1. REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Bolt Biotherapeutics' BDC-1001 in combination with Bristol Myers Squibb's PD-1 checkpoint inhibitor Opdivo® (nivolumab). BDC-1001 is a HER2-targeting Boltbody™ immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors.

    "We look forward to working…

    REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Bolt Biotherapeutics' BDC-1001 in combination with Bristol Myers Squibb's PD-1 checkpoint inhibitor Opdivo® (nivolumab). BDC-1001 is a HER2-targeting Boltbody™ immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors.

    "We look forward to working with BMS in our continued development of BDC-1001, which has shown promising results in preclinical and early clinical studies," said Randall Schatzman, CEO of Bolt Biotherapeutics. "Our unique ISAC approach initiates an innate and an adaptive immune response that may be synergistic with BMS' innovative PD-1 inhibitor Opdivo. The combination of BDC-1001 and Opdivo holds potential as a treatment for cancer patients, and we welcome the opportunity to investigate this in a clinical setting." He added, "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Bolt's clinical studies."

    BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists with an intervening non-cleavable linker, for the treatment of patients with HER2-expressing solid tumors. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with solid tumors, including breast, gastroesophageal and colorectal, that are HER2+ or HER2-low, for which Bolt recently presented preliminary data detailing safety, tolerability, and signs of activity at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial is being conducted in four parts, with dose-escalation and dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. The combination dose escalation is expected to start later in 2021.

    Opdivo® is a trademark of Bristol-Myers Squibb Company.

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Bristol-Myers Squibb to investigate combination therapeutics for the treatment of cancer, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended March 31, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com  



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  2. REDWOOD CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that management will present a corporate update and conduct meetings with the investment community at four upcoming virtual investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference
      Meetings with investors on Wednesday, Sept. 8
    • Wells Fargo Virtual Healthcare Conference
      Presentation on Thursday, Sept. 9, at 12:30 p.m. PT (3:20 p.m. ET)
    • Morgan Stanley 19th Annual Global Healthcare Conference
      Fireside chat on Monday…

    REDWOOD CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that management will present a corporate update and conduct meetings with the investment community at four upcoming virtual investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference

      Meetings with investors on Wednesday, Sept. 8

    • Wells Fargo Virtual Healthcare Conference

      Presentation on Thursday, Sept. 9, at 12:30 p.m. PT (3:20 p.m. ET)

    • Morgan Stanley 19th Annual Global Healthcare Conference

      Fireside chat on Monday, Sept. 13, at 12:30 p.m. PT (3:30 p.m. ET)

    • 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

      Presentation on Thursday, Sept. 30, at 11:00 a.m. PT (2:00 p.m. ET)

    A live webcast of the presentations will be available on the Events and Presentations page of Bolt's website at www.boltbio.com. Archived replays will be available for 30 days following the event.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugate (ISAC) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1. For more information, visit https://www.boltbio.com/.

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com



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  3. SAN FRANCISCO and SUZHOU, China, Aug. 26, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Bolt Biotherapeutics, Inc. ("Bolt") (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's…

    SAN FRANCISCO and SUZHOU, China, Aug. 26, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Bolt Biotherapeutics, Inc. ("Bolt") (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients. The Boltbody ISAC platform combines a tumor-targeting antibody, a stable non-cleavable linker, and a proprietary immune stimulant. Boltbody ISACs unite the precision of antibody targeting with the power of innate and adaptive immune system response.  

    Under the agreement, Innovent has the rights to all three programs in Greater China, and retains an option to license global rights for one program, as well as rights for all territories except North America for another program. Bolt retains the option to license global rights outside of Greater China for one program, and North American rights for another program. Innovent is responsible for all research and development costs through clinical proof-of-concept (POC).  Upon review of the initial clinical proof-of-concept data, the companies can exercise licensing options for continued development and exclusive commercialization rights in specific territories on a program-by-program basis. Bolt will receive an upfront payment of US$5 million in cash from Innovent at signing and a possible future equity investment of up to US$10 million. Furthermore, both Innovent and Bolt are eligible to receive additional milestones payments and royalties associated with the development and commercialization of products in each other's territories.

    Dr. Yong Jun Liu, President of Innovent Biologics, stated, "We are very excited about the potential for the Boltbody ISAC platform to generate best-in-class approaches treating multiple tumor types. Bolt has spent several years building and optimizing this platform, which we can leverage to expedite the development of important new products. We look forward to working together with Bolt to bring innovative therapies to patients as soon as possible."

    "Innovent is a leader in the development of innovative antibody therapeutics for the treatment of cancer, with advanced research and development teams and an expanding commercial infrastructure in China. We look forward to collaborating with Innovent on the development of novel ISAC anti-cancer therapeutic candidates," said Randall Schatzman, Ph.D., CEO of Bolt. "Our preclinical and early clinical studies have demonstrated  the safety and efficacy of the ISAC approach and the benefits of stimulating both the innate and adaptive arms of the immune system in the fight against cancer."

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Innovent

    Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

    Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

    Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

    Note:

    Sintilimab is not an approved product in the United States.

    BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

    TYVYT® (sintilimab injection, Innovent)

    BYVASDA® (bevacizumab biosimilar injection, Innovent)

    SULINNO® (adalimumab biosimilar injection, Innovent)

    Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Innovent Biologics, Inc. Forward-Looking Statements

    This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

    These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

    Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

    Cision View original content:https://www.prnewswire.com/news-releases/innovent-and-bolt-biotherapeutics-announce-collaboration-to-develop-three-new-oncology-boltbody-isac-programs-301363537.html

    SOURCE Innovent Biologics, Inc.

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    • Innovent will provide proprietary antibodies for selected tumor targets and Bolt will provide its proprietary Boltbody™ technology to create new immune-stimulating antibody conjugates (ISACs)

    • Innovent will pay Bolt an upfront payment and fund development through clinical proof of concept

    • Innovent has rights to all programs in Greater China, and both parties have options to participate in full development and commercialization for various regions

    REDWOOD CITY, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, and…

    • Innovent will provide proprietary antibodies for selected tumor targets and Bolt will provide its proprietary Boltbody™ technology to create new immune-stimulating antibody conjugates (ISACs)



    • Innovent will pay Bolt an upfront payment and fund development through clinical proof of concept



    • Innovent has rights to all programs in Greater China, and both parties have options to participate in full development and commercialization for various regions

    REDWOOD CITY, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, and Innovent Biologics, Inc. (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients. The Boltbody ISAC platform combines a tumor-targeting antibody, a stable, non-cleavable linker, and a proprietary immune stimulant. Boltbody ISACs unite the precision of antibody targeting with the power of innate and adaptive immune system response.

    "Innovent is a leader in the development of innovative antibody therapeutics for the treatment of cancer, with advanced research and development teams and an expanding commercial infrastructure in China. We look forward to collaborating with Innovent on the development of novel ISAC anti-cancer therapeutic candidates," said Randall Schatzman, Ph.D., CEO of Bolt Bio. "Our preclinical and early clinical studies have demonstrated the safety and efficacy of the ISAC approach and the benefits of stimulating both the innate and adaptive arms of the immune system in the fight against cancer."

    "We are very excited about the potential for the Boltbody ISAC platform to generate best-in-class approaches treating multiple tumor types," said Dr. Yong Jun Liu, President of Innovent Biologics. "Bolt has spent several years building and optimizing this platform, which we can leverage to expedite the development of important new products. We look forward to working together with Bolt to bring innovative therapies to patients as soon as possible."

    Under the agreement, Innovent has the rights to all three programs in Greater China, and retains an option to license global rights for one program, as well as rights for all territories except North America for another program. Bolt retains the option to license global rights outside of Greater China for one program, and North American rights for another program. Innovent is responsible for all research and development costs through clinical proof-of-concept. Upon review of the initial clinical proof-of-concept data, the companies can exercise licensing options for continued development and exclusive commercialization rights in specific territories on a program-by-program basis. Bolt will receive an upfront payment of $5 million in cash from Innovent at signing and a possible future equity investment of up to $10 million. Furthermore, both Bolt and Innovent are eligible to receive additional milestone payments and royalties associated with the development and commercialization of products in each other's territories.

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    About Innovent Biologics, Inc.

    Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

    Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

    Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Innovent to discover and develop therapeutics for the treatment of multiple types of cancer, our ability to leverage Innovent's antibody portfolio in connection with our technology and expertise, our ability to develop multiple ISAC therapeutics with Innovent, the achievement of milestone payments or royalties, and our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended June 30, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Investor Relations and Media Contacts:    

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com  



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  4. – BDC-1001 Phase 1/2 trial in HER2-expressing solid tumors on track for data update in 2H 2021–

    – Announced R&D collaboration with Genmab to develop multiple bispecific ISACs for treatment of cancer –

    – Ended second quarter 2021 with strong cash position of $310.9 million –

    REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today reported financial results for the second quarter ended June 30, 2021 and provided an update on recent business highlights.

    "We continue to build strong momentum with…

    – BDC-1001 Phase 1/2 trial in HER2-expressing solid tumors on track for data update in 2H 2021–

    – Announced R&D collaboration with Genmab to develop multiple bispecific ISACs for treatment of cancer –

    – Ended second quarter 2021 with strong cash position of $310.9 million –

    REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today reported financial results for the second quarter ended June 30, 2021 and provided an update on recent business highlights.

    "We continue to build strong momentum with our business strategy and remain on target for a BDC-1001 Phase 1/2 clinical data update later this year," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Our recently announced Genmab collaboration expands our proprietary Boltbody platform into novel bispecific ISAC applications, while fortifying our strong cash position. Furthermore, our CEA-targeted candidate BDC-2034 made steady progress towards an IND filing that is expected next year. I am proud of the passionate and experienced team we have assembled at Bolt, including recent additions to our leadership, who share our commitment to advancing targeted immuno-oncology therapies that will benefit patients with cancer."

    Recent Business Highlights and Anticipated Milestones

    • Lead program BDC-1001 on track for anticipated Phase 1/2 trial data update in 2H21 – In June 2021, Bolt presented a poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting that expanded on the preliminary data, as of January 29, 2021, from the first 20 patients in an ongoing BDC-1001 Phase 1/2 clinical trial. The monotherapy dose-escalation portion of the trial is proceeding on plan, with a further data update expected in the second half of 2021. This Phase 1/2 trial is being conducted in four parts: [1] Phase 1 monotherapy dose escalation, [2] Phase 1 dose escalation in combination with PD-1 checkpoint inhibitor, [3] Phase 2 monotherapy expansion cohorts, and [4] Phase 2 expansion cohorts in combination with a PD-1 checkpoint inhibitor. Bolt also remains on track to initiate the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation of BDC-1001 in combination with an anti-PD-1 antibody in the second half of 2021.



    • Announced oncology research and development (R&D) collaboration with Genmab to develop multiple bispecific ISACs – In June 2021, Bolt announced an oncology R&D collaboration with Genmab to discover and evaluate novel bispecific immune-stimulating antibody conjugate (ISAC) products for the treatment of multiple types of cancer. The collaboration will combine Bolt's BoltBody™ ISAC platform with Genmab's proprietary antibodies and bispecific technology, and Genmab will fully fund three programs through initial clinical proof-of-concept. Bolt received a $10 million USD upfront payment and a $15 million USD equity investment from Genmab, is eligible to receive up to $285 million USD for each program exclusively developed and commercialized by Genmab, and has the option to participate in the development and commercialization of one candidate after seeing clinical proof-of-concept data.



    • Expanded leadership team, adding expertise across research, clinical development, regulatory, quality and technical operations over the last year.

      • Amreen Husain, M.D., Vice President, Clinical Development and Translational Medicine. Dr. Husain brings more than a decade of experience in oncology drug development with a focus on breast and gynecological cancers and immuno-oncology. Dr. Husain joined Bolt from Roche/Genentech. Prior, Dr. Husain was as a practicing oncologist and clinical researcher at Stanford University Medical Center.
      • Bruce Hug, M.D., Ph.D., Vice President, Early Development and Research Collaborations. Dr. Hug joins Bolt from GlaxoSmithKline, bringing more than 16 years of oncology, hematology and immunotherapy experience, with a focus on early development.
      • Karen L. Bergman, Vice President, Communications and Investor Relations. Ms. Bergman has more than two decades of experience in biopharma communications, spanning corporate roles at companies such as ALZA and FibroGen, and 15 years heading a life science practice specializing in strategy, positioning, communications, and investor relations.
      • Liang Fang, Ph.D., Vice President, Biometrics and Bioinformatics. Dr. Fang brings more than 15 years of experience in developing and applying statistical methods and data sciences to drug development in oncology and the biotechnology industry from MyoKardia, Gilead Sciences, Genentech, and Amgen.
      • Triona O'Hanlon, Vice President, Program Management. Ms. O'Hanlon joined Bolt from Gilead, where she led program and portfolio management for hematology/oncology and cell therapy. Ms. O'Hanlon brings more than 20 years of experience in program and alliance management from Gilead Sciences, Kite Pharma, Elan Pharmaceuticals, and Ambit Biosciences.
      • Wesley Burwell, Vice President, Head of Human Resources. Mr. Burwell most recently worked at Global Blood Therapeutics and brings more than 20 years of experience building and driving HR strategy for biopharma companies.



    • Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, which is expected to fund operations and the advancement of its oncology product pipeline to achieve multiple key milestones through the end of 2023.

    Upcoming Events

    • Bolt Biotherapeutics will be attending the following conferences in September 2021:
      • Citi's 16th Annual Biopharma Virtual Conference, September 8-10
      • Wells Fargo Virtual Healthcare Conference, September 9-10
      • Morgan Stanley Global Healthcare Conference, September 9-15
      • Cantor Fitzgerald Global Healthcare Conference, September 27-30

    Second Quarter 2021 Financial Results

    Cash Position – Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, compared to $302.9 million as of March 31, 2021. Bolt expects its cash balance to fund operations through the end of 2023.

    Research and Development Expenses – R&D expenses were $19.7 million for the quarter ended June 30, 2021, compared to $9.2 million for the same quarter in 2020, primarily due to increases in manufacturing expenses related to BDC-1001 and BDC-2034, increased personnel expenses relating to an increase in headcount, increased facility-related expenses, and increased clinical trial expenses.

    General and Administrative (G&A) Expenses – G&A expenses were $4.1 million for the quarter ended June 30, 2021, compared to $2.0 million for the same quarter in 2020, primarily due to increased personnel expenses relating to an increase in headcount and increased professional services expenses related to consulting services, legal fees and other professional services.

    Loss from Operations – Loss from operations was $23.8 million for the quarter ended June 30, 2021 compared to $11.1 million for the same quarter in 2020.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugate (ISAC) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1. For more information, visit https://www.boltbio.com/.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our clinical trials, the timing of enrollment for our ongoing Phase 1/2 trial for BDC-1001, the timing of our Phase 2 dose expansion and the dose escalation in combination with an anti-PD-1 antibody, the timing that BDC-2034 will enter clinical trials, the availability of additional BDC-1001 clinical data by the end of 2021, the initiation of the BDC-1001 monotherapy Phase 2 dose-expansion cohorts in the second half of 2021, our ability to fund our clinical programs and the sufficiency of our cash, cash equivalents, and marketable securities to fund operations through the end of 2023, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    BOLT BIOTHERAPEUTICS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited, in thousands, except share and per share amounts)

      Three Months Ended June 30, Six Months Ended June 30,
      2021 2020 2021 2020
    Collaboration revenue $  $67  $  $231 
    Operating expenses:                
    Research and development  19,707   9,166   33,834   15,953 
    General and administrative  4,054   2,011   8,353   4,133 
    Total operating expense  23,761   11,177   42,187   20,086 
    Loss from operations  (23,761)  (11,110)  (42,187)  (19,855)
    Other income (expense), net                
    Interest income, net  176   51   232   163 
    Change in fair value of preferred stock right liability        (6,084)   
    Total other income (expense), net  176   51   (5,852)  163 
    Net loss  (23,585)  (11,059)  (48,039)  (19,692)
    Net unrealized gain (loss) on marketable securities  41   11   (23)  1 
    Comprehensive loss $(23,544) $(11,048) $(48,062) $(19,691)
    Net loss per share, basic and diluted $(0.64) $(5.29) $(1.65) $(9.45)
    Weighted-average shares outstanding, basic and diluted  36,595,112   2,089,320   29,088,267   2,083,197 
                     

    BOLT BIOTHERAPEUTICS, INC.

    CONDENSED BALANCE SHEETS

    (Unaudited, in thousands)

      June 30, December 31,
      2021 2020
    Assets      
    Current assets:        
    Cash and cash equivalents $58,302  $5,542 
    Short-term investments  186,686   17,296 
    Prepaid expenses and other current assets  3,163   2,523 
    Total current assets  248,151   25,361 
    Property and equipment, net  4,551   4,083 
    Operating lease right-of-use assets  25,977   12,267 
    Finance lease right-of-use assets  25   34 
    Restricted cash  1,565   1,565 
    Deferred offering costs     2,357 
    Long-term investments  65,938    
    Other assets  867   875 
    Total assets $347,074  $46,542 
    Liabilities, convertible preferred stock, and stockholders' equity (deficit)        
    Current liabilities:        
    Accounts payable $1,614  $1,598 
    Accrued expenses and other current liabilities  10,983   6,663 
    Deferred revenue  4,330   1,502 
    Operating lease liabilities  2,323   1,501 
    Total current liabilities  19,250   11,264 
    Operating lease liabilities, net of current portion  23,160   9,376 
    Deferred revenue, non-current  8,535    
    Convertible preferred stock purchase right liability, non-current     25,224 
    Other long-term liabilities  233   329 
    Total liabilities  51,178   46,193 
    Commitments and contingencies        
    Convertible preferred stock     105,296 
    Stockholders' equity (deficit):        
    Common stock      
    Additional paid-in capital  452,357   3,452 
    Accumulated other comprehensive loss  (23)   
    Accumulated deficit  (156,438)  (108,399)
    Total stockholders' equity (deficit):  295,896   (104,947)
    Total liabilities, convertible preferred stock, and stockholders' equity (deficit) $347,074  $46,542 
             

    BOLT BIOTHERAPEUTICS, INC.

    CONDENSED STATEMENTS OF CASH FLOWS

    (Unaudited, in thousands)

      Six Months Ended June 30,
      2021 2020
    CASH FLOWS FROM OPERATING ACTIVITIES:        
    Net loss $(48,039) $(19,692)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Depreciation and amortization  528   211 
    Stock-based compensation expense  4,132   448 
    Accretion of premium/discount on marketable securities  1,034   (53)
    Unrealized gain (loss) on marketable securities, net  (23)  1 
    Change in fair value of convertible preferred stock purchase rights liabilities  6,084    
    Non-cash lease expense  1,174   885 
    Changes in operating assets and liabilities:        
    Prepaid expenses and other assets  (632)  (382)
    Accounts payable and accrued expenses  4,110   (438)
    Operating lease liabilities  (278)  (2,821)
    Deferred revenue  11,363   (69)
    Other long-term liabilities  2   7 
    Net cash used in operating activities  (20,545)  (21,903)
    CASH FLOWS FROM INVESTING ACTIVITIES:        
    Purchase of property and equipment  (761)  (1,213)
    Purchases of marketable securities  (247,768)  (13,235)
    Maturities of marketable securities  11,406   5,247 
    Net cash used in investing activities  (237,123)  (9,201)
    CASH FLOWS FROM FINANCING ACTIVITIES:        
    Proceeds from issuance of preferred stock, net of issuance cost  51,902   41,546 
    Proceeds from initial public offering, net of issuance cost  244,316    
    Proceeds from issuance of common stock related to stock purchase agreement  13,638    
    Proceeds from issuance of common stock  572   39 
    Net cash provided by financing activities  310,428   41,585 
    Net increase in cash  52,760   10,481 
    Cash, cash equivalents and restricted cash at beginning of year  7,107   35,410 
    Cash, cash equivalents and restricted cash at end of period $59,867  $45,891 
    Reconciliation of cash, cash equivalents and restricted cash:        
    Cash and cash equivalents $58,302  $45,307 
    Restricted cash  1,565   584 
    Total cash, cash equivalents and restricted cash $59,867  $45,891 
    Supplemental schedule of non-cash investing and financing activities:        
    Vesting of early exercised options $98  $9 
    Purchases of property and equipment included in accounts payable and accrued liabilities $226  $280 
    Deferred offering costs in accounts payable and accrued liabilities $  $216 
    Right of use assets obtained in exchange for operating lease obligations $14,884  $324 
             

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com



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    • Poster showcases positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody™ ISAC BDC-1001 as of January 29th cutoff date
    • Monotherapy dose expansion and anti-PD-1 antibody combination parts of study expected to start in 2H 2021

    REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that a poster presentation discussing preliminary data from the Phase 1/2 clinical trial of BDC-1001, Bolt's lead candidate, was presented at the 2021 American Society of Clinical…

    • Poster showcases positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody™ ISAC BDC-1001 as of January 29th cutoff date

    • Monotherapy dose expansion and anti-PD-1 antibody combination parts of study expected to start in 2H 2021

    REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that a poster presentation discussing preliminary data from the Phase 1/2 clinical trial of BDC-1001, Bolt's lead candidate, was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from June 4-8, 2021. The poster is titled "Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors."

    BDC-1001 is a human epidermal growth factor receptor 2, or HER2, ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists, for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors. As of January 29, 2021, Bolt had treated 20 patients and BDC-1001 appeared to be well tolerated with mild to moderate adverse events; no dose-limiting toxicities or drug-related serious adverse events were observed. Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action.

    "This poster reinforces the favorable safety and tolerability demonstrated in the first 20 patients treated with BDC-1001 in this first-in-human study in patients with HER2-expressing cancers," said Manish R. Sharma, M.D., of START Midwest, a principal investigator in Bolt's ongoing BDC-1001 Phase 1/2 trial. "We have seen signs of activity, including a patient with a confirmed partial response and others with stable disease, in a population with diverse tumor types and a median of four prior lines of therapy."

    The BDC-1001 Phase 1/2 trial is expected to enroll up to a total of 390 patients and is being conducted in four parts, with dose-escalation dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. The monotherapy dose-escalation part of the trial continues to proceed according to plan, and full results are expected to be presented in the second half of 2021. Bolt plans to advance to the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation combining BDC-1001 with an anti-PD-1 antibody later this year.

    "I am grateful to everyone on the team for their hard work throughout this trial, especially during the pandemic," said Ecaterina Dumbrava, M.D., of The University of Texas MD Anderson Cancer Center, a principal investigator of the BDC-1001 Phase 1/2 trial. "These initial data provide additional support for the ISAC targeted approach that stimulates both the innate and adaptive immune systems in the treatment of cancer patients."

    The abstract and poster from the ASCO presentation can be found on the ASCO website, as well as on the Bolt website.

    About Bolt Biotherapeutics' Immune-stimulating Antibody Conjugate (ISAC) Platform Technology

    The Boltbody™ ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

    About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors

    The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. The study also includes similar dose escalation and expansion portions evaluating the combination of BDC-1001 with an anti-PD1 checkpoint inhibitor. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugate (ISAC) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1. For more information, visit https://www.boltbio.com/.

    Forward Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our clinical trials, the timing of enrollment for our Phase 1/2 trial for BDC-1001 for the treatment of patients with HER2-expressing solid tumors, the potential of BDC-1001's anti-tumor activity while minimizing the formation of anti-drug antibodies, the potential that APCs may result in a productive and durable anti-tumor immune response, and the prediction that Boltbody ISACs may translate into more durable clinical responses for patients. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



    Primary Logo

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    • Collaboration to discover and evaluate novel product concepts based on the combination of Genmab's antibodies and bispecific antibody technologies with Bolt's proprietary immune-stimulating antibody conjugate (ISAC) platform
    • Companies intend to develop multiple bispecific ISACs
    • Genmab has option to develop and commercialize up to three therapeutic candidates; Bolt has option to participate in development and commercialization of one candidate
    • Bolt to receive USD 10 million upfront payment and USD 15 million equity investment from Genmab

    Genmab A/S (NASDAQ:GMAB) and Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) announced today that the companies have entered into an oncology research and development collaboration. Together, the companies…

    • Collaboration to discover and evaluate novel product concepts based on the combination of Genmab's antibodies and bispecific antibody technologies with Bolt's proprietary immune-stimulating antibody conjugate (ISAC) platform
    • Companies intend to develop multiple bispecific ISACs
    • Genmab has option to develop and commercialize up to three therapeutic candidates; Bolt has option to participate in development and commercialization of one candidate
    • Bolt to receive USD 10 million upfront payment and USD 15 million equity investment from Genmab

    Genmab A/S (NASDAQ:GMAB) and Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) announced today that the companies have entered into an oncology research and development collaboration. Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt's proprietary Boltbody™ immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. This research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept.

    "This exciting collaboration will provide a unique opportunity to combine Genmab's innovative bispecific antibody technologies with Bolt's powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab's partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options."

    Randall Schatzman, Ph.D., Chief Executive Officer of Bolt, explained, "Our joint vision is to leverage Genmab's and Bolt's innovative technologies to develop a completely new type of ISAC with the aim to transform the way cancer is treated. Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients. We are delighted to be collaborating with the Genmab team and to have their deep expertise in discovering and developing bispecific antibodies brought to bear on this approach as we continue our mission to develop treatments that address key unmet needs for patients with cancer."

    Financial Terms

    Under the terms of the agreement, Genmab will pay Bolt an upfront payment of USD 10 million. Genmab will also make a USD 15 million equity investment in Bolt. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund pre-clinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.

    About Genmab

    Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab's proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Genmab Forward-Looking Statements

    This Media Release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

    Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®.

    Bolt Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Genmab A/S to discover and develop therapeutics for the treatment of multiple types of cancer, our ability to develop multiple next-generation, immune-stimulatory conjugate therapeutics with Genmab A/S, the achievement of milestone payments or any tiered royalties, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended March 31, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

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  5. Media Release

    • Collaboration to discover and evaluate novel product concepts based on the combination of Genmab's antibodies and bispecific antibody technologies with Bolt's proprietary immune-stimulating antibody conjugate (ISAC) platform
    • Companies intend to develop multiple bispecific ISACs
    • Genmab has option to develop and commercialize up to three therapeutic candidates; Bolt has option to participate in development and commercialization of one candidate
    • Bolt to receive USD 10 million upfront payment and USD 15 million equity investment from Genmab

    COPENHAGEN, Denmark and REDWOOD City, Calif., June 02, 2021 (GLOBE NEWSWIRE) -- Genmab A/S (NASDAQ:GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) announced today that the companies have entered…

    Media Release

    • Collaboration to discover and evaluate novel product concepts based on the combination of Genmab's antibodies and bispecific antibody technologies with Bolt's proprietary immune-stimulating antibody conjugate (ISAC) platform
    • Companies intend to develop multiple bispecific ISACs
    • Genmab has option to develop and commercialize up to three therapeutic candidates; Bolt has option to participate in development and commercialization of one candidate
    • Bolt to receive USD 10 million upfront payment and USD 15 million equity investment from Genmab

    COPENHAGEN, Denmark and REDWOOD City, Calif., June 02, 2021 (GLOBE NEWSWIRE) -- Genmab A/S (NASDAQ:GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) announced today that the companies have entered into an oncology research and development collaboration. Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt's proprietary Boltbody™ immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. This research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept.

    "This exciting collaboration will provide a unique opportunity to combine Genmab's innovative bispecific antibody technologies with Bolt's powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab's partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options."

    Randall Schatzman, Ph.D., Chief Executive Officer of Bolt, explained, "Our joint vision is to leverage Genmab's and Bolt's innovative technologies to develop a completely new type of ISAC with the aim to transform the way cancer is treated. Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients. We are delighted to be collaborating with the Genmab team and to have their deep expertise in discovering and developing bispecific antibodies brought to bear on this approach as we continue our mission to develop treatments that address key unmet needs for patients with cancer."

    Financial Terms

    Under the terms of the agreement, Genmab will pay Bolt an upfront payment of USD 10 million. Genmab will also make a USD 15 million equity investment in Bolt. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund pre-clinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.

    About Genmab

    Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab's proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Contacts for Genmab:

    For Media:

    Marisol Peron, Senior Vice President, Global Investor Relations & Communications

    T: +1 609 524 0065; E: mmp@genmab.com

    For Investor Relations:

    Andrew Carlsen, Vice President, Head of Investor Relations

    T: +45 3377 9558; E: acn@genmab.com

    Contacts for Bolt:

    For Media:

    Maggie Beller or David Schull, Russo Partners, LLC

    T: 646-942-5631, E: maggie.beller@russopartnersllc.com or david.schull@russopartnersllc.com

    For Investor Relations:

    Sarah McCabe, Stern Investor Relations, Inc.

    T: 212-362-1200, E: sarah.mccabe@sternir.com

    Genmab Forward-Looking Statements

    This Media Release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

    Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®.

    Bolt Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Genmab A/S to discover and develop therapeutics for the treatment of multiple types of cancer, our ability to develop multiple next-generation, immune-stimulatory conjugate therapeutics with Genmab A/S, the achievement of milestone payments or any tiered royalties, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended March 31, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.



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  6. – Strong cash position of $302.9 million as of March 31, 2021 expected to deliver key value-creating milestones and fund operations into 2023 –

    – Upsized IPO in February 2021 raised $264.5 million in gross proceeds –

    – Lead program, BDC-1001, Phase 1/2 trial advancing on track with trial and data update expected in 2H21 –

    REDWOOD CITY, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business highlights…

    – Strong cash position of $302.9 million as of March 31, 2021 expected to deliver key value-creating milestones and fund operations into 2023 –

    – Upsized IPO in February 2021 raised $264.5 million in gross proceeds –

    – Lead program, BDC-1001, Phase 1/2 trial advancing on track with trial and data update expected in 2H21 –

    REDWOOD CITY, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business highlights.

    "Our successful IPO in the first quarter of 2021 places us in a position of strength to deliver on value-creating milestones in 2021 and 2022. We continue to advance our Phase 1/2 trial for our lead candidate, BDC-1001, for the treatment of patients with HER2-expressing solid tumors. We look forward to completing the monotherapy dose escalation and initiating the monotherapy Phase 2 dose expansion cohorts as well as the evaluation of combining BDC-1001 with an anti-PD-1 antibody later in 2021," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Beyond BDC-1001, we continue to advance our pipeline and are on track to initiate clinical trials for CEA-targeted ISAC BDC-2034 in 2022 and we expect to designate our third clinical candidate later this year."

    Recent Business Highlights and Anticipated Milestones

    • Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, which is expected to fund operations into 2023 – Bolt is well positioned to continue to drive growth across the company and advance the pipeline through key milestones, with cash to fund operations into 2023.



    • Completed upsized Initial Public Offering in February 2021 – In February 2021, Bolt completed its Initial Public Offering (IPO) of 13,225,000 shares of common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares, at a public offering price of $20.00 per share. Gross proceeds from the IPO were approximately $264.5 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $242.0 million.



    • Presented on the HER2-targeting Boltbody™ ISAC BDC-1001 in the "New Drugs on the Horizon" symposium and in a trial-in-progress poster in April at the American Association for Cancer Research (AACR) Virtual Annual Meeting



      • At AACR's New Drugs on the Horizon symposium, Bolt's Chief Scientific Officer David Dornan, Ph.D. presented key data-driven decisions made during the development of Bolt's lead program, BDC-1001, a novel HER2-targeting ISAC. Dr. Dornan's presentation included a discussion of immunosuppression mediated by various cells in the tumor microenvironment (TME), as well as the tumor-supportive nature of antigen presenting cells (APCs) in the TME in preclinical models. Reawakening these immunosuppressed APCs can result in a productive and durable anti-tumor immune response, as evidenced by BDC-1001 achieving complete tumor regression in preclinical tumor models.
      • A Trial in Progress poster was also presented at AACR by Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt's ongoing BDC-1001 Phase 1/2 trial. The poster detailed the design of the four-part study evaluating BDC-1001 administered intravenously with or without an immune checkpoint inhibitor targeting PD-1 in up to 390 patients with HER2-expressing or HER2-amplified advanced or metastatic solid tumors. The dose escalation parts will evaluate sequential doses of BDC-1001 as a monotherapy or in combination with a PD-1 checkpoint inhibitor in a 3+3 design, with the ability to backfill up to a total of 15 patients in each dose cohort. The dose expansion parts will evaluate the recommended Phase 2 dose as monotherapy or in combination with a PD-1 checkpoint inhibitor in four cohorts of patients. Bolt expects to provide a further update on the trial sometime in the second half of 2021.

    Upcoming Events

    • At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt's ongoing BDC-1001 Phase 1/2 trial will present a poster entitled "Preliminary results from a Phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors." This poster will provide more details on the initial 20 patients treated with BDC-1001, as of the initial data cutoff date of January 29, 2021.

    First Quarter 2021 Financial Results

    Cash Position – Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, compared to $22.8 million as of December 31, 2020. Bolt expects its cash balance to fund operations into 2023.

    Research and Development (R&D) Expenses – R&D expenses were $14.1 million for the quarter ended March 31, 2021, compared to $6.8 million for the same quarter in 2020. The increase in R&D spending in the comparative periods was due primarily to increased manufacturing of BDC-1001 and BDC-2034 (CEA-targeting Boltbody ISAC program), increased personnel-related expenses due to additional hiring and increased facility-related expenses and outside services.

    General and Administrative (G&A) Expenses – G&A expenses were $4.3 million for the quarter ended March 31, 2021, compared to $2.1 million for the same quarter in 2020. The increase in G&A spending in the comparative periods was due primarily to increased personnel-related expenses due to additional hiring and increased accounting and legal fees associated with the Company's Initial Public Offering which was completed in February 2021.

    Loss from Operations – Loss from operations was $24.5 million for the quarter ended March 31, 2021 compared to $8.6 million for the same quarter in 2020.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our clinical trials, the achievement of certain milestones in 2021 and 2022, the timing of enrollment for our Phase 1/2 trial for BDC-1001 for the treatment of patients with HER2-expressing solid tumors, the timing of our Phase 2 dose expansion part and the combination with an anti-PD-1 antibody part, the initiation of our monotherapy Phase 2 dose expansion cohorts, the timing of designating additional clinical candidates, the timing that Boltbody ISAC BDC-2034 will enter clinical trials, our ability to fund our clinical programs and the sufficiency of our cash, cash equivalents, and marketable securities to fund operations into 2023, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the three months ended March 31, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.





    BOLT BIOTHERAPEUTICS, INC.


    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited, in thousands, except share and per share amounts)

      Three Months Ended March 31, 
      2021

     2020

    Collaboration revenue $  $164 
    Operating expenses:        
    Research and development  14,127   6,787 
    General and administrative  4,299   2,122 
    Total operating expense  18,426   8,909 
    Loss from operations  (18,426)  (8,745)
    Other income (expense), net        
    Interest income, net  56   112 
    Change in fair value of preferred stock right liability  (6,084)   
    Total other income (expense), net  (6,028)  112 
    Net loss  (24,454)  (8,633)
    Net unrealized loss on marketable securities  (64)  (10)
    Comprehensive loss $(24,518) $(8,643)
    Net loss per share, basic and diluted $(1.14) $(4.16)
    Weighted-average shares outstanding, basic and diluted  21,498,306   2,077,365 







    BOLT BIOTHERAPEUTICS, INC.


    CONDENSED BALANCE SHEETS

    (Unaudited, in thousands)

      March 31,

     December 31,

      2021

     2020

    Assets      
    Current assets:        
    Cash and cash equivalents $95,481  $5,542 
    Short-term investments  171,188   17,296 
    Prepaid expenses and other current assets  4,541   2,523 
    Total current assets  271,210   25,361 
    Property and equipment, net  3,910   4,083 
    Operating lease right-of-use assets  11,478   12,267 
    Finance lease right-of-use assets  30   34 
    Restricted cash  1,565   1,565 
    Deferred offering costs     2,357 
    Long-term investments  36,236    
    Other assets  208   875 
    Total assets $324,637  $46,542 
    Liabilities, convertible preferred stock, and stockholders' equity (deficit)        
    Current liabilities:        
    Accounts payable $2,888  $1,598 
    Accrued expenses and other current liabilities  5,994   6,663 
    Deferred revenue  1,502   1,502 
    Operating lease liabilities  1,628   1,501 
    Total current liabilities  12,012   11,264 
    Operating lease liabilities, net of current portion  9,056   9,376 
    Convertible preferred stock purchase right liability, non-current     25,224 
    Other long-term liabilities  321   329 
    Total liabilities  21,389   46,193 
    Commitments and contingencies        
    Convertible preferred stock     105,296 
    Stockholders' equity (deficit):        
    Common stock      
    Additional paid-in capital  436,165   3,452 
    Accumulated other comprehensive income  (64)   
    Accumulated deficit  (132,853)  (108,399)
    Total stockholders' equity (deficit):  303,248   (104,947)
    Total liabilities, convertible preferred stock, and stockholders' equity (deficit) $324,637  $46,542 







    BOLT BIOTHERAPEUTICS, INC.


    CONDENSED STATEMENTS OF CASH FLOWS

    (Unaudited, in thousands)

      Three Months Ended March 31, 
      2021

     2020

    CASH FLOWS FROM OPERATING ACTIVITIES:        
    Net loss $(24,454) $(8,633)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Depreciation and amortization  272   101 
    Stock-based compensation expense  2,109   225 
    Accretion of premium/discount on marketable securities  335   (23)
    Unrealized loss on marketable securities, net  (64)  (10)
    Change in fair value of convertible preferred stock purchase rights liabilities  6,084    
    Non-cash lease expense  530   426 
    Changes in operating assets and liabilities:        
    Prepaid expenses and other assets  (1,351)  33 
    Accounts payable and accrued expenses  (88)  (540)
    Operating lease liabilities  66   (1,223)
    Deferred revenue     (2)
    Other long-term liabilities  2   8 
    Net cash used in operating activities  (16,559)  (9,638)
    CASH FLOWS FROM INVESTING ACTIVITIES:        
    Purchase of property and equipment  (58)  (373)
    Purchases of marketable securities  (198,069)  (13,235)
    Maturities of marketable securities  7,606    
    Net cash used in investing activities  (190,521)  (13,608)
    CASH FLOWS FROM FINANCING ACTIVITIES:        
    Proceeds from issuance of preferred stock, net of issuance cost  51,902    
    Proceeds from initial public offering, net of issuance cost  244,988    
    Proceeds from issuance of common stock  129   34 
    Net cash provided by financing activities  297,019   34 
    Net increase (decrease) in cash  89,939   (23,212)
    Cash, cash equivalents and restricted cash at beginning of year  7,107   35,410 
    Cash, cash equivalents and restricted cash at end of period $97,046  $12,198 
    Reconciliation of cash, cash equivalents and restricted cash:        
    Cash and cash equivalents $95,481  $11,614 
    Restricted cash  1,565   584 
    Total cash, cash equivalents and restricted cash $97,046  $12,198 
    Supplemental schedule of non-cash investing and financing activities:        
    Vesting of early exercised options $10  $5 
    Purchases of property and equipment included in accounts payable and accrued liabilities $37  $17 
    Deferred offering costs in accounts payable and accrued liabilities $672  $ 
    Right of use assets obtained in exchange for operating lease obligations $  $254 

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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  7. REDWOOD CITY, Calif., April 10, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that an online oral presentation with live Q&A and a Trial in Progress poster presentation for lead agent BDC-1001 are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2021 being held virtually from April 10-15th.

    The oral presentation explores immunosuppression mediated by various cells in the tumor microenvironment (TME), as well as the tumor-supportive nature of antigen presenting cells…

    REDWOOD CITY, Calif., April 10, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that an online oral presentation with live Q&A and a Trial in Progress poster presentation for lead agent BDC-1001 are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2021 being held virtually from April 10-15th.

    The oral presentation explores immunosuppression mediated by various cells in the tumor microenvironment (TME), as well as the tumor-supportive nature of antigen presenting cells (APCs) in the TME in preclinical models. Reawakening these immunosuppressed APCs may result in a productive and durable anti-tumor immune response. Bolt is utilizing its Boltbody™ platform to create immune-stimulating antibody conjugates (ISACs), such as BDC-1001, that invoke this mechanism and provided complete tumor regression in preclinical tumor models.

    "In murine models we have seen efficacy in a variety of tumors that are immunologically cold and well-established. Furthermore, consistent with our proposed mechanism of action for ISACs, we see evidence of increased myeloid and T cell infiltration in the tumor microenvironment mediated by BDC-1001 surrogate ISACs," said David Dornan, Ph.D., Chief Scientific Officer at Bolt Biotherapeutics. "We're excited to share our rationale for selecting the linker-payload for BDC-1001 to optimize anti-tumor activity while minimizing the potential for the formation of anti-drug antibodies."

    BDC-1001 is comprised of a tumor antigen-targeting monoclonal antibody (mAb), a trastuzumab biosimilar and an immune-stimulating agent (a TLR7/8 agonist) conjugated to each other with a non-cleavable linker. In a series of preclinical studies with BDC-1001, Bolt demonstrated the mechanism of action for their HER2-targeted ISAC. BDC-1001 surrogate was able to eliminate established, treatment-resistant tumors through the engagement of both innate and adaptive immunity. There were no adverse findings in toxicology studies of BDC-1001.

    A Trial in Progress poster is also being presented by Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt's ongoing BDC-1001 Phase 1/2 trial. The poster details the design of the study: a four-part study with two dose-escalation parts and two dose-expansion parts. The study is evaluating BDC-1001 administered intravenously with or without an immune checkpoint inhibitor targeting PD-1 in up to 390 patients with HER2-expressing or HER2-amplified advanced or metastatic solid tumors. The dose escalation parts will evaluate sequential doses of BDC-1001 as a monotherapy or in combination with a PD-1 checkpoint inhibitor in a 3+3 design, with the ability to backfill up to an additional 12 patients in each dose cohort. The dose expansion parts will evaluate the recommended Phase 2 dose as monotherapy or in combination with a PD-1 checkpoint inhibitor in four cohorts of patients.

    The primary objective of the dose escalation portion of the study is to assess safety as measured by the incidence of adverse events and serious adverse events; dose-limiting toxicities within the 3+3 design; and potential immune-related toxicities and determine the recommended phase 2 dose. Secondary objectives will evaluate pharmacokinetic parameters and pharmacodynamic biomarkers in tumor tissue and in peripheral blood associated with drug exposure. These exploratory studies will help reinforce the ISAC mechanism of action in humans and seek to identify biomarkers associated with BDC-1001 biological activity with or without an immune checkpoint inhibitor.

    In January, Bolt presented a preliminary clinical update on the first 20 patients that showed early signs of clinical activity, including stable disease in several patients and a confirmed partial response by RECIST, and acceptable safety with all 20 patients completing their dose-limiting toxicity (DLT) evaluation period without DLTs or drug-related serious adverse events. Treatment-emergent adverse events deemed to be related to BDC-1001 have been mild or moderate in severity, including mild infusion-related reactions without interruption to dosing. Bolt expects to provide an update on the trial sometime in the second half of 2021.

    About Bolt Biotherapeutics' Immune Stimulating Antibody Conjugate (ISAC) Platform Technology

    The Boltbody™ ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

    About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors

    The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1.

    For more information, visit https://www.boltbio.com/.

    Forward Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our clinical trials, the timing of enrollment for our Phase 1/2 trial for BDC-1001 for the treatment of patients with HER2-expressing solid tumors, the potential of BDC-1001's anti-tumor activity while minimizing the formation of anti-drug antibodies, the potential that APCs may result in a productive and durable anti-tumor immune response, and the prediction that Boltbody ISACs may translate into more durable clinical responses for patients. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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  8. REDWOOD CITY, Calif., April 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that Randall C. Schatzman, Ph.D., Chief Executive Officer, will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 AM ET.

    A live webcast of the presentation will be available on the Events and Presentations page of Bolt's website at www.boltbio.com. An archived replay will be available for 90 days following the event.

    About Bolt Biotherapeutics, Inc.
    Bolt Biotherapeutics…

    REDWOOD CITY, Calif., April 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that Randall C. Schatzman, Ph.D., Chief Executive Officer, will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 AM ET.

    A live webcast of the presentation will be available on the Events and Presentations page of Bolt's website at www.boltbio.com. An archived replay will be available for 90 days following the event.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists currently undergoing phase 1/2 clinical testing for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing an additional Boltbody ISAC product candidate targeting CEA (BDC-2034).

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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  9. – Upsized IPO in February 2021 raised $264.5 million in gross proceeds plus Series C raised $93.5 million for a total of $358 million in recent fundraising –

    – Advanced first-in-class Boltbody ISAC into the clinic in 2020 and continued to expand pipeline of pioneering immuno-oncology assets –

    – Reported positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody ISAC BDC-1001 in ongoing Phase 1/2 clinical trial in early 2021; monotherapy dose expansion and anti-PD-1 antibody combination parts of study expected to start in 2H, 2021 –

    REDWOOD CITY, Calif., March 31, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology…

    – Upsized IPO in February 2021 raised $264.5 million in gross proceeds plus Series C raised $93.5 million for a total of $358 million in recent fundraising –

    – Advanced first-in-class Boltbody ISAC into the clinic in 2020 and continued to expand pipeline of pioneering immuno-oncology assets –

    – Reported positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody ISAC BDC-1001 in ongoing Phase 1/2 clinical trial in early 2021; monotherapy dose expansion and anti-PD-1 antibody combination parts of study expected to start in 2H, 2021 –

    REDWOOD CITY, Calif., March 31, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent business highlights.

    "Our upsized Initial Public Offering, which we completed in February 2021, leaves us in a strong financial position to execute on our vision of developing this new class of immuno-oncology products to help patients. We continue to enroll patients in the dose escalation part of our Phase 1/2 trial for our lead candidate, BDC-1001, for the treatment of patients with HER2-expressing solid tumors. We reported preliminary clinical results from an initial 20 patients at a data cutoff of January 29, 2021, which demonstrated 4 patients with stable disease and one patient with a confirmed partial response. We're looking forward to completing the dose escalation and initiating both the monotherapy Phase 2 dose expansions part and the combination studies with an anti-PD-1 antibody part later in 2021," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "We continue to progress our broader pipeline of targeted immunotherapies derived from our Boltbody ISAC platform, a novel technology that can be applied across a diverse range of tumor targets and has the potential to enable cancer patients to generate immunological memory against their own tumors. We plan to advance our second Boltbody ISAC BDC-2034, which targets the cancer antigen CEA, into the clinic in 2022."

    Recent Business Highlights and Anticipated Milestones

    • Completed upsized Initial Public Offering in February 2021 – In February 2021, Bolt completed its Initial Public Offering (IPO) of 13,225,000 shares of common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares, at a public offering price of $20.00 per share. Gross proceeds from the IPO were $264.5 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $241.7 million.



    • Reported preliminary clinical results from the first 20 patients from the ongoing Phase 1/2 trial of lead candidate BDC-1001 for the treatment of patients with HER2-expressing solid tumors –BDC-1001 is a human epidermal growth factor receptor 2, or HER2, Boltbody Immune-Stimulating Antibody Conjugate (ISAC) comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists, for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors. A Phase 1/2 study evaluating BDC-1001 in patients with HER2-expressing cancers, which includes patients with breast and gastric cancers that are refractory to Herceptin® and Kadcyla®, as well as cancers for which no HER2-targeting therapies have yet been approved, is ongoing. Bolt is currently enrolling patients in the dose escalation portion of the trial. As of January 29, 2021, Bolt had treated 20 patients and BDC-1001 appeared to be well tolerated with mild to moderate adverse events and no dose-limiting toxicities or drug-related serious adverse events were observed. Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action. Later this year, Bolt plans to advance to part 3 of the trial, monotherapy Phase 2 dose expansion cohorts, and part 2, BDC-1001 dose escalation in combination with an anti-PD-1 antibody.



    • Strengthened Board of Directors with appointment of Kathleen LaPorte – In January 2021, Kathleen LaPorte joined the Board of Directors as Chair of Bolt's Audit Committee. Ms. LaPorte has more than 30 years of experience in building and operating private and public biotech companies as former chief executive officer of Nodality Inc. and a founding partner of New Leaf Venture Partners. The addition increased Bolt's board to eight members.



    • Published data in Nature Cancer highlighting proof of concept for Boltbody ISAC platform to eliminate tumors following systemic administration – In December 2020, Bolt announced the publication of a manuscript in Nature Cancer highlighting the development and use of Boltbody ISACs for the treatment of HER2-expressing tumors in preclinical models. The data indicate that Boltbody ISACs activate the innate and adaptive immune systems, ultimately resulting in complete tumor regressions in multiple tumor models and durable anti-tumor immunity. ISAC-mediated immunological memory extended beyond the target antigen as ISAC-treated mice were protected from re-challenge with the parental tumor lacking HER2 expression.



    • Completed an oversubscribed $93.5 million Series C financing with notable crossover investors – In July 2020 and January 2021, the Company raised funding to support BDC-1001 and continued development of the Boltbody ISAC platform and Bolt's pipeline of immuno-oncology programs. Sofinnova Investments led the investment, which included notable crossover investors RA Capital Management, Surveyor Capital (a Citadel Company), Rock Springs Capital and Samsara BioCapital.

    Upcoming Events

    • Bolt's Chief Scientific Officer David Dornan, Ph.D. will present a talk on BDC-1001 as part of "New Drugs on the Horizon: Part 2" at the American Association for Cancer Research (AACR) Virtual Annual Meeting on Saturday, April 10, 2021, from 4:00 PM - 5:45 PM ET.



    • Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt's ongoing BDC-1001 Phase 1/2 trial, will present a trial-in-progress e-poster entitled "CT218 - Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001" in the session "PO.CT08.01 - Phase I Clinical Trials in Progress" at AACR on Saturday, April 10, 2021, from 8:30 AM - 11:59 PM ET.



    • Bolt's CEO, Randall Schatzman, Ph.D., will present a corporate overview at the virtual 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 AM ET.

    Fourth Quarter and Full Year 2020 Financial Results

    Cash Position – Cash, cash equivalents, and marketable securities were $22.8 million as of December 31, 2020, as compared to $34.8 million as of December 31, 2019. Total cash, cash equivalents, and marketable securities at December 31, 2020 does not include total net proceeds of approximately $293.6 million from Bolt's C-2 convertible preferred stock offering in January 2021 and its IPO in February 2021. Bolt expects its cash balance to fund operations into 2023, through achievement of key milestone for the BDC-1001 and BDC-2034 programs.

    Research and Development (R&D) Expenses – R&D expenses were $14.9 million for the quarter and $40.4 million for the full year ended December 31, 2020, compared to $7.4 million and $26.0 million for the same quarter and year in 2019. The increase in R&D spending from 2019 to 2020 is due primarily to the 2020 start of Bolt's Phase 1/2 clinical trial for BDC-1001, increased manufacturing of BDC-1001 to support the clinical trial and additional hiring.

    General and Administrative (G&A) Expenses – G&A expenses were $2.1 million for the quarter and $9.1 million for the full year ended December 31, 2020, compared to $2.1 million and $5.2 million for the same quarter and year in 2019. The increase in G&A spending from 2019 to 2020 is due primarily to an increase in accounting and legal fees associated with IPO preparation and additional hiring to support operations as a public company.

    Loss from Operations – Loss from operations was $16.9 million for the quarter and $49.2 million for the full year ended December 31, 2020 compared to $9.5 million and $31.0 million for the same quarter and year in 2019.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems. Bolt's proprietary Boltbody Immune-stimulating Antibody Conjugate (ISAC) approach combines an antibody that targets a tumor antigen with an immune stimulant that triggers an innate and adaptive immune response in the tumor microenvironment. These systemically-delivered Boltbody ISACs are designed to target tumor cells for elimination by myeloid cells, which are then activated and recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our clinical trials, the timing of enrollment for our Phase 1/2 trial for BDC-1001 for the treatment of patients with HER2-expressing solid tumors, the timing of our Phase 2 dose expansion part and the combination with an anti-PD-1 antibody part, the timing that Boltbody ISAC BDC-2034 will enter clinical trials, our ability to fund our clinical programs and the sufficiency of our cash, cash equivalents, and marketable securities, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

     
    BOLT BIOTHERAPEUTICS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except share and per share amounts)

     
     For the three months ended

     For the years ended

     December 31,

     December 31,

     2020 2019 2020 2019

    Collaboration Revenue$  $65  $231  $215 
    Operating expenses:               
    Research and development 14,864   7,435   40,357   26,002 
    General and administrative 2,058   2,137   9,056   5,182 
    Total operating expense 16,922   9,572   49,413   31,184 
    Loss from operations (16,922)  (9,507)  (49,182)  (30,969)
    Other income (expense), net               
    Interest income, net 12   145   199   524 
    Change in fair value of preferred stock right liability (14,125)     (11,745)  (42)
    Total other income (expense), net (14,113)  145   (11,546)  482 
    Net loss and comprehensive loss$(31,035) $(9,362) $(60,728) $(30,487)
    Net loss per share, basic and diluted$(14.58) $(4.55) $(28.89) $(15.29)
    Weighted-average shares outstanding, basic and diluted 2,129,133   2,056,459   2,102,328   1,993,477 
                    



     
    BOLT BIOTHERAPEUTICS, INC.

    BALANCE SHEETS

    (in thousands, except share and per share amounts)

     
     December 31,

     2020 2019
    Assets      
    Current assets:      
    Cash and cash equivalents$5,542  $34,826 
    Short-term investments 17,296    
    Prepaid and other current assets 2,523   1,074 
    Total current assets 25,361   35,900 
    Property and equipment, net 4,083   1,387 
    Operating lease right-of-use asset 12,267   10,079 
    Finance lease right-of-use asset 34   51 
    Restricted cash 1,565   584 
    Deferred offering costs 2,357    
    Other assets 875   446 
    Total assets$46,542  $48,447 
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)      
    Current liabilities:      
    Accounts payable$1,598  $2,095 
    Accrued expenses and other current liabilities 6,663   2,866 
    Deferred revenue 1,502   599 
    Operating lease liabilities 1,501   3,096 
    Total current liabilities 11,264   8,656 
    Operating lease liabilities, net of current portion 9,376   7,089 
    Deferred revenue    972 
    Convertible preferred stock purchase right liability, non-current 25,224    
    Other Long-term liabilities 329   71 
    Total liabilities 46,193   16,788 
    Convertible preferred stock 105,296   77,505 
    Stockholders' equity (deficit)      
    Common stock     
    Additional paid-in capital 3,452   1,825 
    Accumulated deficit (108,399)  (47,671)
           
    Total stockholders' equity (deficit) (104,947)  (45,846)
    Total liabilities. convertible preferred stock and stockholders' equity (deficit)$46,542  $48,447 
           



     
    BOLT BIOTHERAPEUTICS, INC.

    STATEMENTS OF CASH FLOWS

    (in thousands)

     
     Years Ended December 31,
     2020 2019
    Cash flows from operating activities       
    Net loss$(60,728) $(30,487)
    Adjustments to reconcile net loss to net cash used in operating activities:       
    Depreciation and amortization 611   335 
    Stock-based compensation 1,420   508 
    Accretion of premium/discount on short-term investments 34    
    Change in fair value of convertible preferred stock purchase right liabilities 11,745   42 
    Non-cash lease expense 1,893   994 
    Changes in operating assets and liabilities:       
    Prepaid expenses and other assets (1,878)  (620)
    Accounts payable and accrued expenses 2,882   2,121 
    Operating lease liabilities (3,389)  (823)
    Deferred revenue (69)  1,571 
    Other long-term liabilities 171   16 
    Net cash used in operating activities (47,308)  (26,343)
    Cash flows from investing activities       
    Purchase of property and equipment (3,262)  (508)
    Purchases of short-term investments (33,229)   
    Maturities of short-term investments 15,899    
    Net cash used in investing activities (20,592)  (508)
    Cash flows from financing activities       
    Repayments of financing lease obligations    (40)
    Proceeds from issuance of convertible preferred stock, purchase rights and warrants, net of issuance costs 41,270   48,595 
    Payments of deferred offering costs (1,967)   
    Proceeds from issuance of common stock and warrants 294   72 
    Net cash provided by financing activities 39,597   48,627 
    Net (decrease) increase in cash, cash equivalents and restricted cash (28,303)  21,776 
    Cash, cash equivalents and restricted cash at beginning of year 35,410   13,634 
    Cash, cash equivalents and restricted cash at end of year$7,107  $35,410 
    Reconciliation of cash, cash equivalents and restricted cash:       
    Cash and cash equivalents$5,542  $34,826 
    Restricted cash 1,565   584 
    Total cash, cash equivalents and restricted cash$7,107  $35,410 
            

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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  10. REDWOOD CITY, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage immuno-oncology company, announced today the closing of its initial public offering of 13,225,000 shares of its common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares of common stock, at a price to the public of $20.00 per share. The shares are listed for trading on The Nasdaq Global Select Market under the ticker symbol "BOLT".

    Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities acted as joint bookrunners for the offering.

    The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from Morgan Stanley…

    REDWOOD CITY, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage immuno-oncology company, announced today the closing of its initial public offering of 13,225,000 shares of its common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares of common stock, at a price to the public of $20.00 per share. The shares are listed for trading on The Nasdaq Global Select Market under the ticker symbol "BOLT".

    Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities acted as joint bookrunners for the offering.

    The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105 or by email at syndicate@svbleerink.com.

    Registration statements relating to these securities have been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. ("Bolt") is a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1.

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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  11. REDWOOD CITY, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage immuno-oncology company, announced today the pricing of its upsized initial public offering of 11,500,000 shares of common stock at a price to the public of $20.00 per share. In addition, Bolt has granted the underwriters a 30-day option to purchase up to an additional 1,725,000 shares of common stock solely to cover over-allotments, if any, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the symbol "BOLT" on February 5, 2021.

    Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities are acting as joint bookrunners…

    REDWOOD CITY, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage immuno-oncology company, announced today the pricing of its upsized initial public offering of 11,500,000 shares of common stock at a price to the public of $20.00 per share. In addition, Bolt has granted the underwriters a 30-day option to purchase up to an additional 1,725,000 shares of common stock solely to cover over-allotments, if any, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the symbol "BOLT" on February 5, 2021.

    Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities are acting as joint bookrunners for the offering.

    The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105 or by email at syndicate@svbleerink.com.

    Registration statements relating to these securities have been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 

    Media Contacts:

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com

    Investor Relations Contact:

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com



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