advancing BDC-1001 and BDC-3042, two drug candidates that we believe have high potential to benefit patients," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We are winding down spending on BDC-2034, pausing other early-stage research programs, and prioritizing ISAC programs that bring forward the latest generation of our ISAC technology – including our collaboration programs. The combination of these strategic initiatives extends our expected cash runway an additional two years through 2025."

Dr. Schatzman continued, "We have a lot to look forward to with strong investigator and collaborator interest in our programs, data readouts from the BDC-1001 monotherapy and combination dose-escalation studies on the horizon as well as the advancement of BDC-3042 through IND-enabling activities."

Recent Business Highlights and Anticipated Milestones

Clinical data and recommended Phase 2 dose (RP2D) expected in the second half of 2022 from BDC-1001 monotherapy and combination dose-escalation study – Weekly dosing is well underway in the Phase 1/2 multi-dose, multi-center study of BDC-1001, a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC), in monotherapy and in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab).
To date, BDC-1001 has demonstrated a favorable safety profile, changes in intratumoral biomarkers consistent with its novel mechanism of action, and early signs of durable clinical disease control.
Completed companywide review and prioritization of portfolio and capital allocation strategy – Bolt now expects its current cash position to fund operations for an additional two years through 2025 based on the following initiatives:
Focus on development of our internal BDC-1001 and BDC-3042 programs while advancing next-generation ISAC technology and programs with partners.
Discontinue development of BDC-2034 and focus on most promising next-generation ISAC programs, including our collaborations. The decision to discontinue BDC-2034 was based on off-target toxicity related to the targeting antibody. CEA remains a viable Boltbody ISAC target with a more selective antibody
BDC-3042 advancing toward the clinic in 2023; IND-enabling studies underway – BDC-3042 is an agonist antibody that stimulates Dectin-2, a novel target found on tumor-associated macrophages across a broad range of solid tumors. Stimulating Dectin-2 leads to tumor macrophage reprogramming and anti-cancer activity in our preclinical studies. Bolt is currently conducting IND-enabling studies for BDC-3042 and is on track to initiate clinical development of BDC-3042 in 2023.
Presented poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – In June, Bolt presented ex vivo data demonstrating that myeloid cells are abundant in many solid tumors, even when T cells are not present. These data support the potential for myeloid-directed therapies to activate the innate immune system as a bridge to adaptive immunity in patients, independent of T cell-mediated immune checkpoint blockade.
Presented data from three preclinical pipeline programs at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – In April, Bolt Biotherapeutics’ scientists presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting 2022 highlighting the Company’s proprietary pipeline, including BDC-2034, BDC-3042, and a PD-L1 Boltbody ISAC.
Third U.S. patent issued covering lead HER2-targeting Boltbody ISAC BDC-1001 – The U.S. Patent and Trademark Office (USPTO) issued the U.S. Patent 11,400,164 on Aug. 2, 2022, titled "Immunoconjugates Targeting HER2." This U.S. patent strengthens the Company’s intellectual property position and contains composition of matter claims covering BDC-1001. This patent provides the Company coverage on the composition of matter of BDC-1001 until 2040, without any patent term extension.
Cash, cash equivalents, and marketable securities were $223.6 million as of June 30, 2022 – Cash on hand, including long-term marketable securities, is expected to fund multiple key milestones and operations through 2025.
Second Quarter 2022 Financial Results

Collaboration Revenue – Collaboration revenue was $1.4 million for the quarter ended June 30, 2022, compared to $0 for the same quarter in 2021. This represents 75% growth over the first quarter of 2022 as Bolt ramps up activities supporting its collaborations. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.
Research and Development (R&D) Expenses – R&D expenses were $18.9 million for the quarter ended June 30, 2022, compared to $19.7 million for the same quarter in 2021. The decrease was primarily due to a reduction in manufacturing expenses, offset by an increase in expenses due to continued progress in our clinical trial for BDC-1001 and the development of other product candidates, including an increase in contract and consulting services and higher personnel-related expenses relating to an increase in headcount.
General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the quarter ended June 30, 2022, compared to $4.1 million for the same quarter in 2021, primarily due to increased expenses related to being a public company, including higher personnel expenses relating to increased headcount.
Loss from Operations – Loss from operations was $23.1 million for the quarter ended June 30, 2022, compared to $23.8 million for the same quarter in 2021.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform unites the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment for a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lowering the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.